Research Policy Handbook (Complete)

0. What's New in the RPH?

0.1 Updates, Additions, Deletions and Publishing

1. How to Publish, Update and Archive Policies in the RPH

The Office of the Vice Provost and Dean of Research is responsible publishing of all policies in the Research Policy Handbook on the DoResearch website. Individual organizations such as the Academic Senate, Dean of Research, EH&S etc.  are responsible for the approval, creation, maintenance and archiving of individual policies. Please contact Patti McCabe if you need to publish a new policy or revise an existing policy.  

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2. Updates, Additions, Deletions to the RPH

 

 

RPH

Date

Description

10.3 Postdoctoral Scholars

 

Updated Attachment A, deleted section on appealing to the president. The appeal process will now only go as far as the Provost

4.7 Institutional COI in Research Involving Human Subjects

2/26/20

Modify language about the composition of ICOIC members.

2.1 PI Eligibility

12/17/19

Administrative update to add research rank to SLAC exception.

10.1 Policy and Procedures for Appointment and Promotion: Academic Staff - Research

8/29/2019

New title of policy, clarified the Visiting Student Researcher policy, substantial change in organization and text.

2.1 PI Eligibility

5/22/19

Update to clarify language in expanded career development award section.

13.8 Post Doctoral Scholars

3/1/2019

Updates resources in Attachment A

13.4 Establishment of Industrial Affiliates and Related Membership-Supported Programs

2/11/2019

Updates section 2. 2 Company Engagement

1.10 Information Security

01/16/19

This policy articulates security practices and guidelines for research computing systems.

10.1 Academic Staff-Research

10/23/18

Update to affirmative action statement for job postings, per Office of General Counsel.

4.1 Faculty COI Policy

10/18/18

Update to clarify U.S. government service in relation to outside activities

4.3 Faculty Consulting Policy

10/18/18

Update to clarify faculty must disclose outside activities related to foreign entities.

5.4

Use of Human Subjects in Student Projects, Pilot Studies, Oral Histories and QA/QI Projects

 

10/8/2018

Updated section 5, primarily administrative updates

10.1

Academic Staff-Research

9/6/18

Added clarifying sentence about dual appointments for teaching and research activities

13.6

Memoranda of Understanding and Letters of Intent

8/20/2018

Clarification about policy added to About Section: This policy does not apply to sponsor funding announcements that require a Letter of Intent with a project description for the sponsor to review and determine which investigators will be invited to submit a full proposal.  These types of LOIs are allowable and do not require special approval.

13.6

Memoranda of Understanding and Letters of Intent

8/6/2018

New Policy on Memoranda and Letters of Intent

10.2

Academic Staff Grievance Policy

7/24/18

Updated contact information

10.1

Policy and Procedures for Academic Staff-Research Appointments

7/23/18

Updates for grammar, insert reminders about when research appointments required and COI policy, update supplemental comp language, insert related items links

3.1 

Preparation and Submission of Proposal Budgets

6/4/2018

Updated in paragraph 3.1.4  the sentence "Research-only faculty on 12-month appointments may typically charge up to 95% to sponsored projects year round (Adding) and must reserve a minimum of 5% effort for non-sponsored activities.

10.3 

Postdoctoral Scholars

 

5/31/2018

Updated two forms in Section 2, paragraph G;  a request from the PI form and a training plan from the scholar form.

3.1 

Preparation and Submission of Proposal Budgets

5/16/2018

Updated paragraph 3.1.4 to include the School of Medicine's (SOM) long standing policy on effort (applicable only to SOM faculty) and for clarifying what is meant by ‘research activities’.

10.6

 Relationship Between Students and Outside Entities

5/10/2018

Updated policy to address that students must follow the same policy as faculty.

2.1 

Principal Investigator Eligibility and Criteria for Exceptions

5/8/2018

Update policy to continue indefinitely the expanded career development award exceptions for selected School of Medicine clinical fellows and postdoctoral fellows.

4.3 

Consulting and Other Outside Professional Activities by Faculty

5/4/2018

Added clarifying language on the use of titles by faculty involved in outside activities.

4.1 

Faculty Policy on Conflict of Commitment and Interest

5/4/2018

Added clarifying language on the use of titles by faculty involved in outside activities.

3.2

Management of Project Expenditures

2/22/2018

Added to section 5. responsibilities if the PI of an on-going sponsored project will not be engaged in the project for a period of three months or more with regards to PI review and certification. 

3.2 

Management of Project Expenditures

 

1/23/2018

Has been updated to align with the new eCertification System.

13.2

 Categories of Sponsored Projects

1/18/2018

Updated to provide updated definition of University Research for the purpose of making the definition clearer. Please see the updated definition and the new checklist in order to determine whether research funding is university research or departmental research.

10.3 

Post Doctoral Scholars

1/11/2018

Section 2, Terms of Appointment, add a new section, entitled “H. Early Termination by Appointing Department”.

 

10.3

Post Doctoral Scholars

11/17/2017

Added to Attachment B. "Stanford files employment-based visa petitions only on behalf of beneficiaries receiving 100% of the support described in their offer letter as income reportable on a W-2 document.”

15.9

Program Income

10/26/2017

New RPH Policy on Program Income. The policy defines Program Income and describes how to account for it.

13.3

 Specialized Categories of Sponsored Projects

 

8/25/2017

Updated definition of Industry Sponsored Clinical Trials

9.2

Copyright Policy

8/3/2017

Deleted teaching and/or and scholarship in Paragraph 2c. Patent and Copyright Agreement: SU-18

5.2

Federal-wide Assurance for Protection of Human Subjects

 

 

 

7/26/2017

Updated the Veteran's Administration Palo Alto Health Care System Federal-wide Assurance expiration date to 7/18/2022.

RPH 3.2

Management of Project Expenditures

5/25/2017

Deleted reference to Annual Payroll Distribution Certification as this is not required in CY 17.

RPH 8.7

Recordkeeping Requirements (Export Controls)

4/19/2017

House keeping updates and deletion of statement: Furthermore, each original Stanford Certification must be provided to the Office of the Dean of Research.”Statement predates electronic submission of Stanford export certifications, obviating physical submissions to DoR."

 

RPH 8.4

Accepting a Third Party’s Export Controlled Items or Information

4/6/2017

Edited for readability.

RPH 8.3

Export Licenses for Overseas Shipments

4/6/2017

Edited for readability.

RPH 8.1

Applicability and Policy Background, and Regulatory Authority

4/6/2017

Edited for readability.

RPH 5.7

Training in the Protection of Human Subjects in Research

2/24/2017

Revision to policy to include Good Clinical Practice Training. Stanford University has determined Good Clinical Practice training will apply to all human subjects clinical trials regardless of funding source. This includes sponsored projects funded by external sponsors and non-sponsored projects funded with department or gift funding.

RPH 7.10

 

Operation of Unmanned Flying Vehicles

1/24/2017

Updated UFV Application Form (current date 10/25/2016)

RPH 10.9

Visiting Postdoctoral Scholars

11/4/2016

This new policy sets forth policies and procedures related to the appointment, roles, requirements and responsibilities of Visiting Postdoctoral Scholars at Stanford.

RPH 15.8

Cost Transfer Policy for Sponsored Research

11/1/2016

Small changes, most notable: added non-capital ET changes in same award as exception, added refunds and credits as exception.

SECTION 4B (Documentation): a. Quantified “large transfers” b. Added additional documentation requirements for large, late or early/late transfers c. Added examples of acceptable documentation for these transfers (BI and FFIT reports)  

RPH 10.1

Policy and Procedures for Appointment and Promotion: Academic Staff - Research

9/29/2016

Update title for Academic Staff and other administrative changes.

RPH 10.3

Postdoctoral Scholars

7/26/2016

Medical Insurance: changed PPO Plans to Aetna Choice POS II.  Updated Life and Accidental Death Insurance from $20,000 to $50,000 in both places in section

RPH 3.1

Submission of Proposal Budgets

7/15/2016

Changed title to Preparation and Submission of Proposal Budgets from Preparation and Submission of Proposed Budgets. Added requirement for those with University Research be required to take PI Training. Updated cost sharing section to be consistent with the Cost Sharing Policy

RPH 3.2

 Management of Project Expenditures

7/15/2016

Updated Section 3 SBS to exclude honorarium (effective CY2015) and vacation accrual to be consistent with annual payroll certification. Updated certification to include the use of the OBI 149 Report. 

RPH 4.7

Institutional Conflict of Interest in Research Involving Human Subjects

4/26/2016

Added to Section 3.A 3   2) that clinical trial research ends at Stanford, [ and or when the license is terminated, or the product which was the subject of the clinical trial is no longer being developed by a licensee/sublicensee.

RPH 1.4

Openness in Research

4/14/2016

Updated & Approved by the Academic Senate Addressed the transition from the document being about "non-secrecy" to "openness". Updated section 4.b to reflect modern National Security Controls and made grammatical corrections.

RPH 13.1

Gift vs. Sponsored Projects and Distinctions from Other Forms of Funding

4/08/2016

 

Updated Title to better reflect policy content.

1. The period of performance and return of unspent funds are no longer by themselves an indication that funding must be accepted as a sponsored project.

2. Attachment A. to RPH 13.1, Determining Whether Funding is a Gift or Sponsored Project has been updated to reflect the new Gift or Sponsored Project Screening Questions in the Gift Transmittal System.    

RPH 15.2

Indirect  (F&A) Cost Waivers

4/04/2106

Changed Title to reflect the Uniform Guidance name for Indirect Cost.

RPH 10.7

Procedures for Appointing Visiting Student Researchers

4/04/2016

Added to Paragraph 2. Enrollment Status, or audit to the following sentence. Persons registered in the VSR category are not permitted to enroll in or audit any classes.

RPH 10.3

Postdoctoral Scholars

3/08/2016

A five year term limit policy (extended from the previous four year limit) for postdoctoral scholars was approved by the university.

RPH 5.4

Use of Human Subjects in Student Projects, Pilot Studies, Oral Histories and QA/QI Projects

1/25/2106

Updated determination of Human Subject Research application document.

RPH 10.7

Procedures for Appointing Visiting Student Researchers

1/25/2016

Clarified how clarify how Visiting Student Researchers can and cannot be paid.

RPH 5.2

Federal-wide Assurance for Protection of Human Subjects

1/13/2016

Updated the  Federal Wide Assurance (FWA) document for LPCH. The new expiration date is 12/20/2020.

RPH 15.2 

Facilities and Administrative (Indirect) Cost Waivers

12/10/2015

Updated procedure so outside of the School of Medicine, indirect (F&A) cost waiver requests can be launched from the budget page of the PDRF (Proposal and Development Routing Form) in SeRA.

RPH 18.4

Confidentiality of Administrative Panel Proceedings

9/02/2015

Updated annual reports to go to the Vice Provost and Dean of Research.

RPH 18.3

Administrative Panels for Research Compliance

 

9/02/2015

Updated reporting from the President to the Vice Provost and Dean of Research.

RPH 15. 8

Cost Transfers

7/23/2015

Added to section 4. b The allocation methodology used if transferring expenses to multiple PTAs.

RPH 10.3

 Post Doctoral Scholars

7/20/2015

Updated section Attachment D. 3.A. Sick Leave to comply with the new State of CA  sick time law (AB1552) which is applicable to some postdocs.

RPH 18.3

Administrative Panels for Research Compliance

6/23/2015

Updated Section 3. based on a AAHRPP accreditation.

RPH 10.3 

Post Doctoral Scholars

6/20/2015

Update Benefits information deleting Blue Shield EPO. This plan was replaced with Stanford Healthcare Alliance (SHCA).

RPH 16.4

Subrecipient Monitoring

6/16/2015

Updated section 5.3 to include PI signature requirement and required language effective September 1, 2015.

RPH Chapter 16

Subawards

3/27/2015

Updated to include references to the Uniform Guidance.

RPH 14.1

Preparation, Review, and Submission of Sponsored Project Proposals

3/26/2015

Revised information on the proposal submission deadline.

RPH 2.1

Principal Investigator Eligibility and Criteria for Exceptions

2/19/2015

The Senate of the Academic Council approved a policy to allow the director of SLAC to approve SLAC distinguished and senior staff scientists to be principal investigators (PIs) on non-Department of Energy-funded research proposals.

RPH 2.1

Principal Investigator Eligibility and Criteria for Exceptions

2/09/2015

¶P 2. A. 4 Pending Appointments for New Faculty

Faculty whose appointment start date is in the future may apply for proposals but an award cannot be accepted until the appointment has begun.

RPH 3.1

Preparation and Submission of  Proposed Budgets

 

2/09/2015

¶P 3. A. Voluntary Cost Sharing

Propose cost sharing on federal proposals with the understanding it will not be part of the merit review unless stated in the solicitation.

¶P6. Budget Justification

Propose administrative/clerical salaries that are integral to the project and detail benefit in the budget justification.

RPH 3.3

Special Requirements Related to Sponsor Notifications and Prior Approvals

2/09/2015

¶P 1. A Changes in PI Status

Recognizes that a PI can be absent from campus and remain engaged in the project

RPH 14.1

Preparation, Review, and Submission of Sponsored Project Proposals

 

 

 

2/09/2015

¶P 2. Submitting Proposals

Added information about the SOM Policy on proposal submission timeline.

¶P 2 B. Budget Justifications

Propose administrative/clerical salaries that are integral to the project and detail benefit in the budget justification.

RPH 14.2

Academic Policies Pertaining to Sponsored Project Proposals

 

 

2/09/2015

¶P 4. Presence at Stanford

Recognizes that a PI can be absent from campus and remain engaged in the project.

RPH 14.3

University Commitments Pertaining to Sponsored Project Proposals

 

2/09/2015

¶P 5. Participation by Faculty or Staff from Multiple Departments

Deleted entire paragraph requiring the Department Head and Dean's Office must approve participation of faculty or staff in sponsored projects outside their own academic department or School via the PDRF.

RPH 15.1

Facilities & Administrative (Indirect Cost) and Fringe Benefits Rates

 

2/09/2015

¶P 3.MTDC

MTDC is the base to which F&A (indirect cost) rates are applied. The Uniform Guidance now excludes participant support costs from the MTDC base. Participation support cost are not subject to F&A costs for federal projects. Non- federal projects participant support costs are subject to F&A. Once an award is made use expenditure type 52436 for participant support costs for all sponsored projects awarded on or after December 26, 2014 that are subject to the Uniform Guidance.

RPH 15. 3

Cost Sharing Policy

 

2/09/2015

¶P 1. C. Voluntary Cost Sharing

Cost sharing on federal proposals will not be a factor during the merit review of a proposal except when allowed in the program announcement.

¶P 3. B  Facilities and Administrative Costs (Indirect Costs)

For federal awards, unrecovered indirect costs on cost sharing may be included as part of cost sharing only with prior approval of the federal sponsoring agency.

¶P 5. Source of Funds for Cost-Shared Expenditures

In the School of Medicine, neither operating budget nor designated clinic accounts can be used for this purpose.

RPH 15.4 

Charging for Administrative and Technical Expenses

 

2/11/2015

¶P 3.  Uniform Guidance Implementation

Follows the Uniform Guidance concept administrative salaries that are integral to the project.

4. OMB Circular A-21  Implementation

Follows the A-21 concept of major project or activity.

RPH 1.2

Rights and Responsibilities in the Conduct of Research

12/15/2014

Updates section 4, Proposal Preparation 

RPH 3.2 

Fiscal Responsibilities of the PI: Management of Project Expenditures

12/15/2014

Updates section 8, Charging Proposal Expenses to Ongoing Projects

RPH 13.4 

Establishment of Industrial Affiliates and Related Membership-Supported Programs

9/23/2014

The changes clarify Affiliate Program policies, particularly in the area of the minimum requirements for website content.  A new requirement is that, in order to remain active, affiliates programs must submit a form each year with information about program operations. The Industrial Affiliates Program Approval and Renewal Form must be filled in, signed and emailed ICO by October 15 of each  year, beginning October 15, 2014.  Programs in compliance with the policies will be approved for active operations in the subsequent fiscal year.

RPH 5.2 

Federal-Wide Assurance for Protection of Human Subjects

8/06/2014

Changed to accommodate the name change of the VA’s Palo Alto Institute for Research and Education (PAIRE) to Palo Alto Veterans Institute for Research (PAVIR). Also update PAVIR Assurance.

 

RPH 3.2

Management of Project Expenditures

3/31/2014

Updated to include the new requirement for Annual Payroll Distribution review and certification

RPH 15.5

Salary Cap Administration

2/11/2014

Updated to include the FY 2014 NIH Salary cap ($181,500)

RPH 4.7 

Institutional Conflict of Interest in Research Involving Human Subjects

2/07/2014

Updated key elements

RPH 3.2

Management of Sponsored Projects

10/16/2013

Changes review requirement for expenditure statement (RM 149) to quarterly

RPH 9.2 

Attachment A to  Statement on Teaching and Outside Activities

10/01/2013

Provides guidance to the university  in the areas of educational technology and its use both on-campus and off.

RPH 4.2 

PHS and NSF Requirements Regarding Financial Disclosures and Agency Notifications

10/01/2013

Institutional Review of COI disclosures, requirements for the University tp provide information to the NIH

RPH 4.1

Attachment B 

Faculty Investment in Stanford Student Companies

9/18/2013

Q&A on Faculty Investment in Stanford Student Companies

 

RPH 5.2

Federal-wide Assurance for Protection of Human Subjects

9/04/2013

FWA for Protection of Human Subjects Updated                                  

 

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1. Conduct of Research

1.1 Principles Concerning Research

Presents broad principles to guide the research enterprise and assure the integrity of scholarly inquiry at Stanford University. 

Authority

Senate of the Academic Council

Contact

Kathryn Moler

Vice Provost and Dean of Research

Kristi Geerke

Dean's Assistant/ Project Manager

Vice Provost and Dean of Research

(650) 723-7248

1. Introduction

The transmission of knowledge and conduct of scholarly inquiry are central and complementary functions of the University. They can be carried out effectively only if scholars are guaranteed certain freedoms and accept corresponding responsibilities.

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2. Overview

The Senate of the Academic Council of Stanford University hereby affirms the following principles concerning research:

  • Individual scholars should be free to select the subject matter of their research, to seek support from any source for their work, and to form their own findings and conclusions. These findings and conclusions should be available for scrutiny and criticism as required by the University's Policy on Openness in Research.

  • Research techniques should not violate established professional ethics pertaining to the health, safety, privacy, and other personal rights of human beings or to the infliction of injury or pain on animals.

  • The University should foster an environment conducive to research. Where, because of limited resources, the University cannot support all research demands, it should allocate space, facilities, funds, and other resources for research programs based on the scholarly and educational merits of the proposed research, and not on speculations concerning the political or moral impropriety of the uses which might be made of its results.

The above principles circumscribe the University's role with respect to University-connected research. They in no way diminish, and indeed they reinforce, the individual researcher's personal responsibility to assure that the conduct of research, the sources of funding for that research, and its perceived applications are consistent with the individual researcher's judgment and conscience, and with established professional ethics.

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1.2 Rights and Responsibilities in the Conduct of Research

Presents a summary of Stanford's policies and practices related to research, including a review of obligations to students, staff, and sponsors.

1. Introduction

This policy outlines faculty members' rights and responsibilities in the conduct of research at Stanford.

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2. Rights of Faculty Members

To carry out Stanford's research mission effectively, scholars are guaranteed certain freedoms.  Faculty have the right to academic freedom in the pursuit and support of research as defined in the statement of Principles Concerning Research, found in the Research Policy Handbook. Faculty have the right to disseminate the results and findings of his or her research without suppression or modification from external sponsors beyond those provisions explicitly stated in the policy on Openness in Research.  Members of the Academic Council have the right to engage in external consulting activities, subject to the University's, and in some cases their School's, limitations. It's important that faculty adhere to both the spirit and the letter of the policy.

Along with these freedoms come corresponding responsibilities:

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3. Responsibilities of Faculty to Staff and Students

Faculty members must be aware of their obligations to staff and students working as part of the research team. It is particularly important that at least annually, each faculty member should review intellectual and tangible property rights and responsibilities (for management of data in all media, for proper authorship attribution, etc.), with all members of the group under his or her direction, including staff, students, postdocs, and visiting scholars. Each member has the right to know who is sponsoring the research and supporting his or her salary or stipend.

On an individual level, the best interests of each staff member and student should be of particular concern. The University is committed to demonstrate support and appreciation for its staff. To that end, faculty members are encouraged to provide staff development opportunities and, if possible, a mentor relationship for those in their group.

Health and Safety

Each faculty member is responsible for training members of his or her team in appropriate health and safety procedures for that particular research area, and for management of those procedures in his or her laboratory or other workplace. PIs are also responsible to assure the periodic inspection of lab facilities, and to cooperate in any inspections by Stanford personnel or by external agencies.

Consulting by Academic Staff - Research

On an exception basis, members of the Academic Staff-Research occasionally may be permitted to engage in outside consulting activities under conditions outlined in the RPH, Conflict of Commitment and Interest for Academic Staff and Other Teaching Staff.

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4. Responsibilities to Sponsors

Fiscal Obligations

Although the legal agreement funding a sponsored project is between the sponsor and the Stanford University Board of Trustees, the overall responsibility for management of a sponsored project within funding limitations rests with the PI. Funds must be expended within the restrictions of the contract or grant, and if any overdraft should occur, it is the responsibility of the PI to clear the overdraft by transferring charges to an appropriate account.

Equipment Control

The control of both Stanford and Government-owned equipment is mandatory under Stanford's externally sponsored contracts and grants as well as under University policy. PIs are responsible for securing necessary approvals for the purchase of the equipment, proper tagging, inventory, utilization of equipment and disposal once equipment becomes excess.  For specific guidance, please refer to the Property Administration Manual.

Proposal Preparation

The cost of proposal preparation activities in support of new directions in research may not be charged to sponsored projects. Department Chairs and School Deans must ensure that non-sponsored project funds are available to offset the portion of the investigator's and his or her staff's salaries from sponsored projects for effort spent preparing proposals to support new directions in research. The cost of proposal preparation efforts for continuing research is appropriately charged to current projects. Also, should there be questions on which direct costs are subject to indirect costs as proposal budgets are prepared, please refer to the appropriate documents in the Research Policy Handbook.

Certification of Salaries and Expenses to Sponsored Projects

Sponsored project and cost sharing accounts must be reviewed and certified by the PI quarterly. It is the responsibility of each department chair and school dean to see that a system is in place to ensure that the PIs in their areas fulfill the requirement for review and certification of salaries and other expenditures, and to assure that salaries charged to sponsored projects correspond to effort expended on those projects, within the appropriate limitation for their school.

Technical and Invention Reports

Principal Investigators are responsible for submitting sponsor-required reports through the Office of Sponsored Research or the Research Management Group (OSR or RMG) on a timely basis.  The reports must be sent directly to your project monitor, with a copy to OSR or RMG at the same time so that contract and grant files are complete.

Patents and Copyrights

All participating researchers, including postdocs, students, and visiting scholars, must sign Stanford's Patent and Copyright Agreement (SU-18) before the commencement of any research activities.

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5. Other Responsibilities

A. Conflict of Interest

The key to Stanford's policy pertaining to conflict of interest is the trust in the integrity of the individual faculty member to disclose any situation that could lead to real or apparent conflict of interest. Stanford policy requires an annual certification of compliance and disclosure of potentially conflicting relationships. In addition, situations which arise during the year in which outside obligations have the potential for conflict with the faculty member's allegiance and responsibility to the University require a prompt ad hoc disclosure.

 

B. Research Protocols

Faculty members also need to ensure that approved research protocols for the use of human and animal subjects in research are obtained and followed.

1.3 Academic Freedom

Assures the fullest protection of freedom of inquiry, thought, expression, publication, and peaceable assembly at Stanford University.

Authority

Research Policy Handbook

Senate of the Academic Council, April 18, 1974

Approved by the Board of Trustees September 10, 1974

Ammended by Faculty Senate 4/16/1998

Contact

Kathryn Moler

Vice Provost and Dean of Research

1. Introduction

This Statement on Academic Freedom was adopted by the Senate of the Academic Council on April 18, 1974, and approved by the Board of Trustees September 10, 1974 upon the understanding that, as stated by the President of the University in his written recommendation to the Board, "The University's processes of search and evaluation are designed to produce the best possible persons for membership on the faculty. The Statement on Academic Freedom would in no way change that goal or the practices used to reach it."

Conforming to 1989 and 1990 actions of the Senate of the Academic Council on the recommendations of the Second Committee on the Professoriate, "faculty" refers to titles included in the "professoriate," defined (in the Stanford University Faculty Handbook) as: the tenure-line faculty; assistant professors (Subject to Ph.D.); the non-tenure line faculty; Senior Fellows and Center Fellows at specified policy centers and institutes; and the Medical Center Line faculty. The Statement was amended by the Senate of the Academic Council on April 16, 1998.

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2. Preamble

Stanford University's central functions of teaching, learning, research, and scholarship depend upon an atmosphere in which freedom of inquiry, thought, expression, publication, and peaceable assembly are given the fullest protection. Expression of the widest range of viewpoints should be encouraged, free from institutional orthodoxy and from internal or external coercion. Further, the holding of appointments at Stanford University should in no way affect the faculty members' rights assured by the Constitution of the United States.

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3. Furtherance of These General Principles

In furtherance of these general principles:

Decisions concerning:

  1. the search for, and appointment and promotion of, faculty
  2. the assignment of teaching and other primarily academic responsibilities
  3. the support and sponsorship of scholarly research
  4. any other granting or withholding of benefits or imposition of burdens

shall be made without regard to a person's political, social, or other views not directly related to academic values or to the assumption of academic responsibilities; without regard to the conduct of a person holding an appointment at Stanford unless such conduct is directly related to academic values or to the assumption of academic responsibilities or is determined, in a proceeding pursuant to the Statement on Faculty Discipline, to come within the provisions of Section I of that Statement; and without regard to an individual's race, ethnic origin, sex, or religion. Nothing in the foregoing shall be deemed to affect the University's application of affirmative action policies in its faculty search procedures.

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4. Grievance Procedures

The grievance procedures outlined below are designed to assure that decisions by faculty members and administrators comply with the standards of academic freedom established in Section 2. These procedures are internal to the University and are aimed at preserving confidentiality and academic integrity while protecting the rights of individual faculty members. The provisions of Section 2 do not create contractual rights subject to review by agencies outside the University. The procedures outlined below, however, constitute the administrative remedies for faculty grievances covered by parallel rights established under applicable federal and state laws (such as Civil Rights Acts).

The following procedures shall apply to all grievances (defined as in the Statement on Faculty Grievance Procedures) arising under this Statement on Academic Freedom:

  1. The rights herein conferred shall be enforceable only by a person who is directly aggrieved and who holds a faculty (as defined above) position; no other person or persons shall have standing to complain.
  2. If any faculty member feels aggrieved by a decision that he or she believes to be in violation of this Statement, he or she may file a grievance pursuant to the Statement on Faculty Grievance Procedures and its attendant standing rules.
  3. For grievances brought in whole or in part for alleged violation of the Statement on Academic Freedom, the rules and procedures of the Statement on Faculty Grievance Procedures shall be modified as follows:

  • For a grievance not arising out of a negative decision on appointment, reappointment or promotion (and therefore for which consideration by the Advisory Board would otherwise be unavailable), the grievance and appeal structure shall nonetheless include the Advisory Board as to that portion of the grievance raising an alleged violation of the Statement on Academic Freedom.
  • To the extent that a grievance or appeal does not involve a violation of Section 3.1 of this Statement (that is, relating to the search for, and appointment and promotion of, faculty), the Advisory Board may, at its option, refer the grievance to any faculty member or committee of faculty members as it deems appropriate, which faculty member or committee of faculty members shall consider the matter and make recommendations to the President directly.
  • For each grievance or appeal raising an alleged violation of the Statement on Academic Freedom, the Standards for Review under Section V of the Statement on Faculty Grievance Procedures shall be expanded to include the consideration: "Did the decision give weight to one or more of the factors ruled out of proper consideration by Section 3 of the Statement on Academic Freedom?"

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1.4 Openness in Research

Expresses Stanford's commitment to openness in research; defines and prohibits secrecy, including limitations on publishability of results; specifies certain provisions that are acceptable under this policy.

Authority

Senate of the Academic Council

Contact

Kathryn Moler

Vice Provost and Dean of Research

1. Resolved

That the principle of openness in research - the principle of freedom of access by all interested persons to the underlying data, processes, and to the final results of research - is one of overriding importance. Accordingly, it is the decision of the Senate that this principle be implemented so that no program of research that requires secrecy (as hereafter defined) be conducted at Stanford University, subject to the provisions set forth in Section 4. of this Resolution.

 

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2. A Research Program Shall be Regarded as Requiring Secrecy

That a research program shall be regarded as requiring secrecy:

  • If any part of the sponsoring or granting documents that establish the project is not freely publishable
  • If there is a reasonable basis for expectation that any documents to be generated in the course of the research project will be subjected by an outside sponsor to restrictions on publication for a period in excess of that reasonably required (more than 90 days) so that the sponsor can ascertain whether information he or she is entitled to have treated as confidential would be disclosed by publication
  • If access will be required in the course of the project to confidential data so centrally related to the research that a member of the research group who was not privy to the confidential data would be unable to participate fully in all of the intellectually significant portions of the project

 

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3. Rules Adopted by the Academic Council

The rules adopted by the Academic Council on September 29, 1967, are hereby amended and, as amended, are reaffirmed:

  1. No research on a thesis or dissertation should be undertaken if, at the time the topic is set, there is any substantial possibility that it will lead to a secret thesis or dissertation.
  2.  No secret thesis or dissertation should be accepted as the basis for a degree.
  3. Scholarly activities not accessible for scrutiny by the entire Advisory Board should not be considered in connection with appointments, reappointments or promotions.
  4. The University should enter no contract and accept no grant to carry out research if the grant or contract restrains the freedom of the University to disclose the:
  • Existence of the contract or grant or,
  • General nature of the inquiry to be conducted or,
  • Identity of the outside contracting or granting entity or,
  • The research results

provided that this clause shall not apply either (a) to anonymous gifts or grants that do not call for the performance of specified lines of inquiry, or (b) to research grants or contracts from individuals or non-governmental entities who request anonymity out of a justifiable motivation to protect individual privacy.

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4. Programs of Research With Certain Provisions That Are Allowable

A. Living Human Beings

In a program of research involving the examination, through interview techniques or otherwise, of a living human being, reasonable provision may be made to protect the rights of that individual to privacy.

B. National Security Controls

In a program of research, the purposes of which would be significantly advanced by access to information generated elsewhere that had been subjected to export or other national security controls, provision may be made for access to that information on the part of one of several of the participating investigators provided that the information falling under national security controls is peripheral to the research program in the following sense: the relationship between the data falling under national security controls and the overall research endeavor must be sufficiently remote so that

  • a member of the research group who is restricted from accessing the data falling under national security controls would nevertheless be able to participate fully in all of the intellectually significant portions of the project (i.e., would not be placed at an intellectual disadvantage by the access restriction); and
  • there is no substantial basis for an expectation that any part of the final results of the research, or any but a trivial part of the research processes, will be subject to restriction on publication more enduring than those described in Section 2.

 

C. Publication Delays

In a program of sponsored research, provision may be made in the contractual agreement between Stanford and the sponsor for a delay in the publication of research results, in the following circumstances:

  1. For a short delay (the period of delay not to exceed 90 days), for patenting purposes or for sponsor review of and comment on manuscripts, providing that no basis exists at the beginning of the project to expect that the sponsor would attempt either to suppress publication or to impose substantive changes in the manuscripts.
  2. For a longer delay in the case of multi-site clinical research (the period of delay not to exceed 24 months from the completion of research at all sites), where a publication committee receives data from participating sites and makes decisions about joint publications. Such delays are permitted only if the Stanford investigator is assured the ability to publish without restrictions after the specified delay.
  3. When it is in the best interests of the research, the Vice Provost and Dean of Research may approve contractual arrangements that could lead to longer publication delays. Requests for the Dean to approve such contractual arrangements should include:
  • the rationale for the request
  • a description of who will have authority over publication decisions, and
  • a statement of the provisions that will allow the investigator to publish within a defined period of time, regardless of other considerations.

Under no circumstances should a faculty member engage a student or trainee in a project governed by an extended publication delay agreement or contractual arrangement that could present a barrier to the timely submission of the student's thesis or dissertation or to the publication of a trainee's work.

 

D. Confidentiality

If, in a program of research, an outside person or entity has made available to the investigator confidential information, provision may be made to preserve confidentiality and/or a short delay in the publication of research results during which time the information source may examine the proposed publication in order to assure that the investigator has not disclosed, intentionally or unintentionally, any portion of the confidential information supplied, provided that any such provision for delay must contain assurance from the information source that they will conduct their review as expeditiously as possible, that they will not attempt to thwart publication for any reason except to protect confidential information previously supplied, and that they will indicate with specificity a sentence or sentences which they contend constitute such a disclosure.

E. Private Papers, Documents, Diaries or Analogous Materials

If, in a program of research, private papers, documents, diaries or analogous materials have been provided to the investigator, provision may be made to preserve the confidentiality of those materials for the purpose of protecting the individual privacy of the author, or of the addressee.

5. Review

This policy shall be reviewed at least annually by the Committee on Research in one of its meetings. This meeting and others primarily devoted to considering a revision of research policy shall be announced publicly through the website of the Committee on Research and/or other suitable means.

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1.5 On Academic Authorship

Presents a systematic discussion of two related issues: first, the allocation of responsibility and credit for scholarly work; and second, those forces that are pushing toward a level of complexity in the conduct of research at which it becomes difficult to determine responsibility of authorship.

Authority

Committee on Research

Contact

Kathryn Moler

Vice Provost and Dean of Research

1. Committee on Research Resolution

The 1986-87 Committee on Research examined the issues raised in this paper and resolved that:

  • Copies of the Kennedy paper shall be widely circulated to encourage discussion of authorship before research projects commence
  • No attempt shall be made to establish University guidelines to define "significant intellectual contribution" or impose formal mechanisms for determining authorship
  • Faculty shall be reminded of their responsibilities to insure authorship rights and responsibilities of students and members of the AS-R
  • Periodic surveys shall be conducted to determine if academic authorship problems emerge in the future.

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2. Paper by Donald Kennedy, then President, Endorsed by the Committee on Research

Dear Friends:

For some time, I have felt a need for systematic discussion within this faculty of two related issues: first, the allocation of responsibility and credit for scholarly work; and second, those forces that, in many disciplines, are pushing us toward a level of complexity in the conduct of research at which it becomes difficult to determine responsibility of authorship.

I am sure you are aware of the national attention given to cases involving misconduct and alleged misconduct in the production and publication of research results. You may not know that at Stanford we have been hearing increasing numbers of complaints and disagreements between students (postdoctoral, graduate, and undergraduate) and their faculty sponsors over credit for work to which both may have contributed.

The pattern of research in many fields is changing. Large laboratories may be under the general directorship of one or two individuals but often include relatively independent work being performed by groups of shifting composition. These changes often produce exciting developments, but at the same time they pose novel problems for the allocation of credit and responsibility.

Increased administrative burdens on principal investigators, arising in part out of more onerous government regulation, may also contribute - by decreasing the time available for active participation in research, just when its importance to academic careers is increasing.

For these and perhaps other reasons, matters of authorship, attribution, and acknowledgment have become more complex; responsibility for work in which we are less personally involved has become more common; and the customs prevailing in different fields have diverged. It is also likely that the incentive for claiming credit has increased.

In the past, appropriate standards in these matters have been determined by the individuals involved, based upon traditions that have grown up in the profession as a whole and in the separate fields. But the steady stream of problems now coming before me suggests that isolated individual judgments by faculty members may no longer be adequate. So I write this memorandum in the hope that it may initiate discussion among my colleagues.

Let me first describe how these problems tend to arise. Some actions, of course, remain relatively simple to label - and to condemn. One who has had no connection with a research project but presents its methods, data, or conclusions as his or her own has committed plagiarism; if the writings of another are taken essentially verbatim, there may be copyright infringement as well. I do not think our common understanding about the straightforward theft of intellectual product has been eroded.

But there are more difficult cases, and they generally involve the allocation of credit for work to which several individuals have contributed something. Often, one participant claims that the joint effort permits publication without the consent of the others, or publication as a sole author, or publication without acknowledgment of the contribution of others.

The following scenario is not atypical: Graduate student S is working in Professor P's laboratory on an experimental problem within P's general field of interest and competence. Perhaps S has a research assistantship funded by P's grant. S conducts an experiment, gathers a set of interesting data, and writes up the results as part of what is expected to become a doctoral dissertation. S discusses the results with Professor P, who subsequently incorporates the data and new findings in a symposium article (or perhaps a grant application), with a cursory acknowledgment of S's role, or none. S considers that original data from an independent experiment was wrongfully appropriated by P. P views the work as having been done with his support, in his laboratory, within the conceptual framework devised by him, and accordingly views the results as a joint intellectual product in which both have full rights of authorship. Cases of this kind are especially resistant to easy solution because we are such a diverse and complex scholarly community. Each of us will think of factors not given in this bare sketch that would incline us toward one view or the other - but they will not always be the same factors.

Notions about how to handle joint student and faculty work in laboratories in organic chemistry at Stanford and at MIT will resemble one another much more closely than do those applying to organic chemistry and, say, economics within either institution.

In some disciplines it is quite customary for graduate students to publish their own research results by themselves, even when their work involves fairly close supervision by a faculty member - and in others, the professor's name goes on virtually every paper produced in the laboratory.

This heterogeneity of custom sometimes makes it very difficult to decide, in disagreements like the one between S and P, whether we are dealing with professional misconduct (the wrongful appropriation of another's intellectual product) or whether we are in a domain of ethical judgments about the proper allocation of credit between joint researchers - judgments so close that they should be resolved by personal values, etiquette, and generosity, rather than by a faculty disciplinary process. It is especially difficult for the disputing parties to see a matter in the same way.

The resulting level of bitterness can be very high, and the University should bend every effort toward its reduction. Although we probably cannot hope for a set of specific rules that could set criteria for the shared ownership of intellectual product in all scholarly disciplines, some clarification ought to be possible. Here are some propositions that I think are generally true:

First

In settings like ours, research and training are closely related, deeply interpenetrating functions. The research apprenticeship undertaken by any student - undergraduate, graduate, or postdoctoral - in the academic domain of a faculty sponsor has as one of its purposes the training and development of the student. The other purpose, of course, is the advancement of the scholarly program of which the faculty member is the leader. The relationship between the two is complementary; but the functions of the student participation, and its value to the student on the one hand and the faculty member on the other, will vary.

In particular, the functions served and the kinds of benefits to each party change with the student's academic level. In some fields, for instance, undergraduates and beginning graduate students rarely contribute significantly to the intellectual design and content of advanced research; they can be useful as "hands." The benefits they realize may chiefly be that of becoming familiar with fairly routine procedures, learning the methodology of research, the operation of any relevant equipment, and absorbing the "culture" of the discipline. These are substantial benefits, and the contributions they make are helpful to the enterprise without being essentially scholarly. However, we also should be cognizant of our primary responsibility to our students and alert to opportunities to involve them as early as possible in the genuinely intellectual aspects of the discipline. If we keep using them for routine tasks long after they have gained command over them - or if we fail to recognize by appropriate credit in publications that they have progressed and are making intellectual contributions - the relationship becomes exploitative. And even in the case of undergraduates or beginning graduate students, there will be situations in which they are in fact contributing to the intellectual content of the project, and thus functioning as colleagues. To fail to maximize all these opportunities for our students is to default on one of our central missions as educators.

Second

There is a cluster of questions about authorship and intellectual "ownership" that includes these, among others: What level of contribution by the various parties to a research enterprise qualifies for (co) authorship of the product? What circumstances entitle one to independent or first publication or to the use of data in another publication or project without attribution? In considering these, I am struck by the seamlessness that often characterizes collaborative research, and I wonder if we would do better if we gave thought - and voice - to our assumptions at the outset, even as we understand that those initial assumptions may well change as the course of research progresses.

Even at its beginning, it is often difficult to trace the source of the ideas and insights from which a research project originates; it is hard to say what was identifiably generated by one individual and what was "in the air" in the intellectual domain. Although my personal experience is with the natural sciences, I know that ideas in the social sciences and the humanities are likely to be of similarly elusive, and mixed, parentage. In those sciences where the gathering of experimental data is a regular part of the work, there are matters of experimental concept, design, instrumentation, hands-on execution, and data interpretation; in other fields, an idea is shaped and developed as it is committed to writing, so that the original inspiration may defy reconstruction by the time the project is completed. One member of an experimental team that includes a professor, graduate students, postdoctoral fellows, and technicians may provide an absolutely critical skill, without which the entire venture could not proceed; one contributor to a scholarly project may have had an idea that was essential to the working out of the problem - even though by the time the project is completed it may have so changed from the original conception that the germinal idea is no longer central. The more interactive the process, the less we can retrospectively divide the work into parts corresponding to particular roles or contributions.

Furthermore, faculty members often rely on their own familiarity with the conventions of the discipline regarding coauthorship and other forms of credit, forgetting that students and other participants in a project may be unacquainted with them. Again, I wonder whether departments or laboratories could ameliorate the bitterness of disappointed expectations by a general discussion, in advance, of the ground rules. The understanding in my laboratory was this: If I had contributed to the idea of the project and had also contributed significantly to the hands-on work, coauthorship was justified; but any coauthor had to have a complete enough grasp of the whole effort to defend it effectively in a scientific meeting. This test, or course, is tailored to an experimental science and surely is not the only one applicable even there. Whatever the agreement, it is necessary also that there be a prior understanding of the scope of the particular project or sub-project - that is, both should know the anticipated product to which the agreement applies.

Third

Another aspect of the same cluster of issues - who may publish first, who must consent, what connections with the work need be acknowledged and how - is associated particularly with review articles, books (or chapters of books), or symposium contributions, especially "state of the discipline" pieces. Opportunities to produce more comprehensive works of this kind come mainly to senior scholars. In describing the significant developments in one's field, there is a natural tendency to include work done by oneself and one's students and junior associates. In the usual case, the scope of the topic is broad enough so that including all associates as coauthors is impractical and/or silly (although in a few cases it may be managed). Where the piece deals with data or results of others that are already published as a paper or dissertation, or have been accepted for publication, then employing them with appropriate citation is obviously proper.

If the material is yet unpublished but will be issued as a joint work, I think it is generally accepted that any of its prospective coauthors may refer to it, even at length, in a separate work of sole authorship - provided that its joint origin is prominently acknowledged and provided that the opportunity for regular scholarly publication is not preempted. Common courtesy as well as an appropriate concern for the welfare of coauthors of the yet-unpublished work - especially, of course, if they are one's own students - requires that they be consulted and that reasonable requests be accommodated. If the material is as yet unpublished and if it will not be a joint work, permission must be obtained for any extended discussion and should be obtained as a matter of courtesy even for a passing notice. (Acknowledgment of the source is always essential, of course; if one permits it to be understood that the work is one's own, I think we are back to plagiarism of the simple kind.)

Fourth

There is a tight coupling between authorship and responsibility. Let us suppose that the name of a faculty member has been included on a paper resulting from the relatively independent experiments done by a student or fellow. If the data are then shown to be faulty, or worse, invented, it seems clear to me that the faculty member is responsible. Indeed, as Provost Albert Hastorf's 1984 memorandum on academic fraud pointed out, faculty members are generally responsible for the scholarly conduct of staff and students involved in their research enterprises. When one assumes coauthorship, a still higher duty of certainty prevails. The defense of minimal participation in work done in one's laboratory is generally questionable; surely it is entirely inapplicable when one is coauthor of the disputed work.

Once again, however, clarity is clouded by differences in disciplinary culture. An individual's place in the list of authors of a work may or may not be a meaningful signal about the degree of contribution: in some fields the authorship sequence is rich in meaning, elsewhere it may be entirely empty. Even within a discipline, customs vary: In most biological papers, the sequence of authors is in approximate order of extent of contribution; but there is also a tradition that places the chief of the laboratory last regardless of the relative weight of contribution, and at least one leading journal extracts all meaning from sequence by requiring alphabetical listing of authors.

But those complexities only underscore the importance of establishing sound principles for determining coauthorship and provide further reason for extreme care by faculty members. While I understand the need to respect the nuances that readers (including prospective employers) will derive from author sequence in a journal article, it does seem to me that as a prima facie matter, each coauthor of a work is accountable for its authenticity and quality. Shared credit should entail shared responsibility. Where, by custom or agreement, that is not the case-in fields where 10 or more names regularly appear on a single paper as coauthors, for example, or where the work is a collaboration between scholars from different fields who lack intimate command of one another's areas-some explicit disclosure of that fact would seem desirable.

Finally, let me offer an observation on a different topic, one that has an oblique relationship to the issues considered above. I note that the pressures have increased - unacceptably, in some disciplines - to produce immense lists of publications. Those who have served on the Advisory Board, or who have seen promotion and tenure files from throughout the University for other reasons, will know the extraordinary range in numbers of publications. In the humanities, most social sciences, and some natural sciences, only a handful of works will be listed. In some Medical School departments especially, there may be more than 100 publications in a period of five or six years.

Again, the functions and traditions of publication vary by field: In some, it is (or seems) important that each small step be documented and circulated as soon as possible. In other disciplines, even primary research work is published only after extensive collection of data and the attainment of some theoretical outcome. Works of the same size can, of course, be more or less significant, as scholars in the field will immediately discern.

Nonetheless, I think the exaggerated growth of publications in some fields has become pathological, and I would like to see the problem addressed here at Stanford and, perhaps, in conference with our colleagues elsewhere. It seems likely that the pressure to have a list of publications several pages long to achieve tenure, or to produce a dozen or more papers a year to maintain one's status as a productive scholar, may lead to the kinds of behavior mentioned above: to the seizing of authorial credit where it is not due and, perhaps, to ungenerous attempts to exclude others from authorship. Indeed, there are suggestions that it contributes to the likelihood of outright academic fraud. It is very well to say that such behavior is improper even in the face of great pressure. We do say it, and mean it. But should we not question the propriety of letting the pressure continue to increase, and address ourselves to means of relieving it while maintaining (indeed, enhancing) the quality of scholarly output?

These reflections do not cover the full range of problems in connection with authorship, acknowledgment, and use of intellectual product. As I said, I hope they will provoke discussion and, if not resolution, at least steps toward the expression of commonly held principles. Surely many problems can be ameliorated by a constant awareness of the special duty of faculty to foster the intellectual growth and independence of their students, by a habit of generosity in giving as much credit to their contributions as is consistent with realistic appraisal, and by the meticulous observation of strict standards of citation and acknowledgment. Others are harder; they may ultimately yield, if at all, only to the careful development of consensus about the ethics of our profession.

To begin our consideration of these issues, I am asking the Committee on Research to examine them during the coming academic year and to forward their views to the Provost and to me. We shall then discuss their further disposition with the Academic Senate.

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1.6 Multi-Authored Research Papers

Presents guidelines for manuscripts produced by multi-investigator research teams, addressing coherence, review, co-authorship, and maintenance of data.

Authority

Senate of the Academic Council, upon the recommendation of the Committee on Research

Contact

Kathryn Moler

Vice Provost and Dean of Research

1. Introduction

Multi-investigator research teams differ significantly from the individual faculty/graduate student research teams, which are the norm at Stanford. In particular, the former often consist of colleagues from different disciplines who perform different, specialized functions. It is possible for participants to have little knowledge or understanding of parts of the work performed by their colleagues. Sometimes, there is no single person who understands all the research.

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2. Guidelines

With this in mind, the Committee on Research has drawn up the following guidelines for scholarly manuscripts emanating from multi-investigator research. We have endeavored to keep these simple and fundamental. As a consequence, the guidelines appear applicable to all scholarly collaborations in which multiple authorship is anticipated.

  1. Principal investigators and senior faculty have special responsibilities to assure the overall cohesiveness and validity of the publications on which they appear as coauthors.
  2. All authors in a group effort have a shared responsibility for the published result and should have the opportunity to review all sample preparation procedures and data, as well as all data acquisition and analysis procedures.
  3. Each author in a group effort should have access to the manuscript prior to its being submitted for publication, and should agree to his or her inclusion as a coauthor. All the participants in the program should know that the paper is being prepared for publication.
  4. Early in the project, each research group should define appropriate practices for the maintenance of data.

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1.7 Research Misconduct: Policy on Allegations, Investigations, and Reporting

Presents procedures for reporting and investigating allegations of research misconduct, and for the required notifications to federal agencies of such allegations and investigations.

Authority

University Provost, reflecting the requirements of federal agencies endorsed by the Senate of the Academic Council

Contact

Kathryn Moler

Vice Provost and Dean of Research

1. Introduction

Each member of the University community has a responsibility to foster an environment which promotes intellectual honesty and integrity, and which does not tolerate misconduct in any aspect of research or scholarly endeavor.

Research misconduct is extremely troubling - in spite of its infrequency - because when it occurs, it is very destructive of the standards we attempt to instill in our students, of the esteem in which academic science in general is held by the public, and of the financial support of the government and other sponsors for academic research. The importance of integrity in research cannot be overemphasized.

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2. Applicability

Stanford's definition of research misconduct, and procedures for investigating and reporting allegations of misconduct, conform to the definitions and regulations of those federal funding agencies which have policies on this subject. Stanford policy is applicable to:

  1. research proposed, conducted or reported at Stanford by Stanford University-related individuals, i.e., those with an appointment or official affiliation with Stanford University, including faculty, academic staff, students, postdoctoral scholars, visiting scholars who make significant use of university research resources (including participation in any sponsored project awarded to Stanford University), and those with any other Stanford University teaching and/or research titles such as adjunct or clinical :

  2. research proposed, conducted or reported elsewhere by such Stanford University-related individuals as part of their Stanford University-related duties or activities; and

  3. at the discretion of the University, to research proposed, conducted or reported where such research is claimed, cited or implied to have been done at Stanford, or where a Stanford appointment or official affiliation is claimed, cited or implied in connection with the research.

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3. Definitions

A. Research Misconduct

"Research misconduct" is defined as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.

  • Fabrication means making up data or results, and recording or reporting them.
  • Falsification means manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record.
  • Plagiarism means the appropriation of another person's ideas, processes, results, or words without giving appropriate credit.

Research misconduct does not include honest error or honest differences in interpretations or judgments of data.


A finding of research misconduct requires that:

  • there is a significant departure from accepted practices of the relevant research community
  • the misconduct is committed intentionally, or knowingly, or recklessly
  • the allegation is proven by a preponderance of the evidence. (Stanford University's disciplinary procedures may establish a different standard of proof for disciplinary actions.)

This policy addresses only research misconduct. Stanford's statement on faculty discipline has been interpreted to include such other misdeeds as reckless disregard for accuracy, failure to supervise adequately, and other lapses from professional conduct or neglect of academic duties. Findings (pursuant to this research misconduct procedure) of serious academic deficiencies in proposing, conducting or reporting research - but not constituting research misconduct - are to be addressed by the cognizant dean, or by initiating the relevant disciplinary process, as appropriate. Allegations or suspicions of misconduct outside the scope of this policy should be referred for investigation to the cognizant dean, vice provost or vice president; the process of investigation and reporting obligations may differ from those required for research misconduct cases.

B. Inquiry

An inquiry consists of preliminary information-gathering and preliminary fact-finding to determine whether an allegation or an apparent instance of misconduct has substance. The outcome of an inquiry is a determination as to whether or not an investigation is to be conducted.

C. Investigation

An investigation is a formal examination and evaluation of relevant facts to determine whether or not misconduct has taken place.

4. Federal Funding Agency Requirements

Some federal funding agencies have their own policies regarding research misconduct, and require notification to the agency in the event of such an allegation or investigation. Where required, this notification will be made by the Vice Provost and Dean of Research (herein referred to as the Dean of Research). See Section 7, Internal Coordination/Reports to the Dean of Research, and Section 8, Notification to External Agencies.

While federal funding agencies recognize that the primary responsibility for the prevention and detection of misconduct, and for the conduct of inquiries and investigations, rests with the awarded institution, a number of agencies have retained the right to initiate their own investigations at any time.

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5. Individual Reporting Responsibility

Any individual who believes an act of research misconduct has occurred or is occurring should notify the dean of the appropriate school, who, after preliminary assessment indicating grounds to proceed, should immediately begin an inquiry and so inform the Dean of Research, who acts on behalf of the Provost. Reporting such concerns in good faith is a service to the University and to the larger academic community, and will not jeopardize anyone's employment. Stanford University prohibits retaliation of any kind against a person who, acting in good faith, reports or provides information about suspected or alleged misconduct.

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6. Procedure for School Dean's Review

The dean's review of an allegation of research misconduct and, if called for, the inquiry and investigation may be carried out personally or through such standing or ad hoc arrangements as each dean deems best. (See Section 10, Cautions and Assistance.)

The processes described below should be carried out in a manner that is thorough, competent, objective, fair and appropriately protective of the confidentiality and reputations of all participants. Such assessments, inquiries and investigations should be coordinated with the office of the Dean of Research to assure that they are carried out in conformance with applicable regulations (if any) in cases where the research is funded by a federal agency.

A. Preliminary Assessment

Upon receipt of an allegation, the school dean should assess the information presented to determine whether it constitutes alleged research misconduct as defined by this policy, and whether the allegation is sufficiently credible and specific so that potential evidence of research misconduct may be identified. If both of these criteria are met, the school dean shall immediately begin an inquiry and shall so inform the Dean of Research, identifying any outside funding source(s) for the research that is the subject of the allegation.

B. Inquiry

An inquiry is to determine whether a formal investigation is warranted, and will be guided by the following:

  1. As noted above, the school dean shall identify any outside funding source(s) for the research that is the subject of the inquiry.
  2. Those conducting such inquiries or investigations are promptly to take all reasonable and practical steps to obtain custody of the research records and/or evidence needed to conduct the misconduct proceeding, inventory the records and evidence, and sequester them in an appropriate manner.
  3. At the time of, or before the beginning of an inquiry, the accused individual (hereafter "the respondent") shall be informed of the allegations, and be invited to comment on them. The respondent shall also be provided with a copy of the draft report of the inquiry, and be given an opportunity to comment on the findings for the consideration of those conducting the inquiry. In so doing, best efforts shall be made (where feasible) to protect the confidence of the individual(s) who brought forward the complaint (hereafter "the complainant(s)").
  4. Other relevant individuals, including the complainant(s), if known, should be interviewed.
  5. The final report, including a recommendation as to whether or not a full investigation is warranted, is to be submitted by the school dean to the Dean of Research within 60 days of receipt of the allegation. (If this time frame is not possible in a particular case, the reasons are to be documented and the Dean of Research so informed.) The final report shall include any comments provided by the respondent in response to the draft report.
  6. The documentation should include sufficient detail to permit a later assessment of the determination of whether or not a full investigation was warranted. It should describe the information reviewed, include a summary of the interviews conducted, state conclusions reached, and indicate whether or not the school dean believes an investigation is warranted.
  7. The final report of the inquiry and a copy of the documentation are to be transmitted to the Dean of Research and maintained in the school for seven years.
  8. Unless the Dean of Research has further concerns, a dean's recommendation that an investigation is not warranted will be final.

C. Investigation Procedures

If the inquiry leads to the conclusion that an investigation is warranted, it will be guided by the following considerations:

  1. The formal investigation should begin within 30 days of the completion of the inquiry and after written notice to the respondent. The investigation is to be completed and the final report sent to the Dean of Research within 90 days (from the start of an investigation). If an investigation cannot be completed within this time frame, the Dean of Research should be notified as soon as possible. In such cases, it may be necessary for the Dean of Research to request an extension of time from federal funding agencies.
  2. An investigation should normally include an examination of the relevant documentation, including but not limited to relevant research data and proposals, publications, correspondence, and memoranda of telephone calls.
  3. Complainants, respondents, and witnesses who may have information related to the matter should be interviewed. Complete written summaries of each interview should be provided to the individual being questioned, and any comments should be appended to the summary, or reflected in a revised summary if the interviewer agrees. The summaries must be retained by the school dean.
  4. All significant issues should be pursued until the investigator is reasonably certain that he or she has amassed all necessary and appropriate information.
  5. A draft written report of findings shall be made available to the respondent with the opportunity to provide comments for the consideration of those conducting the investigation. Where identified and appropriate, complainants should also receive the portions of the draft report which concern the role or opinions they had in the investigation. Any comments on the draft from the respondent (and from the complainants, if applicable) shall be appended to the final report. NOTE: If there is more than one respondent, and their involvements are found not to be identical, separate draft reports should be prepared if practical, in order to preserve confidentiality.

  6. In addition to the interview summaries and comments by the respondent and complainant(s) (if applicable) on the draft report, the final written report should include:
  • 
a description of the policies and procedures followed
  • how and from whom relevant information was obtained

  • the findings and basis for them.

7. If either the school dean or the Dean of Research considers that sanctions may be warranted, the Dean of Research shall refer the final report to the University official who makes that determination (See Section 9) The report should be sufficient for the appropriate University officer to determine whether disciplinary action is called for. If any sanctions result, the Dean of Research shall be informed, and he or she should append that information to the final report.

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7. Internal Coordination/Reports to the Dean of Research

In order to assure compliance with external notification requirements, school deans must report the following circumstances to the Dean of Research in a timely manner:

  • commencement of an inquiry
  • conclusion of an inquiry
  • commencement of an investigation
  • consultation if an investigation will take more than 90 days to complete
  • conclusion of an investigation

If termination of an inquiry or investigation before its completion is contemplated for any reason, this should be reported and discussed with the Dean of Research.

In addition, the Dean of Research is to be advised at once if any of the following circumstances is discovered:

  • an immediate health hazard, including to human or animal research subjects
  • an immediate need to protect federal or University funds or equipment
  • an immediate need to protect the integrity of the research and/or the research misconduct proceeding
  • an immediate need to protect the interests of those involved in the research misconduct proceeding
  • likelihood that an alleged incident will be reported publicly
  • a reasonable indication of a possible criminal violation

In emergency situations, deans are authorized to take all appropriate actions, including notifying external agencies directly, if conference with the Dean of Research is not possible in a timely manner. (See Section 8 , Notification to External Agencies, below.) The Dean of Research is also authorized to take all appropriate actions.


The dean shall also take interim action as necessary to protect federal funds and the purposes of the federal grant or contract that may be involved. Such action is administrative and not disciplinary. The school dean shall inform the Dean of Research of such actions.

If, during an investigation, facts come to light that could affect current or potential funding of the people under investigation, or that may, in the dean's judgment, need to be disclosed in order to ensure proper use of research funds or protection of the public interest, these facts should be reported to the Dean of Research as they are learned.

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8. Notification to External Agencies

Stanford University will comply with the applicable requirements and regulations of its funding agencies, and will cooperate with those agencies in the agencies' own procedures in regard to research misconduct. In any particular situation, school deans are advised to review current regulations and requirements, and to consult with the Dean of Research.

Under circumstances not involving federal funding agencies, the President will make the decision whether information about the charges and their disposition will be disclosed publicly or to specific parties, including the research sponsor. This decision will normally be made upon the conclusion of the final report. However, if required by urgent circumstances, such a disclosure may be made at any time. The President may consult with the Advisory Board to the extent feasible and appropriate in such cases. Absent such urgent need, Stanford will not make interim reports to outside agencies unless required by external regulation.

In accord with the requirements of federal funding agencies, in cases involving research funded by those agencies, the agency will be informed in the following situations. Except as specifically described at the end of this section, the following notifications to federal funding agencies will be made only by the Dean of Research, acting on behalf of the Provost, and on the basis of the information provided by the school dean:

  1. Outcome of an Inquiry

Federal funding agencies will be notified of the outcome of an inquiry involving funds from their agency only if that outcome includes the recommendation to conduct a full investigation. (Documentation from inquiries, even those that do not recommend further investigation, will be made available by the Dean of Research upon an agency's request.)

  1. Commencement of an Investigation 


Written notification will be provided to federal funding agencies upon determination that an investigation will be conducted. This notice is to be provided on or before the commencement of the investigation, and must include all information required by the agency. Generally, this notice must include at least the following: name(s) and position(s) of the respondent(s); general nature of the allegation(s); the agency support including any proposal or award numbers; the basis for the recommendation of an investigation; any comments by the respondent. This information will be held in confidence to the extent permitted by law.

  1. Written Request for a Time Extension 


Although regulations generally permit 120 days for completion of the investigation and submission of the final report, Stanford requires deans to consult with the Dean of Research if it appears that the final report will take more than 90 days to complete. This allows 30 days for the disciplinary process, if it is decided to pursue one. The final report to the federal funding agency must include a statement about the sanction (if any) imposed by the institution.
If the investigation and determination of discipline are likely to take more time than specified by the relevant funding agency's regulations to complete, the Dean of Research will so notify the federal funding agency, including reasons for the delay, interim progress reports, the estimated date of completion of the report, and any other necessary information. If an extension is granted, the agency may (if so provided by its regulations) require the submission of periodic interim reports, or the agency may undertake its own investigation prior to the University's completion of its investigation.

  1. Interim Reports 


Federal funding agencies must be apprised during an investigation of facts that may affect current or potential funding of the individual(s) under investigation, or that may need to be disclosed in order to ensure proper use of federal funds or protection of the public interest.

  1. Early Termination 


Federal funding agencies must be notified of any decision to terminate an inquiry or investigation prior to the completion of all relevant requirements. This notice must include the reasons for such action. Some agencies have retained the right to investigate the matter further on their own.

  1. Final Outcome 


Federal funding agencies will be notified of the final outcome of an investigation involving their funded project(s), and provided with a complete copy of the final report.

  1. Special Emergency Notifications


In addition, federal funding agencies will be informed at any stage of an inquiry or investigation if any of the following is discovered:

  • an immediate health hazard, including an immediate need to protect human or animal subjects
  • an immediate need to protect federal or University funds or equipment
  • an immediate need to protect the integrity of the research and/or the research misconduct proceeding
  • an immediate need to protect the interests of those involved in the research misconduct proceeding
  • a likelihood that an alleged incident is going to be reported publicly
  • a reasonable indication of possible criminal activity

In special emergency circumstances as defined above, the school dean should attempt to reach the Dean of Research (by phone if necessary; in writing, if possible). However, each dean is authorized to make such reports directly to the agency, and to so inform the Dean of Research afterwards, if, in the judgment of the dean, such action is necessary.

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9. Determination of Discipline

The determination as to whether discipline is to be imposed is governed by existing University policies. In cases involving faculty, disciplinary sanctions may only be imposed through the faculty disciplinary process. The Dean of Research will refer cases of significant student misconduct to the Student Judicial Officer. Cases involving staff members will be referred to the appropriate administrator. As noted above, serious academic deficiencies not constituting research misconduct are to be addressed by the relevant school dean, or by initiating the relevant disciplinary process as appropriate.

Federal funding agencies have retained the right to impose additional sanctions, beyond those applied by the institution, upon investigators or institutions, if they deem such action appropriate in situations involving funding from their respective agencies; such agencies may also have standards of proof that differ from those used in Stanford's disciplinary proceedings.

In addition, in cases where research misconduct is found, the school dean and/or the Dean of Research may take all other appropriate actions (including the correction of the public record) as deemed necessary and advisable to address the consequences of the research misconduct.

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10. Cautions and Assistance

The gathering and assessing of information in cases of alleged research misconduct can be extremely difficult. It is essential to protect the professional reputations of those involved, as well as the interests of the public and of any who might be harmed by the alleged misconduct. In the course of conducting inquiries or investigations, the following provisions are applicable:

  • Expert assistance should be sought as necessary to conduct a thorough and authoritative evaluation of all evidence.
  • Precautions should be taken to avoid unresolved personal, professional or financial conflicts of interest on the part of those involved in the inquiry or investigation.
  • The anonymity of respondents and, if they wish it, the confidentiality of complainants shall be protected (where feasible), and care shall be taken to protect the positions and reputations of those involved in the research (including research subjects) and in the research misconduct proceeding from harm (including retaliation). Except as required in the reporting provisions above, only those directly involved in an inquiry or investigation or with a need to know should be aware that the process is being conducted or have any access to information obtained during its course. Where appropriate, efforts will be made to restore the reputations of the respondent(s) when allegations are not confirmed.

Because this policy is designed primarily to protect the integrity of the public research record, instances of alleged research misconduct by students in practicum-type courses, and in coursework and classroom activities, may in many cases be better addressed through student Honor Code or Fundamental Standard procedures, rather than through the procedures of this policy. Such determination of applicability or non-applicability should be made in light of the particular facts and circumstances of a student's case.

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1.8 Nondiscrimination in Research Agreements

Stanford University does not engage in research agreements which permit discrimination on the basis of any characteristic protected by law, and does not limit participation in research on the basis of citizenship.

Authority

Senate of the Academic Council Senate of the Academic Council, reaffirmed in 1988 by the Committee on Research Revised and expanded in 2009 based on the recommendation of the Committee on Research

Committee on Research Last Reviewed: Spring 2016

Contact

Kathryn Moler

Vice Provost and Dean of Research

1. Introduction

Stanford University does not discriminate on the basis of race, religious creed, color, national origin, ancestry, physical, or mental disability, medical condition, marital status, sex, age, sexual orientation, gender identity, veteran status, or any other characteristic protected by law, in connection with any aspect of employment at Stanford, or in its research agreements. Stanford also prohibits discrimination for any of these reasons in the admission of students, and in the administration of its educational policies and programs.

In addition, and in accordance with its policy on Openness in Research, Stanford does not limit participation in research activities on the basis of citizenship. This commitment to an open research environment supports the principle of freedom of access by all interested persons to the underlying data, to the processes, and to the final results of research, and preserves the ability of Stanford faculty to select the best qualified individuals to participate in research, including student participants.

Therefore, as a general proposition, Stanford does not enter into research agreements which permit discrimination on the basis of citizenship against individuals engaged in research activities proposed or conducted under its auspices.

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2. Provisions for Exceptions in Regard to Citizenship

In the following circumstances, where and to the extent permitted by applicable law and consistent with the principle stated above of freedom of access and participation, an exception to this policy may be considered in regard to citizenship restrictions.

A. Citizenship Restrictions Established by Training Grants, Scholarships or Fellowships

The US Government has established funding mechanisms as a primary means of supporting graduate and postdoctoral research training to help ensure that a diverse and highly trained workforce is available to assume leadership roles related to the nation's research agenda. Typically, these funding mechanisms include training grants, fellowships, and scholarships within particular disciplines with the restriction that students to be supported by these funds must be US citizens (or permanent residents). In addition, other organizations, including foreign governments, may provide support in the form of scholarships or fellowships to students meeting certain citizenship requirements.


Several differences should be noted between the funding being described in this category and research project funding.

  1. Although they may focus on particular disciplines, training grants, scholarships and fellowships do not require the accomplishment of specific research Statements of Work. Their purpose is the training and support of student researchers, as opposed to the accomplishment of technical objectives. These awards may be considered as a form of financial aid to the individuals being supported.
  2. Unlike students funded to work on research projects (Graduate Research Assistants), the students funded on training grants, scholarships, or fellowships are not paid a salary as student employees. Rather, their support is provided typically through the payment of a stipend to help meet living expenses, and the direct payment of some or all of the student's tuition and fees.

Stanford University may, in general and without prior review and approval beyond normal process, submit proposals for, and accept the award of such training grants, scholarships, and fellowships in support of the education of its students.

B. Citizenship Restrictions for "Early Career" Type Awards

Similar to the training awards described above, several Federal agencies award financial support for the explicit purpose of advancing the development within certain disciplines of individuals at the early stages of their academic careers. Typically such awards are limited to individuals within a certain period of time from the receipt of a doctoral degree or an initial academic appointment. They are awarded to support the individual, rather than to accomplish a specified Statement of Work. As with training grants, some such awards are limited to US citizens or permanent residents.


Stanford University may, in general and without prior review and approval beyond normal process, submit proposals for, and accept the award of such "Young Faculty", "Young Investigator", or "Early Career"-type awards. Acceptance of such an award does not limit the recipient's ability to conduct his or her research program in compliance with Stanford University policies.

C. Citizenship Restrictions in Foreign-Sponsored Research Agreements

If a sponsoring country restricts entry of citizens of other nations into its country, the Principal Investigator should try to organize the research project and the University should try to draw up the agreement in such ways as to eliminate or reduce as far as practicable the discriminatory effect of those restrictions on participating Stanford personnel. 


In such cases, the Office of Sponsored Research (OSR) will review the proposed research agreement for purposes of assessing any discriminatory impact. If, in its judgment, the proposed agreement would have a potentially significant discriminatory impact on Stanford personnel because of restrictions on travel by Stanford employees or students into the sponsoring country as part of the research activity, OSR will refer the proposal to the Vice Provost and Dean of Research to determine whether the proposed research agreement will be accepted.

D. Citizenship Restrictions Imposed by Export Control or Other Regulations

In rare circumstances, the conduct of research may require that a member of the research group must meet certain citizenship requirements in order to obtain or have access to certain proprietary or US Government-restricted information, where that information is subject to security classification, export control, or other regulatory restrictions. Such information or access may be accepted only to the extent that the provisions of Stanford's Openness in Research policy are met.

E. Other Circumstances

In the rare event that (consistent with applicable law and with the principle of freedom of access to and participation in research) other circumstances arise in which a Principal Investigator wishes to request an exception to the nondiscrimination policy defined here in regard to citizenship, that request shall be sent for review and preliminary approval to the faculty member's school dean, and shall then be forwarded to the Vice Provost and Dean of Research for his or her determination.

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3. Review

The Committee on Research shall review the implementation of the above policy, and report its findings to the Senate of the Academic Council within three years of the 2009 revision.

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4. Policy Last Review

This policy was reviewed by the Committee on Research Spring 2016.  No changes were made to this policy.

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1.9 Retention of and Access to Research Data

Establishes University policy to assure that research data is appropriately recorded, archived for a reasonable period of time, and available for review under the appropriate circumstances.

Authority

Senate of the Academic Council, upon recommendation of the Committee on Research

Contact

Kathryn Moler

Vice Provost and Dean of Research

1. Introduction

Accurate and appropriate research records are an essential component of any research project. Both the University and the PI have responsibilities and rights concerning access to, use of, and maintenance of original research data.

Except where precluded by the specific terms of sponsorship or other agreements, tangible research property, including the scientific data and other records of research conducted under the auspices of Stanford University, belongs to Stanford. The PI is responsible for the maintenance and retention of research data in accord with this policy.

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2. Definition

Research data include laboratory notebooks, as well as any other records that are necessary for the reconstruction and evaluation of reported results of research and the events and processes leading to those results, regardless of the form or the media on which they may be recorded. Stanford must retain research data in sufficient detail and for an adequate period of time to enable appropriate responses to questions about accuracy, authenticity, primacy, and compliance with laws and regulations governing the conduct of the research. It is the responsibility of the PI to determine what needs to be retained under this policy.

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3. Applicability

This policy shall apply to all Stanford University faculty, staff, students and any other persons at Stanford involved in the design, conduct or reporting of research at or under the auspices of Stanford, and it shall apply to all research projects on which those individuals work, regardless of the source of funding for the project.

Where research is funded by a contract with Stanford that includes specific provision(s) regarding ownership, retention of and access to technical data, the provision(s) of that agreement will supersede this policy.

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4. Ownership

The University's ownership and stewardship of the scientific record for projects conducted at the University, under the auspices of the University, or with University resources are based on both Federal regulation and sound management principles. Stanford's responsibilities include but are not limited to:

  • complying with the terms of sponsored project agreements
  • ensuring the appropriate use of animals, human subjects, recombinant DNA, etiological agents, radioactive materials, and the like
  • protecting the rights of students, postdoctoral scholars, and staff, including, but not limited to, their rights to access to data from research in which they participated
  • securing intellectual property rights
  • facilitating the investigation of charges, such as scientific misconduct or conflict of interest

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5. Collection and Retention

The PI is responsible for the collection, management and retention of research data. PIs should adopt an orderly system of data organization and should communicate the chosen system to all members of a research group and to the appropriate administrative personnel, where applicable. Particularly for long-term research projects, PIs should establish and maintain procedures for the protection of essential records in the event of a natural disaster or other emergency.

Research data must be archived for a minimum of three years after the final project close-out, with original data retained wherever possible. In addition, any of the following circumstances may justify longer periods of retention:

  1. Data must be kept for as long as may be necessary to protect any intellectual property resulting from the work.
  2. If any charges regarding the research arise, such as allegations of scientific misconduct or conflict of interest, data must be retained until such charges are fully resolved.
  3. If a student is involved, data must be retained at least until the degree is awarded or it is clear that the student has abandoned the work.

Beyond the period of retention specified here, the destruction of the research record is at the discretion of the PI and his or her department or laboratory.

Records will normally be retained in the unit where they are produced. Research records must be retained on the Stanford campus, or in facilities under the auspices of Stanford University, unless specific permission to do otherwise is granted by the Vice Provost and Dean of Research.

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6. Access

Where necessary to assure needed and appropriate access, the University has the option to take custody of the data in a manner specified by the Vice Provost and Dean of Research.

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7. Transfer in the Event a Researcher Leaves Stanford

When individuals involved in research projects at Stanford leave the University, they may take copies of research data for projects on which they have worked. Original data, however, must be retained at Stanford by the PI.

If a PI leaves Stanford, and a project is to be moved to another institution, ownership of the data may be transferred with the approval of the Vice Provost and Dean of Research, and with written agreement from the PI's new institution that guarantees: 1) its acceptance of custodial responsibilities for the data, and 2) Stanford access to the data, should that become necessary.

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1.10 Information Security

This policy articulates security practices and guidelines for research computing systems.

Contact

Chief Technology Officer - Research Computing

Research Computing Op Budget

(650) 736-9372

Michael Duff, Assistant Vice President and Chief Information Security Officer

1. Overview

Research projects often process large amounts of electronic data both in conducting experiments and disseminating the results. Unlike other data processing systems, research systems are not performing administrative functions nor do they provide critical services for administrative systems. Research systems are also more likely to have unconventional configurations of hardware and software which may evolve rapidly in response to feedback from experiment and analysis in the course of the project.

Because the information processing world contains hostile actors, researchers need to responsibly safeguard data. In addition, since a significant risk posed by research systems is their unauthorized and malicious use to attack other machines, systems running with reduced defenses should employ commensurately enhanced misuse detection and mitigation measures.

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2. Security Principles

Four principles guide the security practices and guidelines for research computing systems: safety, confidentiality, integrity, and availability.

  • Safety is the principle of “do no harm.” Safety is important because it defines what imposed security measures are seeking to prevent. Although a compromise might not directly impinge on research itself, it might lead to abuse of resources to attack others. Since the speculative and unpolished nature of research systems makes breaches more likely, research system safety often involves taking extra measures to reduce, detect, and ameliorate compromises.

  • Confidentiality is the property that information is not made available or disclosed to unauthorized individuals, entities, or processes. Confidentiality is important not only for raw research data, but also notes and metadata. Insufficiently protecting confidentiality can jeopardize the work and privacy of others. Controlling and auditing access is fundamental to confidentiality.

  • Integrity means maintaining and assuring the accuracy and completeness of data over its entire life cycle. Integrity is important because if data is compromised or deleted, it can corrupt the scientific method and the validity of research results. Research systems should have procedures to maintain the integrity of the data they store and to detect modification.

  • Availability means that the system and its data can be used and accessed by authorized users when needed. Availability is important because without it, the systems cannot be used in research: systems that become inaccessible, need to be rebooted, reinstalled, or taken off the network are all examples of reduced availability.

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3. Security Guidelines

The principal investigator (PI) is the primary person responsible for information handling on the project. The PI is responsible for managing information security in accordance with the principles above. Research computing systems must be overseen by a full-time information technology (IT) professional. The level of care required for research computing systems depends solely on the highest designated risk classification of any of the project data.

For projects involving only Low Risk data and systems, research computing systems need to be patched as quickly as possible, and conform to the security policies of their IT professionals. Systems with public IP addresses need to send security logs to a centralized logging system.

For other risk classifications, research projects may fulfill their security responsibilities under the aegis of the Dean of Research in one of two ways:

  • adhering to the information security policies found in Chapter 6 of the Administrative Guide;
  • conducting a risk assessment then collaborating with local IT professionals and consulting with the Information Security Office (ISO) when needed to document the security policies for the project.

The Dean of Research has the final authority on the interpretation of this policy.

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2. Principal Investigatorship

2.1 Principal Investigator Eligibility and Criteria for Exceptions

Establishes the policy that principal investigatorship or co-principal investigatorship on externally funded projects is limited to members of the Academic Council and the Medical Center Line (MCL) faculty, with specific exceptions.

Authority

Senate of the Academic Council

Contact

Kathryn Moler

Vice Provost and Dean of Research

1. Principal Investigator Eligibility Policy

Eligibility to act as a principal investigator (PI) or co-principal investigator (Co-PI) on externally funded projects is a privilege limited to members of the Academic Council and to the MCL faculty. This policy limitation is in place because PIs are responsible for determining the intellectual direction of the research and scholarship, and for the training of graduate students.

The designation of "PI" or "Co-PI" for any member of the Academic Staff, or other individual who is not a member of the University's Academic Council or MCL faculty, requires specific approval by the relevant department chair, school dean and, in some cases, the Dean of Research, as described below.

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2. Exceptions

There are three kinds of exceptions to the PI eligibility policy. The first and second deal with those situations in which exceptions may be granted by the department chair, and school dean or director of the SLAC National Laboratory if all of the prescribed conditions are in place. The third category of exception represents all other situations which require the approval of the department chair, school dean, and Dean of Research. Exceptions in this third category rarely will be granted.

A. Exceptions Subject to the Approval of the Department Chair and School Dean

Requests for PI eligibility for researchers who are not members of the Academic Council or the MCL faculty (e.g., Academic Staff members, Postdoctoral Scholars, Instructors or other researchers) in the following situations may be made on a case-by-case basis by the relevant member of the Academic Council or MCL faculty who has oversight responsibility for the proposed PI.


Such requests are subject to the written approval of the department chair and cognizant dean. (In those cases where the proposals arise from areas outside a school dean's jurisdiction, the Dean of Research will act as the equivalent of the school dean in approving such requests.) The approval of the department chair and the dean shall not be pro forma, but shall take into account the academic quality of the proposal, the qualifications of the proposed PI, and the relevance and importance of the proposal to other activities of the University. Such requests will be made only for a particular project with a specified project period. Documentation of the chair and dean's approval must accompany proposals submitted to the Office of Sponsored Research.

1. Conferences, Exhibits, Workshops or Public Events

Researchers who are not members of the Academic Council or the MCL faculty may be approved to serve as PIs on externally sponsored projects whose sole purpose is to fund short conferences, exhibits, workshops, or other public events of a character appropriate to the University.

2. Specific Projects Which Are Part of Large Interdisciplinary Programs

Researchers who are not members of the Academic Council or the MCL faculty may be approved to serve as PIs on projects within the scope of a large interdisciplinary program. For this purpose a "large interdisciplinary program" is defined as a research program which: a) is directed by a member of the Academic Council or MCL faculty, b) has an expected duration beyond the involvement of any individual faculty participant, c) has more than one faculty member involved, and d) requires expertise in more than one discipline or technical area. All of the following conditions must be met in order for the department chair and school dean to approve PI exceptions in such cases:

  1. The proposed project must be a demonstrably important component of the success of the overall interdisciplinary program, as defined above

  2. There is no member of the Academic Council or MCL faculty associated with the  large interdisciplinary project who is qualified to take responsibility for the scientific direction of the prospective research project

  3. No incremental space will be required for the project

  4. For each graduate student participating on the project, a qualified faculty member has been identified to assure that the student's research program and the education derived from it are consistent with the degree for which the student is a candidate

  5. Exceptions approved under this provision will be reported to the Dean of Research on an annual basis.

3. Career Development Awards

Researchers who are not members of the Academic Council or the MCL faculty may be approved to serve as PIs on a class of projects generically referred to as Career Development Awards, whose stated purpose is to advance the individual's scientific career. Such petitions may be approved if the project is to be carried out under the mentorship of an established faculty or MCL investigator who is named in the proposal, and if the project can be conducted within the overall intellectual scope and laboratory space of the faculty mentor. Often in these cases the awards cover only the individual's salary and incidental expenses, but not incremental staff or students.

Career Development PI Waiver requests are subject to the following:

  1. Written approval of the faculty supervisor (who must be a member of University Tenure Line, Medical Center Line, or Nontenure Line Research professoriate), the relevant department chair, center or institute director (if no departmental resources are to be used), and the School of Medicine Dean’s Office.
  2. A guarantee of space and resources for the duration of the grant by the faculty mentor or department chair.
  3. The understanding that the grant may not, under any circumstances, support a graduate student.  If the grant will have funding to appoint a postdoctoral scholar, the waiver recipient would be responsible for the day-to-day research supervision of the work of the postdoctoral scholar; however, the overall career mentoring of the supported postdoctoral scholar would be the responsibility of an Academic Council or Medical Center Line faculty member.

 

    4. Expanded Career Development Awards

    Expanded Career Development Award Exceptions for MD and MD/PhD Fellows and for PhD Postdoctoral Fellows in the School of Medicine are a very specific category of Career Development PI waivers.  The School of Medicine Dean may approve a limited number of selected exceptional MD, MD/PhD clinical fellows, and PhD postdoctoral fellows with two or more years of research training to serve, with written agreement of their faculty mentor and relevant department chair, as PI for an extramural “R”-type or comparable "non-traditional" career development research award on a one-time basis without possibility of grant renewal.  This one-time opportunity is restricted to only one grant application per applicant and its allowable resubmissions, with no possibility of additional applications or resubmissions beyond those allowable for the specific grant application.

    Expanded Career Development Award exception requests are subject to the following:

    1. Candidates must have two or more years of research training.  In addition, applicants should have a research record (publications and prior research training) that is consistent with their having a reasonable chance of success on the grant application in order to receive this specific expanded PI career development waiver opportunity.
    2. Written approval of the faculty supervisor (who must be a member of University Tenure Line, Medical Center Line, or Nontenure Line Research professoriate), the relevant department chair, center or institute director (if no departmental resources are to be used), and the School of Medicine Dean’s Office.
    3. A guarantee of space and resources for the duration of the grant by the faculty mentor or department chair.
    4. Signature of the postdoctoral trainee to document understanding of the terms of the waiver, including that there is no possibility of renewal if awarded, and no possibility of subsequent submissions (beyond those allowable for the specific grant application) should the application be unsuccessful.
    5. The endorsement and approval of a standing independent faculty review committee, reporting to the Senior Associate Dean for Research at the School of Medicine, that concludes that the postdoctoral candidate is exceptional and has the training, experience, preliminary data and publication track record to indicate that the grant application has a reasonable chance for a positive review and potential funding.
    6. The understanding that the grant may not, under any circumstances, support a graduate student.  If the grant will have funding to appoint a postdoctoral scholar, the waiver recipient would be responsible for the day-to-day research supervision of the work of the postdoctoral scholar; however, the overall career mentoring of the supported postdoctoral scholar would be the responsibility of an Academic Council or Medical Center Line faculty member.

    5. Pending Appointments for New Faculty

    Faculty whose appointment start date is in the future may apply for proposals through Stanford provided the project period start date is not prior to the appointment start date and the appointment has been approved by the Provost. In addition, an award cannot be accepted until the member’s appointment has begun.

    B. Exceptions for Senior and Distinguished Staff Scientists or Engineers of the SLAC National Accelerator Laboratory

    The SLAC National Accelerator Laboratory (SLAC) is a national laboratory of the U.S. Department of Energy operated by Stanford University under contract with the Department of Energy.  SLAC performs mission-driven basic research in particle physics, astrophysics, and photon science including synchrotron radiation.  As an affiliated academic unit of Stanford University, research conducted at SLAC is subject to Stanford University’s policies concerning the conduct of research.

    The Director of SLAC is responsible both for the administration and operation of SLAC as a national laboratory and for academic matters arising from SLAC’s role as an affiliated academic unit.

    SLAC Distinguished Staff Scientist or Engineer and Senior Staff Scientist or Engineer positions are reserved for individuals who have achieved recognition of research leadership nationally or internationally.  Distinguished Staff Scientists or Engineers are appointed by the SLAC Director and Senior Staff Scientists or Engineers are appointed by the Associate Laboratory Director of a particular directorate based on recommendations by a SLAC Appointments and Promotions Committee.

    To carry out SLAC’s research mission, the SLAC Director may approve SLAC Distinguished and Senior Staff Scientists or Engineers to be PIs on non-DOE funded research proposals.

    PI requests from SLAC Distinguished Staff Scientists or Engineers and Senior Staff Scientists or Engineers are subject to the following conditions:

    1. The proposed research must be judged by the SLAC Director to be programmatically relevant to SLAC’s mission.  Proposals that are not deemed to be consistent with SLAC’s mission will not be approved.

    2. The proposed research must be carried out on the SLAC site and not require utilization of space on the Stanford campus.

    3. A member of the Academic Council must serve as mentor for any Stanford graduate students or postdoctoral scholars involved in the proposed research.

    4. The research must be conducted in accord with the University’s policies concerning the conduct of research and approved PIs must receive PI training.

    C. Rare Exceptions Subject to the Approval of the Department Chair, School Dean and Dean of Research

    In addition to the foregoing, rare exceptions to the PI eligibility policy may be made at the discretion of the Dean of Research in unusual and non-recurring situations that meet a particular need or opportunity for the University. Such requests will be considered only for a specific project with a specific project period. Examples of rare exceptions that have been granted are: proposals submitted by visiting faculty members and other senior visitors for a limited period of time; proposals submitted by a faculty candidate selected by a department but not yet approved by the Provost, Advisory Board, and President; permission for administrators to submit proposals in support of a project in their area (e.g., the museum or the Stanford University Press); special cases of sponsored instruction; and situations where an Academic Council or MCL faculty investigator ceases to be available and it is necessary for the proposed PI to oversee an orderly phase out of a project.


    Requests for such exceptions should be made by a member of the Academic Council or MCL faculty on behalf of the proposed PI. Such requests are subject to the approval of the cognizant department chair, school dean, and the Dean of Research.

    In all cases, the following six criteria must be met:

    Criteria for Granting Rare Exceptions

    1. The proposed research must meet a programmatic need of Stanford. Meeting a programmatic need means addressing an area of investigation that is not currently covered at Stanford and is endorsed by a sponsoring member of the Academic Council or MCL faculty as directly relevant to and supportive of the research or teaching programs of the faculty. Research that may be important in its own right and for which outside funding is available will not be judged as meeting the programmatic need criterion unless it facilitates the ongoing objectives of the University in an identifiable and direct way.

    2. The proposed research cannot be funded and/or conducted effectively at Stanford unless the proposed individual is the PI. Among other things, this generally will mean that there is no member of the Academic Council or MCL faculty available to take the responsibility for the scientific direction of the project.

    3. The proposed PI's qualifications to direct the project provide assurance that the work will be conducted in accord with the standards of excellence of the University.

    4. No incremental space will be required for the project.

    5. For each graduate student participating in the project, a qualified faculty member has been identified to assure that the student's research program and the education derived from it are consistent with the degree for which the student is a candidate.

    6. The research must be designed and conducted in such a way that work can be discontinued when programmatic need ends or if the sponsoring faculty member ceases to be available.

    Exceptions to the PI eligibility policy will be rare in situations other than those described in Section 2.A and 2.B above. A written copy of any such requests, along with the justification and approvals of the sponsoring faculty member, the chair, school dean, and Dean of Research should accompany the sponsored project proposal submitted to the Office of Sponsored Research.

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    3. Project Designations Other Than Principal Investigator

    Establishment of project teams is the Principal Investigator's responsibility. In this regard, the PI will consider such factors as project requirements, sponsor guidelines related to key project personnel, and the qualifications and contributions of participating researchers, among other factors. Stanford University considers co-principal investigators (Co-PIs) to be equivalent to principal investigators in all regards; eligibility for co-principal investigator status is therefore the same as for principal investigator status, as defined in this policy. Other project designations are at the discretion of the Principal Investigator, and may include, for example:

    A. Associate Investigators

    In circumstances where this designation would be consistent with sponsor guidelines, the PI may designate members of the Academic Staff-Teaching (AS-T, Lecturers and Sr. Lecturers), Academic Staff-Research (AS-R, Research Scientists, and Sr. Research Scientists, Sr. Research Engineers, and Sr. Research Scholars), Academic Staff - Libraries (Assistant Librarians, Associate Librarians, Librarians, Senior Librarians), Postdoctoral Scholars, Instructors or other researchers as "Associate Investigators" on sponsored projects.

    B. Co-Investigators

    Senior members of the Academic Staff-Research (Sr. Research Scientists, Sr. Research Engineers, and Sr. Research Scholars) and senior members of the Academic Staff - Libraries (Librarians or Senior Librarians) may also be designated by their Academic Council or MCL faculty supervisors as "Co-Investigators" on those externally-funded projects in which such senior Academic staff members (Research or Libraries) carry substantial project leadership roles. It is not expected that this designation will normally be used for Postdoctoral Scholars, Instructors or other researchers, although such designation may be used in cases where the researcher is performing in such a role and the designation is allowed by the sponsor.

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    4. Review

    The PI Eligibility and Criteria for Exceptions policy, including all modifications, should be reviewed by the appropriate body of the Senate of the Academic Council in a period not more than five years from November 1991, and thereafter periodically at intervals not to exceed ten years.

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    2.2 Acting Principal Investigatorship

    Establishes the policy that acting principal investigatorship is subject to the same criteria for eligibility as regular PIship.

    Authority

    Office of the Vice Provost and Dean of Research, Promulgated in 1976 by Vice Provost for Research, William F. Massey

    Contact

    Serena Rao

    Senior Associate Dean for Finance and Administration

    Vice Provost and Dean of Research

    (650) 723-9050

    1. Eligibility

    Responsibilities for the intellectual direction of our externally sponsored teaching and research activities must rest with the faculty and may not be delegated to others, even on a temporary basis, without prior approval. Acting PIship is subject to the same criteria for eligibility as outlined in RPH 2.1, PI Eligibility and Criteria for Exceptions.

    If the PI of an on-going sponsored project will not be engaged in the project for a period of three months or more, another Academic Council member must be named as Acting PI to assume direction of the project, subject to the approval of the sponsoring agency.

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    3. Fiscal Responsibilities of Principal Investigators

    3.1 Preparation and Submission of Proposal Budgets

    Summarizes some of the obligations imposed on Principal Investigators by law and by Stanford policy. Establishes guidelines for the preparation and submission of proposed budgets, including consideration of allowability, cost sharing, commitment of effort, and estimating methods.

    Contact

    Serena Rao

    Senior Associate Dean for Finance and Administration

    Vice Provost and Dean of Research

    (650) 723-9050

    1. Responsibilities of the PI

    At Stanford, the Principal Investigator (PI) has overall responsibility for the technical and fiscal management of a sponsored project. This includes the management of the project within funding limitations, adherence to reporting requirements and assurance that the sponsor will be notified when significant conditions related to project status change. This document addresses specific responsibilities concerned with the financial management of sponsored projects. While responsibility for the day-to-day management of project finances may be delegated to administrative or other staff, accountability for compliance with Stanford policy and sponsor requirements ultimately rests with the PI.

    In proposing budgets for sponsored projects, the PI assures Stanford and the potential sponsor that project finances are represented as accurately as possible. In addition, specific requirements, including cost principles as defined by the federal government in §200 of the Uniform Guidance, and consistency requirements as imposed by the federal Cost Accounting Standards (CAS) Board, must be adhered to at the proposal stage, as well as when funds are expended.

    Stanford University requires all Principal Investigators including those receiving University Research awards to review their obligations for stewardship of sponsor funds and compliance with applicable regulations. This can be accomplished by completing DOR 680, PI Training: Steward and Compliance for Principal Investigators. Individuals can certify their review of this material in the training section of this website.

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    2. Allowability

    Proposals should not include expenses which the federal government (in the Uniform Guidance or other regulations) or the sponsor has identified as unallowable. Similarly, expenses which are to be considered as indirect expenses, e.g., certain types of office supplies and clerical salaries, may not be proposed and budgeted as direct expenses, unless they meet the criteria defined in the RPH, Charging for Administrative and Technical Expenses.

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    3. Cost Sharing

    When a PI proposes, and the University agrees to cost share University resources, the University is required to provide the stated resources in the performance of the awarded project. Considering the administrative requirements and responsibilities inherent in the cost sharing commitment, the PI (or other person responsible for the identified fund) should carefully weigh the cost effectiveness versus the expected benefits of each potential cost sharing commitment. Cost sharing of direct expenditures represents a redirection of departmental or school resources from teaching or other departmental and school activities to support sponsored agreements.  This commitment must be indicated on the Proposal Development Routing Form (PDRF). By approving the PDRF, the department chair or designee approves the cost sharing commitment. 


    Implicit in the University’s commitment to cost share is the PI's agreement to ensure that:

    • Voluntary cost sharing is permitted by the particular sponsor and project for which it is being proposed and that funds are available for cost shared direct costs. 
    •  He/She understands that unless specified in both the Federal awarding agency regulations and in a notice of funding opportunity, voluntary cost sharing is not expected by Federal sponsors and cannot be used as a factor during the merit review of proposals. 
    • Cost shared expenses are necessary and reasonable for proper and efficient accomplishment of project or program objectives.
    • Cost shared expenses will be appropriately charged, tracked, reviewed, certified and accounted for in compliance with University and sponsor requirements. 
    • University space is coded in the University's Space Inventory System, consistent with the coding of expenditures in the accounting system. 

    The PI will review and certify these expenditures in the same manner as all sponsored project spending. The tracking, reporting, and certifying of cost sharing are subject to audit.

     

     Review RPH 15.3 Cost Sharing Policy for more information.

     

     

    A. Federal Agency Guidelines on Cost Sharing

    According to the Uniform Guidance (effective 12/26/14), cost sharing may not be a factor in the review process unless it is both in accordance with Federal awarding agency regulations and specified in the notice of funding opportunity.

    B. NSF Guidelines on Cost Sharing

    The National Science Foundation prohibits the inclusion of voluntary committed cost in proposal budgets. Cost sharing will only be allowed when explicitly authorized by the NSF Director and included in specific program announcements.

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    4. Commitment of Effort

    Stanford University requires a commitment of effort on the part of the PI during the period in which the work is being performed. This effort may be expended during the academic year, summer quarter only, or both. Committed effort shall be direct charged or cost shared.

    The requirement of PI effort does NOT extend to:

    • equipment grants
    • seed grants for students/postdocs where the faculty mentor is named as PI, dissertation support, training grants or other awards intended as "student augmentation"
    • limited-purpose awards characterized by Stanford as Other Sponsored Activities, including travel grants, conference support, etc. (see RPH, Categories of Sponsored Projects for definition and further examples.)

    In preparing proposals, PIs must not over commit themselves or others. Distribution of effort must take into account the time required for teaching and campus citizenship.

    Research-only faculty on 12-month appointments may typically charge up to 95% to sponsored projects year round and must reserve a minimum of 5% effort for non-sponsored activities.

    Individual schools may have their own thresholds for how much FTE faculty members must reserve for non-sponsored activities.  

    • In the School of Medicine, all faculty (University Tenure Line, Medical Center Line, Non-Tenure Line) must reserve effort commensurate with their non-sponsored activities (e.g., clinical, administrative, teaching, proposal writing); 5% being the minimum level of effort which must be reserved for non-sponsored activities.

    See below for requirements for summer salary.

    PIs may submit proposals on the assumption that not all will be awarded, but, at the time of award, a reasonable representation of time to be devoted to the project, whether that effort will be paid for by the sponsor or by Stanford, is necessary. Subsequent changes in levels of effort may also require advance notification to and approval by sponsors (see RPH  Special Requirements Related to Sponsor Notifications and Prior Approvals).

    Find more information and Frequently Asked Questions on Faculty Effort here.

    A. Summer Salary

    A faculty member who is on a nine-month appointment may be paid from federal and/or non-federal sponsored projects for no more than 90% during any of the summer months. Salary charged to sponsored projects during the summer months must be consistent with effort expended during the same period.

    Find more information and Frequently Asked Questions on Summer Salary here.

     

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    5. Estimating Methods

    When estimating dollars to be budgeted for project expenses, estimating methods must be consistent with Stanford accounting practices and must allow expenditures to be accumulated and reported to at least the same level of detail as the estimate.

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    6. Budget Justifications

    Stanford is obligated to treat types of expenses consistently as either direct or indirect costs. If a proposed budget includes the direct expenditure of project funds for costs that would normally be charged indirectly, e.g., clerical and administrative expenses, general-purpose equipment, or operations and maintenance, then those items must be supported in the proposal by an explicit budget justification. In addition, when administrative and clerical salary costs are being proposed to a federal sponsor, the proposal must include an explanation of how the activities being performed by the administrative person are integral (i.e., vital, essential, fundamental) which allow the effort to be direct charged. (see RPH: Charging for Administrative and Technical Expenses).

     This section is not intended to override sponsor requirements related to proposals.

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    3.2 Management of Project Expenditures

    This policy summarizes Principal Investigator (PI) responsibilities outlined by Stanford including quarterly review and certification of salaries, other project costs, cost-shared expenditures, and monitoring of funds within the sponsor's funding limitations and project closeout. Stanford’s policy meets federal requirements.

    Contact

    Serena Rao

    Senior Associate Dean for Finance and Administration

    Vice Provost and Dean of Research

    (650) 723-9050

    1. Principal Investigator Responsibilities

    The PI has overall responsibility for the technical and fiscal management of a sponsored project. This includes the management of the project within funding limitations, adherence to reporting requirements and assurance that the sponsor will be notified when significant conditions related to project status change. This document addresses specific responsibilities concerned with the financial management of sponsored projects. While responsibility for the day-to-day management of project finances may be delegated to administrative or other staff, accountability for compliance with Stanford policy and sponsor requirements ultimately rests with the PI.

    Stanford University requires all Principal Investigators including those receiving University Research awards to review their obligations for stewardship of sponsor funds and compliance with applicable regulations. This can be accomplished by completing DOR 680, PI Training: Steward and Compliance for Principal Investigators. Individuals can certify their review of this material in the training section of this website.

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    2. Authorization of Direct Charges

    To authorize the expenditure of funds to be charged directly to sponsored projects, the PI and originating department must assure that the:

    • estimated charge is reasonable and necessary
    • expenditure is allowable by the funding source and, if charged to a federally funded project, by OMB Circulars A-21 and A-110 or the Uniform Guidance
    • expenditure provides benefit to the project
    • funds are available within the authorized award amount and funding limitations
    • justification for the expenditure is documented
    • method of allocation of costs is appropriate and documented
    • charge is coded with the correct Expenditure Type and charged to the correct account [Project Task Award (PTA)]
    • charge has been processed through the appropriate University system
    • salaries and wages charged are reasonable in relation to the work performed and to the individual’s total payroll distribution
    • payroll charge to each sponsored project account does not exceed the effort devoted to that project 
    • base salaries may not be increased as a result of replacing Stanford’s salary funds with sponsored project funds

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    3. Stanford Base Salary

    Stanford Base Salary (SBS) is the annual compensation paid by Stanford to individuals whose time is spent on research, teaching and/or other activities.

    Stanford Base Salary:

    1. Includes regular and supplemental salary
    2. Excludes honorarium, vacation accrual, bonus payments and extra compensation such as faculty housing allowance, tuition reimbursement, etc.
    3. Excludes any income that an individual is permitted to earn outside of their Stanford responsibilities (e.g., consulting payments)

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    4. Review of Project Expenditures by the Research Administrator (Task Manager)

    Sponsored project and cost sharing accounts must be reviewed by the Research Administrator and the review recorded/verified quarterly in the eCertification system.

    • Project expenses displayed in the eCertification system are the basis for cost reimbursements to Stanford.
    • Expenditures for sponsored projects and cost sharing accounts should be reviewed monthly by a knowledgeable individual i.e., the PI or designee typically the research administrator (the Task Manager).  
      • This review is documented quarterly by the research administrator in the eCertification System and is expected to be completed before the quarterly certification by the PI.
    • Any questionable charges must be brought promptly to the PI's attention, and, if needed, corrected by an appropriate transfer.
    • Transfers should be initiated as soon as possible after a need has been identified. Procedures governing transfers of expense are defined in RPH, 15.8 Cost Transfer Policy for Sponsored Projects.

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    5. Quarterly Review and Certification of Project Expenditures by the Principal Investigator

    Sponsored project and cost sharing accounts must be reviewed and certified by the PI quarterly in the eCertification system.  It is expected that the Research Administrator review the expenditures before the quarterly certification by the PI.  

    The following certification statement appears in the eCertification System.

    As the principal investigator I confirm to the best of my knowledge that the salary and wages charged to this project are appropriate in relation to work performed on this project. All other costs charged to this project are, to the best of my knowledge, appropriate. Where required, corrections have been or will be made through the accounting system.

    This certification is the responsibility of the project PI (or Co-PI). A PI may delegate the review of monthly expenditures for accuracy, but may not delegate certification of the appropriateness of the charges except as follows.

    • The PI may only delegate review and certification to a participating Academic Council member or PI eligible individual who is responsible for the portion of the statement of work for which they are responsible. The designee must be identified as the Task Owner in the accounting system.
    • If the PI of an on-going sponsored project will not be engaged in the project for a period of three months or more, another Academic Council member must be named as Acting PI to assume direction of the project, subject to the approval of the sponsoring agency.  The acting PI will assume the responsibility of review and certification of project expenditures. If the acting PI does not have firsthand knowledge of the appropriateness of project expenditures and is unable to certify he/she should contact please contact the Office of the Vice Provost and Dean of Research.
    • The purpose of the review and certification is to confirm that all expenses charged to the account are allowable, allocable to the project, and reasonable.
    • The certification of salary expenditures confirms that salaries charged to the account are supported by a corresponding expenditure of effort during the time period being certified.
    • The certification also assures that other expenditures are for items or services purchased and used during the project period as specified by the award.
    • Faculty who are not Principal Investigators and whose salary is charged to sponsored projects must review and certify their payroll distribution.
    • Expenditures must be reviewed and certified by the certification due date, which is approximately 75 days after the end of the academic quarter being certified.

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    6. Record Retention

    Adequate explanation and documentation for all project expenditures must be maintained for four years after Stanford closes out the award. Where documentation cannot be provided as to the allowability, allocability and reasonableness of any project expense, including but not limited to expenses incurred late in the project period, the sponsor may deny them. In this case, the PI, department or school will be expected to cover the expense from appropriate sources. All data in the eCertification System will be retained by ORA in accordance with University record retention requirements for sponsored projects (see Guide Memo 3.1.5: Retention of Financial Records.

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    7. Departure from Policy

    Any departure from the policy or procedures regarding Quarterly PI Review and Certification must be approved in advance by the Office of Vice Provost and Dean of Research (DoR) and The Office of Research Administration.

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    8. Charging Vacation to Projects

    Staff at Stanford University, including Academic Staff-Research (non-faculty), accrue vacation as specified by University policy  (Administrative Guide memo 2.1.6: Vacations). Stanford and the Office of Naval Research have established Vacation Accrual/Disability Sick Leave rates for exempt and nonexempt/bargaining unit staff. These accrual rates, reviewed and negotiated annually, enable Stanford to charge the appropriate funding source for vacation earned by benefits-eligible staff as they are working.

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    9. Charging Proposal Expenses to Ongoing Projects

    Proposal preparation costs are the costs of preparing proposals on potential Federal and non-Federal projects, including the development of data necessary to support Stanford's proposals.  These costs typically include salary for the PI and/or others. 

    The cost of proposal preparation activities in support of new and competing sponsored proposals cannot be charged to sponsored projects except when explicitly allowed or required by the sponsor (e.g. NIH Mentored Career Development Awards).

    The cost of proposal preparation efforts for a non-competing extension or continuing research may be charged to current related projects.

    Work performed by faculty, academic staff researchers, instructors and regular staff that is related to current projects may also be related to new projects in development. Only the incremental effort associated with proposal preparation that does not benefit the existing project(s) needs to be identified and charged to an appropriate non-sponsored account.

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    10. Monitoring of Funds within Sponsor Funding Limitations

    PIs are responsible for the ongoing fiscal management of awarded projects, including regular monitoring against project period budgets. Federal grants policy establishes the approved project budget as the financial expression of the project, and sponsors may evaluate the project against the budget at any time. Although sponsors allow certain flexibility with respect to rebudgeting, unobligated balances, and preaward costs, Stanford University and sponsors expect expenditures to be reasonably consistent with the approved project and budget. Sponsors may question or restrict expenditures that appear inconsistent with the project plan and budget. PIs are obligated to request prior approval when budget and program plan revisions indicate a significant change in scope. Indicators of a change in scope can include, for example, significant expenditures beyond the amount authorized on the award, or requests for additional funding.

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    11. Overdrafts

    It is Stanford's expectation that projects will be managed within their established budgets. If, as a result of unusual circumstances or unanticipated project expenses, an account is in overdraft upon expiration of the term of the sponsored project, and if additional funds have not been received from the sponsor, the PI must identify an appropriate source of funds (e.g., gift, endowment, or operating budget) to cover the expense. The overdraft must be transferred to a cost sharing award in sufficient time to permit Stanford to comply with the financial reporting requirements of the original award (See Project Closeout, below).

    The department must identify the source of funds to the Office of Sponsored Research or designated School office, which will create a cost sharing account. The department will then initiate the necessary expense transfer, including documentation of the nature of the expenses, noting they were legitimate project expenses but the funding was inadequate, and other reasons for the transfer. Such transfers must occur in sufficient time to permit Stanford to comply with the financial reporting requirements of Closeout, and the RPH: Cost Transfer Policy for Sponsored Projects.

    The PI, department or school is responsible for the timely clearance of any unfunded expenditures from within its resources.

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    12. No Cost Time Extensions

    If additional time is needed to complete a project and there is an unexpended balance in the award, PIs may request that the period of performance of an award be extended. In some cases, Stanford officials are authorized to approve no cost time extensions; in other cases, agency prior approval is required. Requests for extensions should be initiated by a PI and processed in accordance with the terms of the sponsored award; in most cases, the countersignature of an authorized institutional officer is required. To ensure compliance with the reporting requirements of awards, PIs are urged to submit no-cost time extension requests as soon as the need becomes apparent. Requests for a no cost time extension should be submitted no later than the end date of the award (unless an earlier date is required by the agency.) Award closeouts cannot be delayed to accommodate pending requests submitted after the award end date.

    If final technical reports are to be completed after the project end date, and funds from the project are available to pay these expenses, a no cost extension should be obtained from the sponsor to cover the expense of producing and distributing those reports. If funds are not available from the project, then the PI, department or school must identify unrestricted funds to pay final report costs.

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    13. Project Closeout

    PIs are responsible for overseeing the proper closeout of sponsored projects, including the timely submission of all required reports (including final technical reports). While central offices prepare and submit final administrative reports, including financial and property reports, they do so on the basis of documentation created in the department. PIs must assure that such documentation is adequate and readily available. In addition, PIs are responsible for ensuring that any necessary final financial adjustments and documentation (e.g., final invoices from vendors or subrecipients) are received promptly after the end of the award.

    If an approval to close an award has not already been provided by the PI, the Office of Sponsored Research will prepare and submit financial reports based on the information reflected in the financial system. In addition, some financial reports may require the PI's signature.

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    3.3 Sponsor Notifications and Prior Approvals

    The PI must assure that ongoing fiscal management is accomplished in accordance with sponsor requirements, including necessary notifications to the sponsor about project status.

    Contact

    Serena Rao

    Senior Associate Dean for Finance and Administration

    Vice Provost and Dean of Research

    (650) 723-9050

    1. Principal Investigator Responsibilities

    The PI is responsible for necessary notifications to the sponsor about project status. In all cases, required notifications or requests for prior approval of contract or grant status, including those described in the sections below, should be made in writing to the sponsor. Such notifications must be coordinated through the Office of Sponsored Research (OSR) or the Research Management Group (RMG) in the School of Medicine.

    A. Changes in PI Status

    In addition, sponsors often have requirements regarding notification or prior approval of changes in availability of the PI:

    • For federal contracts and non-federal projects, the terms and conditions of the particular agreement will govern 
    • For federal grants, OMB requires prior written approval from the awarding agency for either of the following circumstances involving the PI or approved Project Director:

    1. A reduction in time devoted to the project of 25% or more from the proposed and awarded level

    2. Disengagement from the project for more than three months (see RPH 2.2 Acting PIship)

    For any additional requirements, review the grant award and grant policy of the specific agency.

    The PI, Department Chair, or department administrator should contact OSR or RMG to coordinate securing required approvals in either of the circumstances above. If, in the original award, Stanford committed to cost share any PI effort and the PI reduces his or her overall committed level on the project, OSR or RMG will also negotiate reductions in levels of the cost-shared component of effort, as appropriate.

    In addition, when a PI's faculty appointment will terminate prior to or during a project's period of performance, OSR or RMG must inform the sponsor.

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    4. Conflicts of Commitment and Interest

    4.1 Faculty Policy on Conflict of Commitment and Interest

    Presents and discusses circumstances which can create real or perceived conflicts of commitment and conflicts of interest for faculty. Establishes requirements for annual disclosures and certifications, and for those made at the time of a transaction such as a sponsored project or gift.

     

    Authority

    Developed by the Committee on Research and approved by the Senate of the Academic Council. Sections on Intellectual Property also approved by the Board of Trustees.

    Contact

    Mary Lee

    Director, University Conflicts of Interest Office

    Vice Provost and Dean of Research

    (650) 736-6518

    1. Introduction

    Stanford's policy and procedures regarding conflict of commitment (COC) and conflict of interest (COI) apply to all members of the Stanford faculty (Academic Council and Medical Center Line) including faculty members serving as University officers. (See the Stanford Faculty Handbook for policies governing those with adjunct, visiting and acting faculty appointments and the School of Medicine Faculty Handbook, Chapter 8.6.C, for policies governing Clinician Educators.). School deans are responsible for ensuring implementation of this policy. The Vice Provost and Dean of Research (Dean of Research) is responsible for interpretation and overall coordination of the policy. Violation of any part of this policy may cause a faculty member to be subject to sanctions, including those described in the Statement on Faculty Discipline. This policy will be modified as necessary to be in compliance with the requirements of external agencies.

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    2. General Principles

    A. Conflict of Commitment

    Stanford faculty members owe their primary professional allegiance to the University, and their primary commitment of time and intellectual energies should be to the education, research and scholarship programs of the institution. The specific responsibilities and professional activities that constitute an appropriate and primary commitment will differ across schools and departments, but they should be based on a general understanding between the faculty member and his or her department chair and school dean.

    Even with such understandings in place, however, attempts of faculty to balance University responsibilities with external activities--such as consulting, public service or pro bono work--can result in conflicts regarding allocation of time and energies. Conflicts of commitment usually involve issues of time allocation. Whenever an individual's outside professional activities as defined in Stanford's policy on Consulting and Other Outside Professional Activities exceed the permitted limits (normally thirteen days per quarter), or whenever a full-time faculty member's primary professional loyalty is not to Stanford, a conflict of commitment exists. If a situation that raises questions of about a possible conflict of commitment arises, faculty should discuss the situation with their department chair or school dean, or the Dean of Research.

    B. Conflict of Interest

    Stanford University is an institution of public trust; faculty must respect that status and conduct their affairs in ways that will not compromise the integrity of the University or that trust.

    A conflict of interest occurs when there is a divergence between an individual's private interests and his or her professional obligations to the University such that an independent observer might reasonably question whether the individual's professional actions or decisions are determined by considerations of personal financial gain. A conflict of interest depends on the situation, and not on the character or actions of the individual.

    Conflicts of interest are common and practically unavoidable in a modern research university. At Stanford, conflicts of interest can arise out of the fact that a mission of the University is to promote the public good by fostering the transfer of knowledge gained through University research and scholarship to the private sector. Important means of accomplishing this mission include faculty consulting, outside speaking engagements, publications, and the commercialization of technologies derived from faculty research. It is appropriate that faculty be rewarded for their participation in these activities through consulting fees, honoraria and sharing in royalties resulting from the commercialization of their work. It is wrong, however, for an individual's actions or decisions made in the course of his or her University activities to be determined by considerations of personal financial gain; faculty should be sensitive even to the appearance of that possibility. Such behavior calls into question the professional objectivity and ethics of the individual, and it also reflects negatively on the University.

    Faculty members should conduct their affairs so as to avoid or minimize conflicts of interest, and must respond appropriately when conflicts of interest arise. To that end, the purposes of this policy are to educate faculty about situations that generate conflicts of interest, to provide means for faculty and the University to manage conflicts of interest, to promote the best interests of students and others whose work depends on faculty direction, and to describe situations that are prohibited. Every Stanford faculty member has an obligation to become familiar with, and abide by, the provisions of this policy. Conflicts of interest must be disclosed to Stanford when personal financial relationships or activities with outside entities occur that would reasonably appear to be related to a faculty member's Stanford institutional responsibilities for research/scholarship, education/teaching, administration or clinical care. All such financial activities and relationships must be disclosed annually and at the time of a specific transaction. Disclosure and University review also allow faculty to comply with federal agency regulations for example, see RPH: PHS and NSF Requirements Regarding Financial Disclosures and Agency Notifications.

    Common sense must prevail in the interpretation of these policies. That is -- no matter what the circumstances -- if an independent observer might reasonably question whether the individual's professional actions or decisions are determined by considerations of personal financial gain, the relationship should be disclosed to the public during presentations, in publications, teaching, or other public venues.

    3. Key Provisions - Summary

    Below is a summary of the key provisions of this policy. Faculty should read the document in its entirety to fully understand the spirit of these provisions, the bona fide exceptions, and the requirements for compliance. (See section 4.  for discussion and detail for each of the following provisions.)

    1. Faculty must maintain a significant physical presence on campus (main or overseas) throughout each quarter they are on active duty.
    2. Faculty must not allow other professional activities to detract from their primary allegiance to Stanford. For example, a faculty member on full-time active duty must not have significant outside managerial responsibilities or titles that suggest such responsibilities (e.g., chief operating officer), or act as a PI on sponsored projects that could be conducted at Stanford University but instead are submitted and managed through another institution (excluding such agreements as Stanford-managed sub-awards or collaborations).
    3. Faculty must foster an atmosphere of academic freedom by promoting the open and timely exchange of results of scholarly activities, and ensuring that their advising of students (defined for this policy to include postdoctoral scholars and other trainees) and their supervision of staff are independent of personal financial interests. Faculty should inform students and colleagues about outside obligations that might influence the free exchange of scholarly information between them and the faculty member.
    4. Faculty may not use University resources or personnel, including facilities, staff, students or other trainees, equipment, or confidential information, except in a purely incidental way, as part of their outside consulting or business activities or for any other purposes that are unrelated to the education, research, scholarship, and public service missions of the University.
    5. Faculty must disclose on a timely basis the creation or discovery of all potentially patentable inventions created or discovered in the course of their University activities or with more than incidental use of University resources. If intellectual property rights are to be claimed, ownership of such inventions is assigned to the University regardless of the source of funding. The inventor will share in royalties earned. The inventor(s), acting collectively where there is more than one, are free to place their inventions in the public domain if they believe that would be in the best interest of technology transfer and if doing so is not in violation of the terms of any agreements that supported or are related to the work.
    6. Faculty must disclose to the University whether they (or their spouse/domestic partner or dependent children) have a financial interest (defined below) in an outside entity that would reasonably appear to be related to their institutional responsibilities. Disclosures of such interests are also required when the faculty member is involved in a specific transaction, including:
    • gifts
    • sponsored projects
    • technology licensing arrangements
    • protocols that use human subjects, animals or stem cells
    • material transfer and collaboration agreements
    • certain procurements (e.g., sole source or from a privately-held company) 

    In such cases, review and approval by the school dean, the cognizant dean for COI or the designated COI program administrator will be required prior to entering into the proposed arrangement.

    1. Financial interests that are disclosed and deemed to be related to one or more of the faculty member's institutional responsibilities will be further reviewed to determine if the financial interest or relationship could have a direct and significant effect on the faculty member's performance of his or her responsibilities. If such a situation exists, the conflict will need to be eliminated or managed according to a plan provided to the faculty member by the cognizant dean for COI. Other administrative actions, such as disclosure in publications and public talks, may be required when the financial interest is not considered likely to directly and significantly affect performance of institutional responsibilities.
    2. On an annual basis all faculty members must certify to their school deans their compliance with Stanford's policies related to conflict of commitment and conflict of interest. They must also disclose information not previously reported about their existing or new financial relationships (or those of their spouse/domestic partner or dependent children) with outside organizations, which would reasonably appear to be related to their institutional responsibilities, as soon as such situations become known to the faculty member.
    3.  School deans shall establish procedures to ensure timely review of their faculty’s disclosures of potential or apparent conflicts of interest, both annually and at the time of a specific transaction, and to ensure (in consultation with the Dean of Research office) the elimination or appropriate management of such conflicts. School deans will file their own annual disclosures and certifications of compliance with the Dean of Research.
    4. The Dean of Research shall:
    • approve each school dean's plans for implementing this policy
    • interpret policy provisions in consultation with school deans
    • respond to faculty wishing to appeal a school dean’s decisions
    • report to the Committee on Research annually on the status of this policy and its implementation
    1. Should a faculty member wish to appeal a decision made by the Dean of Research, he or she may present the appeal to the Provost, who will consider the case in consultation with the Advisory Board of the Academic Council.

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    4. Discussion and Detail

    A. Presence on Campus

    Appointment as a faculty member of Stanford University confers the privilege and obligation to pursue teaching, research, scholarship, and clinical care (whichever are appropriate to the position held). In addition, Academic Council members are expected to participate in University governance, in the formulation of academic policy, and in the determination of the intellectual directions and academic priorities of the University. Fulfillment of these obligations requires a primary commitment of expertise, time, and energy.


    A full-time appointment conveys an obligation for a faculty member to have a significant physical presence on campus (main or overseas), to be accessible to students and staff, and to be available to interact with Stanford colleagues throughout every quarter during which he or she is on active duty, unless the department chair and/or school dean has granted specific prior approval for extended or frequent absences from campus. Because requirements for field research and other reasons for absence from campus differ across the University, schools and departments should define for their faculties what qualifies as inappropriate, extended, or frequent absences.

    B. Limitations on Outside Professional Activities

    Stanford encourages faculty to become involved in the transfer of knowledge from the University to the public and into the commercial marketplace. It is an appropriate role for the University to facilitate the transfer of the knowledge gained through academic research to applications that can benefit the general population. Moreover, experience gained by faculty in the course of outside professional activities can enhance their teaching and research or scholarship within the University. But the process of information and technology transfer can create the potential for conflicts of commitment and/or interest, particularly when there is opportunity for personal financial gain on the part of the faculty. The intent of this provision of the policy is to minimize these conflicts and provide means of managing them when they arise.

    An implicit assumption underlying the University's policy RPH: Consulting and Other Outside Professional Activities is that such outside professional activities are a privilege and not a right and must not detract from a faculty member's full-time obligation to his or her University duties. When any outside activity detracts from the conduct of University duties, a conflict of commitment will result. Even activities such as pro bono work, U.S. government service in the public interest, and any outside employment unrelated to the faculty member's University responsibilities (therefore not included as "consulting" in the policy on outside professional activities), should be managed so they do not take precedence over a faculty member's primary commitment to the University. See below in Related Items: Faculty Handbook, Section 2.7.G, for limitations on faculty appointments at other academic institutions.

    Outside professional activities can also generate conflicts of commitment regardless of the time involved. Stanford faculty members on active duty normally are prohibited from serving as principal investigators on sponsored projects submitted and managed through other institutions. This stipulation is not intended to limit faculty from participating in multi-site training or research programs for which Stanford University receives a subaward or has a collaborative or other agreement, nor is it intended to apply to circumstances in which the faculty member's research requires access to specialized facilities not available at Stanford.

    Because full-time faculty are expected to devote their primary energies and professional interests to their University obligations, they may not accept significant managerial responsibilities or titles that suggest or connote managerial or supervisory responsibilities (e.g., CEO, Director, Scientific Officer, or Vice President) as part of their outside consulting activities. To avoid implying a line management role, terms such as ‘officer’ or ‘vice-president’ must not be used; on the other hand, the terms ‘ Advisor’ or ‘Consultant’ may be used, e.g., ‘Chief Scientific Advisor’, or ‘Chief Technical Consultant'.  Normally it will be necessary for faculty to take a full leave of absence from their University responsibilities in order to take on a significant management role in an outside entity; doing so while on sabbatical is not permitted. Service on boards of directors or advisory boards is allowed.

    Faculty members must establish clear boundaries that separate their University and outside obligations, so as to avoid questions about their appropriate use of resources and attributions of products of their work. The Stanford name and logo may not be used in consulting activities. Outside activities may not include either:

    • A promise or assignment to a third party of intellectual property conceived, or first reduced to practice, in whole or in part, in the course of University responsibilities, or with more than incidental use of University resources, to the third party; or
    • The extension of Stanford research into the consulting activity, such that a third party receives early or exclusive access to Stanford research results.

    If a faculty member is listed as an author on any publication resulting from performance of consulting services, a disclosure should be included clearly stating that the contribution to the publication was as a paid consultant, and was not part of his/her Stanford University duties or responsibilities. The same disclosure should be given in speaking activities related to consulting services see RPH: Consulting and Other Outside Professional Activities.

    C. Free and Open Exchange of Research Results

    The integrity of the University as a community of scholars requires the free and open exchange of ideas and the results of scholarly activities. Faculty are obligated to maintain an atmosphere free from unwarranted external influences. Students and collaborators must be able to pursue topics of interest, have access to available information and facilities, and be able to communicate the results of their work to other scholars and the public. Therefore, faculty must ensure that:

    • The results of research or scholarship undertaken at Stanford are disseminated on an open and timely basis to the broader scholarly community and public in keeping with Stanford's RPH: Openness in Research policy
    • The academic activities of students and postdoctoral scholars are free from the personal commercial interests of the faculty member
    • The work of students, staff, postdoctoral scholars and collaborators is not exploited in the course of a faculty member's outside obligations. To this end, a faculty member should be open with his or her students, staff and colleagues about the faculty member’s involvement with and obligations to outside third parties who could benefit from their work or ideas. Similarly, students, associates, and staff should have access to information about the sources of funds that support their research

    This policy requires that consulting, technology licensing or other agreements with third parties, including nondisclosure or confidentiality agreements, must not delay or prohibit publications resulting from Stanford research and scholarship. In addition, faculty should, and in some circumstances will be required to, disclose their financial relationships in publications and public discussions of research or scholarship supported by or in a field relevant to the interests of the company/organization.

    D. Appropriate Use of University Resources, Including Facilities, Personnel, Equipment, and Information

    Faculty may not use University resources or personnel, including facilities, staff, students or other trainees, equipment, or confidential information, except in a purely incidental way, as part of their outside consulting or business activities or for any other non-University purposes. Inappropriate use of University resources includes the following:

    • Assigning tasks to the faculty member's students, staff, or postdoctoral scholars for purposes of potential or real financial gain of the faculty member rather than the advancement of the scholarly field or the students' educational needs.
    • Involvement of the faculty member's students or staff in his or her outside consulting or business activities without prior review and approval by the school dean and the Dean of Research.
    • Granting external entities access to Stanford resources, personnel or services for purposes outside the University's missions, or offering inappropriate favors to outside entities in an attempt to unduly influence them in their dealings with the University or for personal financial gain.
    • Using confidential information acquired through conduct of University business or research activities for personal gain, or granting unauthorized access of others to such information. Confidential information includes, but is not limited to, medical, personnel, or security records of individuals; proprietary knowledge about corporate anticipated material requirements or price actions; and proprietary knowledge of possible new sites for government operations or information about forthcoming programs or selection of contractors or subcontractors in advance of official announcements.
    • Providing preferential access to research results, materials or products generated from University teaching or research and scholarly activities to an outside entity for personal financial gain. (This would not preclude appropriate licensing arrangements for inventions, or consulting on the basis of sponsored project results where there is significant additional work or expertise involved.)

    E. Disclosure and Ownership of Intellectual Property

    All potentially patentable inventions, including patentable software, created or discovered by faculty in the course of their University activities, or with more than incidental use of University resources, must be disclosed to the University on a timely basis. If intellectual property rights are to be claimed, ownership of these inventions is assigned to the University regardless of the source of funding. The inventor(s), acting collectively where there is more than one, are free to place their inventions in the public domain if they believe that would be in the best interest of technology transfer and if doing so is not in violation of the terms of any agreements that supported or are related to the work.

    Institutional management of the commercialization of technologies developed using University resources guarantees that contractual obligations to sponsors are fulfilled. Stanford management of technology also reduces the potential for individual conflicts of interest, since the institutional managers of the assets do not have personal financial interests in the outcomes of licensing processes nor do they participate in making academic or future research decisions.

    In this context, "invention" includes tangible research property. The term does not, however, include books, scholarly articles, musical and artistic works, and other forms of educational media, title to which remains with the creator. In accord with academic tradition, except to the extent required by the terms of funding agreements, Stanford does not claim ownership to pedagogical, scholarly, or artistic works, regardless of their form of expression. Such works may represent the personal or scholarly beliefs of the author. The protection of academic freedom of the faculty requires that the University not attempt, nor have the right, to control the content or distribution of such works. An additional consideration is that the University does not wish to accept liability for a faculty member's works that are individual forms of expression.

    Ownership of computer software requires special consideration. Some forms of software are patentable, and thus are governed by Stanford RPH policy on patentable inventions. Other forms of software are more like books in that they are digital expressions of scholarly, artistic, or educational works, in which case title rests with the creator. Rights to software that is not patentable rest with the individual faculty creator except in the following circumstances: the work is supported by a direct allocation of funds through the University for the pursuit of a specific project, is commissioned by the University, or is otherwise subject to contractual obligations. In addition, Stanford University resources are to be used solely for University purposes and not for personal gain or personal commercial advantage, nor for any other non-University purposes. Therefore, if the creator of a copyrightable work makes significant use of the services of University non-faculty employees or University resources to create the work, he or she shall disclose the work to the Office of Technology Licensing and assign title to the University. Ordinary use of desktop computers, University libraries and limited secretarial or administrative resources is not considered to be significant.

    Title to software created jointly with students or other faculty shall be jointly owned by the creators. Title to software created jointly by faculty and University staff members will be jointly owned between the faculty creator and the University. Faculty must be aware, however, that the creation, upgrade, or maintenance of commercializable software, when done as part of a faculty member's University activities, can lead to the same types of conflicts of commitment and interest as patentable inventions. It is the responsibility of the faculty member to avoid such conflicts. One way of doing so is to voluntarily assign copyright and licensing authority to the University.

    This policy is not intended to slow or restrict the transfer of technology, so if the University does not proceed in a timely manner (e.g., sixty days) to initiate patenting of a technology and/or licensing it, the ownership may be reassigned to the creator at his or her request if permitted by contractual obligations. In those cases where the sponsor requires the University to take title, the University may recommend to the sponsor that ownership be assigned to the inventor. When the University is successful in the licensing of a technology created by a faculty member, he or she will share in the royalties earned under the terms of the applicable University policy. Further development of the intellectual property is the responsibility of the licensee and must be pursued without use of University resources.

    F. Faculty Disclosure of Financial Interests in Outside Entities Related to Their Institutional Responsibilities

    A faculty member must disclose personal financial interests (or those of his or her spouse/domestic partner or dependent children) to the University when the interest reasonably appears to be related to his or her institutional responsibilities. 


    Disclosure must be made when the faculty member (or his or her spouse/domestic partner or dependent children) has:

    • One or more financial interests, including payment for services, income such as consulting fees, paid honoraria, equity, stock/stock options or other ownership interest, royalties from intellectual property not owned by Stanford; or salary for spouse/domestic partner 
and
    • The financial interest reasonably appears to be related to one or more of the faculty member's Stanford institutional responsibilities, including research/scholarship, teaching/education, administration or clinical care.

    This information will be reviewed to determine whether a "significant financial interest" (SFI) exists. Criteria to be used to help define SFI include:

    • any current or pending ownership interests (including shares, partnership stake, or derivative interests such as stock options) in a privately-held entity (e.g., in a "start up" company)
    • any current or pending ownership interests of $5,000 or more (including shares, partnership stake, or derivative interests such as stock options) in a publicly-traded entity (except when the ownership interest is managed by a third party such as a mutual fund)
    • any income amounting to $5,000 or more per year per company/organization, including, for example, payment for services, consulting fees, honoraria, licensing or royalty income; or any financial interests in a single company/organization ( listed above) that amount to $5,000 or more in aggregate.

    The faculty member's financial interest in the company/organization will be considered as reasonably appearing to be related to his or her research or other University responsibilities in circumstances such as when the company/organization:

    • Sponsors research at Stanford in which the faculty member is directly involved
    • Has interests that could reasonably be considered to have a potential influence on the design, conduct or reporting of the faculty member's research/scholarship
    • Has company interests such that the faculty member's research/scholarship could reasonably be considered to have a possible effect on the company/organization's interests
    • Sponsors or makes a product that is under study in any research (including, but not limited to, human subjects or animal research) in which the faculty member is directly or indirectly involved
    • Makes gifts to Stanford of funds or property (including equipment loans), which will be under the control of, or will directly support the teaching or research activities of the faculty member
    • Licenses Stanford intellectual property in which the faculty member has a financial interest
    • Has a Materials Transfer Agreement (MTA) to provide materials used in the faculty member's research or for materials to be provided by the faculty member
    • Is the sole-source provider of materials or services or of procurements from a privately-held entity
    • Provides financial support for the faculty member's trainees (including graduate students and postdoctoral fellows)
    • Has products (excluding textbooks) or devices that are used in the faculty member's teaching
    • Produces or markets online learning services or materials in which the faculty member has an interest
    • Supports the faculty member's participation as a lecturer/speaker in continuing education activities or on-line education programs
    • Has financial interests that would reasonably appear to be related to the faculty member's administrative duties 
    • Has financial interests that would reasonably appear to be related to the faculty member's clinical care responsibilities.

    When a “significant financial interest” (SFI) related to the faculty member's institutional responsibilities is identified, the circumstances will be evaluated further, as described below. In addition, faculty are strongly encouraged to disclose to the public any financial interests related to their institutional responsibilities whether or not these interests meet the SFI criteria in order to maximize transparency. Faculty receiving PHS awards must also disclose sponsored travel. See below in related items: PHS and NSF Requirements Regarding Financial Disclosure and Agency Notifications.

    Faculty must complete training about COI according to University requirements.

    G. Review of Disclosures of Faculty Financial Interests in Outside Entities Related to Their Institutional Responsibilities

    When a faculty member makes a disclosure, the school dean, the cognizant dean for COI or the designated COI program administrator shall review the circumstances to determine whether it represents a significant financial interest (SFI) and reasonably appears to be related to one or more of the faculty member's institutional responsibilities. The circumstances will then be assessed to determine whether the SFI could have a direct and significant effect on the faculty member’s performance of these duties. If so, the SFI will be deemed a "financial conflict of interest (FCOI)" as defined by federal regulations and management options will be provided to the faculty member depending upon whether the conflict involves research/scholarship, teaching/education, administration or clinical care duties. See RPH: PHS and NSF Requirements Regarding Financial Disclosures and Agency Notifications, and the School of Medicine Industry Interactions Policy and Clinical Care Policy.

    The faculty member may decide to discontinue the relationship or divest the financial interest that creates the conflict, or decide not to participate in the specific institutional activity that generates the conflict. In some circumstances, the conflict may be managed by requiring one or more of the following:

    • Public disclosure of the significant financial interest;
    • Training about conflicts of interest and commitment for involved students and personnel;
    • Independent monitoring and oversight of the activity;
    • Modification of the Stanford activity to remove the conflicted faculty member from participation in all or some portion of the activity
    • Other mitigating strategies.

    When the significant financial interest is related to research involving human subjects and is greater than $10,000, the situation will be considered a financial conflict of interest (FCOI) as defined by PHS regulation. In such cases, the investigator must provide compelling reasons, detailing his or her unique contribution to the study, in order to justify continued involvement. Without compelling reasons to maintain direct involvement or a plan that isolates the investigator from direct interaction with the human subjects, identified patient specimens or research data, the investigator will be required to reduce his or her financial interest below $10,000 or the work may not be done at Stanford or by the investigator at another location.

    When conflicts of interest are related to gifts, faculty must follow University procedures to document the terms of all such gifts so that the exact nature of the exchange is spelled out. Gifts should not create a venue for privileged access to research results or an opportunity for promoting a company's product or products, or provide the company with preferential treatment. See RPH: Establishment of Industrial Affiliates and Related Membership-Supported Programs, in regard to Industrial Affiliate programs.

    Conflicts of interest involving technology transfer, material transfer or collaborative agreements require review and approval by the Dean of Research.

    H. Certification of Compliance with the Conflict of Commitment and Conflict of Interest Policy

    On an annual basis and at any time when a situation that requires disclosure occurs, all faculty members must certify to their school deans their compliance with Stanford's policies related to conflict of commitment and conflict of interest. These reports are considered confidential and will be reviewed only by the school dean, or designated individuals such as an associate dean, the department chair, senior administrative staff, the Dean of Research, and University officials in Internal Audit and Office of General Counsel. Disclosures that are identified by the review as financial conflicts of interest related to PHS (NIH) funded research must be reported to the NIH and made available to the public. See RPH: PHS and NSF requirements regarding financial disclosures and agency notifications. 


    All faculty members must provide the information requested through the OPACS Outside Professional Activities Reporting Dashboard. Individual schools of the University may request additional information as needed to evaluate conflicts of interest in their fields and disciplines.


    In addition, faculty members must disclose to their school situations that may raise questions of conflict of commitment or interest, as soon as such situations become known to the faculty member and as required at the time of a particular transaction, such as submission of grants or human subjects research protocols, receipt of gifts, technology licensing, and materials transfer agreements.

    I. Responsibilities of the School Deans

    Each school dean is responsible for the timely collection and review of annual certifications related to conflicts of commitment and conflicts of interest, as well as of new disclosures that occur during the year, and (in consultation with the Dean of Research office) for the management of conflicts of interest that arise. The review process in each school may be assigned to a faculty senior associate dean and designated COI administrators. The school dean or the Dean of Research may convene a committee to advise him or her in the evaluation and options for management of conflicts of interest. The committee may include other members of the faculty and/or individuals not otherwise affiliated with Stanford who have no vested interests in the outcome of the proposed arrangements Individual schools may have more, but not less, restrictive internal policies than those set forth by the University. School deans will file their own annual disclosures and certifications of compliance with the Dean of Research.

    J. Responsibilities of the Dean of Research

    The Dean of Research is the University officer responsible for interpreting and overseeing implementation of and compliance with this policy. He or she is responsible for reviewing and approving each school's mechanisms for implementing this policy, for consulting with school deans to determine appropriate strategies for managing conflict situations, and for reporting annually to the Committee on Research on the effectiveness of the policy throughout the University. In addition, the Dean of Research shall adjudicate situations in which faculty wish to appeal a decision of a school dean. The Dean of Research shall work with school deans to ensure that this policy is implemented with consistency across the University.

    K. Appeals of Decisions Made by the Dean of Research

    Should a faculty member wish to appeal a decision made by the Dean of Research, he or she may present the appeal to the Provost, who will consider the case in consultation with the Advisory Board of the Academic Council.

    5. Attachment A: Stanford University Requirements for Faculty Consulting Activities and Agreements

    Print RPH 4.1 Attachment A

    Stanford University Requirements For Faculty Consulting Activities and Agreements

    The terms of consulting and non-disclosure agreements between faculty and external organizations must be consistent with all of the following requirements:

    1. Stanford University is not a party to consulting or non---disclosure agreements between faculty and external organizations, shall have no obligations or potential liability under the agreements, and its rights may not be impaired in any way by the agreement. The university does not provide indemnity insurance for these activities.

    1. Consultant’s Obligations to Stanford

      • Consulting is permitted provided the faculty member's full---time obligation to the University is met.

      • Stanford faculty members owe their primary professional allegiance to Stanford University, and their primary commitment of time and intellectual energies should be to the education, research, and scholarship programs of the institution.  Outside professional activities must not detract from a faculty member's full---time obligation to these duties.

    1. Limitations on time spent as a consultant and type of responsibilities

      • The maximum number of consulting days permissible for faculty on a full-time appointment is 13 days per academic quarter.

      • A faculty member on full---time active duty or sabbatical leave must not have outside managerial responsibilities and may not have titles that imply management responsibilities, e.g. Chief Scientific Officer, Chief Technical Officer, Director of Research, regardless of actual consulting duties.

    1. Restrictions concerning students and research staff

      • The academic activities of students and postdoctoral scholars must be free from the personal commercial and consulting interests of the faculty member.

      • The work of students, staff, postdoctoral scholars and collaborators must not be exploited in the course of a faculty member's outside obligations.

      • Faculty may not hire or directly supervise a Stanford student in employment activities outside the University while serving as the student's advisor or as a participant on the student's dissertation committee without written approval.

    1. Restrictions on use of University resources

      • Stanford facilities, personnel and equipment may not be used except in a purely incidental way, as part of outside consulting activities.

      • Preferential access to research results, materials or products generated from University teaching or research activities may not be provided to an outside entity for personal financial gain.

      • Confidential information acquired through conduct of University business or research activities may not be used for personal gain, or to grant unauthorized access to others; confidential information includes any information that comes into your possession as a result of your employment by Stanford that is not broadly available to the general public.

    1. Ownership of intellectual property

      • Stanford owns the title to all potentially patentable inventions conceived, or first reduced to practice, in whole or in part, by faculty in the course of University responsibilities, or with more than incidental use of University resources, and must be assigned to the University.  Faculty members do not have the authority to assign or otherwise transfer rights in any of the University’s inventions.

      • Any publication, invention, discovery, improvement, or other intellectual property that results solely and directly from Consultant’s services either alone or with employees of or other consultants or advisors to the external organization are not subject to Stanford disclosure and ownership policies.

    1. Use of the Stanford name

      • The Stanford name and logo may not be used in any consulting activities.

      • The office address of the consultant may be used for convenient communication.

    1. Authorship, speaking and marketing activities

      • If a faculty member is listed as an author on any publication resulting from performance of consulting services, a disclosure should be included stating that “Dr./Professor [NAME]’s contribution to this publication was as a paid consultant, and was not part of his/her Stanford University duties or responsibilities”.

      • The same disclosure should be given in speaking activities related to consulting services.

      • Stanford School of Medicine faculty are prohibited from publishing articles under his/her own name that are written in whole or material part by company employees (so---called “Ghost Written”).

      • Stanford School of Medicine faculty are not permitted to participate in dedicated marketing and training programs designed solely or predominantly for sales or marketing purposes. All faculty are strongly discouraged from performing any sales, marketing, or promotional services for the company requesting consulting services. This includes promotional marketing activities to academic colleagues, clinical colleagues, the media, the public or as an exhibitor.

      • Stanford School of Medicine faculty are prohibited from being members of ‘Speakers Bureaus’.

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    6. Attachment B: Faculty Investment in Stanford Student Companies

    Created: September 18, 2013

    Faculty Investment in Stanford Student Companies

     

    Are faculty permitted to invest in start-up companies of current Stanford University students?

    All faculty should consider carefully whether investing in any current student or postdoctoral fellow’s company is in the best educational interest of the student or fellow, whether or not the faculty member has any involvement with the student’s academic program. However, a higher standard applies when a faculty member has direct involvement in a student or postdoctoral fellow’s academic program, including as the academic advisor, an honors/PhD thesis advisor, or a classroom teacher in the student’s major. In these circumstances, a faculty member who wishes to invest in a current student or postdoctoral fellow’s start-up company must receive approvals from the Dean of the student or postdoctoral fellow’s school, the Dean of the faculty member’s school and the Vice Provost and Dean of Research. The strong presumption is that such involvement would constitute a significant conflict of interest that could not be mitigated or managed and that it would therefore not be permitted. Academic staff, other teaching staff, and those who directly interact with students and postdoctoral fellows in the role of instructor or advisor should also follow these procedures.

    What would be the nature of the conflict of interest in this situation?

    University policy states that “a conflict of interest occurs when there is a divergence between an individual’s private interests and his or her professional obligations to the University such that an independent observer might reasonably question whether the individual’s professional actions or decisions are determined by considerations of personal financial gain.” More specifically regarding conflicts of interest in teaching and educational activities, University policy states that: “education and guidance given to students by faculty, including the nature and direction of research or other studies, should be governed by what is in the academic interest of the student.”

    A faculty member investing in a current student or postdoctoral fellow’s company inherently creates a situation in which an independent observer might reasonably question whether the individual’s professional actions or decisions in relation to that student or fellow are determined by considerations of personal financial gain. Examples of actions that could be based – or perceived to be based – on considerations other than the academic interest of the student or fellow include:

    • Advising a student to leave school to devote full time to his/her company rather than staying in school to complete his/her degree
    • Permitting a student to spend an inordinate amount of time on company activities, rather than focusing on his/her academic program as expected by Stanford policy (RPH 10.6 Relationships Between Students (Including Postdoctoral Scholars) and Outside Entities
    • Directing a student or fellow’s research toward a topic that might increase the potential success of the company
    • Generally treating a student or fellow that has  a company in which the faculty member has invested more favorably than other students or fellows

    Even if the faculty member is not involved in the student or fellow’s program, he/ she could still put pressure (or be perceived to put pressure) on the student or fellow to alter his or her academic program in favor of increasing the chances of success of the start-up. This is because of the inherently unequal power relationship between faculty and student, which exists even if the faculty member is not in a position to evaluate the student or influence the student’s academic program.   Similar circumstances may arise for academic staff, other teaching staff or those who have instruction or advising roles for the student.

    I understand how a faculty member who supervises or directly teaches a student is in a significant conflict of interest situation, but why should a faculty member who has nothing to do with the student’s academic program be advised to give careful consideration before investing in his/her company?

    As noted above, the inherently unequal power relationship between faculty and student at a university exists even if the faculty member is not in a position to evaluate the student or influence the student’s academic program. A faculty member’s influence and authority are grounded in the role of educator per se and extend far beyond the classroom or laboratory.  For example, a student may perceive, rightly or wrongly, that a prominent faculty member has influence over decisions regarding students’ academic progress, access to lab space or funding for research.  The role of educator must always take precedence for faculty members or others who are directly involved in instruction or advising of the student.

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    4.2 PHS and NSF Requirements Regarding Financial Disclosures and Agency Notifications

    Establishes guidelines for implementation of agency requirements related to 
financial disclosures by faculty members and other key personnel involved with 
submitting proposals and notifications to agencies in the event a financial conflict of 
interest (FCOI) is identified.

    Contact

    Mary Lee

    Director, University Conflicts of Interest Office

    Vice Provost and Dean of Research

    (650) 736-6518

    1. Introduction

    Stanford's Faculty Policy on Conflict of Commitment and Interest establishes requirements for faculty disclosures (on both an annual and an ad hoc basic) of financial interests and professional relationships related to research projects, and for annual certifications of policy compliance. In addition, Stanford's policy requires that faculty members seeking funding from an external sponsor comply with the disclosure requirements of that sponsor.

    In addition to requirements for an institutional policy on conflict of interest, several federal agencies have their own requirements for disclosures related to their sponsored research projects; these include the Public Health Service (PHS) and related components such as the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC), as well as the National Science Foundation (NSF). This policy provides specific guidance related to the requirements of those agencies.

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    2. PHS Investigator Disclosures [1]

    PHS requires that, for each proposal submitted to that agency, the Principal Investigator (PI) and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research (Investigators) certify that he or she has appropriately disclosed any Significant Financial Interests (SFI) related to his or her institutional responsibilities to Stanford. These SFI disclosures must be updated at least annually and within thirty days of entering into a new relationship with a company/organization or discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new SFI. Before an award can be accepted, Stanford must determine:

    1. If the SFI is related to the Investigator's research responsibilities and to the specific research award in question
    2. If the SFI creates an FCOI
    3. If an FCOI is determined to exist, then a Management Plan detailing how the conflict will be managed, reduced, or eliminated must be developed and implemented.

    At Stanford, each School will handle this responsibility for its own Investigators, relying on the annual (OPACS) and transactional/ad hoc disclosures submitted by faculty as required by Stanford's Faculty Policy on Conflict of Commitment and Interest in RPH.

    PHS components including the NIH require that Investigators disclose to a designated representative of the institution all SFIs that would reasonably appear to be related to the Investigator's institutional responsibilities which include: research and other scholarly activities; clinical care activities; teaching or educational activities; and administrative activities.

    SFI means a financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator's spouse/domestic partner or dependent children) that reasonably appear to be related to the Investigator's institutional responsibilities:

    • With regard to any publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000
    • With regard to any non-publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator's spouse or dependent children) holds any equity interest
    • Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests that is not paid through Stanford

    An FCOI means an SFI that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.

    [1] The requirements regarding Investigator financial conflicts of interest in research funded under PHS grants or cooperative agreements can be found at http://grants.nih.gov/grants/FCOI_Final_Rule_inspection_Desk.pdf, pp 53283-53288.

    A. Stanford University Implementation, PHS Requirements

    PIs must complete a Proposal Development & Routing Form (PDRF) in order to document that all requirements related to the submission of a funded research proposal have been met. One requirement is for Stanford to ensure that if there are personal financial interests related to the funded research, these relationships are examined and dealt with according to institutional and funding agency policies on conflict of interest. A personal financial interest with an entity would be reasonably considered related to an investigator's research study in circumstances such as the following:

    • Entity sponsors research at Stanford in which the investigator is directly involved
    • Entity has financial interests that could reasonably be considered to have a potential influence on the design, conduct or reporting of investigator's research/scholarship
    • Entity has a reasonable possibility of being financially affected by investigator's research/scholarship
    • Entity makes gifts to Stanford that benefit investigator's research/scholarship (including equipment gifts or loans)
    • Entity makes a product that is under study in research in which investigator is involved
    • Entity licenses Stanford intellectual property in which investigator has a financial interest
    • Entity has a Materials Transfer Agreement or Human Tissue Agreement (MTA/HTA) to provide materials used in investigator's research or for materials provided by investigator to the company/organization
    • Entity sponsors or makes a product that is under study in human subjects in which investigator is directly or indirectly involved

    If a related financial interest exists, the PDRF links to questions about personal financial interests that may reasonably appear to be related to the research project (see Attachment A - Evaluation of Financial Interests in Related Items below).

    B. Agency Notifications, PHS Only

    Upon receipt of an award from the Public Health Service and prior to the expenditure of any funds, as well as within 60 days for any interest that the Institution identifies as conflicting subsequent to the Institution's initial report under the award, Stanford is obligated to notify the sponsoring institute or agency of any FCOI associated with that award. In addition Stanford will provide annual updates on any previously-identified FCOI for the duration of the research project or until the FCOI ceases to exist. The annual FCOI report will address the status of the financial conflict of interest and changes to the management plan and is done at the same time as the Investigator’s submission of the annual progress report, multi-year progress report, or extension.

    If an FCOI is identified at the time a proposal is submitted, and that proposal is subsequently awarded, or if an FCOI is identified subsequent to the award of the project, Stanford must prepare a notification to the eRA Commons FCOI Module. That notification is to consist of the following:

    1. Grant number
    2. PD/PI or contact PD/PI
    3. Name of Investigator with the FCOI
    4. Name of the entity with which the Investigator has an FCOI
    5. Nature of FCOI (e.g., equity, consulting fees, travel reimbursement, honoraria)
    6. Value of the financial interest (in pre-specified dollar ranges) or a statement that a value cannot be readily determined
    7. A description how the financial interest relates to NIH-funded research and the basis for the Institution’s determination that the financial interest conflicts with such research
    8. Key elements of the Institution’s management plan including:role and principal duties of the conflicted Investigator in the research project
    • Conditions of the management plan
    • How the management plan is designed to safeguard objectivity in the research project
    • Confirmation of the Investigator's agreement to the management plan
    • How the management plan will be monitored to ensure Investigator compliance. Stanford will monitor Investigator compliance until the completion of the PHS-funded research project.
    • Other information as needed
    • In the event that Stanford identifies a significant financial interest that was not disclosed in a timely fashion by the Investigator or previously reviewed by Stanford during an on-going PHS-funded research project, Stanford will, within 60 days, determine whether it is related to PHS-funded research and, if so, whether a financial conflict of interest exists. If an FCOI exists, Stanford will implement a management plan.

      In addition, whenever a financial conflict of interest is not identified or managed in a timely manner, Stanford will, within 120 days of its determination of non-compliance, complete a retrospective review of the Investigator’s activities and the PHS-funded research project. The purpose of the review is to determine whether any PHS-research conducted during the period of non-compliance was biased in its design, conduct or reporting.

      The documentation of the retrospective review will include these elements:

    • Project number
    • Project title
    • PD/PI or contact PD/PI if a multiple PD/PI model is used
    • Name of the Investigator with the FCOI
    • Name of the entity with which the Investigator has a financial conflict of interest
    • Reason(s) for the retrospective review and methodology used for the review
    • Findings and conclusions of the review

    Based on the the retrospective review, if appropriate, Stanford will update the previously submitted FCOI report, specifying the actions that will be taken to manage the FCOI

    If bias is found, Stanford will notify the PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component. The mitigation report will include the key elements documented in the retrospective review, the impact of the bias on the research project and Stanford’s plan of action or actions to eliminate or mitigate the effect of the bias.

    In any case in which Health and Human Services (HHS) determines that a PHS-funded project of clinical research whose purpose is to evaluate the safety or effectiveness or a drug, medical device, or treatment has been designed, conducted or reported by an Investigator with a financial conflict of interest that was not managed or reported as required by PHS regulations, Stanford will require the Investigator involved to disclose the financial conflict of interest in each public presentation of the results of the research and to request an addendum to previously published presentations.

    Stanford will maintain records relating to all Investigator disclosures of financial interests and Stanford’s review of and actions taken related to such disclosures for at least three years from the date of the final expenditures report is submitted to the PHS, or, where applicable, from other dates specified in PHS regulations. 

     

    C. Other PHS Requirements

    1. Public Accessibility

    Prior to the expenditure of funds, Stanford will make certain that information concerning FCOIs held by senior/key personnel is publicly accessible via a Web site or by a written response to any requester within five business days of a request or as required by law.
 This information will include: the Investigator’s name; the Investigator’s title and role with respect to the research project; the name of the entity in which the significant financial interest is held; the nature of the significant financial interest; and the approximate dollar value of the significant financial interest (in pre-specified dollar ranges), or a statement that a value cannot be readily determined. This information will remain publicly accessible for at least three years from the date that it was most recently updated.

    2. Investigator Training

    Each Investigator must have completed the training class: Stanford University Conflict of Interest Training for PHS-Funded Investigators and Faculty New to Stanford prior to engaging in research related to any PHS-funded grant. The training must be re-taken at least every four years. In addition, education is required immediately when:

    • Financial conflict of interest policies are revised in a manner that changes researcher requirements.
    • A researcher is new to the organization.
    • A researcher is non-compliant with financial conflict of interest policies and procedures.

    3. Subawards

    If an institution carries out agency-funded research through subawardees, contractors, or collaborators, the institution must take reasonable steps to ensure that the collaborating entity has its own policies in place that meet the requirements of the PHS policy or that investigators working for such entities follow the policies of the primary institution.

    4. Travel

    Investigators who are planning to participate in PHS-funded research must disclose their reimbursed or sponsored travel related to their institutional responsibilities over the previous twelve-month period to their Institution no later than the time of application for PHS-funded research. They must also submit an updated disclosure of reimbursed or sponsored travel within 30 days of each occurrence.

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    3. NSF Investigator Disclosures [2]

    NSF requires Stanford to maintain an appropriate written and enforced policy on conflict of interest and that all conflicts of interest for each award be managed, reduced or eliminated prior to the expenditure of the award funds. If an institution carries out agency-funded research through subawardees, contractors, or collaborators, the institution must take reasonable steps to ensure that the collaborating entity has its own policies in place that meet the requirements of this policy or that investigators working for such entities follow the policies of the primary institution.

    As provided by Stanford’s Faculty Policy on Conflict of Commitment and Interest in RPH, NSF requires that each investigator disclose to a responsible representative of the institution all significant financial interests of the investigator (including those of the investigator’s spouse and dependent children) that would reasonably appear to be affected by the research or educational activities funded or proposed for funding by NSF or in entities whose financial interests would reasonably appear to be affected by such activities.

    The term “investigator” means the principal investigator, co-principal investigators/co-project directors, and any other person at the institution who is responsible for the design, conduct, or reporting of research or educational activities funded or proposed for funding by NSF.

    As specified by NSF, the term “significant financial interest” (SFI) means anything of monetary value, including, but not limited to, salary or other payments for services (e.g., consulting fees or honoraria); equity interest (e.g., stocks, stock options, or other ownership interests); and intellectual property rights (e.g., patents, copyrights, and royalties from such rights).

    The term does not include:

    • salary, royalties, or other remuneration from the applicant institution
    • income from seminars, lectures, or teaching engagements sponsored by public or non-profit entities
    • income from service on advisory committees or review panels for public or nonprofit entities
    • an equity interest that, when aggregated for the investigator and the investigator’s spouse and dependent children, meets both of the following tests: does not exceed $5,000 in value as determined through reference to public prices or other reasonable measures of fair market value, and does not represent more than a 5% ownership interest in any single entity
    • salary, royalties or other payments that, when aggregated for the investigator and the investigator’s spouse and dependent children, are not expected to exceed $5,000 during the twelve month period

    NOTE: Although current NSF regulations specify a higher threshold for SFI than PHS (NIH), Stanford policy identifies $5,000 as the monetary threshold. Similarly, in non-publicly traded companies, PHS and Stanford policy identify any equity amount as the threshold.

    NSF requires Stanford to ensure that investigators have provided all required financial disclosures at the time the proposal is submitted to NSF. Stanford must also ensure that those financial disclosures are updated during the period of the award, either on an annual basis, or as new reportable significant financial interests are obtained.

    Stanford designates individuals to review financial disclosures, determine whether a conflict of interest exists, and determine what conditions or restrictions, if any, should be imposed by the institution to manage, reduce or eliminate such conflict of interest. A conflict of interest exists when the reviewer(s) reasonably determines that a significant financial interest could directly and significantly affect the design, conduct, or reporting of NSF-funded research or educational activities.

    Examples of conditions or restrictions that might be imposed to manage, reduce or eliminate conflicts of interest include, but are not limited to:

    • public disclosure of significant financial interests
    • monitoring of research by independent reviewers
    • modification of the research plan
    • disqualification from participation in the portion of the NSF-funded research that would be affected by significant financial interests
    • divestiture of significant financial interests
    • severance of relationships that create conflicts

    Stanford must have adequate enforcement mechanisms, provide for sanctions where appropriate and must keep NSF’s Office of the General Counsel appropriately informed if the institution finds that it is unable to satisfactorily manage a conflict of interest. Grantee notifications of conflict of interest that cannot be managed, reduced, or eliminated must be submitted electronically via the NSF FastLane system by the Dean of Research Office.

    Stanford must maintain records of all financial disclosures and of all actions taken to resolve conflicts of interest for at least three years beyond the termination or completion of the grant to which they relate, or until the resolution of any NSF action involving those records, whichever is longer.

    [2] The conflict of interest policies of the NSF can be found at: http://www.nsf.gov/pubs/policydocs/pappguide/nsf08_1/aag_4.jsp

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    4. Attachment A: Evaluation of Financial Interests

    Date: August 22, 2012

    Principal Investigators must complete a Proposal Development & Routing Form (PDRF) in order to document that all requirements related to the submission of a funded research proposal have been met. If the PI indicates the existence of a related financial interest, the PDRF links to questions about those financial interests that may reasonably appear to be related to the research project, including:

    1.     Name of company/organization (foundation, society, other)  

    2.     What is the nature of your activity/financial interest with the company/organization? (check all that apply)

    __ Board of Directors membership  __ Advisory Board membership __ Consultant (other than Advisory Board or Board of Directors membership) __ Licensing of your Stanford or non-Stanford intellectual property __ Ownership of stock or stock options or other ownership interests     (excluding investments for which you do not directly control investment       decisions, such as mutual funds)  __ Payment for royalties for inventions (not paid through Stanford) __ Payment for lectures __ Payment for preparation of papers or reports     __ Payment for product evaluation  __ Legal consultant or expert witness __ Executive or other employee position with company/organization __ This is a financial interest/activity of my spouse/domestic partner or dependent child   

    3.     What is the total amount of your financial interest (or that of your spouse/domestic partner or dependent children) in this company/organization?

    __ $1 - 4,999

    __ $5K - $9,999K

    __ $10K - 19,999K

    __ $25 - 49,999K

    __ $50K - 99,999K

    __ $100 - 199,999K

    __ greater then $200,000

    4.     If this entity is a company, is it

    __ Publicly traded or  __ Privately held or Start Up

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    4.3 Consulting and Other Outside Professional Activities by Members of the Academic Council and Medical Center Line Faculty

    Establishes limits on the amount of time that may be spent on outside consulting activities by Stanford faculty, and describes procedures for implementing this policy. 2003 clarification relates to consulting and outside management responsibilities.

    On September 7, 2010, the University Provost implemented a requirement for faculty to provide the summary of Stanford University Requirements for Faculty Consulting Activities and Agreements whenever entering into a consulting or non-disclosure agreement. You can also find the document in the Related Items section below under the Documents tab.

    Authority

    Senate of the Academic Council

    Contact

    Mary Lee

    Vice Provost and Dean of Research

    Vice Provost and Dean of Research

    (650) 736-6518

    1. Principles and General Standards

    This policy is applicable to all members of the Stanford faculty (Academic Council and Medical Center Line) including faculty members serving as University officers. (See the Stanford Faculty Handbook for policies governing those with adjunct, visiting and acting faculty appointments and the School of Medicine Faculty Handbook, Chapter 8, Section 8.6.C, for policies governing Clinician Educators.)

    The purpose of the policy on consulting and related activities is to state with both clarity and generality the limits on such activities and the reasons for those limits. Consulting and other outside professional activities can provide an important means of continuing education for the faculty and can provide them with a currency and experience in aspects of their professional fields outside the context of the University itself. These activities can also provide a mechanism for transfer of knowledge from the University to the public good. Though such attributes of consulting may make faculty better scholars and teachers, the employer-employee nature of the consulting process has in it the potential for diversion of faculty from their primary activities and responsibilities. Therefore, the basic principle of this policy statement is that there needs to be a limitation upon the time that a Stanford faculty member may spend in consulting. The limits set forth below are intended to strike a fair balance between consulting and regular faculty duties within the University and serve to safeguard the interests of both parties.

    Though comprehensive, the policy cannot deal unambiguously with every instance of consulting or other outside professional activities. In cases of doubt, the primary guide should be the intention to promote the interests of the University as a place of education, learning, and research. Whenever uncertainty exists, it is the faculty member’s obligation to obtain prior consent from the appropriate University officer.

    See also the summary below Attachment A: Faculty Consulting Policies, distributed by the University Provost September 7, 2010, and the document “Stanford University Requirements for Faculty Consulting Activities and Agreements.

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    2. Definition of "Consulting"

    In general, consulting is defined as professional activity related to the person's field or discipline, where a fee-for-service or equivalent relationship with a third party exists.

    There are many types of consulting relationships and fee arrangements, and the precise form entered into may vary. The principle is that, in consulting, a person agrees to use his or her professional capabilities to further the agenda of a third party, in return for an immediate or prospective gain. Activities or titles that constitute or imply managerial or supervisory responsibility are not permitted under Faculty Conflict of Commitment and Interest policy, and are not allowable as consulting relations. Titles such as CEO, Director, Scientific Officer, or Vice President, etc., are designations generally assigned to people with line management responsibilities. Faculty must avoid titles that include terms such as executive, officer, director, manager, or chief as they imply or indicate management responsibilities and create real or perceived conflicts of commitment.  To avoid implying a line management role, terms such as ‘officer’ or ‘vice-president’ must not be used; on the other hand, the terms ‘ Advisor’ or ‘Consultant’ may be used, e.g., ‘Chief Scientific Advisor’, or ‘Chief Technical Consultant'. Situations arise in which a Stanford faculty member is chosen to serve on a Board of Directors of a company, or on a company's advisory council or scientific advisory board. These appointments and titles are different from managerial roles and titles, and are permitted as consulting relationships.

    Several types of faculty activity, other than regular University duty, are not “consulting.” These are:

    A. Publication

    Scholarly communications in the form of books, movies, television productions, art works, etc., though frequently earning financial profit for a faculty member and for another party (e.g., publisher), are not viewed as consultation. To attempt to distinguish between types of books, to assess the roles of book publication in different disciplines, or to challenge the historical relation between authorship and manuscript ownership would be fraught with danger and confusion. These reservations apply equally to the other types of scholarly communication cited above. However, faculty may not publish articles or other forms of scholarly communication under their own names in the course of their outside professional activities that are written in whole or material part by employees of the outside entity (i.e., “ghost written”). If a faculty member is listed as an author on any publication resulting from performance of consulting services, a disclosure should be included stating that the work was done as a paid consultant and was not part of the individual's Stanford duties and responsibilities.

    B. Professional Service (Other Outside Professional Activities)

    Under this rubric falls service to United States (U.S.) national commissions, U.S. governmental agencies and boards, U.S. federal and state granting agency peer review panels, philanthropic organizations or charities, professional societies, visiting committees or advisory groups to other U.S. universities, and analogous bodies. The fundamental distinction between these activities and consulting is that they are public or University service. Although an honorarium or equivalent sometimes is forthcoming, these professional service activities are not undertaken for personal financial gain. Therefore, such service does not fall within the consulting category as defined by Stanford policy. However, federal regulations related to PHS-funded research consider income provided for service to some foundations and professional societies to be consulting and reporting is required PHS and NSF Requirements Regarding Financial Disclosures and Agency Notifications in RPH. In addition, even activities such as pro bono work, U.S. government service in the public interest, and any outside employment unrelated to the faculty member's University responsibilities (therefore not included as "consulting" in the policy on outside consulting), should be managed so they do not take precedence over a faculty member's primary commitment to the University.  Faculty members must disclose all outside professional activities related to and financial interests received from any foreign entity (that is, any non-U.S. entity), including but not limited to a foreign institution of higher education (either private or public) or the government of another country (which includes local, provincial, state, or equivalent government units, parastatal organizations, and any other quasi-governmental organization of another country) in the Outside Professional Activities Certification System (OPACS).

    C. "Moonlighting"

    Faculty members may pursue a variety of endeavors for financial profit that are not directly related to the person's field or discipline. These efforts are part of the faculty member's private life and do not come under University regulation or this consulting policy. To emphasize again, however, such endeavors may only be pursued after the full-time commitment to Stanford has been fulfilled. Faculty in the School of Medicine must adhere to policies on “moonlighting” when it involves providing clinical care.

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    3. Number of Permissible Consulting Days

    Consulting is permitted provided the faculty member's full-time obligation to the University is met. The maximum number of consulting days permissible for a member of the Academic Council or the Medical Center Line Faculty on a full-time appointment is 13 days per academic quarter. This limit is based on a judgment about incentives and is aimed at furthering Stanford's teaching and research objectives; it is not derived from accounting principles. University holidays are included in each 13-week academic quarter from which the 13-day consultation limit is derived. A limited amount of “averaging” of consulting time among full-time quarters is permissible if, on occasion, a faculty member plans to consult for more than 13 days in one quarter but no more than 39 days for three academic quarters (the Guidelines for Policy Implementation, below, deal with averaging in more detail). Thirteen days of consulting per quarter, or 52 days for four quarters of active duty, is intended to be a liberal allocation, yet one that is fair to the University. In addition to this general policy on consulting, University policies exist or may be instituted in individual schools or academic units, e.g., those currently applying to full-time faculty members in clinical departments of the Medical School.

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    4. Responsibilities of Faculty Members

    The responsibility for adhering to the limit on consulting days, and other aspects of Stanford's consulting policy, lies first with the individual faculty member. Faculty members should resolve any questions and/or ambiguities with their department chairperson or dean before the fact, so that the University community is not injured by their actions. The University has the right, and indeed the obligation, to protect itself from losses due to excess consulting and to seek reimbursement from the faculty member for salary and benefits covering time spent on consulting beyond the limits provided for by this policy, especially in cases where amounts are significant and the faculty member did not seek prior consultation or follow the advice given by his or her department chairperson or dean. Faculty members have an obligation to report fully the level (i.e., number of days) of their consulting activities when asked to do so by the University so that it may be determined whether the principles set forth herein are being adhered to.

    Furthermore, faculty must disclose their financial interests in outside entities that are related to their institutional responsibilities for research/scholarship, teaching/education, administration or clinical care as required by the Faculty Policy on Conflict of Commitment and Interest in RPH.

    NOTE: Faculty entering into a consulting or non-disclosure agreement with a commercial entity must provide to that entity a copy of the summary of "Stanford University Requirements for Faculty Consulting Activities and Agreements".

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    5. Guidelines for Policy Implementation

    A. General

    The nature of the consulting work should in no way detract from the prestige of the University or the professional stature of the faculty member. Consulting obligations undertaken should conform to this objective.

    B. Averaging

    Full-time Academic Council members who expect to consult for more than 13 days in any one academic quarter, but not more than 39 days in the academic year, should so inform their department chairperson or dean on a prospective basis. A reasonable amount of “averaging’’ over the quarters of the academic year (or the full year, if the person is at 100 percent time for all four quarters) ordinarily is acceptable, although particular circumstances such as teaching loads or the terms of support under grants or contracts will need to be taken into account. Averaging of consulting time from quarters of less than full-time service to quarters of full-time service is not permitted.

    C. Consulting During Periods of Part-Time University Employment

    The 13-day limit should be pro-rated for those members of the Academic Council holding part-time appointments, using the following formula: [13 x F] + [(1-F) x 6 x 13], where F is the fraction of full-time duty, 13 represents the average number of weeks per quarter, and 6 represents the maximum number of days per week which are likely to be devoted to professional activities during the period of off-duty time. Thus, a faculty member holding a 75% appointment is permitted up to 29-1/4 days of consulting per quarter.

    D. Consulting During the Fourth Quarter or During Periods of Leave Without Salary

    Faculty members on nine-month appointments with no salary supplement for the fourth quarter (usually, but not always, the summer quarter) are not subject to the 13-day limit during that quarter. Nor does the limit apply to faculty members on leave without salary. The 13-day limit should be prorated on the basis of one day per calendar week of duty time for those on leave without salary for less than a quarter.

    If the faculty member receives a 3/9 salary supplement for the fourth quarter the regular 13-day consulting limit shall apply. If the appointment is for less than 3/9 time, one of two conditions applies: (a) the appointment specifies a particular calendar period as “on duty,’’ in which case the regular consulting policy applies during that period and there is no limit during the remaining time; or (b) the appointment is at part-time for all or part of the quarter, in which case the above paragraph applies.

    E. Consulting While on Sabbatical Leave

    The purpose of sabbatical leave is to permit faculty members to take time off from normal University duties to advance their scholarly interests so that they may return to their posts with renewed vigor, perspective, and insight. A faculty member on sabbatical leave receiving full-time University salary may consult up to the regular 13-day limit per quarter during the period of sabbatical. A person on sabbatical receiving less than full-time University salary may supplement income up to the full-time equivalent salary, and in addition, may devote up to a maximum of 13 days per quarter to consulting.

    F. Hourly Consulting

    Some consultation is carried out by the hour and not by the day. In such cases, a total of 130 consulting hours is permitted per full-time academic quarter. Stipulation of this total, as opposed to an hour-to-day conversion formula, permits faculty members added flexibility in carrying out consulting and still protects the primary interests of the University. The figure 130 does not derive from accounting principles, but stems from subjective judgments about the length of average faculty work days, the work days of businesses employing consultants, and the desire to accommodate legitimate needs of some University faculty. For those individuals who consult on both a daily basis and an hourly basis during one academic quarter, a formula of one consulting day equals 10 consulting hours should be used in calculating total consultation time.

    G. Use of University Facilities or Services

    The facilities and services of the University may not be used in connection with compensated outside work, except in a purely incidental way.

    H. Conflict of Interest

    In April 1994 the Senate of the Academic Council approved the Faculty Policy on Conflict of Commitment and Interest, which states in part:

    "An implicit assumption underlying the University's [consulting policies] is that such outside professional activities are a privilege and not a right and must not detract from a faculty member's full-time obligation to his or her University duties."

    Consulting agreements involving Stanford faculty should specifically address this concern by acknowledging that:

    1. The primary duty of the Consultant, who is a Stanford faculty member, is to Stanford University
    2. The Consultant is subject to Stanford's policy on outside consulting activities of its faculty
    3. The Consultant may have obligations to Stanford by reason of agreements between Stanford and external organizations for research or other activities performed in part by the Consultant in fulfilling his/her duties to the University

    In addition, faculty are required to disclose to the University whether they (or members of the immediate family) have consulting arrangements, significant financial interests, or employment in an outside entity before the University will approve the following proposed arrangements between such entities and Stanford: a) gifts; b) sponsored projects; c) technology licensing arrangements; and d) procurements.

    On an annual basis, and when situations arise that require disclosure as specified in the Faculty Policy on Conflict of Commitment and Interest, all faculty members must certify to their school deans their compliance with Stanford's policies related to conflict of commitment and interest.

    6. Attachment A: Provost's 2010 Letter on Faculty Consulting Policies, including required Stanford University Requirements for Faculty Consulting Activities and Agreements

    Print Attachment A to RPH 4.3

    Attachment A: Consulting and Other Outside Professional Activities by Members of the Academic Council and Medical Center Line Faculty

    Date: Promulgated by the University Provost, September 7, 2010

    Dear Colleagues,

    As you know, Stanford encourages research relationships with other entities as a way to foster the transfer of knowledge gained through University research and scholarship for societal benefit. We also recognize, however, that our concern to preserve openness in research may be at odds with the need of for-profit companies to keep research information and materials proprietary. With these differences in mind, I would like to review Stanford’s policies governing two types of agreements that faculty enter into without direct University oversight. These are personal consulting agreements and non-disclosure agreements (NDAs). As a Stanford faculty member, it is your responsibility to know the principles and policies that must be followed when entering into such agreements.

    If you enter into a consulting or non-disclosure agreement with a commercial entity, a copy of the attached summary of Stanford University Requirements for Faculty Consulting Activities and Agreements must be provided to the company.

    Consulting:

    Any consulting agreements with outside entities should carefully delineate and separate your university responsibilities from consulting responsibilities. Specifically, these agreements must not involve or address Stanford University, or its resources and people, including students, postdoctoral scholars and staff. You are responsible for making sure that your consulting activity and the terms of any written agreements are consistent with requirements of the faculty Conflict of Commitment and Interest policy and your university obligations related to inventions and other intellectual property . The School of Medicine also prohibits consulting that is solely or primarily for commercial marketing purposes. To avoid confusion, correspondence and agreements related to consulting activities must not use Stanford letterhead or appear to be Stanford documents. Finally, facilities and services of the University may not be used in connection with your consulting, except in a purely incidental way.

    Non-Disclosure Agreements:

    In their capacity as University employees, Stanford faculty and staff may not engage in confidential work for an entity other than Stanford. Confidential work for another entity may only be pursued during time allowed for consulting.

    Any confidential information received for research purposes at Stanford must be incidental to University research activities and may not interfere with the participation of anyone at Stanford in the intellectually significant portions of the research activity Openness in Research Policy. Within these important limits, if it becomes necessary for you to share confidential information with, or receive information from, another entity for your work at the University, you may personally sign a Confidentiality Disclosure Agreement (CDA) or Non-Disclosure Agreement (NDA). The agreement must state clearly that you are signing in your individual capacity and covers only your own activities. If it is necessary for those you supervise to receive confidential information, they must separately sign a confidentiality agreement, but only if the confidential information to be received is incidental and with approval of your school dean. (See also Export Control information.)

    Some CDAs or NDAs presented to faculty for signing may contain intellectual property provisions impacting Stanford’s rights in patents, copyrights, or patentable technology or copyrightable works. Faculty may not sign any agreement that could affect Stanford’s or other Stanford researchers’ rights in intellectual property or your Stanford obligations related to intellectual property.

    The CDA/NDA must not include Stanford University as a party. Individual researchers, faculty members and other employees have no authority to sign CDAs or NDAs on behalf of the University, their school or department, or any other division or department of the University. Stanford generally does not sign CDA/NDAs on behalf of the University, because there is no institutional mechanism to ensure the confidentiality of information received.

    NOTE: The summary of Stanford’s policies will be available for downloading on the Research Policy Handbook website, the Office of Technology Licensing, and from your school dean’s office.

    Please contact your school dean’s office or the office of the Dean of Research to discuss any questions that you may have concerning consulting agreements; the Industrial Contracts Office will advise about CDA/NDAs related to your Stanford work.

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    4.4 Conflict of Commitment and Interest for Academic Staff and Other Teaching Staff

    Applies principles of the Faculty Policy on Conflict of Commitment and Interest to members of the Academic Staff and Other Teaching Staff, while recognizing that consulting privileges are not normally extended to members of the Academic Staff and Other Teaching Staff, and that they are not expected to complete the annual Outside Professional Activities Certification (OPACS).

    Contact

    Mary Lee

    Director, University Conflicts of Interest Office

    Vice Provost and Dean of Research

    (650) 736-6518

    1. Introduction

    The general concepts of conflict of commitment and interest, as set forth in the Faculty Policy on Conflict of Commitment and Interest in RPH, and PHS and NSF Requirements Regarding Financial Disclosures and Agency Notifications in RPH. are applicable with certain modifications to the Academic Staff and Other Teaching Staff. Academic Staff and Other Teaching Staff members are referred to the full text of the Faculty Policy on Conflict of Commitment and Interest in RPH for further discussion of the points presented here.

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    2. Conflict of Commitment

    Academic Staff and Other Teaching Staff, employed on a full-time basis at Stanford, owe their primary professional allegiance to the University, and their primary commitment of time and intellectual energies should be to the programs on which they are working. Whenever an individual's outside activities interfere with professional obligations to Stanford, a conflict of commitment exists. In the case of Academic Staff and Other Teaching Staff working at Stanford on a part-time basis, this general principle applies to the extent of the Stanford appointment. Individuals on less than full-time appointments may engage in consulting relationships and other employment, to the degree that those activities do not interfere with their obligations to Stanford.

    The following points of policy relate to conflicts of commitment:

    1. Outside consulting privileges are not normally available to full time Academic Staff and Other Teaching Staff. They may consult only with permission, as noted below. Under no circumstances may any Academic Staff or Other Teaching Staff member's outside consulting work exceed the limits imposed by the faculty consulting policy, i.e., 13 days per calendar quarter (that is, one day in seven) on a full-time equivalent basis. (See further discussion in Section IV, below.) Academic Staff and Other Teaching Staff may not use University resources or personnel, including facilities, staff, students or other trainees, equipment, or confidential information, except in a purely incidental way, as part of any outside consulting or business activities or for any other purposes that are unrelated to the education, research, scholarship or public service missions of the University. 


    NOTE: Permission for full-time members of the Academic Staff or Other Teaching Staff to consult, including the reasons for such permission, must be in writing, normally on a prospective basis, by the department/program chairman (for members of the Academic Staff-Teaching or Other Teaching Staff), or by the principal investigator (for members of the Academic Staff-Research), or by the director of the appropriate library (for members of the Academic Staff-Libraries). If such permission is granted, the department/program chair or PI or library director is responsible for assuring that the consulting activities of the Academic Staff member individual do not adversely impact the achievement of program or project goals or subject the University to financial or reputation risk. He or she may require periodic written or oral reports from the Academic Staff or Other Teaching Staff member in order to discharge this responsibility. The content of these reports, and the basis for the permission itself, are subject to review by the department chair, relevant dean, or Vice Provost and Dean of Research. See further discussion below. 


    1. Academic Staff and Other Teaching Staff must maintain a significant presence on campus (main or overseas) throughout each quarter in which they are employed by Stanford, consistent with the scope of their appointment.
    2. Academic Staff and Other Teaching Staff must not allow other professional activities to detract from their primary allegiance to Stanford. For example, individuals employed on a full-time basis must not have outside managerial responsibilities nor act as a principal investigator on sponsored projects that could be conducted at Stanford University but instead are submitted and managed through another institution.

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    3. Conflict of Interest

    Stanford University is an institution of public trust; Academic Staff as well as faculty must respect that status and conduct their affairs in ways that will not compromise the integrity of the University or that trust.

    A conflict of interest occurs when there is a divergence between an individual's private interests and his or her professional obligations to the University such that an independent observer might reasonably question whether the individual's professional actions or decisions are determined by considerations of personal financial gain. A conflict of interest depends on the situation, and not on the character or actions of the individual.

    Academic Staff and Other Teaching Staff should conduct their affairs so as to avoid or minimize conflicts of interest, and must respond appropriately when conflicts of interest arise. Conflicts of interest must be disclosed to Stanford when personal financial relationships or activities with outside entities occur that would reasonably appear to be related to an Academic Staff member's Stanford institutional responsibilities for research/scholarship or education/teaching.

    The following points of policy relate to conflicts of interest:

    1. Academic Staff and Other Teaching Staff must foster the open and timely exchange of results of scholarly activities, informing faculty, students and colleagues about outside obligations and activities that might influence the free exchange of scholarly information.
    2. Academic Staff and Other Teaching Staff must disclose on a timely basis the creation or discovery of all potentially patentable inventions created or discovered in the course of their University activities or with more than incidental use of University resources. If intellectual property rights are to be claimed, ownership of such inventions must be assigned to the University regardless of source of funding. The inventor will share in royalties earned.
    3. Academic Staff and Other Teaching Staff must disclose on an annual and transactional/ad hoc basis to their supervisor, or to the principal investigator on their research, when they (or their spouse/domestic partner or dependent children) have a financial interest (defined below) in, an outside entity that would reasonably appear to be related to their institutional responsibilities. Disclosures of such interests are also required when the individual  is engaged in a specific transaction, including:
    • gifts
    • sponsored projects
    • technology licensing arrangements
    • protocols that use human subjects, animals, or stem cells
    • material transfer and collaboration agreements
    • certain procurements (e.g., sole source or from a privately-held company)

    In such cases, review and approval by the school dean, the cognizant dean for COI or the designated COI program administrator will be required prior to entering into the proposed arrangement.

    1. Financial interests or other outside activities that are disclosed and deemed to be related to one or more of the Academic Staff or Other Teaching Staff member's institutional responsibilities will be further reviewed to determine if the financial interest or relationship could have a direct and significant effect on the performance of his or her responsibilities. If such a situation exists, the conflict will need to be eliminated or managed according to a plan provided to the individual by the cognizant dean for COI. Other administrative actions, such as disclosure in publications and public talks, may be required when the financial interest is not considered likely to directly and significantly affect performance of institutional responsibilities.
    2. Academic Staff and Other Teaching Staff who are approved for Principal Investigator status are required to file appropriate transactional/ad hoc COI disclosures as required as well as an annual disclosure certifying compliance with the Faculty Conflict of Commitment and Interest Policy in RPH.

    If a situation raising questions of conflict of commitment or interest arises, Academic Staff and Other Teaching Staff must discuss the situation with their supervisor, principal investigator, or with the department chair or school dean or the person designated to assess conflicts of commitment and interest in their school or independent laboratory.

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    4. Further Discussion of Consulting by Academic Staff and Other Teaching Staff

    The decision to permit consulting by an Academic Staff or Other Teaching Staff member will depend on the circumstances of each situation, including the needs of the program or project, the individual's role and the scope of his or her appointment. Such permission is subject to review as circumstances change. If permission is granted, time spent on consulting must be in addition to, rather than part of, the regular effort expected of the individual's University work.

    It is the responsibility of each Academic Staff and Other Teaching Staff member who wishes to engage in outside consulting to be aware of the University's limits on such activities. A full-time Academic Staff member's consulting activities may never exceed 13 days per calendar quarter (that is, one day in seven). This maximum applies to all periods of University employment, including vacations, quarter breaks, or other paid time off from work. Department chairs or PIs may limit an Academic Staff member's outside consulting activities to fewer than 13 days per quarter as necessary to meet University programmatic needs or project goals.

    This policy is a University-wide policy. In addition, there may be further restrictions placed on Academic Staff and Other Teaching Staff consulting activities within individual schools or independent laboratories, centers and institutes. Academic Staff should request information about further policy limits from the school dean's office or the Dean or Research.

    When an Academic Staff or Other Teaching Staff member is involved in activities not directly associated with Stanford (e.g., independent consulting, other business activities, publications, etc.), use of Stanford's name and marks is limited to identification of the individual by his or her affiliation (e.g., Jane Smith, Senior Lecturer, Stanford University) and must be consistent with the guidance provided in Administrative Guide Memo 15.5. The title may only be used only during the term of the appointment at the University and must always be used in its entirety; it cannot be abbreviated or altered.

    In the event of conflict between the provisions of any consulting agreement and the terms and conditions of employment of an Academic Staff or Other Teaching Staff member by Stanford, the latter shall prevail. The following sentence (or one similar) should be included in Academic Staff or Other Teaching Staff member's outside consulting agreements: “The terms and conditions of employment and appointment by Stanford University and the provisions of any agreement between Stanford and external sponsors of projects on which the consultant works as part of his/her University duties, shall prevail in the event of any conflict with the provisions of this Agreement."

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    4.5 University Investments in Start-Up Companies Involving Stanford Faculty

    Establishes guidelines under which Stanford University may invest in start-up companies in which Stanford faculty also have equity interests.

    Authority

    Stanford Board of Trustees

    Contact

    Karin H Immergluck

    Executive Director

    Office of Technology Licensing (OTL)

    2:(650) 723-0651

    1. Background

    Each year Stanford invests a small portion of its investment capital in start-up companies that are exploiting new technologies. Although many such companies do not succeed, those that do offer the potential for high returns to their investors.

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    2. Start-ups with Faculty Involvement

    On occasion Stanford may be faced with an opportunity to invest in a start-up company in which one or more Stanford faculty members also have equity interests. The University ordinarily will not invest in such companies if any of the involved faculty members also have line management responsibilities in them, given the potential for apparent or real conflicts of interest. See Faculty Policy on Conflict of Commitment and Interest  in RPH for guidance regarding faculty management responsibilities in outside companies.)

    However, Stanford may invest in start-ups in which the extent of its faculty involvement is limited to equity holdings (or rights to equity) and/or advisory roles under the following conditions:

    • Stanford will not act as a lead investor or syndicating agent. All investments will be as a "passive investor."
    • Stanford will not acquire an equity holding greater than 10% of the ownership of the company.
    • No Stanford officer is to be a member of the board, or be an officer of the company, or have a personal equity position in the company at the time of Stanford's investment in any of the equity rounds before the company goes public.
    • University investments in start-up companies in which Stanford faculty have equity interests are subject to the case-by-case approval of the Provost, based upon recommendations by the Chief Executive Officer of the Stanford Management Company. If the involved faculty member(s) subsequently creates University-owned data or inventions for which the start-up company seeks a license for commercial use or development, the licensing request will be subject to the review and approval of the relevant department chair and school dean, in consultation with the Vice Provost and Dean of Research.

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    4.6 Equity Acquisition in Technology Licensing and Distance Learning Agreements

    Establishes specific conditions under which Stanford may acquire equity as part of an agreement.

    Authority

    Board of Trustees

    Committee on Finance

    Contact

    Karin H Immergluck

    Executive Director

    Office of Technology Licensing (OTL)

    2:(650) 723-0651

    1. Policy

    In the course of technology licensing, and in developing, marketing, selling and licensing various types of distance learning, Stanford University sometimes has the opportunity to acquire equity. This policy enables Stanford University to receive a benefit from equity. While potential conflict of interest issues are addressed through the Faculty Policy on Conflicts of Commitment and Interest RPH, the policy on Conflict of Commitment and Interest for Academic Staff in RPH, the Staff Policy on Conflict of Commitment and Interest in the Administrative Guide Memo 15.4 and through management of the University's equity separate from the Office of Technology Licensing (OTL) or an affected school or department. Equity includes shares of stock, and also other forms of equity (such as warrants, options, interest in limited partnerships or limited liability companies) that lend themselves to distribution in the manner contemplated.

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    2. Technology Licensing Agreements

    1. The University may accept equity as one form of compensation for license rights, subject to a conflict of interest review if appropriate.
    2. Of the total amount of equity which is to be issued for a particular license, fifteen percent (15%) of such equity ("the Administrative Share") will be issued to the University for the benefit of the Office of Technology Licensing ("OTL") to cover its general administrative expenses.
    3. The remaining equity to be issued for the license, after deducting the Administrative Share, will be considered as "Net Equity."
    4. One third (1/3) of the Net Equity will be issued to the Inventor(s) as the Inventor(s)'s Shares. Following issuance of Net Equity, it shall be the sole responsibility of the Inventor(s) to manage the Inventor(s)'s Shares and to comply with any tax, legal or contractual obligations associated with the distribution, ownership, or disposition of the Inventor(s)'s Shares.
    5. The remaining two thirds (2/3) of Net Equity will be issued to the University as the University Share. The OTL Research and Fellowship Fund, administered by the Vice Provost and Dean of Research, will receive the University Share, less any unreimbursed OTL direct expenses.
    6. All equity received by the University will be managed by Stanford Management Company.

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    3. Distance Learning Agreements

    1. The University may accept equity as one form of compensation for distance learning, subject to a conflict of interest review.
    2. The Provost, or his designees, will determine the allocations of equity under this policy. In making this determination, factors to take into account include: 1) any royalties or other compensation received from the affected parties; 2) any seed funds or other support given by the school or department to the long distance venture; 3) the value of the university's name to the venture; 4) the value to the distance learning venture that was added by each of the parties; and 5) such other factors as are deemed relevant.
    3. Of the total amount of equity which is to be issued for a particular venture, fifteen percent (15%) of such equity ("the Administrative Share") will be issued to the University for the benefit of the Office of Technology Licensing (OTL). If Learning Technology and Extended Education (LTEE) or the Stanford Center for Professional Development (SCPD) has contributed significantly to the licensing of the work, the Dean of Research may allocate a portion of the 15% to LTEE or SCPD, as appropriate.
    4. The remaining equity to be issued for the license, after deducting the Administrative Share, will be considered as "Net Equity."
    5. Up to one third (1/3) of the Net Equity may be issued to the Creator(s) as the Creator(s)'s Shares. Following issuance of Net Equity, it shall be the sole responsibility of the Creator(s) to manage the Creator(s)'s Shares and to comply with any tax, legal, or contractual obligations associated with the distribution, ownership, or disposition of the Creator(s)' Shares.
    6. The "Creator" or "Creators" are those individual(s) who created the intellectual content for the distance learning venture. If there is more than one Creator, they will generally share equally in the Creators' Share. If there are no readily identifiable Creators because the distance learning venture is a group project, was largely created by University or Departmental resources or for any other reason, then the Creators' Share will go to the University as set forth in paragraph 7. A committee appointed by the Provost [see 2 above] will make the determination of the apportionment of the "Creator" share.
    7. The remaining Net Equity will be issued to the University as the University Share. The Office of the Provost will determine how such proceeds are to be distributed. A department or school may petition the Office of the Provost to receive a portion of the equity for its particular teaching and education purposes.
    8. All equity received by the University will be managed by Stanford Management Company.
    9. Any disputes about any issues covered by this policy shall be submitted to the Provost who will attempt to informally resolve the dispute and, failing that, appoint a Panel to decide each dispute. Any objections to the decision of the Panel must be made in writing within 30 days of the decision of the Panel to the President, and the President of his designee will make a final and binding determination of the dispute.

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    4. Equity

    It may be in the best interests of technology transfer and distance learning to include equity as partial consideration of a license agreement. Young, privately-held companies often do not have the requisite cash reserves to compete with an established company for rights to Stanford property. An offering of equity is a means of enabling small companies to license Stanford technology or otherwise participate with Stanford in distance learning ventures. However, the acceptance of equity presents two potential problems: risk and the generation of conflicts of interest.

    Risk is an issue because, at the time equity is given, it generally has no value. Whether or not it will acquire value will depend on the overall success of the company, which is a function of many factors that may not relate to the technology being licensed or the educational content being distributed. Therefore, Stanford University will always require some cash as part of the upfront license agreement.

    Equity has considerable potential for creating conflicts of interest for inventors, creators and the University because equity holders are part owners of the company. As owners, they stand to gain considerably if the company does well, and therefore there may be incentives to take actions and make decisions that favor the interests of the company over the academic missions of the University.

    Stanford's Faculty Policy on Conflict of Commitment and Interest in RPH recognizes these potential conflicts and requires disclosure and intervention as necessary to manage them. However, since departments and schools are involved in key personnel and facilities decisions, conflict of interest can also be a concern at the organizational and institutional levels.

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    4.7 Institutional Conflict of Interest in Research Involving Human Subjects

    Establishes principles and procedures designed to ensure that research involving human subjects at Stanford University is conducted without untoward influence resulting from either the University's financial investments or holdings or the personal financial interests or holdings of key institutional leaders.

    In developing this policy and related procedures, the University has taken into account the issues identified and discussed in "Protecting Patients, Preserving Integrity, Advancing Health: Accelerating Implementation of COI Policies in Human Subjects Research," published in 2008 by the Association of American Medical Colleges (AAMC) and the Association of American Universities (AAU).

    Authority

    University President

    University President

    Contact

    Mary Lee

    Director, University Conflicts of Interest Office

    Vice Provost and Dean of Research

    (650) 736-6518

    1. Definitions

    For purposes of this policy:

    A. Institutional Conflict of Interest (ICOI) Involving Human Subjects Research

    "Institutional conflict of interest (ICOI) involving human subjects research" is defined as a situation in which the financial investments or holdings of Stanford University or the personal financial interests or holdings of institutional leaders might affect or reasonably appear to affect institutional processes for the design, conduct, reporting, review, or oversight of human subjects research.

    B. Human Subjects Research

    "Human subjects research" is defined as any research that requires panel review and approval by a Stanford Institutional Review Board (IRB).

    C. Institutional Leaders

    "Institutional leaders" are those who have direct authority over faculty appointments, salaries, promotions, and/or allocation of institutional resources, such as assignment of graduate students or other trainees, funding or space, for faculty who are conducting human subjects research.

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    2. General Principles

    Institutional conflicts of interest are of significant concern when financial interests create the potential for inappropriate influence over the institution's activities, personnel, or resources. The risks of such conflicts include the possibility that the integrity and objectivity of the institution's research may be threatened or may be perceived to be threatened; such risks are particularly acute in human subjects research, when the protection of human subjects may be adversely affected. The principle underlying this policy is that the University is obligated to protect against exposure to these risks as they may affect the integrity of human subjects research or the safety of participants when performed at or under the auspices of the institution.

    This policy recognizes the principle that individual scholars at Stanford are free to select the subject matter of their research and to seek support from any source for their work, under provisions that are stated in the Principles Concerning Research in RPH. This ICOI policy for research involving human subjects provides a process to address circumstances in which an ICOI has the potential to impact a faculty member's research adversely if it is not managed appropriately or eliminated.

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    3. Institutional Conflicts of Interest Arising from the Financial Holdings or Investments of Stanford University

    A. Licensing Activities

    When Stanford University licenses technology or other intellectual property, it may receive equity in a company as a result of that license and/or a royalty or other fee as compensation for the use of that intellectual property and may also receive equity or other financial interests as part of a co-investment in the company by the University. An institutional conflict of interest is created if an investigator at Stanford subsequently undertakes to do human subjects research on a drug, device, biologic or other item on which Stanford has the potential for financial gain through future royalties or equity appreciation. Stanford will sequester such financial interest (both equity and royalty) in an account held by an independent third party to eliminate the ICOI as soon as the sequestration can practically be accomplished.

    Procedures for identification and elimination of ICOI related to licensing

    1. The Stanford Research Compliance office requires all new human subjects research protocols submitted for IRB review to indicate the nature and source(s) of all drugs, devices, or biologics which will be used in the proposed research, and the source(s) of all funding to be used in supporting the research, including unrestricted school, department, or individual accounts.

    2. The Office of Technology Licensing (OTL) director or designee reviews this information to identify situations in which licensed Stanford-owned intellectual property was directly involved in the creation of the drugs, devices, biologics, diagnostics or other technology being studied.

    3. If an ICOI is identified, the OTL director or designee informs the Stanford Management Company (SMC) and the Chief Financial Officer (CFO). Normally Stanford will place all such financial interests related to the ICOI in a sequestration account managed by a third party, which will maintain an ethical wall between it and the University such that the University will not know whether the conflicting financial interests have been sold and the third party will not know the results of any related human subjects research unless it is published. In addition, SMC will not release the proceeds from the potentially conflicted financial interest of the University for 10 years after (1) publication of all the Stanford research results that created the conflict or (2) that clinical trial research ends at Stanford. In addition, the third party manager will not sell any equity or right to receive future royalties during this period unless forced to do so by a merger, acquisition or bankruptcy of the company or similar event.

    For avoidance of doubt, sequestration ends immediately when a product has been approved for commercial sale by a U.S. regulatory agency, or when the license is terminated, or the product which was the subject of the clinical trial is no longer being developed by a licensee/sublicensee.

    Exceptions may include:

    • When the faculty member decides not to undertake the research
    • When there are circumstances that involve the use of platform technology or a generic method used broadly, in which case the specific situation will be evaluated by the ICOI committee which may recommend an exception to the requirement for sequestration to the Provost
    • OTL will notify the Office of Research Compliance and the office of the Conflict of Interest Review Program of the action that has been taken to address the ICOI.

    B. Investments

    Except for equity acquired as part of a licensing agreement and gifts of equity to the University, only the Stanford Management Company (SMC) and the Chief Financial Officer (CFO) are authorized to acquire equity in companies on behalf of the University. The policy of SMC and CFO is to maintain a separation of the sources of information and decision-making related to the investment of Stanford's assets and the operations of the University, including the conduct of research. This firewall is important to separate the research and other academic functions and the investment function of the University. In addition, it is SMC policy not to make direct investments in individual stocks or equity in companies. Instead, SMC invests with outside fund managers who make the independent decisions as to which specific stocks or equity to buy and sell.

    As a matter of policy, SMC does not advise its outside fund managers whether to purchase or sell any individual stocks or equities held on Stanford's behalf except for maintaining a list of prohibited stocks as noted below. Some schools and departments may acquire stocks or other equity when friends of the school or department donate to a venture fund and select stocks or other equity to be purchased by the fund. In all cases, the selection of these stocks must be made by someone who is not an employee of the University and must be made without influence, information or advice from any University employee.

    If a school, unit or department has a venture fund, it must designate a senior university official who will ensure that this policy is followed and the venture fund will request that equity be purchased or sold only after the senior official conducts a thorough review to exclude possible reliance on information from University employees or attempts to influence the buying or selling of equity by them. SMC will then carry out the directions of those who are making the investment decisions for the venture fund after receiving written confirmation from the University official that this process was followed. No schools, units or departments may start new venture funds without written permission of the President.

    When notified about human subjects research directly involving licensed Stanford-owned technology by OTL, neither SMC nor the CFO will directly acquire equity in the licensee or permit any separately managed account or other account that it controls to directly acquire any such equity. It is acknowledged that SMC and accounts controlled by it may invest in commingled funds and other accounts that are managed by third parties not controlled by the University and that these accounts may invest it in equity of companies involved in conflicted human subjects research. SMC and the CFO shall not be required to sequester, or cause any account to sequester, equity in a listed company that SMC or an account acquired (or had entered into a binding agreement to acquire) prior to the time SMC was advised in writing that the company was involved in human subjects research at Stanford.

    C. Gifts

    Any gifts to the University of equity in individual companies directly utilizing Stanford intellectual property to produce a drug, device, diagnostic, etc. and that are involved in human subjects research at Stanford will be transferred to the sequestration account as soon as it can be practically and legally accomplished. Stanford may receive gifts from corporate entities that may also sponsor research involving human subjects according to policies described in RPH: Definitions and Categories of Sponsored Projects. Stanford's policies on such gifts are described in Research Policy Handbook, and in the Stanford Industry Interactions Policy, which applies to the School of Medicine, the Stanford Hospital and Clinics and the Lucile Packard Children's Hospital.

    The financial interests or holdings of institutional leaders must not affect, or reasonably appear to affect, the design, conduct, reporting, review or oversight of human subjects research carried out in the Stanford unit(s) over which they have authority, or by individuals whose Stanford appointments, or whose access to Stanford resources are under their direct oversight. Institutional leaders can include the President, the Provost, the Vice Provost and Dean of Research, School Deans, Senior Associate Deans, Department Chairs, Division Chiefs, and Institute and Center Directors. Potential institutional conflicts of interest that may involve members of IRB panels or of the individuals who serve on Conflict of Interest Committees or various committees involved with drug, device, or diagnostics procurement are governed by policies and procedures that regulate these committees.

    Any direct financial interests of an institutional leader in a company that is sponsoring human subjects research or a financial interest related to intellectual property that is the subject of human subjects research at Stanford must be disclosed when an individual(s) in the unit for which they are the institutional leader proposes such research, subject to the thresholds described below.

    Direct financial interests include:

    • Equity holdings that are held directly by the institutional leader or their immediate family but exclude (a) mutual funds for which the individual has no control over the investment decisions of the fund or (b) funds that are not actively managed by the institutional leader and they certify that the investments are managed under agreement with a professional, outside manager and that they do not participate in any way in decisions about the purchase of or sale of individual stocks
    • Royalties (whether paid through Stanford or through another source)
    • Payments for consulting, board service, or other services and any other financial relationship that involves payments by the company to the institutional leader

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    5. Procedures for Identification and Disclosure of Potential ICOI Arising From the Personal Financial Interests or Holdings of Institutional Leaders

    A. Identification of Potential ICOI by Chairs, Division Chiefs, and Institute and Center Directors

    Department chairs are required to review and sign off on all research proposals being submitted by faculty in their departments, divisions, or institutes, including those involving human subjects research. This review occurs when the proposal is submitted for funding to an extramural sponsor (as part of the electronic submission of the Proposal Development & Routing Form, PDRF) or in meeting their obligation to provide scientific evaluation when internal funds are used to support a human subjects research project. In carrying out these duties, the chair must identify any personal financial conflict of interest, regardless of value, that they have in the research sponsor or in an entity that owns or controls the investigational product that is the subject of the research. In departments that have division chiefs, the chair must also determine whether the division chief has any personal financial conflicts related to the HSR. Center and Institute directors who have a role comparable to chairs or division chiefs are also subject to these requirements. In addition, at the beginning of the initial term of a department chair, a division chief or center or institute director who has these duties, must review all active research projects involving human subjects in the department, division, or institute to identify any potential conflicts of interest that exist at that time.

    B. Disclosure of Potential ICOI by Chairs, Division Chiefs, Institute and Center Directors

    Any conflicts that are identified through these procedures, regardless of the value of the interest, must be disclosed to the School Dean or designee for review.

    The conflict will be determined to be significant if it involves:

    • any financial interest in a non-publicly traded company (e.g., in a 'start up' company)
    • current or pending ownership interests (including shares, partnership stake, or derivative interests such as stock options) in a public company of $25,000 or more
    • income of $25,000 or more including consulting, honoraria, licensing or royalty income, or employment of an immediate family member

    Any conflict of an institutional leader that is found to be significant by these criteria must be referred to the ICOI Committee (ICOIC) for its evaluation and recommendation to the Provost.

    C. Identification and disclosure of potential ICOI of the President, Provost, Vice Provost and Dean of Research, School Deans and Senior Associate Deans for Research (or equivalent)

    These institutional leaders do not have direct knowledge of all of the human subjects research at Stanford and do not have a role in reviewing the submission of specific research proposals or internally funded human subjects research. Therefore, as part of their annual conflict of interest disclosure, they will disclose all of their direct financial interests and indicate whether they are significant. For these purposes, a direct financial interest is deemed significant if it involves:

    • any financial interest in a non-publicly traded company (e.g., in a 'start up' company) that is more than 0.5% of the ownership interest in the company or valued at more than $50,000
    • current or pending ownership interests (including shares, partnership stake, or derivative interests such as stock options) in a public company of $50,000 or more
    • income of $50,000 or more including consulting, honoraria, licensing or royalty income, or employment of an immediate family member

    Senior Associate Deans for Research (or equivalent) will disclose to the School Dean. The School Deans and the Vice Provost and Dean of Research will disclose to the Provost, the Provost will disclose to the President and the President will disclose to the Chair of the Board of Trustees. The annual disclosures that list companies in which these institutional leaders have a significant financial interest will be provided to Office of Research Compliance by the person responsible for receiving the individual's annual COI disclosure. If any human subjects research is proposed during the year involving one of these companies, the institutional leader(s) and the Dean of Research, who chairs the ICOIC, will be notified by the Office of Research Compliance. If at any time during the year, an institutional leader becomes aware of actual or proposed human subjects research involving a company or the product of a company for which they have a significant financial interest, they shall advise the Office of Research Compliance and the Dean of Research, as chair of the ICOIC of the possible ICOI. If the Dean of Research has the potential ICOI, an alternate chair will serve during the ICOIC review.

    D. Procedures for Review and Disposition of Potential ICOI of Institutional Leaders

    The ICOIC will review cases arising from the significant personal financial interests of institutional leaders. This committee is not charged with reviewing institutional conflicts of interest resulting from the financial investments or holdings of Stanford University because the ICOI policy requires sequestration of such holdings in a lockbox account. An exception (which requires ICOIC review and the Provost’s approval) may occur when the conflict is associated with intellectual property involving platform technology not obviously directly related to a specific human subjects research protocol. In all cases, the ICOIC will report to the Provost who will make the final decision about its recommendations.

    The members of the ICOIC will be appointed by the Provost. The Dean of Research, or designee, will chair the ICOIC. At a minimum, the ICOIC members will include the Dean of Research (or designee), a Senior Associate Dean of Research or a senior faculty member with relevant expertise from three (3) Schools, a member of the public, and one or more additional members. If the Dean of Research has a conflict, the Provost will prepare the relevant materials and submit them directly to the ICOIC; the Dean of Research will be recused and an alternate chair appointed by the Provost. The dean of the school from which the ICOI is generated may be invited to serve as an ad hoc member for the discussion of cases pertaining to their school. Any member should abstain from ICOIC business when they have a personal COI or involvement in ICOI that relates to a research proposal under review. When an ICOI that involves a human subjects research project is identified that results from a significant financial interest of an institutional leader, the relevant school dean or designee will prepare a case document describing the nature of the ICOI. The case document will be submitted to the Dean of Research and must include a statement from the institutional official whose personal financial interests have created the conflict, from the faculty member whose research is potentially affected, and from the IRB as to the level of risk to human subjects. The ICOIC will review and assess the case document using the criteria listed below. As a result of this assessment, the recommendation to the Provost may:

    • prohibit the research from proceeding at or under the auspices of Stanford unless the institutional leader divests or terminates the financial relationship
    • propose a plan to manage the conflict
    • remove the institutional leader from such leadership position

    In determining whether a recommendation to manage the ICOI should be considered, the ICOIC will evaluate all relevant factors, including:

    • The level of risk to human subjects in the research as determined by the IRB panel given the specific circumstances
    • The level of risk to the integrity and objectivity of the research given the specific circumstances
    • The level and type of the financial interests or relationship held by the institutional leader
    • How direct and immediate the institutional leader's authority is over the research and the people involved in conducting the research
    • The status of the company, e.g. privately-held start-up company, small publicly-traded or large publicly- traded company, and the importance or perceived importance of the research to the finances of the company
    • Whether a plan for separation of oversight of the faculty conducting human subjects research by the institutional official with the conflict can be implemented that is both practical and effective while the institution official remains in the assigned leadership position
    • The risk to the academic freedom and unbiased treatment of the faculty member who has proposed the research
    • The perceived risk to the reputation of the institution

    If the ICOIC makes a recommendation for management, the report to the Provost must provide a management plan that includes some or all of the following recommendations:

    • In all cases, there must be identification of the individual, usually the School Dean or his or her designee, who will be directly responsible for ensuring that the requirements of the management plan are implemented and monitored for continued compliance. If the conflicted individual is the School Dean, the Provost will designate the responsible individual
    • A formal recusal of the conflicted leader from the chain of authority over the project and from authority over salary, promotion, space, and trainee assignment decisions affecting the investigator
    • A direct communication of the recusal arrangements to the institutional leader's superior, colleagues, and affected faculty
    • Designation of a "safe haven," e.g., a non-conflicted senior individual, with whom the investigator can address ICOI-related concerns
    • Instructions to the investigator(s) to disclose the institutional COI in public presentations and publications
    • Disclosure of the ICOI in the informed consent process and review of the consent by the IRB at each annual renewal of the study protocol
    • Disclosure of the ICOI to other centers in a multi-center trial
    • Any other requirements that the ICOI committee deems necessary

    The Provost will review the ICOI committee's recommendations and make the final decision about whether a proposed management plan is acceptable. The Provost will report the decision to the relevant school deans and the Dean of Research.

    If the conflicted institutional leader is a dean, or vice provost or provost, the case document and the Provost's decision will be transmitted to the President. If the conflict involves the President or Provost (for example if the Dean of a School is conducting human subjects research for a company in which the Provost has a direct financial interest), then the final decision will be made by the President (in the case of the Provost) or the Chair of the Board of Trustee's Audit and Compliance Committee (in the case of the President).

    The Dean of Research will communicate the Provost's decision to the Office of Research Compliance for notification of the IRB, to the Office of Sponsored Research (OSR) if the ICOI involves a sponsored research project, so that OSR can meet any reporting obligations, and to the relevant dean or associate dean so that the recommendations can be implemented at the level of the individual schools.

     

    5. Human Subjects and Stem Cells in Research

    5.1 Human Research Protection Program

    Provides comprehensive information about the organization, scope, authority and responsibilities associated with Stanford University's program for the protection of human research subjects.

    Contact

    Kathy McClelland

    Research Compliance Office Director

    Vice Provost and Dean of Research - Research Compliance

    (650) 723-4697

    1. Introduction

    This Human Research Protection Program (HRPP) policy is provided in an effort to give comprehensive information about the organization and focus of the human research protection program to the members of the research community at Stanford University and affiliated organizations. Stanford University has had a program to protect human participants for many years. Prior to September 1, 2005, a large portion of the program was described in writing in the Institutional Review Board's (IRB's) standard operating procedures, the "Human Subjects Manual," the IRB's website, the official charge to IRB members upon their appointment, and other sections of this Research Policy Handbook. With the issuance of this HRPP policy, the program has been incorporated into one core document and reorganized around the principles and standards of the Association for the Accreditation of Human Research Protection Programs. It continues to require compliance with applicable laws such as the Common Rule (45 CRR Part 46) and FDA regulations relating to human subjects (21 CFR Parts 50 and 56) and includes ethical standards such as the Belmont Report. All members of the Stanford community who engage in research involving human subjects must be knowledgeable about the requirements of the HRPP.

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    2. Authority and Responsibility

    The Vice Provost and Dean of Research (VP and Dean) has been given the authority and responsibility to establish, maintain, and oversee the HRPP by the President of Stanford University. The primary administrative responsibility for the day-to-day operation of the HRPP lies with the Research Compliance Office and the Administrative Panels on Human Subjects in Medical Research and the Administrative Panel on Human Subjects in Non-Medical Research (IRBs). The Research and Development Committee at the Veterans Affairs Palo Alto Health Care System (VAPAHCS) retains ultimate responsibility for the maintenance of its overall institutional system to protect human subjects.

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    3. Participating Organizations

    The HRPP applies to the human subject research done at Stanford University and also at affiliate organizations for which it has an agreement to provide services related to the HRPP. The organizations covered by and participating in the HRPP are:

    • Stanford University
    • Stanford Hospital and Clinics
    • Lucile Packard Children's Hospital
    • Veterans Affairs Palo Alto Health Care System (VAPAHCS)
    • Palo Alto Institute for Research and Education (PAIRE)

    (This coverage includes any subsidiary entities listed in the Federalwide Assurance filed by these organizations.)

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    4. Human Research Protection Program Policies

    The VP and Dean or Associate Dean has approved the policies that constitute the HRPP. The VP and Dean may add or modify policies as necessary and appropriate to incorporate changes in the law and accreditation standards and to improve the effectiveness of protections for human subjects.

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    5. Compliance and Monitoring

    The IRBs acting on behalf of the five organizations covered by the HRPP will institute a continual process for reviewing and monitoring human subject research and its compliance with the HRPP.

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    6. Role of the IRBS

    The IRBs play a primary role in the HRPP through such activities as:

    1. Prospective and continuing review of each research protocol involving human subjects, including an evaluation of its risks and benefits to the human subjects
    2. Reviewing the adequacy of the informed consent document, particularly as to its description of the risks and benefits
    3. Receiving, evaluating and conducting reviews concerning reports of unanticipated problems, possible non-compliance, and other information and incidents that might affect its approval of the protocol or the subjects' willingness to continue to participate

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    7. Training Concerning the HRPP

    Stanford University and its affiliates train and require documentation of training for all investigators, research staff, students, IRB members and staff, and others engaged in human subject research about the requirements of the HRPP.

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    8. Non-compliance

    Anyone who knows that, or has reason to believe that human research is being conducted in a manner that is not in compliance with the HRPP must report the matter promptly to the Director of Research Compliance, or the VP and Dean. All reported matters will be reviewed in a timely manner and, when possible, will be handled confidentially. Where appropriate, sanctions will be considered and imposed. Any attempt to retaliate against a person for reporting possible non-compliance with the HRPP may itself be considered a violation of the HRPP.

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    9. Sanctions

    Non-compliance, protocol deviations, and violations are addressed in the HRPP Non-adherence to Stanford policies and procedures, and applicable local, state and federal regulations concerning human subject research may, under certain circumstances, result in administrative, civil, or criminal penalties against individuals and the organizations participating in the HRPP. These penalties include action by the FDA to suspend or terminate an investigator or an organization's ability to participate in clinical trials for investigational drugs, devices, and biologics, and action by the US Department of Health and Human Services to suspend funding for human subject research. Employees, students, and contractors of the participating organizations who are not in compliance with the HRPP in the conduct of human subject research or related activities may be subject to disciplinary action up to and including termination of employment, contract, or other relationship with the participating organization.

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    10. Information and Reporting

    If any member of the Stanford community has any questions about the HRPP or wishes to make a report related to human subjects in a research protocol, the protocol director of the relevant research protocol, the IRB, or the Research Compliance Office should be contacted. Contacting the IRB and Research Compliance Office, may be done anonymously.

    Contact Information for IRB and Research Compliance Office

    Telephone: 650-724-8943; email: anastasia.doherty@stanford.edu; US mail: 1705 El Camino Real, Palo Alto, CA 94306

    Contact Information for Director of Research Compliance

    Telephone: 650-723-4697; email: kathy.mcclelland@stanford.edu; US mail: 1705 El Camino Real, Palo Alto, CA 94306

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    5.2 Federal-wide Assurance for Protection of Human Subjects

    Provides assurance of Stanford compliance with Department of Health and Human Services (DHHS) regulations for the protection of human research subjects.

    Authority

    United States Department of Health and Human Services

    Contact

    Kathy McClelland

    Research Compliance Office Director

    Vice Provost and Dean of Research - Research Compliance

    (650) 723-4697

    1. Statement

    Stanford University's Federalwide Assurance for the protection of human subjects, along with the related assurances for Stanford Hospital and Clinics, Lucille Salter Packard Children's Hospital, the Palo Alto Veterans Institute for Research, and the Veteran's Administration Palo Alto Health Care System can be found in the Research Compliance Office site. 

    Incorporated into Stanford's Federalwide Assurance are The Belmont Report and Code of Federal Regulations, 45 CFR 46, Protection of Human Subjects.

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    5.3 Women as Subjects in Research

    Presents requirements for the participation of women with child-bearing potential in research trials, including clinical trials.

    Authority

    Vice Provost and Dean of Research (DoR), endorsed by the Committee on Research

    Contact

    Kathy McClelland

    Research Compliance Office Director

    Vice Provost and Dean of Research - Research Compliance

    (650) 723-4697

    1. Introduction

    Historically, there have been concerns about the participation of women with child-bearing potential in research trials due to potential risks of fetal harm should a woman become pregnant. Such apprehension has resulted in guidelines or policies from Federal agencies that called for special protection for women.

    Over the past decade, questions have been raised by professional, consumer, and governmental groups about whether clinical treatments are adequately tested in various populations that are the recipients of such therapies. In terms of drug development, the FDA began to consider information available pertaining to the safety and effectiveness of drugs for women and subpopulations such as the elderly and diverse racial groups. In 1988, the Agency issued a guideline that called for safety and efficacy profiles for these groups as part of new drug applications (NDAs). (FDA Guideline for the Format and Content of the Clinical and Statistical Sections of New Drug Applications, 1988). Then in 1993, following broad public discussion about participation of women in clinical trials, FDA issued a new guideline that eliminated the restriction on participation of women with childbearing potential from all phases of drug trials. It detailed procedures to minimize the risks of pregnancy in women participants such as contraceptive counseling, pregnancy tests, timing of short term studies in relation to the menstrual cycle, and the process of informed consent.

    The guideline underscored that while FDA remained involved in general risk/benefit determinations for subjects entering various phases of clinical trials, initial determinations about whether fetal risk is adequately addressed are properly left to patients, physicians, local IRBs, and study sponsors. The new guideline also called for gender analyses with special attention to factors affecting pharmacokinetics, e.g. the role of the menstrual cycle and exogenous hormone therapy in relation to the drug, as well as the influence of the drug on oral contraceptives.

    The NIH has also examined carefully the issue of participation of women in research. It has determined that since the primary aim of biomedical and behavioral research is to provide scientific evidence leading to a change in health policy or a standard of care, it is imperative to determine if the intervention or therapy being studied affects men and women differently.

    The agency has concluded that the inclusion of women in research is sufficiently important that the only justifiable reason to exclude women of child-bearing potential from federally funded research is compelling evidence that the proposed project would be inappropriate with respect to the health of the subject or the purpose of the research. (Federal Register, Vol. 58, No. 139, p 39406 -39416, H, Thursday, July 22, 1993 and NIH Guidelines On The Inclusion of Women and Minorities as Subjects in Clinical Research. NIH Guide, Vol. 23, No. 11, 3/18/94.)


    The following policy statement pertains primarily to the inclusion of women as subjects in clinical trials, i.e., medical research. However, the inclusion of women in behavioral research studies is also important and must be accomplished unless there is a compelling rationale which establishes that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research.

    Significant portions of the text below are presented verbatim as published in the Code of Federal Regulations and the Federal Register.

    Stanford University endorses these changes and has adopted the following policy regarding the inclusion of women as subjects in human research as a guideline to researchers.

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    2. Pregnant Women as Human Research Subjects

    Drug research using pregnant women as subjects is governed by federal regulations. Stanford University considers it prudent to apply these requirements to clinical research involving pregnant women, as follows:

    
"No pregnant woman may be involved as a subject in a human clinical research project unless (1) the purpose of the research is to meet the health needs of the mother and the fetus will be placed at risk only to the minimum extent necessary to meet such needs, or (2) the risk to the fetus is minimal. 
{Research involving the use of pregnant women as subjects} may be conducted only if the mother and father are legally competent and have given their informed consent after having been fully informed regarding possible impact on the fetus, except that the father's informed consent need not be secured if (1) the purpose of the research is to meet the health needs of the mother; (2) his identity or whereabouts cannot reasonably be ascertained; (3) he is not reasonably available; or (4) the pregnancy resulted from rape." (45 CFR 46.207)

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    3. Women of Childbearing Potential as Human Research Subjects


    Women should not be excluded from any phase of research unless the science of the project or the health of the subject will be compromised. Regarding clinical drug research, Phase I, II, and III trials should have the proportion of women in the study which at least reflects the proportion of women in the population which will receive the drug when it is marketed, and should enroll numbers adequate to detect clinically significant sex differences in drug metabolism and response.

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    4. Risk to Fertility

    It is expected that experimental subjects will be informed about potential risks to their fertility including the development of any abnormalities or abnormalities in function of reproductive organs as a consequence of the proposed study intervention.

    A.

    "Where abnormalities of reproductive organs or their function (spermatogenesis or ovulation) have been observed in experimental animals as a consequence of the proposed study intervention, the decision to include patients of reproductive age in a clinical study should be based on a careful risk-benefit evaluation, taking into account the nature of the abnormalities, the dosage needed to induce them, the consistency of findings in different species, the severity of the illness being treated, the potential importance of the drug, the availability of alternative treatment and the duration of therapy.


    Where [women] of reproductive potential are included in studies of drugs showing reproductive toxicity in animals, the clinical studies should include appropriate monitoring and/or laboratory studies to allow detection of these effects. Long-term follow-up will usually be needed to evaluate the effects of such drugs in humans." (Federal Register, Vol. 58, No. 139, p 39411, H, Thursday, July 22, 1993.)


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    5. Risk to Fetus and/or Infant

    General Guidelines:

    "Appropriate precautions should be taken in research studies to guard against inadvertent exposure of fetuses to potentially toxic agents and to inform subjects and patients of potential risk and the need for precautions. In all cases, the informed consent document and investigator's [drug information] brochure should include all available information regarding the potential risk of fetal toxicity. If animal reproductive toxicity studies are complete, the results should be presented, with some explanation of their significance in humans. If these studies have not been completed, other pertinent information should be provided, such as general assessment of fetal toxicity in drugs with related structures or pharmacological effects. If no relevant information is available, the informed consent should explicitly note the potential for fetal risk.
In general, it is expected that reproductive toxicity studies will be completed before there is large-scale exposure of women of child-bearing potential, i.e., usually by the end of phase II and before any expanded access program is implemented." (Federal Register, Vol. 58, No. 139, p 39411, G, Thursday, July 22, 1993.)

    Minimizing the Possibility of Fetal Exposure

    Pregnancy testing may be used to detect unsuspected pregnancy prior to initiation of study treatment. Timing of the start of the study to coincide with or immediately follow the onset of menses is also an adequate indication that the subject is not pregnant. The investigator should ascertain that the subjects will responsibly employ a reliable method of contraception or abstinence for the duration of the drug or treatment exposure, which may exceed the length of the study. If requested, the investigator should be able to refer the subject to a knowledgeable counselor or physician for contraceptive advice.

    Inclusion of Women in Early Clinical Trials (Phase I and early Phase II)

    
"In some cases, there may be a basis for requiring [inclusion] of women in early studies. When the disease under study is serious and affects women, and especially when a promising drug for the disease is being developed and made available rapidly under FDA's accelerated approval or early access procedures, a case can be made for requiring that women [be allowed to] participate in clinical studies at an early stage. When such a drug becomes available under expanded access mechanism (for example, treatment IND or parallel track) or is marketed rapidly under subpart E procedures (because an effect of survival or irreversible morbidity has been shown in the earliest controlled trials), it is medically important that a representative sample of the entire population likely to receive the drug has been studied, including representatives of both genders. Under these circumstances, clinical protocols should not place unwarranted restrictions of the participation of women." (Federal Register, Vol. 58, No. 139, p 39409, G, Thursday, July 22, 1993.)

    Risk to Infant of Nursing Mother

    The potential for harm from exposure to a drug with unknown risks exists for nursing infants as well as fetuses. Therefore, this policy applies to breast feeding female subjects who are potential subjects in a drug trial in the same manner in which it applies to gestating women.

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    6. Active Recruitment of Women

    In order to assure that adequate numbers of women are included, researchers are encouraged to actively recruit women into their trials. For specific outreach methodologies, researchers may obtain the "NIH Outreach Notebook of the Inclusion of Women and Minorities in Biomedical and Behavioral Research."

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    The following language is recommended when women of child-bearing potential (non-pregnant) will be enrolled into a potentially toxic drug study:


    "If you are a woman who is able to become pregnant, it is expected that you will use an effective method of birth control to prevent exposing a fetus to a potentially dangerous agent with unknown risk. If you are pregnant or currently breast feeding, you may not participate in this drug study. You understand that if you are pregnant, if you become pregnant, or if you are breast-feeding during this study, you or your child may be exposed to an unknown risk [or state specific risk].


    To confirm to the extent medically possible that you are not pregnant, you agree [to have a pregnancy test done before beginning this research study] [to begin the study after the onset of your next menstrual period] (choose one). You must agree to avoid sexual intercourse or use a birth control method judged to be effective by the investigator and which will not interfere with the proposed investigation. You must accept the risk that pregnancy could still result despite the responsible use of reliable method of birth control. You agree to notify the investigator as soon as possible of any failure of proper use of your birth control method, or if you become pregnant, either of which may result in your being withdrawn from the study.
"

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    8. Protocol Renewal

    Investigators applying for a renewal of their research protocols are encouraged to comply with these new guidelines to the extent that the science of their project is not compromised.

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    5.4 Use of Human Subjects in Student Projects, Pilot Studies, Oral Histories and QA/QI Projects

    Discusses the responsibilities for use of human subjects in student projects, pilot studies, oral histories, and QA/QI projects, and describes conditions under which Administrative Panel (IRB) review and approval is needed.

    Authority

    Administrative Panel on the Use of Human Subjects in Non-Medical Research


    Reseach Compliance Director

    Contact

    Panel Coordinator

    (650) 723-8666 (for meeting & deadline dates) (650) 723-2480 (for other questions)

    1. Introduction

    Some specific types of studies have triggered questions with respect to investigators' responsibilities and the need to obtain prospective review and approval of the IRB:

    • Student Projects
    • Pilot Studies
    • Oral Histories
    • Quality Assurance/Quality Improvement Projects

    Human Subject Research

    Does My Project Need IRB Review?

     

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    2. Student Projects

    Stanford University supports a wide range of both undergraduate and graduate student research projects involving human subjects -- from course-related research exercises to Ph.D. dissertation studies.

    Generally, student research involving human subjects falls into one of two categories, research practica and directed, independent research projects. 

     

    A. Research Practica

    Research Practica are class projects designed to provide students an opportunity to practice various research methods such as interview, observation and survey techniques, as well as data analysis. Such projects typically do not lead to generalizable knowledge and are not undertaken with that goal in mind. Research practica do not require IRB review. Data that are collected during a research practicum project may be used in independent research projects at a future time. In such a case, the IRB should be consulted, because an IRB application for use of existing data may be required.

    Although the IRB does not review such class projects, we strongly encourage instructors to become fully familiar with each student's project(s), and to discuss it with the student. Experience has taught us that time spent with students discussing matters such as courtesy, and avoidance of unnecessary discomfort or invasion of privacy, will be time well spent. Explicit recognition of the existence of the IRB and discussion of its goals and concerns should be an integral part of introducing students to research methodologies .

     

    B. Directed or Independent Research Projects

    Directed or Independent Research Projects are any research conducted by students, graduate or undergraduate which involve human subjects, employs systematic data collection, is intended to contribute to generalizable knowledge, and does not fall under the definition of research practicum. These projects include, but are not limited to, independent undergraduate research projects and honors theses, masters' theses and dissertations. Student projects in this category must be reviewed and approved by the IRB. It is possible that a research project may be exempt from ongoing IRB review, but it must meet explicit criteria and the IRB must certify the exemption.

    If you have questions regarding the distinction between these categories, please do not hesitate to contact the IRB for assistance. 

     

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    3. Pilot Studies

    A pilot study is a preliminary investigation of the feasibility of a study, usually done on a small scale (approximately 10 or fewer subjects) and exploratory in nature. It is designed to help the investigator refine data collection procedures and instruments or prepare a better, more precise research design. Such a pilot would not contribute to generalizable knowledge and therefore is not considered research and does not require IRB review. Data collected from a pilot study cannot be used as research data.

    Medical interventions or interactions for research purposes, especially those involving invasive procedures, do require IRB review regardless of the size of the study.

     

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    4. Oral History

    An oral history study may not require IRB review because it is not generally thought to be a systematic investigation designed to contribute to generalizable knowledge beyond the individual being interviewed. However, when using oral history as a technique in human subject research it may require IRB review. Researchers proposing such work are strongly encouraged to contact the IRB to determine whether their project requires approval.

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    5. Quality Assurance or Quality Improvement Projects

    Research conducted in conjunction with program evaluations or quality assurance measures may not fall under the jurisdiction of the IRB, although if the project is intended to develop or contribute to generalizable knowledge, and involves human subjects, the project should be submitted for IRB review:

    • Visit the Human Subjects informational website for more information about what constitutes human subject research and whether IRB review is necessary
    • To verify whether your project requires IRB review, please contact the IRB directly at (650) 724-7141 or at IRBEducation@lists.stanford.edu
      • The IRB offers written documentation as a courtesy. To submit a written request for a Human Subjects Research determination, submit the Determination of Human Subject Research application via eProtocol by selecting ‘Create a Protocol’ on the ‘My Dashboard’ webpage, entering a small amount of information about your project, and selecting the ‘HSR’ or ‘Human Subject Research’ category of review
    • To submit an IRB protocol, access the electronic protocol submission application and go to ‘My Dashboard’

     

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    5.5 Use of Employees or Laboratory Personnel as Research Subjects

    Presents guidelines for participation by employees or laboratory personnel as subjects in Stanford research projects.

    Authority

    Originally issued as a memorandum from James Theodore, Chairman, Administrative Panel on the Use of Human Subjects in Medical Research

    Contact

    Kathy McClelland

    Research Compliance Office Director

    Vice Provost and Dean of Research - Research Compliance

    (650) 723-4697

    1. Overview

    The Human Subjects Panel considered and reviewed the above referenced topic at the December 1988, January 1989, August 1995 and October 2001 meetings and requests that you address this important matter when preparing your protocol applications.

    1. Whenever employees or laboratory personnel participate as subjects in a formally approved research project, they should render the same written informed consent as any other participant in the study.
    2. Research directors should understand that, by virtue of their dependent positions, employees or laboratory personnel represent a vulnerable population with regard to acting as research subjects. The directors should be sensitive to the need to avoid even subtle coercion and to ensure that all personnel who participate in even minimal risk research activities do so entirely voluntarily.
    3. In general, studies involving any type of intervention (e.g. the ingestion or injection of a substance, or venipuncture, solely for the sake of the study) should be considered research, subject to the need for written and signed informed consent. The Protocol Director is urged to contact the Human Subjects Office (724-7141) for guidance in questionable cases.
    4. In principle, the Panel feels that if compensation is allowed, it should go to all subjects; however, compensation of individuals who are full-time members of the academic staff or regular exempt staff may not be allowed.
    5. As mentioned above (see #3), if doubt exists as to the appropriateness of having employees or laboratory personnel participate in even minimal risk activities, the Protocol Director is urged to contact the Human Subjects Office (724-7141) for guidance.

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    5.6 Guidelines for Studies Involving Human Volunteers Receiving Potentially Addicting Drugs

    Presents guidelines for participation by human subjects in studies involving potentially addicting drugs; discusses informed consent, and conditions for exclusion of subjects.

    Authority

    Administrative Panel on the Use of Human Subjects in Medical Research

    Contact

    Kathy McClelland

    Research Compliance Office Director

    Vice Provost and Dean of Research - Research Compliance

    (650) 723-4697

    1. Introduction

    In developing and testing new drugs with therapeutic potential it is usually necessary to conduct studies on human volunteers. This remains true for drugs, including but not limited to opiate analgesics, which are known to have significant potential for addiction in some individuals. In order to serve the goal of minimizing potential risk to human subjects, these guidelines review special features of studies involving human volunteers receiving potentially addicting drugs.

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    Human volunteer subjects who may receive drugs with significant potential for addiction (examples include but are not limited to opiates, cocaine, alcohol) in a study must be informed that the drug(s) they may (or will) receive are known to have a significant potential for addiction in some individuals. If the magnitude of the risk of addiction in relevant populations is known it should be specified.

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    3. Exclusion of Subjects with a History of Addiction

    With some exceptions, potential volunteer subjects who have a known history of addiction should be excluded from studies of drugs with a significant potential for addiction. The informed consent should indicate that potential subjects should not participate in the study if they have any history of addiction to a drug or to alcohol. Subjects should be asked to check off a box on the consent form to indicate that they do not have such a history.


    Furthermore, investigators may wish to incorporate a confidential pre-screening questionnaire about prior drug use history in such studies. Investigators may also choose to perform urine drug screening of subjects. If pre-screening questionnaires or urine testing is utilized, subjects should be informed as to how the confidentiality of these data will be maintained, and to whom they may be released.

    The exceptions to this exclusion policy are those protocols which require the participation of addicted patient subjects to answer a scientific question (e.g., the effect of moderate doses of alcohol on a biologic variable which might predict subsequent relapse or give insight into the etiology of the disorder.) The justification for experimental ingestion or intoxication must be included in the application.

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    4. Exclusion of Subjects with Direct Access to the Class of Addicting Drug Under Study

    Potential volunteer subjects who have direct physical access to and routine handling of addicting drugs in the regular course of their work duties should be excluded from studies of drugs with a significant potential for addiction and to which the subject has access.


    It is known clinically that addiction to certain types of medications is an occupational hazard of certain groups of health care workers. Although the prevalence within each group is not well-established, it is a well-described hazard for personnel who meet the following functional definition: personnel with direct physical access to and routine handling of addicting drugs in the regular course of their work duties. In particular, there is a risk for addiction to opiates, sedative-hypnotics, and cocaine. The health care workers in this group may vary depending on the drug involved and on the practice setting of the worker. However, typically the group with regular access includes: anesthesiologists; emergency room physicians; ward, operating room, post-anesthesia care unit, emergency room, and intensive care unit nurses; pharmacists. The exclusion stated above applies to those who meet the functional definition above, and not specifically to any general title or job description.


    It is also known that health care workers who are addicted to medications can often effectively hide the signs and symptoms of their addiction. This exclusion guideline would therefore operate to prevent the harm that would result if an addicted subject was inadvertently included in a study of the drug to which the subject is addicted.

    Health care workers who would be excluded under this Guideline make up a small component of the available volunteer pool for the testing of new therapeutic drugs. Thus, their participation is not required to ensure proper testing and validation of the safety of new or existing addicting drugs. Therefore, any risk of addiction in this group, no matter how small, cannot ordinarily be justified by the scientific benefit to be gained by their participation in studies of addicting drugs. It is generally expected that potential subjects who are health care workers who have direct physical access to and/or routine handling of addicting drugs in the regular course of their clinical duties will be excluded from studies in which an addicting drug to which they have access will be administered. If an investigator believes that inclusion of such personnel is necessary for the scientific goal of the study, a special application that justifies inclusion of these personnel must be made in the submission to the IRB.


    The informed consent should indicate that potential subjects who meet the functional definition should not participate in the study, and subjects should be asked to check off a box indicating that they do not meet this functional definition.

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    5.7 Training in the Protection of Human Subjects in Research

    Presents requirements for training in the protection of human subjects for any individuals at Stanford who are involved in research using human subjects in either medical or nonmedical research.

    Authority

    Contact

    1. Policy

    Stanford University requires that all individuals working with human subjects in either medical or nonmedical research complete an instructional program in the protection of human subjects. Training must be completed before the University will approve a project protocol or release project funds. This requirement reflects the University's commitment to the protection of the rights and welfare of human subjects in research, and incorporates the requirements of the National Institutes of Health (NIH).


    At Stanford, the required tutorial is provided through the Collaborative IRB Training Initiative (CITI). The tutorial covers both IRB Training and Good Clinical Practices (below).

    Upon review of the information presented at this site, individuals must identify themselves and certify their completion of the tutorial. Falsification in this regard is a violation of Stanford policy subject to appropriate corrective action.

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    2. Applicability

    This policy applies to all individuals working with human subjects under the auspices of Stanford, whether at Stanford facilities or at another location, and regardless of their institutional affiliation or source of funding. In the event that individuals from other institutions conduct research under the auspices of Stanford, they must complete the necessary training, but may do so at their home institution.

    The training requirement applies to all faculty, staff, students, visitors, or any other individuals who work with human subjects in research. Some examples include: individuals who obtain informed consent, administer surveys, or collect private or personal information from individuals. It is applicable for both medical and nonmedical research

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    3. Implementation

    The PI is responsible for assuring that all personnel working with human subjects on the project complete the necessary training in accordance with the requirements listed below. An award will not be made unless the training is completed. 

    The Certification of Human Subjects Training is required for all research projects involving human subjects being conducted under the auspices of Stanford University regardless of the source of funding for the project. Where required by sponsoring agencies, the PI will need to obtain a Certification of Human Subjects Training form found below in Related Items, for the institutional representative to endorse and forward to the sponsor.

    1.  NIH grants/contracts: When preparing a proposal for a project involving human subjects, the Principal Investigator (PI) identifies key project personnel who are responsible for the design and conduct of the study. Per NIH Policy, for projects funded by the NIH, training in the protection of human research subjects must be verified. The Certification of Human Subjects Training form is completed with the names of the key personnel that are involved with human subject research. The form is endorsed by the institutional official and must be provided to the agency before awarded funds will be released to Stanford University. A copy is also retained in the institutional file.
    2. All other non-NIH grants/contracts: For all non-NIH projects involving research on human subjects, training is verified for the PI and faculty only that are involved with human subject research. Certification of Human Subjects Training form is completed and retained in the institutional file unless otherwise requested by the sponsor.

    Subcontractors, consultants and other non-Stanford personnel must also complete this training. Key non-Stanford personnel must provide certification of human subjects training. They may satisfy this requirement at their home institutions provided that Stanford is assured of completion of the necessary training. A certificate confirming the training completed or a letter countersigned by a representative from the home institution will satisfy this requirement.

    Members of Stanford's Administrative Panels for Human Subjects in either Medical or Nonmedical Research must complete initial and refresher Collaborative IRB Training Initiative (CITI) courses.

    Stanford University reserves the right to require additional training for researchers working with human subjects where it is deemed to be necessary. 

     

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    4. Good Clinical Practice (GCP) Training Requirement

    On September 16, 2016, NIH issued a policy establishing the expectation that all NIH-funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials as defined by NIH should be trained in Good Clinical Practice (GCP), consistent with the principles of the International Conference of Harmonisation (ICH) E6 (R2).[1]  The NIH policy is effective January 1, 2017. As a result, the Institutional Review Board (IRB) will require assurance that GCP training will be completed. Your institutional official in RMG or OSR also will require verification that GCP training has been completed before sponsored project awards are issued. Awards will be withheld pending completion of GCP and human subjects (HS) training as required below:

    Definitions

    Investigator:  The individual responsible for the conduct of the clinical trial at a trial site. If a clinical trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator.

    Clinical trial staff includes:  Individuals, identified by the investigator, who are responsible for study coordination, data collection and data management. The central focus of clinical trial staff is to manage participant recruitment and enrollment, to maintain consistent study implementation, data management, and to ensure integrity and compliance with regulatory and reporting requirements. These individuals may also seek informed consent from prospective participants, enroll and meet with research participants, and collect and record information from research participants. Clinical trial staff may also be called the research coordinator, study coordinator, research nurse, study nurse or sub-investigator.

    Stanford University fully endorses the need for clinical research investigators and staff to meet international ethical and scientific quality standards for the design, conduct, recording, and reporting of research involving human subjects. Therefore, Stanford University has determined GCP training will apply to all human subjects clinical trials regardless of funding source. This includes sponsored projects funded by external sponsors and non-sponsored projects funded with department or gift funding.

    The Principal Investigator is responsible for identifying which staff are required to take the training and for ensuring the training is completed before participating in the study.

    Go to Training

    A. Decision Tree: NIH Definition of Clinical Trials

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    5. Good Clinical Practice (GCP) FAQs

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    5.8 Human Stem Cell Research

    Discusses issues related to research involving:

    • Development or use of human pluripotent stem cell lines, including human Embryonic Stem Cells (hESC), stem cells derived by Somatic Cell Nuclear Transfer (SCNT), and Induced Pluripotent Stem Cells (iPSC)

    • Human non-pluripotent stem cells, including cancer stem cells, progenitor cell populations containing stem cells, mesenchymal stem cells, and fetal-derived stem cells

    • Human embryos and parthenotes

    • Human gametes: oocytes, sperm

    Also establishes a combined Institutional Review Board/Stem Cell Research Oversight Panel (IRB/SCRO) to advise the Vice Provost and Dean of Research regarding issues related to the conduct of human stem cell research at Stanford.

    This statement contains Stanford University's policy regarding the conduct of human stem cell research and applies to all who conduct such research at Stanford. The Vice Provost and Dean of Research is responsible for interpretation and overall coordination of the policy. Violation of any part of this Policy may cause a faculty member to be subject to sanctions as described in the Statement on Faculty Discipline. This policy will be modified as necessary to comply with all applicable regulations and statutes.

    Contact

    Kathy McClelland

    Research Compliance Office Director

    Vice Provost and Dean of Research - Research Compliance

    (650) 723-4697

    1. Definitions

    “Human embryonic stem cells” (hESC) are derived from human embryos.

    “Nuclear transfer derived stem cells” (nt-hESC) are derived from human blastocysts generated by Somatic Cell Nuclear Transfer (SCNT).

    “Induced Pluripotent Stem Cells” (iPSC) are derived from somatic cells.

    All of the above are pluripotent cells that are self-renewing and capable of developing into cells and tissues of the three primary germ layers: endoderm, mesoderm, and ectoderm. Although human embryonic stem cells may be derived from embryos, such stem cells are not themselves embryos. Non-pluripotent stem cells, sometimes referred to as “adult” stem cells, are those cells that can self-renew but are not considered capable of developing into cells and tissues of all three primary germ layers.

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    2. General Principles

    California law requires that human stem cell research that requires review be reviewed and approved by a stem cell research oversight committee. In addition, the State of California has mandated that all human embryonic stem cell research funded by the California Institute for Regenerative Medicine (CIRM) must be undertaken with "...full consideration of the ethical and medical implications of this research." (California Health and Safety Code Section 125300).

    Similarly, the State of California has mandated that "research involving the derivation and use of human embryonic stem cells, human embryonic germ cells, and human adult stem cells, including somatic cell nuclear transplantation, shall be reviewed by a stem cell research oversight committee." (California Health and Safety Code Section 125300)

    In light of these considerations, Stanford University has established the following policy related to human stem cell research.

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    3. Review and Approval

    Research involving human stem cells that require review must follow existing University policies and undergo IRB/SCRO review and approval. The goals of this policy are to ensure that:

    1. Stanford University is aware of all relevant human stem cell research activities conducted by University faculty, staff, postdoctoral scholars, students, and visiting scholars, including, to the maximum extent possible, the sources or derivation of any human pluripotent stem cells planned for use or being used.
    2. Every person at Stanford working on such research is fully aware of the compliance requirements associated with the work, including the requirement for annual review.
    3. Stanford complies with any special reporting requirements for such research imposed by federal, state and local regulations, and by sponsors and donors.
    4. Existing SCRO protocol review procedures are followed.
    5. Provisions exist to monitor compliance with this policy continuously and make changes in it as are deemed appropriate.

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    4. Tracking all Human Stem Cell Research Undertaken at the University or by University Principal Investigators 


    Any research proposals for funding to support research involving human stem cells must be identified on the Stanford Proposal Development and Routing Form (PDRF). Such research will require SCRO notification or IRB/SCRO review and approval prior to initiating research involving human stem cells. In addition, it may be necessary to file a Human Subjects protocol application (see Stem Cell Research Oversight).

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    5. Guidelines that Regulate Stem Cell Research


    Because of the complexity of rules and restrictions associated with such research, all University personnel, including faculty, staff, postdoctoral scholars, and students, as well as visiting scholars and other researchers, who plan to engage in its conduct are required to complete training before they begin work on any project involving human embryonic stem cells.

    Research involving human stem cells may be regulated by one or more of the below guidelines, depending on funding sources, applicable regulations and standards, and the University’s policies.

    A. State Guidelines

    California State law regulates all research involving human stem cells with the exception of research funded exclusively by the California Institute for Regenerative Medicine (CIRM). Information can be found on the California Department of Public Health Stem Cell Research website. See link below in Related Items.

    B. California Institute for Regenerative Medicine Guidelines

    The California Institute for Regenerative Medicine (CIRM) Medical and Ethics Standards working group (MES) provides guidelines for CIRM-funded research involving human stem cells. These guidelines are effective for all research supported in full or in part by CIRM. Information can be found on the CIRM website. See link below in Related Items.

    C. NIH Guidelines

    The National Institutes of Health Guidelines for Human Stem Cell Research are effective as of July 7, 2009. These Guidelines apply to other federal departments and agencies as well.

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    6. Responsibilities of the Vice Provost and Dean of Research


    The Vice Provost and Dean of Research is the University official responsible for interpreting and overseeing implementation of and compliance with this Policy. Questions may be addressed to the Vice Provost and Dean of Research, or to the Research Compliance Director.

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    7. Institutional Review Board/Stem Cell Research Oversight Panel

    In order to provide the required oversight for human stem cell research, the Vice Provost and Dean of Research has established the Institutional Review Board/Stem Cell Research Oversight Panel (IRB/SCRO Panel) within the Research Compliance Office (RCO). As mandated by State Law, all University research projects involving human stem cells must be reviewed and approved by the IRB/SCRO Panel. Such review by the IRB/SCRO Panel shall be in accordance with all relevant University policies, federal, CIRM, and state regulations. The IRB/SCRO Panel, reporting to the Vice Provost and Dean of Research, is responsible for providing scientific and ethical review of all proposed research projects involving all human stem cells. This review is in addition to other compliance panel reviews that may be required such as Animal Care and Use, or Biosafety. Under no circumstances may the research begin before these approvals are granted.

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    8. Material Transfer Agreements


    The transfer of human stem cell lines into or out of the University must be authorized under a Material Transfer Agreement (MTA) signed by:

    1. Stanford's Industrial Contracts Office (ICO)
    2. The providing or receiving researcher (at Stanford); and
    3. The providing or receiving party (outside of Stanford)

    An MTA typically obligates the recipient and the recipient’s employer to abide by specific restrictions and limitations on use of the cells, consistent with the consent obtained, and with applicable federal and state laws and regulations. Before finalizing an MTA for stem cells brought into the University, the Industrial Contracts Office (ICO) requires confirmation that the proposed research is approved by the IRB/SCRO Panel and any other required entities. The fully executed MTA must be in place before cells are received in a Stanford lab.

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    6. Laboratory Animals in Research

    6.1 Animal Welfare Assurance of Compliance

    Provides assurance of Stanford compliance with PHS Policy on Humane Care and Use of Laboratory Animals. Includes a description of Stanford policies and procedures for the Administrative Panel on Laboratory Animal Care (APLAC).

    This Assurance renewal, identified as #A3213-01, is approved for a four-year period, the approval dates are: 6/17/2013 - 5/31/2021.

    Login to the DoResearch website (upper left corner) with your SUNet  id and password prior to accessing the Assurance.

     

    The Assurance can be found here

     

    Authority

    United States Public Health Service

    Contact

    6.2 Use of Vertebrate Animals in Teaching Activities

    Establishes policy and procedures for the use of live or deceased vertebrate animals for instructional purposes.

    Authority

    Senate of the Academic Council

    Contact

    Cheryle Aird, Associate Director for Institutional Animal Care and Use Program (IACUP)

    1. Instructional Use

    It is the policy of Stanford University that the use of either live or deceased vertebrate animals for solely instructional purposes is permitted when:

    1. The cognizant instructor(s) judges that the educational goals of the program or course will be best achieved by such usage
    2. The Administrative Panel on Laboratory Animal Care determines that such usage is humane, proper, and appropriate, consistent with government principles and regulations for the utilization and care of vertebrate animals used in teaching and research. Only the minimum number of animals essential to instructional objectives should be used. Instructors should be encouraged to use alternatives to animals whenever possible

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    2. Information to Students

    Academic departments and programs should alert prospective students if any courses which are required for a major or degree involve the use of animals. This requirement may be met by a statement to the effect that some required courses for certain degrees may involve use of animals tissue, and that interested students should seek further information about such requirements from the department. Normally this statement should appear in Courses and Degrees.

    Instructors must inform their students during the first week of class if animals or animal tissue will or may be used as part of that course. Students who have concerns about the use of animals may then choose whether or not to take the class. Students should feel free to discuss their concerns with the instructor, but should be aware that instructors and departments are not obligated to alter course requirements which are consistent with University policies.

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    3. Procedures for Use of Animals

    Any faculty member who intends to use vertebrate animals for teaching purposes must submit an Animal Use Protocol signed by the department chairperson to the Administrative Panel on Laboratory Animal Care. Reuse of previously approved preserved material requires no approval. Courses taught each year with no significant changes in animal usage must submit a Renewal Animal Use Protocol each year.

    The protocol must include information about the source from which animals are procured. In addition, the protocol must explain why animals are needed to achieve the goals of the course, and justify the species and the number of animals to be used. If the Administrative Panel on Laboratory Animal Care questions the species of animal chosen, the procurement process, the number of animals to be used or other related matters, such questions need to be resolved before the animals may be ordered.

    Live vertebrate animals must be cared for according to the Department of Comparative Medicine policies and procedures governing the use of laboratory animals. Disposal of animal tissue must be in compliance with relevant health and safety regulations.

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    6.3 Responsibilities for the Humane Care and Use of Laboratory Animals

    Establishes policy to comply with all relevant laws and regulations governing the humane care and use of laboratory animals.

    Contact

    Cheryle Aird, Associate Director for Institutional Animal Care and Use Program (IACUP)

    1. Introduction

    It is Stanford University policy that all faculty, staff, visiting scholars and students comply with the applicable provisions of the US Department of Agriculture (USDA) Animal Welfare Act, the University's Assurance of Compliance with Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals, other Federal and State of California statutes, local regulations, and all other University policies and procedures relating to laboratory animals (living or dead). Failure to comply may result in a suspension of privileges to use laboratory animals in teaching and research activities.

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    2. Authority and Responsibility for Ensuring Compliance

    A. Institutional Official

    The Vice Provost and Dean of Research is the institutional official responsible for ensuring that activities using laboratory animals at Stanford are humane and in compliance with all applicable external regulations. To achieve that end, he or she is responsible for establishing and enforcing relevant University policies and procedures.

    B. Administrative Panel on Laboratory Animal Care

    The Administrative Panel on Laboratory Animal Care (A-PLAC) reports to the President of the University through the Vice Provost and Dean of Research. The Panel is charged with reviewing and approving all teaching and research activities involving laboratory animals. A protocol application form "For Care and Use of Laboratory Animals" must be submitted to the A-PLAC for its review and approval before a project is initiated. A-PLAC is also responsible for semi-annual inspections of all laboratory animal housing areas at Stanford and a semi-annual evaluation of the overall program for the care and use of laboratory animals.

    C. Attending Veterinarian

    The Attending Veterinarian is a member of the Veterinary Service Center (VSC) of the Department of Comparative Medicine and has oversight authority for all activities involving laboratory animals. That individual, or designee, is a voting member of the A-PLAC. Investigators are encouraged to call upon the Attending Veterinarian or other VSC staff for guidance in protocol development and consultation on experimental procedures.

    D. Veterinary Service Center

    The VSC is responsible for the procurement of laboratory animals, providing housing and care of laboratory animals, providing and maintaining certain facilities for animal research such as surgery suites, overseeing transportation of laboratory animals onto or off of the Stanford campus or from site to site on the campus, and providing veterinary services for laboratory animals and veterinary consultation for investigators.

    E. Department of Comparative Medicine

    The Department of Comparative Medicine (DCM) is an academic department within the School of Medicine. It is responsible for the operations of the VSC and for providing education on the humane care and use of laboratory animals.

    F. Department of Environmental Health & Safety

    The Department of Environmental Health & Safety (EH&S) is responsible for implementing an A-PLAC approved Laboratory Animal Occupational Health Program (LAOHP) for individuals working in laboratory animal facilities and having substantial animal contact (see Research Policy Handbook document 7.4).

    G. Stanford Faculty, Staff, Students and Visiting Scholars

    Investigators using laboratory animals must comply with the following:

    • Investigators must file a protocol application form with the A-PLAC for prospective review and approval of all activities involving the use of laboratory animals. Such uses include pilot projects and preliminary studies, whether or not they are part of a sponsored project. Approval is granted for a maximum of one year, and protocols must be updated at least annually or whenever a significant change occurs.
    • All laboratory animals purchased from outside sources must be ordered through the VSC. Laboratory animals obtained by other means must be coordinated with the VSC. No animals can be obtained without having an A-PLAC approved protocol. All transfers of ownership of laboratory animals must be made through the VSC.
    • No laboratory animal may be brought to or taken from the Stanford campus without the prior review and approval of the A-PLAC. The A-PLAC will review such requests in consultation with the Attending Veterinarian and will notify the VSC of approved requests. The VSC must be notified in advance when approved transportation of laboratory animals will occur.
    • Principal Investigators (PIs) must take responsibility for the appropriate training of their research staff in the humane care and use of laboratory animals, ensuring that they are qualified to perform their duties, and that they understand their obligations to comply with all relevant regulations and the specifics of the approved protocol. Documentation of this training may be requested by regulatory and accrediting agencies or by the institution.
    • PIs must be aware that PHS and the US Department of Agriculture (USDA) have specific requirements when animal use takes place off of the Stanford campus as a consequence of a subgrant or subcontract (including antibody production). Proof of PHS Assurance of Compliance must be provided to the A-PLAC whenever PHS-supported animal use activities are performed by an off-campus entity. In addition, when certain species are utilized at an off-campus site, that entity must be registered with the USDA and proof of that registration must be provided to the A-PLAC. (Contact the Research Compliance office for more information.)
    • Animals may not be housed for more than 12 hours outside designated housing areas without the prior review and approval of the A-PLAC. The A-PLAC will review any new housing requests in consultation with the Attending Veterinarian.
    • All survival surgical procedures on rabbits, cats, dogs, nonhuman primates, or other large animals must be performed in designated surgical suites approved by the A-PLAC in consultation with the Attending Veterinarian.

    Any person may contact (anonymously, if they wish) the Compliance Manager (736-7065) or the Attending Veterinarian (723-3876) if there are concerns regarding the humane care and use of laboratory animals at Stanford University.

    6.4 Transport, Care, and Use of Non-Stanford Owned Laboratory Animals on the Stanford Campus

    Outlines procedures for transportation, care, and use on the Stanford campus of laboratory animals which are not owned by Stanford.

    Contact

    Cheryle Aird, Associate Director for Institutional Animal Care and Use Program (IACUP)

    1. Introduction

    The care and use of laboratory animals procured by Stanford University for teaching, research, and related activities are governed by policies designed to keep the University in compliance with all relevant external regulations for the humane treatment of laboratory animals. Occasionally, Stanford investigators engage in collaborations with or provide services to outside institutions that require the transportation of non-Stanford owned laboratory animals onto the Stanford campus. This document sets forth procedures that must be followed in these situations so that the animals involved are treated humanely, there is appropriate risk management, and the University remains in compliance with relevant external regulations.

    The owners of non-Stanford laboratory animals must assume responsibility for the animals' welfare while on the campus and act in a supervisory role in overseeing the animals' welfare. Stanford personnel may serve as assistants.

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    2. Procedures

    When non-Stanford owned laboratory animals are to be brought to Stanford as a result of a collaboration between Stanford investigators and an outside institution, the Administrative Panel on Laboratory Animal Care (A-PLAC) requires the following:

    • an A-PLAC application form, for review and approval, covering the work to be done at Stanford
    • an abstract of an approved protocol covering the portion of the collaborative effort to take place at the outside institution and the corollary IACUC approval document. (In special circumstances, the full protocol may be required.)
    • the outside institution's Public Health Service (PHS) Assurance Number, US Department of Agriculture (USDA) Registration Number, or their certificate of registration from the State of California. (This will be required in most, if not all, cases.)

    When non-Stanford owned laboratory animals are to be brought to campus as a result of Stanford providing services to an outside entity (e.g., use of special equipment), the A-PLAC requires the following before approval can be granted:

    • Proof that a Research Participation Agreement or other contractual arrangement has been approved by the University
    • A description of the procedures to be performed on the animals at Stanford including: transportation arrangements, anesthesia or other chemical or physical restraint methods, experimental manipulation, euthanasia, or anything else pertinent to the care and use of the laboratory animals while they are on the campus
    • Documentation showing that all portions of the research activity occurring at the outside entity involving these animals have been approved by that entity's Institutional Animal Care and Use Committee. That document must further display either the outside institution's PHS Assurance Number, USDA Registration Number, or their certificate of registration from the State of California.

    Animals may not be held on the Stanford campus overnight without a formal transfer of ownership to Stanford. The A-PLAC and the Attending Veterinarian must approve all such arrangements.

    Non-Stanford owned laboratory animals may not be brought to or taken from the Stanford campus without the prior review and approval of the A-PLAC. The A-PLAC will review such requests in consultation with the Attending Veterinarian who must be notified in advance when approved transportation of laboratory animals will occur. The Attending Veterinarian can be reached at 723-3876.

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    6.5 Animal Care and Use Training and Education Program

    Describes training sessions provided for those involved in the care or use of laboratory animals, and indicates who should attend.

    Authority

    Vice-Provost and Dean of Research

    Lloyd B.Minor, Dean of the School of Medicine

    Professor Michael E. Moseley, Chair, APLAC

    Sherril L. Green, Chair, Department of Comparative Medicine

    Contact

    Cheryle Aird, Attending Veterinarian, Department of Comparative Medicine

    1. Introduction

    The privilege of conducting research using animal subjects at Stanford University depends on the University's compliance with federal and state regulations governing the humane care and use of laboratory animals. The Health Research Extension Act of 1985 (1) and the Animal Welfare Act Regulations (2) both require that individuals involved in the care and use of animals in research be adequately educated, trained, and/or qualified in basic principles of laboratory animal science to help ensure high-quality science and animal well-being to perform their duties. To that end, the University must provide appropriate training and instruction to all personnel involved in animal research.

    This memo confirms that a web-based course, the “Animal Care and Use Training Program” (VSC-PROG-0001), is one of the primary sources for this training and describes who is required to complete this training course. We recognize that much relevant training occurs within each research unit, and that many individuals have background experience that qualifies them in certain aspects of the care and use of animals. However, we believe completion of introductory core training by all those involved in animal research at Stanford is essential.

    Principal Investigators (PIs) must keep in mind that it is their responsibility to guarantee the appropriate training of their students, associates, and staff, and to make sure that their research programs are in compliance with all regulations and policies governing the care and use of animals. This brief course will help PIs do this, and it will enable the Department of Comparative Medicine’s Veterinary Service Center (VSC) to document the delivery of this introduction to the care and use of animals in research and teaching at Stanford University.

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    2. Who Must Complete the Animal Care and Use Training Program?

    It is a Stanford requirement that all faculty, researchers, students, and staff who are new to animal research at Stanford will complete this web-based course that consists of reviewing a training module and passing a quiz. This includes all those who intend to file a protocol for the first time, or whose names are being added to existing protocols. In addition, completion of the online course is required for any investigators, graduate students, fellows, and staff engaged in animal research who did not attend the previous lecture-based training on animal care and use. The information in the course will make it easier to prepare protocols properly and to comply with current regulations regarding housing, use, care, and euthanasia.

    This core training program, which has been reviewed and approved by the Administrative Panel on Laboratory Animal Care (APLAC), is available online, and information regarding enrollment is available on the VSC website. Documentation of completion requires that personnel take and pass a brief quiz upon finishing the course. The VSC also offers an extensive list of seminars, workshops, and training, both didactic and hands-on, targeted for individuals whose use of animals in research and teaching creates special training needs (e.g., rodent handling and basic techniques, work with non-human primates, rodent survival surgery, introduction to stereotaxic surgery, breeding mice, and the use of biohazardous agents in animals).

    We encourage all faculty, researchers, students, and staff who work with research animals at Stanford University to take advantage of the many training opportunities and resources that are made available through the VSC in the Department of Comparative Medicine. For questions about the training program, please visit the VSC website.

     

    1. Office of Laboratory Animal Welfare  Health Research Extension Act of 1985, P.L. 99-158, November 20, 1985 “Animals in Research,” http://grants.nih.gov/grants/olaw/references/hrea1985.htm  

    2.    Animal Welfare Act Regulations, Title 9 CFR, Chapter 1, Subchapter A, §2.32,  http://www.aphis.usda.gov/animal_welfare/downloads/Animal%20Care%20Blue%20Book%20-%202013%20-%20FINAL.pdf

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    7. Environmental Health and Safety

    7.1 Charge to the University Committee on Health and Safety

    Presents the general charge and the specific duties of the Committee on Health and Safety. Membership and reporting responsibilities are discussed.

    Authority

    Office of the President

    Contact

    1. Background

    Stanford has various offices and panels that participate in the establishment, implementation and support of health and safety policies. Examples include the offices of the Provost, Dean of Research, University Department of Environmental Health and Safety, the University Safety Partners and the Administrative Panels charged with approving research procedures involving use of human or animal subjects, radiological hazards, recombinant DNA molecules, and/or biohazardous agents.

    It is desirable, however, to have a body charged with policy development and oversight over the full range of health and safety issues at Stanford. Therefore, the University Committee on Health and Safety was established in 1988.

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    2. Charge to the Committee

    The University Committee on Health and Safety is charged with the following responsibilities:

    • Exercise oversight over all health and safety programs at Stanford
    • Advise the President on the adequacy of Stanford's health and safety programs, policies and organization
    • Recommend needs, priorities and strategies to promote good health, safety, and environmental practices on campus
    • Foster cooperation among those units at Stanford having operational responsibility for health and safety
    • Recommend to the President University-wide policies with respect to those health and safety matters which are not addressed by the existing administrative panels

    This charge shall be reviewed by the Committee periodically to assure continued effectiveness of the role of the Committee. This committee in no way replaces or supersedes line management responsibility for health and safety.

    Each year, one meeting of the Committee shall be publicized and open to all members of the University community and its neighbors. This meeting will provide an opportunity to report to the community on health and safety conditions at Stanford. It will also provide an opportunity for University community members or neighbors to raise questions or concerns about Stanford’s teaching or research activities, facilities or support services as they may affect the health and safety of lab personnel, laboratory subjects, employees, students, the general public, and the environment.

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    3. Membership

    Members of the University Committee on Health and Safety shall be appointed by the President. Its voting members shall consist of six faculty members, at least four of whom shall be experienced in issues of laboratory safety; two students, of whom at least one shall be a graduate student with laboratory experience; the Associate Vice Provost for Environmental Health and Safety; the Vice Provost and Dean of Research; the Associate Vice President for Academic Projects and Operations; and a member of the general public. The Chair of the Committee shall be one of the faculty members and shall be named by the President. The terms of membership for faculty shall be for three years and for all other members one year, effective October 1st of the year of appointment and ending September 30th of the year in which the term expires.

    The Committee shall establish such permanent or ad hoc subcommittee or task forces from among its membership or otherwise, as it shall deem useful in carrying out its charge. The Committee shall seek advice from the Office of the General Counsel as necessary and appropriate.

    The Committee on Committees of the Faculty Senate shall be asked to nominate the faculty members. The Associated Students of Stanford University shall be asked to nominate the student members.

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    4. Reporting Requirements

    By no later than October 1st of each year, the Chair of the Committee shall provide an annual report to the President summarizing key issues and new policies addressed by the Committee during the committee year. Copies of these reports shall be publicly available. The Committee or its members may also submit confidential reports to the President as deemed necessary.

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    7.2 Health and Safety: Principles, Responsibilities and Practices

     

    This manual provides information about policies, procedures, and guidelines related to health and safety at Stanford. Topics covered include responsibilities, services provided by the Department of Environmental Health and Safety (EH&S), a variety of topics related to workplace safety (e.g. asbestos, ergonomics), the management of hazardous materials, and how to prevent and handle emergencies.

    Authority

    University Committee on Health and Safety

    Operations Council

    University Cabinet

    Contact

    1. Principles

    Safety is a core value at Stanford and the University is committed to continued advancement of an institutional safety culture with strong programs of personal safety, accident and injury prevention, wellness promotion, and compliance with applicable environmental and health and safety laws and regulations.

    Stanford University makes all reasonable efforts to:

    • Promote occupational and personal safety, health and wellness;
    • Protect the health and safety of Stanford University faculty, staff and students;
    • Provide information to faculty, staff, and students about health and safety hazards;
    • Identify and correct health and safety hazards and encourage faculty, staff, and students to report​ potential hazards;
    • Conduct activities in a manner protective of the environment, and inform the Stanford community regarding environmental impacts associated with institutional operations; and
    • Maintain a risk-based emergency management program to reduce the impact of emergency events to the Stanford community.

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    2. Responsibilities

    Adherence to good health and safety practices and compliance with applicable health and safety regulations are a responsibility of all faculty, staff, and students. Line responsibility for good health and safety practice begins with the supervisor in the workplace, laboratory or classroom and proceeds upward through the levels of management. For detailed guidance on individual safety responsibilities under Cal/OSHA, refer to the University’s Illness and Injury Prevention Program (IIPP).

    In academic areas, supervisors include faculty/principal investigators, laboratory directors, class instructors, or others having direct supervisory and/or oversight authority. Academic levels of management are the department chairperson or Independent Lab director, dean, the Dean of Research, and the Provost. Administrative levels of management include managers, directors, and vice presidents. Final responsibility for health and safety policy and programs rests with the President of the University.

    The Associate Vice Provost for EH&S and the University Committee on Health and Safety are responsible for recommending University-wide health and safety policies to the President.

    The Associate Vice Provost for EH&S is responsible for ensuring overall institutional compliance with applicable policies, statutes, and regulations; monitoring the effectiveness of the safety programs; and providing central health and safety services and support to all areas of the University.

    A. Supervisory Responsibilities

    University supervisors, including faculty supervisors and Principal Investigators (PIs), are responsible for protecting the health and safety of employees, students and visitors working under their direction or supervision. This responsibility entails:

    • Being current with and implementing Stanford University health and safety policies, practices and programs;
    • Ensuring that workplaces, including laboratories, and equipment are safe and well maintained;
    • Ensuring that workplaces or laboratories are in compliance with Stanford policies, programs and practices, and
    • Ensuring that employees, students and visitors under their supervision or within their work areas have been provided with appropriate safety training and information, and adhere to established safety practices and requirements.

    B. Managerial Responsibilities

    University managers, academic and administrative, are responsible for ensuring that:

    • Individuals under their management have the authority to implement appropriate health and safety policies, practices and programs;
    • Areas under their management have adequate resources for health and safety programs, practices, and equipment; and 
    • Areas under their management are in compliance with Stanford University health and safety policies, practices and programs.

    C. Environmental Health and Safety Responsibilities

    Environmental Health and Safety (EH&S) is responsible for:

    • Reviewing legislation, recommending policies, and monitoring compliance with environmental and health and safety statutes and regulations and University health and safety policies and programs;
    • Developing institutional safety and compliance programs and assisting schools, departments, faculty, and managers with implementation
    • Providing guidance and technical assistance to supervisors and managers in the schools, departments, and other work units in identifying, evaluating, and correcting health and safety hazards;
    • Developing programs for the safe use of hazardous radiological, biological, and chemical substances and lasers;
    • Providing training materials, assistance, and programs in safe work practices;
    • Providing guidance on effective emergency management and business continuity programs, and providing emergency response services for incidents involving hazardous materials;
    • Providing fire prevention, inspection, engineering and systems maintenance services; and
    • Hazardous waste management and disposal services.

    While EH&S is responsible for developing and recommending relevant health and safety policies, institutional policy approval rests with other University authorities,(e.g., President, Provost, Vice Provost and Dean of Research, Faculty Senate, University Cabinet, University Committee on Health and Safety, Committee on Research, Administrative Panels for Research Oversight, etc.) depending on the content of the proposed policies.

    D. Faculty, Staff, and Student Responsibilities

    Faculty, staff and students are responsible for:

    • Keeping themselves informed of conditions affecting their health and safety;
    • Participating in safety training programs as required by Stanford policy and their supervisors and instructors; 
    • Adhering to health and safety practices in their workplace, classroom, laboratory and student campus residences; Advising of or reporting to supervisors, instructors or EH&S potentially unsafe practices or serious hazards in the workplace, classroom or laboratory.

    E. Safety Performance

    Each individual at Stanford is expected to perform all work safely. Managers and supervisors shall establish and maintain a system of positive reinforcement and escalated discipline to support good health and safety practices. Safety performance shall be a part of every individual’s role and responsibility as well as performance expectation and evaluation.

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    3. Providing a Safe Workplace

    Stanford's program for providing a safe workplace for faculty, staff and students includes: facility design; hazard identification, workplace inspection and corrective action; shutdown of dangerous activities; medical surveillance: and emergency preparedness. In addition to this general institutional health and safety policy, additional hazard specific policies and requirements may apply to different work and learning environments at Stanford and will be found in the Research Policy Handbook and at the EH&S Website.

    A. Facility Design

    Facilities will be designed in a manner consistent with health and safety regulations and standards of good design. Those University departments charged with primary responsibility for the design, construction, and/or renovation of facilities, together with EH&S shall ensure that there is appropriate health and safety review of facility concepts, designs, and plans.

    In case of disagreement between EH&S and the cognizant facilities department, the conflict shall be resolved by the Vice Provost and Dean of Research in consultation with the cognizant vice president or dean and the Provost (or designate). The determination of the Vice Provost and Dean of Research may be stayed by the Associate Vice Provost for EH&S pending a prompt appeal to the President.

    B. Hazard Identification and Correction

    Stanford University encourages employees and students to report health and safety hazards to their supervisors, managers, or EH&S. Employees and students shall not be discriminated against in any manner for bona fide reporting of health and safety hazards to Stanford or to appropriate governmental agencies. Supervisors shall inform students and employees of this policy and encourage reporting of workplace hazards.

    Supervisors, both faculty and staff, shall assure that regular, periodic inspections of workplaces are conducted to identify and evaluate workplace hazards and unsafe work practices.

    • The frequency of inspections should be proportional to the magnitude of risk posed in the particular workplace.
    • Means of correcting discovered hazards and/or protecting individuals from the hazards shall be determined and implemented appropriately.
    • Unsafe conditions which cannot be corrected by the supervisor or manager must be reported to the next higher level of management. Any individual, supervisor or manager who becomes aware of a serious concealed danger to the health or safety of individuals shall report this danger promptly to the Department of EH&S and to the faculty, staff and students who may be affected.

    C. Shutdown of Dangerous Activities

    The Associate Vice Provost for EH&S has the authority to curtail or shut down any University activity considered to constitute a clear and imminent danger to health or safety. In the event of such curtailment or shutdown, the cognizant dean, director or vice president and the Provost (or designate) shall be immediately notified.

    In cases of dispute, an order to curtail or shutdown will remain in effect until the Provost or the Vice Provost and Dean of Research (or their respective designates) determine in writing that the danger has passed or been mitigated or that the order should be rescinded for other reasons.

    Should the Associate Vice Provost for EH&S disagree with a determination to restore a curtailed or shutdown activity, the Associate Vice Provost for EH&S may promptly appeal the matter to the President. In the event of an appeal, the order to curtail or shutdown shall be in effect until the President determines otherwise.

    D. Providing Medical Surveillance

    Stanford University shall evaluate and monitor, through a program of medical surveillance, the health of Stanford University faculty, staff and students who are exposed to certain hazardous materials and situations as defined by law or University policy. Each supervisor is responsible for ensuring that employees and students under their supervision participate in the medical surveillance program as required by University policy. EH&S will monitor medical surveillance program participation. Each University department/school shall administer the program for faculty, staff and students covered by University policy.

    E. Emergency Response and Preparedness

    EH&S coordinates overall emergency response planning for the institution and provides guidelines for departmental emergency response plans. Every department shall have an individual emergency response plan and shall develop business continuity and contingency plans and implement appropriate mitigation programs to reduce the impact of emergency events.

    Schools and departments shall maintain local departmental emergency operations centers and communications capabilities according to guidelines in the campus emergency plan. Multiple departments located within individual buildings will jointly develop comprehensive building-based life safety response plans.

    Emergency plans shall include evacuation and assembly procedures, posted evacuation maps, reporting and communication practices, training, and drills.

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    4. Safety Communication and Training

    Safety and compliance required training shall be communicated in a manner readily understandable to faculty, staff and students, in accordance with the communication policy outlined below.

    A. Systems of Communication

    Managers and supervisors, both faculty and staff, shall establish, implement and maintain a system for communicating with employees and students about health and safety matters. Information should be presented in a manner readily understood by the affected employees and students. Due attention must be paid to levels of literacy and language barriers. Verbal communications should be supplemented with written materials or postings if appropriate. Whenever appropriate, statutes and policies affecting employees and students shall be available in the workplaces.

    B. Communication About Hazards

    Faculty, staff, and students who may come in contact with hazardous substances or practices either in the workplace or in laboratories shall be provided information concerning the particular hazards which may be posed, and the methods by which they may deal with such hazards in a safe and healthful manner. In areas where hazardous chemicals or physical agents are used, handled, or stored, communication about these hazards shall conform to the Research Policy Handbook EH&S Requirements for laboratory facilities and the Hazard Communication Program for all other campus workplaces.

    C. Training

    Supervisors, including faculty, shall be experienced, trained or knowledgeable in the safety and health hazards to which employees and students under their immediate direction and control may be exposed, and shall be knowledgeable of current practices and safety requirements in their field.

    Faculty, staff and students shall have or be provided the knowledge to protect themselves from hazards in their working and learning environment. Supervisors, both faculty and staff, shall ensure that employees and students have received appropriate training and information regarding:

    • General health and safety practices of the workplace or laboratory, including emergency procedures;
    • Job-specific health and safety practices and hazards;
    • Recognition and assessment of health and safety risks; and,
    • How to minimize risks through sound safety practices and use of protective equipment; and,
    • Awareness of appropriate practices to protect the environment.

    Training shall occur when:

    • An employee is hired or student is new to the laboratory;
    • An employee or student is given a new assignment for which training has not previously been received; and
    • New hazards are introduced by new substances, processes or equipment.

    Faculty, staff and students should, periodically, be retrained or demonstrate an understanding of current standard safety practices and requirements for their areas.

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    5. Documentation and Recordkeeping

    Documentation and records as required by regulation shall be kept to demonstrate compliance with applicable statutes, regulations and policies. Requirements and procedures for such recordkeeping can be found in the Research Policy Handbook and at the EH&S website.

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    7.3 Emergency and Non-Emergency Hazardous Material Release Response

    Presents Stanford University policy and plan for responding to all incidents involving the release of hazardous materials.

    Authority

    Contact

    1. Introduction

    Federal, state, and local regulations require employers to develop and implement a Hazardous Materials Release Response Plan to provide a consistent and adequate means of handling an incident involving hazardous materials. As part of Stanford’s continuing commitment to develop and implement policies and procedures consistent with these regulations, the policy below has been established. The policy has been designed to assure that PIs are fully informed of and included in the response strategy.

    In the case of an emergency involving a hazardous materials release that is “health threatening” or “imminent danger to the environment” as defined in Appendix I of this policy document, the Palo Alto Fire Department (PAFD) is to be notified immediately by calling 9-911 or at the Medical Center, 286, and/or pulling a fire alarm if the building needs to be evacuated or if a telephone is not available. Once involved, the PAFD is in command until the hazard has been fully abated and they relinquish command. In the case of a significant release that is “non-health threatening” and “contained” as defined, the Department of Environmental Health and Safety (EH&S) Hazardous Materials (HazMat) Response Team should be contacted immediately and will assume command until relinquishing it to the PAFD or the hazard has been fully abated. In the case of a non-emergency (incidental) release, as defined, the person responsible for the spill should clean it up using available materials and appropriate personal protective equipment. (Lab coat, gloves, protective eye wear, long pants, closed toe shoes).

    As stated in the following section of this policy, the participation of all members of the Stanford community is required for its successful implementation. Department Chairs, Laboratory Directors, Principal Investigators, and Supervisors have the specific responsibility to see that individuals for whom they are responsible are trained in proper emergency response procedures and that the work areas for which they are responsible are posted conspicuously with emergency response procedures.  (Please refer to the Definitions section and Activating Procedures for a summary of required responses in an emergency involving hazardous materials.)

    EH&S can provide information for a department in establishing emergency response procedures for a specific area. An “IN CASE OF EMERGENCY” poster is available for posting from EH&S.  Please call that office (723-0448) with any questions you may have.

    Non-compliance with this policy may result in a citation, fine or other civil or criminal penalties by the enforcing agency.

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    2. Policy Statement

    It is the policy of Stanford University to establish and maintain response procedures and capabilities to:

    • Respond to incidents involving hazardous materials
    • Assist the Fire Department with hazardous materials expertise
    • Clean up modest hazardous materials releases
    • Maintain records of all hazardous materials releases and accidents
    • Report incidents to outside agencies as required
    • Review causes of incidents to reduce recurrence
    • Review responses to incidents in order to improve service

    This policy and associated procedures are intended to provide tiered response to incidents involving hazardous materials appropriate to their magnitude and risk. If the appraisal of magnitude and risk is uncertain, the response strategy will address the worst case scenario. Due diligence is expected that these procedures are followed explicitly and consistently and that the reporting party provides accurate and complete information to the responding entity.

    The purpose of this statement is to set forth procedures to be followed in the event of an emergency involving the accidental release of hazardous materials, in order to: 

    • Protect research personnel, the general public, and the environment
    • Protect property and research assets
    • Comply with the regulatory response reporting, recording and abatement requirements
    • Encourage safe practices and requests for assistance when personnel are in doubt about hazardous materials
    • Standardize response procedures throughout the University

    Refer to Definitions for a summary of required responses and actions. 

    Conditions and releases involving asbestos are excluded from this policy (call 723-0486 for attention to asbestos concerns).

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    3. Responsibilities

    Environmental Health & Safety responsibilities:

    • Maintaining a trained hazardous materials response team and equipment capable of addressing modest Hazardous Materials Releases
    • Establishing procedures for use by local personnel for responding to non-emergency releases as defined
    • Maintaining working knowledge of applicable laws and regulations
    • Maintaining records of Hazardous Materials Releases and incidents
    • Informing the campus community of the Emergency and non-Emergency Hazardous Material Release Response Policy

    Medical Center Security responsibilities:

    • Recording information provided by the reporter
    • Securing the area and preventing entry
    • Notifying EH&S and providing incident information

    Department Chairs, PIs, and Supervisors responsibilities:

    • Ensuring the safety of those working under their direction
    • Assisting the Health and Safety Hazardous Materials Response Team or Palo Alto Fire Department in any hazard evaluation in areas under their direction
    • Training those under their direction in correct emergency response procedures
    • Ensuring that emergency response procedures are posted conspicuously in each work area

    Faculty, Students, Staff and Visitors responsibilities:

    • Following sound health and safety practices
    • Reporting any emergency or hazardous situation immediately according to these procedures
    • Cooperating and assisting with any emergency response personnel
    • Cleaning up non-emergency releases as defined
    • Complying with all applicable University policies and practices

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    4. General Procedures Applicable to All Incidents

    These procedures are intended to provide tiered response to incidents involving hazardous materials appropriate to their magnitude and risk. The evaluation of the hazard and of what to report or record, and of how to respond will be made by the HazMat Team Leader in consultation with the PI or other knowledgeable or responsible parties, and the Palo Alto Fire Department (PAFD) when they are involved.

    In the event that there is no time for a full hazard evaluation, or there are many hazardous materials or other complexities involved, or there is insufficient information available about the materials or situation involved, then precautions based on the worst case scenario for the incident will be applied to the response to protect the HazMat Team, the public, and the environment.

    Due diligence must be taken that these procedures are followed explicitly and consistently and the reporting party provides accurate and complete information to the responding entity.

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    5. Activating Procedures for Hazardous Material Release

    Extremely Important: Follow These Steps Explicitly

    In all cases, when any person becomes aware of a hazardous material incident:

    • If in the Medical Center, call 286 regardless of the nature of the incident.
    • If not in the Medical Center, and the incident is Health Threatening, call 9-911 and/or pull the nearest fire alarm if the building needs to be evacuated or if a telephone is not available.
    • If not in the Medical Center, and the release is a Non-Health Threatening Emergency, call EH&S at 725-9999.
    • If an non-Emergency (Incidental) release, and the responsible party is knowledgeable of the hazards of the material spilled, they should clean it up themselves using appropriate personal protective equipment; at a minimum gloves, protective eyewear, closed toe shoes, long pants, and lab coat.
    • If involving radiation or radioactive materials, call 286 from the Medical Center, and from all others call Health Physics at 723-3201.
    • The following procedures are provided as a guideline to biohazardous/rDNA spill cleanup. If the spill is considered too large or too dangerous for laboratory personnel to safely clean up, secure the entire laboratory and call EH&S at 725-9999 immediately for assistance.
    • If the reporting party is unclear of the health threatening nature of the emergency, assume it is health-threatening and proceed accordingly.
    • If the release is in a laboratory, notify the PI or supervisor responsible for that area as soon as it is practical to do so. If any injuries are involved, follow the required University injury procedures, found below in "Related Items".

    IMPORTANT: Any injury/illness resulting in death, permanent disfigurement, dismemberment, or hospitalization expected to last more than 24 hours shall be reported immediately to the EH&S Emergency Hotline at 725-9999. Refer to the attached PDF for details. 
 

    • If the PI unknown or unavailable then notify the Department or Building Administrator, Safety Committee Chairperson, or Department Chairperson. When possible, leave appropriate messages in each case. (The work and home phone numbers of these people should be posted near every room containing hazardous materials.)
    • When Medical Center Security (286) or Central Communications (9-911) receives a report of an emergency involving hazardous materials during working hours, they will notify EH&S immediately.
    • During non-working hours, Medical Center Security or 9-911 will notify EH&S at 725-9999.
    • Medical Center Security or  9-911 will notify the Health Physics Office at 723-3201 in the event of an emergency involving radiation or radioactive materials.

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    6. Definitions

    Emergency

    An unforeseen event that calls for immediate action by responders from outside the immediate area to protect individuals, the environment, or property.

    Non-Emergency (Incidental)Release 

    A spill that is not the result of a container failure, the personnel are knowledgeable of the hazards associated with the release,  and the quantity can be cleaned up by personnel from the immediate area within 15 minutes.  (Non-emergency releases must be cleaned up immediately.  If assistance is required, or to record the incident contact EH&S at 725-9999.) Releases smaller than 30 ml do not need to be reported to EH&S.

    Health Threatening

    An emergency in which there is a clear potential for serious injury to a person or release of contaminants to the environment if immediate action is not taken.  (If in doubt, consider the emergency health-threatening.)

    Non-Health Threatening

    Any emergency in which there is not a clear potential for serious injury to any person.  (If unsure whether an emergency is health-threatening or non health-threatening, assume it is health-threatening.)

    Hazardous Materials Release 


    A Health Threatening or Non-Health Threatening release, unauthorized or unexpected release of a hazardous material from primary containment, as defined in any of the referenced laws or regulations. If Health Threatening, the EH&S Hazardous Material Response Team (HazMat Team) will assist the Palo Alto Fire Department or other responding agency in cleanup and reporting of the incident to regulatory agencies. If Non-Health Threatening, EH&S will call Central Communications if assistance is needed. Conditions and releases involving asbestos are excluded from this policy. Call 723-9747 for attention to asbestos concerns.

    Contained


    Indicates a Hazardous Material Release that is within secondary containment, i.e. a floor, tray or engineered containment system.

    Imminent Danger to the Environment


    Indicates a substantial Hazardous Material Release that is discharged to a stream, creek or other water body or to the storm drain system. (The HazMat Team will coordinate with PAFD and proceed to clean up the release obtaining any other assistance as necessary and reporting to regulatory and other cognizant agencies as required). 

    Any emergency in which there is not a clear potential for serious injury to any person.  (If unsure whether an emergency is health-threatening or non health-threatening, assume it is health-threatening.)

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    7.4 University Laboratory Animal Occupational Health Program

    Describes the occupational health surveillance program for individuals involved with animal care and use. Clarified in August 2007 in regard to the medical oversight of the program.

    Authority

    Administrative Panel on Laboratory Animal Care (A-PLAC)

    Contact

    Kathy McClelland

    Research Compliance Office Director

    Vice Provost and Dean of Research - Research Compliance

    (650) 723-4697

    1. Background

    This memorandum announces changes in the University's Laboratory Animal Occupational Health Program (LAOHP) applicable to all faculty, staff, students and visiting scholars who work directly with vertebrate animals, unfixed animal tissues or body fluids, and those who work in animal housing areas. This program is authorized by federal regulations and Stanford's external accrediting agency. The LAOHP has been designed to:

    • Protect individuals from work-related risks associated with exposure to animals through a program of species-specific health information, education, and risk-based medical evaluation
    • Protect the health of research animals from certain transmissible diseases
    • Be pertinent to the species with which individuals are exposed and the work they perform
    • Be minimally intrusive
    • Be cost-effective

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    2. Changes to the Laboratory Animal Occupational Health Program

    The LAOHP has been revised as follows. Stanford University has opened its own Occupational Health Center (SUOHC) for Stanford employees, which will provide occupational medicine services as well as guidance pertaining to LAOHP.

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    3. Risk-Based Participation

    The requirements for participation in the LAOHP depend upon an individual's level of potential risk. There are two defined categories of risk within the LAOHP: Risk Category 1 (RC1) and Risk Category 2 (RC2). The Administrative Panel on Laboratory Animal Care (A-PLAC) will determine the risk category for research and teaching individuals during the protocol review process.


    Risk Category 1 (RC1)

    Risk Category 1 (RC1) is considered higher risk and encompasses Veterinary Service Center (VSC) personnel, other dedicated animal care staff, and individuals who work with non-human primates (including unfixed tissue and bodily fluids), hoofed mammals (e.g., swine, goats, sheep, cows), wild rodents, and certain field studies. The specific risk factors are variable and dependent upon specific uses and handling identified in the animal care and use protocol application.


    RC1 Participation Requirements

    All individuals in RC1 group must complete and submit the LAOHP Health Questionnaire prior to the A-PLAC approval of an individual to work on a related protocol or assignment. Each questionnaire will be evaluated by a Stanford University Occupational Health Center (SUOHC) Clinician to determine the level of potential exposure and whether further steps are necessary. Specific medical surveillance can also be requested by Environmental Health & Safety (EH&S) and/or the SUOHC for any individual, based upon identified risk factors.



    Risk Category 2 (RC2) 

    Risk Category 2 (RC2) is for all individuals involved in animal care and use protocols that do not fall within the RC1 participation group.


    RC2 Participation Requirements

    All individuals in RC2 group are provided with information, educational materials and periodic updates on potential health and safety issues associated with the particular animal species or research material with which they work. These individuals are strongly encouraged to complete and submit the LAOHP Health Questionnaire, but this questionnaire is optional for members of RC2 participation group.

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    4. New Occupational Health Center

    Another major change in the LAOHP program, as of July 2007, has been the opening of an on-site Occupational Health Center for all Stanford University faculty, staff, students, and visiting scholars who work directly with vertebrate animals, unfixed animal tissues or body fluids, and those who work in animal housing areas.

    The SUOHC is located in the 
Environmental Services Facility
480 Oak Rd. (M/C 8007)
phone: (650) 725-5308.



    The SUOHC is staffed with occupational health clinicians with experience in providing health-care services to individuals involved with laboratory animals. Each Health Questionnaire submitted by individuals from RC1 (mandatory) and RC2 (optional) is evaluated by the SUOHC clinician for potential exposures, individual health risk factors, and a determination as to whether further intervention steps or follow-up interactions are necessary. The SUOHC also provides the health-care services for VSC and other Stanford University Occupational Health programs. Contents of the Health Questionnaire and clinically related communications between the medical provider and the individual become part of the individual's Occupational Medical Record; maintenance and confidentiality of the Medical Record is dictated by appropriate Federal and State Regulations.

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    5. In-Service Training and Education

    The SUOHC staff and other specialized personnel also provide periodic in-service training, seminars and education programs. These programs emphasize the specific risks associated with different types of laboratory animals and provide guidance to research and support personnel on appropriate methods of exposure control and protection.

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    6. Summary

    Stanford is concerned about the safety and welfare of its faculty, staff, and students. We are committed to alerting individuals to potential work-related health risks and counseling them on methods to avoid workplace hazards. We must also comply with outside regulations associated with the use and welfare of animal subjects. The LAOHP for individuals who work with vertebrate animals is an integral part of achieving these goals.

    Your cooperation is essential to the success of this program. If you have any questions about the occupational health program or SUOHC, please contact EH&S (723-0448) or SUOHC (725-5308). Please contact the A-PLAC Office (723-4550) with questions about the animal research protocols and risk level assigned.

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    7.5 Chemical Hygiene Plan and Chemical Hazard Communication

    Summarizes key components of the Chemical Hygiene Plan for Laboratories, an element of Stanford's Chemical Hazard Communication Policy.

    Authority

    Contact

    1. Introduction

    Federal, state, and local regulations require employers to inform employees about the potential hazards of chemicals to which they may come in contact in the workplace or laboratory. Stanford's Chemical Hazard Communication Policy expands this requirement to include students and the University's Chemical Hygiene Plan addresses these requirements in laboratories.

    The Chemical Hazard Communication Policy and Program applies to all workplaces and is included within the University's overall program of Injury and Illness Prevention (Research Policy Handbook document 7.2). For laboratories, the relevant part of the University's Chemical Hazard Communication Program is the Chemical Hygiene Plan. The Chemical Hygiene Plan (CHP) provides for and supports the procedures, equipment, personal protective equipment, and work practices for protecting laboratory personnel from potential health hazards of using hazardous chemicals in the laboratory and to comply with California’s Occupational Safety and Health Administration (Cal/OSHA)

    The Department of Environmental Health & Safety (EH&S) works with academic departments and faculty to develop local programs for the safe use of chemicals.

    It is Stanford University policy that information concerning the particular hazards which may be posed, and the methods by which they can use these materials in a safe and healthful manner, be available to all faculty, staff, and students who use hazardous chemicals in either the workplace or in laboratories.

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    2. Chemical Hygiene Plan for Laboratories

    Stanford has developed and implemented a written Chemical Hygiene Plan, found as a PDF below in "Related Items", which includes the following elements:

    A. Designation of Responsibility for Implementation

    PIs/Laboratory Supervisors are responsible for the health and safety of laboratory personnel doing work in his/her laboratory.

    Provisions for personnel working autonomously are described in section 10.3 of the CHP.

    The University has designated a Chemical Hygiene Officer within the Department of Environmental Health & Safety to administer and oversee the institutional implementation of the CHP. The Associate Vice Provost for Environmental Health & Safety is the cognizant administrator of environmental health and safety programs at the University.

    B. Information and Training

    Per Section 10.0 of the CHP, laboratory personnel are to receive chemical safety information and training, both general and laboratory-specific, at the time of initial assignment to the laboratory, and prior to assignments involving exposure situations, work with Particularly Hazardous Substances, and hazardous operations.

    Information on the provision of general and laboratory-specific chemical safety training is available.

    C. Standard Operating Procedures

    PIs/Lab Supervisors are responsible for establishing Standard Operating Procedures (SOP) relevant to health and safety for laboratory activities he/she directs involving hazardous substances.

    SU’s Laboratory Chemical Safety Toolkit provides guidance on prioritization of SOP development, templates for creating SOPs, and generic SOPs for the major classes of hazardous substances.

    D. Control Measures

    Methods used to minimize exposures to hazardous chemicals includes a hierarchy of control elements including substitution, engineering controls, work practices, and personal protective equipment as described in Section 3.0 of the CHP.

    E. Prior Approval and Consultation

    Prior approval by the PI/Lab Supervisor is required for chemical usage involving SU Restricted Chemicals (i.e., Toxic Gases regulated by Santa Clara County and Dimethylmercury) as described in Section 5.1 of the CHP.

    Laboratory personnel should consult with PI/Lab Supervisor on higher risk chemical usage and operations so that special safety precautions can be taken where appropriate as described in section 5.3 of the CHP.

    F. Fume Hood Operations

    SU’s Laboratory Chemical Safety Toolkit provides information on the application and safe use of laboratory-type fume hoods.

    Performance and certification criteria for fume hoods are available below in "Related Items".

    G. Medical Consultation, Exams and Surveillance

    Stanford University’s Occupational Health Center (SUOHC) is a campus-based medical clinic that offers evaluation and treatment for work-related injuries and illnesses, work-related preventive medical services, and OSHA and departmentally-mandated medical surveillance programs for university staff. 

    Laboratory personnel who work with hazardous chemicals will be provided the opportunity to receive medical attention/consultation when:

    • symptoms or signs of exposure to a hazardous chemical develop
    • exposure monitoring reveals an overexposure
    • a spill, leak, explosion or other occurrence results in a hazardous exposure (potential overexposure)
    • a regulatory standard triggers medical surveillance

    SUOHC is located at:

    Environmental Safety Facility (ESF)
480 Oak Road, Room B15
Stanford, CA 94305 

    Phone: (650) 725-5308
 Fax: (650) 725-9218

    Additional information on the SUOHC is available at: http://ehs.stanford.edu/researchlab/IH/SUOHC/index.html

    H. Additional Protections

    Section 5.3.b of the CHP directs Principle Investigators/Lab supervisors to provide for additional protection to laboratory personnel for work with particularly hazardous substances (i.e., select carcinogens, reproductive toxins, and substances that have a high degree of acute toxicity).

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    3. Additional Requirements of the University's Overall Hazard Communication Program

    Warning Labels

    Per Stanford University’s Hazard Communication Program and 8 CCR 5194, containers of hazardous substances received from a manufacturer or leaving the University shall be labeled to inform personnel of:

    • The identity of the hazardous substance
    • Appropriate hazard warnings
    • Name and address of the manufacturer, importer or responsible party

    Material Safety Data Sheets (MSDSs)

    A MSDS is a detailed informational document prepared by the manufacturer or importer of a hazardous chemical.  It describes the physical and chemical properties of the product. MSDS’s contain useful information such as toxicity, flash point, procedures for spills and leaks, and storage guidelines.

    Stanford University personnel may access MSDSs at http://ehs.stanford.edu/MSDS/index.html

    Hazardous Chemical Inventory/Life Safety Boxes

    University laboratories, departments, and shops are required to maintain an inventory of hazardous substances present in their areas.

    The University’s chemical inventory program is available at http://ehs.stanford.edu/researchlab/chem/inven/index.html

    As part of the University’s overall hazard communication program, Life Safety Boxes are established outside each laboratory and shop; these boxes contain a report of the quantities of each main hazard class present in the room, a room map indicating the location of hazardous materials in the room, and emergency contact. Stickers indicating the hazards the present in the work area are affixed to the Lab Safety Box.

    Resources

    Stanford University’s Department of Environmental Health & Safety Chemical Safety Website which includes:

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    7.6 Radiological Hazards

    Summarizes policies related to radiological hazards.

    Authority

    Contact

    1. Authorization and Registration

    Possession and use of radioisotopes must be authorized under a broad scope radioactive materials license issued to Stanford University by the State of California or the US Nuclear Regulatory Commission. All machines which produce ionizing radiations for which State registration is required must be registered centrally in the name of the Board of Trustees. All projects must comply with pertinent regulations and relevant terms of licenses.

    The authority to review and approve uses of radioactive materials and radiation-producing machines is delegated to the Administrative Panel on Radiological Safety (APRS), which also recommends radiation policies to the President through the Office of the Vice Provost and Dean of Research. The APRS monitors compliance with regulations, license conditions and policies utilizing the Health Physics staff of the Environmental Health and Safety Department. All regulated radiation activities are open to inspection by the Health Physics staff. Detailed policies and procedures governing the acquisition, use, and disposal of radiation sources are found in the Radiation Safety Manual, available from Health Physics. The Manager of Health Physics, i.e., the Radiation Safety Officer (RSO), is designated in all licenses. The RSO may deny or withdraw approval to use a radiation source where an imminent threat to health and safety, non-compliance, or unsafe practice is found, pending review by the APRS.

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    2. Responsibilities

    Some of the responsibilities of Health Physics are to:

    • Serve as consultants to the faculty and staff in radiation safety matters
    • Provide general surveillance of radiation and contamination levels
    • Inspect projects to determine compliance with regulations and standards
    • Distribute personnel dose measurement devices and maintain records of radiation exposures to users
    • Maintain centralized accountability of machines and materials
    • Provide for the inspection of new shipments of radiation sources and safe disposal of materials and devices
    • Provide for the calibration of radiation measurement instruments used in the personnel protection program
    • Provide radiation safety training to personnel

    Health Physics also provides advice and safety support to faculty utilizing lasers, ultra-violet light, radiowave, EMF, MRI, and microwave sources to assist them in maintaining compliance with regulations and published standards.

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    7.7 Laser Safety

    Describes responsibilities and procedures for laser safety at Stanford.

    Authority

    Contact

    1. Principal Investigator Accountability

    The basic accountability for safety and compliance with regulations and safety standards at Stanford rests with the PI, Lab Director, or class instructor. With regard to the use of lasers, the PI has the following responsibilities:

    • To register with Health Physics all Class 3b and 4 lasers, whether procured from vendors or fabricated at Stanford
    • To notify the University of intent to acquire or fabricate a Class 3B or 4 laser by notation on the Proposal Development & Routing Form (PDRF), which replaced the former paper (SU-42) form for externally sponsored projects
    • To ensure that users are given both general and job-specific laser safety training - to provide preplacement eye examinations upon request of persons who may be exposed to Class 3b or 4 laser beams
    • To meet requirements for posting, access controls, and eye protection

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    2. Budget for Laser Safety Expenses

    Where applicable, proposed budgets submitted with funding requests must include items to fund needed facility modifications, personal protective equipment, and other safety expenses associated with the proposed project.

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    3. Guidance for Safe Operation

    It is also the responsibility of the persons performing work with lasers to operate the laser in a safe manner, to observe procedures outlined in the Stanford "Laser Safety Manual" and in the rules promulgated in specific labs.

    The Administrative Panel on Radiological Safety (APRS), which reports to the President, has responsibility to oversee the safe use of lasers on campus, including review and recommendation of laser safety practices and auditing compliance with laser safety standards.

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    4. Compliance Authorities

    The Office of Health Physics provides support for the Administrative Panel and inspects for compliance with regulations and standards.

    The Radiation Safety Office has been delegated authority to suspend the use of a laser system, pending review by the Administrative Panel, if it is deemed to present a clear and present danger to health and safety.

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    7.8 Biohazardous Agents and Recombinant DNA

    Establishes policy for ensuring the safe use and handling of biohazardous agents and recombinant DNA (r-DNA) at Stanford.

    Authority

    Administrative Panel on Biosafety (APB)

    Contact

    1. Overview

    It is Stanford University policy that all PI/Laboratory Directors must assume primary responsibility for the proper use, handling, and disposal of all biohazardous agents and recombinant DNA molecules associated with their research. Stanford PIs and research personnel must comply with applicable Federal, State and local regulatory standards, as well as any administrative requirements established by applicable institutional committees. Failure to comply with this policy may result in an administrative review and a possible suspension of approval by the Administrative Panel on Biosafety (APB) to work with biohazardous agents and/or non-exempt recombinant DNA molecules.

    It is Stanford University policy that:

    • All activities involving the use of Biosafety level (BSL) 2 or 3 agents must have prior approval by the Administrative Panel on Biosafety (APB), who will review the scope of work and assure that the work is being performed at the appropriate biosafety level as described in the CDC/NIH Guideline, Biosafety in Microbiological, and Biomedical Laboratories
    • All research personnel using BSL 2 or 3 biohazardous agents must be appropriately trained and familiar with the safety procedures in handling these materials. The PI/Laboratory Director is responsible for training and ensuring that all biohazardous agents are used at the appropriate level of biological containment
    • All APB approved applications involving the use of BSL 2 agents are valid for a maximum of three years  and must be reviewed for changes annually by the Biosafety Officer; duration of BSL 3 approvals are for one year
    • APB approval is not required for experiments which involve the use of BSL 1 agents exclusively (without the use of recombinant DNA molecules). However, any investigator working with human blood, clinical specimens, human tissues/tissue culture, or other potentially infectious materials must still meet the compliance requirements of the OSHA Bloodborne Pathogen Standard. (See the Stanford Biosafety Manual, Chapter 6 available below in "Related Items")
    • APB approval to work with biological agents does not constitute institutional approval to work with radioactive materials, research laboratory animals, or human subjects. The use of radioactive materials, research laboratory animals, or human subjects as an adjunct to biological research is discussed in Section IIIA of this policy
    • Shipping of biological goods that are classified as hazardous by Federal agencies must be done according to all regulations. Shipping of hazardous or non-hazardous biological goods that entails the use of dry ice must still follow all regulatory restrictions as dry ice is considered a dangerous good for air shipment purposes. Additional information on shipping procedures and requirements can be found at the Biosafety website (Shipping) or in the Biosafety Manual, Chapter 9, available below in "Related Items".

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    2. Biosafety Organization and Responsibilities

    A. Administrative Panel On Biosafety (APB)

    The APB reports to the President of the University through the Office of the Dean of Research and reviews all teaching and research projects involving the use of biohazardous agents and recombinant DNA that require approval (except those conducted under the jurisdiction of Stanford Health Services (SHS). An application form entitled "Request For Institutional Review /Approval For Research Involving Biohazardous Agents, Recombinant DNA and USDA-Regulated Materials" must be submitted to the APB for its review and approval. Through these reviews, the Panel assures that such activities and related facilities are in compliance with applicable University policies and external guidelines and regulations. Licensed clinical laboratories are covered by the guidelines imposed by the licensing board of the State of California.

    • The APB is responsible for advising the University on all matters related to biosafety, for reviewing and approving proposed uses of biohazardous agents, and for advising and guiding the Department of Environmental Health and Safety in carrying out the biosafety program.
    • The APB publishes and distributes the university's Biosafety Manual, which contains biosafety standards from the National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), and other applicable regulations. It also includes information about the specific hazards of each class of biohazardous agents. The Biosafety Manual must be available in every relevant laboratory on campus. Additional copies of the Biosafety Manual may be found at the website or by calling Stanford's Biosafety Officer in the Department of Environmental Health and Safety Office at 725-1473.

    B. Department Of Environmental Health and Safety (EH&S)

    EH&S is assigned the responsibility, subject to review and approval of the APB, for monitoring and providing services in conformity with the policy and standards set forth in the Biosafety Manual. The Associate Vice Provost of EH&S is an ex-officio member of the APB.

    C. Biosafety Officer

    The Biosafety Officer is a member of EH&S and is responsible for facilitating the operation of the biosafety program, for assuring that the use of biohazardous agents conforms with the University policy and applicable governmental regulations, and for referring to the APB matters requiring its review and approval. The Biosafety Officer conducts periodic inspections of biological laboratories and provides biosafety training as needed. The Biosafety Officer is an ex-officio member of the APB.

    D. Principal Investigator/Laboratory Director Hereafter called PI

    The PI has the following responsibilities:

    • Instructing and training laboratory staff in the practices and techniques required to ensure safety and proper emergency response and notification procedures in the event of an accident or injury;
    • Familiarize his/her staff with the symptoms of exposure and other pertinent information about the biohazardous agent used in the experiment before allowing lab personnel to work with the agent;
    • Supervising the laboratory staff's safety performance to ensure that the required safety practices and techniques are employed;
    • Informing the staff of the reasons and provisions for any precautionary medical practices advised or requested, such as immunization or serum collection;
    • Selecting and providing personal protective equipment to all laboratory staff members based on the experimental procedures used in the lab;
    • Making available a copy of the Stanford Biosafety Manual to all laboratory staff members;
    • Maintaining written documentation for all training activities, which includes instruction in laboratory safety procedures, for all laboratory staff personnel;
    • Immediate investigation and verbal reporting to the Biosafety Officer, promptly followed by a written report to the Biosafety Officer and the APB, of any significant problems or incidents pertaining to the operation and implementation of containment practices and procedures;
    • Correcting conditions that may result in the release of biohazardous agents;
    • Having biosafety cabinets certified by the Stanford University approved contractor on an annual basis, or when moved;
    • Ensuring compliance with the other procedures governing the use of biohazardous agents (see Section III below).

    Further guidance in these responsibilities is available from the Biosafety Officer and from the Stanford Biosafety Manual.

    3. Procedures Governing the Use of Biohazardous Agents

    All application forms submitted to the Biosafety Officer are reviewed by the APB at a convened meeting with a quorum. Upon approval, an application will be reviewed on an annual basis. Upon expiration of approval, the PI must submit a new application for review and approval by the APB.

    A. Experimental Applications

    Research with Biohazardous Agents not Involving Recombinant DNA

    PI's are not required to complete an application form when working only with BSL 1 agents. PI's are required to complete an application form and receive APB approval before working with BSL 2 and 3 agents. Currently, there are no BL4 facilities available to conduct work involving BSL 4 agents; therefore, research involving these agents cannot be approved by the APB at this time. All PI's who are considering the use of BSL 3 agents must notify the Biosafety Officer prior to applying to the APB to discuss the unique containment requirements involved with handling these agents.

    Research with Recombinant DNA

    Stanford categorizes experiments using recombinant DNA based on the NIH classification described in the NIH Guidelines for Research Involving Recombinant DNA Molecules. See the document in "Related Items" below for additional information regarding exempt/non-exempt work.

    Research with Biohazardous Agents Involving the Use of Animal Subjects

    Biological research involving any laboratory animals requires an administrative approval from the Administrative Panel on Laboratory Animal Care (A-PLAC).

    Any biological research involving the introduction of BSL 2 or 3 agents or non-exempt recombinant DNA molecules into animal subjects requires both A-PLAC and APB approval. A-PLAC application forms can be obtained online.

    Research with Biohazardous Agents Involving Human Subjects

    Biological research involving human subjects or clinical specimens from human subjects (human blood, tissues, organs, etc.) requires an additional administrative approval, which may be obtained from the Administrative Panel on Medical Human Subjects. For information, call the Office of The Dean of Research, Human Subjects Panel Coordinator, at 723-5244. APB approval will be required if clinical specimens from human subjects who are infected with BSL 2 or 3 agents will be used for research purposes. APB approval is also required if biohazardous agents or recombinant DNA molecules will be introduced to a human subject.

    Research with Biohazardous Agents Involving Radiological Hazards

    Biological research involving the use of radiological materials requires an additional administrative approval, which may be obtained from the Administrative Panel on Radiological Hazards. For more information, call the Environmental Health and Safety Office, Office of Health Physics at 723-3201.

    B. Application Review by the APB

    Upon receipt of either the completed application form or renewal form at EH&S, the Biosafety Officer conducts a detailed review of the proposed experiments. Such a review may include a personal interview with the applicant and an inspection of the proposed laboratory facilities. The Biosafety Officer will present any findings to the APB for review at the APB Meeting.

    Copies of the approved application or renewal form, which constitute authorization to proceed with the research, are to be maintained in the Biosafety Office at EH&S. They are also sent to the applicant and other University Administrative Panels as appropriate (e.g., Administrative Panel on Laboratory Animal Care, Administrative Panel on Human Subjects, etc.).

    C. Annual Review of Approved Applications

    It is the responsibility of the PI to update the approved application annually when notified by the Biosafety Officer. The Biosafety Officer will provide notification and renewal information on an annual basis.

    D. Physical Control of Biohazardous Agents

    A BSL 2 or 3 agent must not be transferred from one laboratory to another without written prior approval of the Biosafety Officer. These agents can only be transferred if the PI who is receiving the biohazardous agents is authorized by the APB in writing to use them. Shipment, packaging and labeling of biohazardous agents shall comply with state and federal regulations. All international transfers of export controlled biological agents and toxins as identified by the CDC must not be sent outside of the US without an export license and prior written approval of Stanford’s Export Control Officer. All biohazardous agents or mixed biohazardous waste shall be disposed of according to regulatory requirements (refer to the Stanford Biosafety Manual, available below in "Related Items").

    E. Medical Program

    During the approval process, the APB may consult with a physician, who may recommend a program of medical surveillance, including immunizations and/or the collection of specimens from laboratory personnel engaged in a project (refer to Stanford Biosafety Manual).

    F. Accidents Involving Biohazardous Agents

     

    Biohazardous Spills

    All spills involving any biohazardous agents must be promptly treated with an appropriate disinfectant agent. Any significant spill involving BSL 2 or 3 agents that occurs outside a biological safety cabinet or containment area must be reported to EH&S (3-0448) immediately. (refer to Stanford Biosafety Manual, Chapter 7).

    Exposure to Biohazardous Agents

    Exposure by inhalation, inoculation, ingestion, or skin contact (including cuts and wounds) to a BSL 2 or 3 agents must be referred to a physician immediately and reported to the individual's supervisor and to the Biosafety Officer (725-1473). Any injured employee should report to Occupational Health or the Stanford Emergency Department, as appropriate, during normal work hours. After hour care is available from the Emergency Department at Stanford Hospital. Students may report to Vaden Health Center.

    Reporting Requirements Involving Recombinant DNA

    In addition to the item above, significant problems with, or violations of, the Recombinant DNA Guidelines, and accidents involving recombinant DNA, must be reported to the Biosafety Officer (5-1473), who is the University official for reporting such matters to the Office of Biotechnology Activities (OBA). Reporting of above incidents that are covered by the rDNA Guidelines will be done within 30 days to NIH/OBA; reporting of all such incidents will be within the appropriate regulatory guidelines.

    G. Termination of APB Approval

    An approved user who willfully or negligently violates the University, federal, or state rules and regulations governing the use of biohazardous agents/rDNA may have his/her APB approval suspended or revoked by the Biosafety Officer pending review by the APB.

    The Biosafety Officer will prepare a report which will describe the violations in detail and will discuss the matter with the Chair of the APB who will then determine the final course of action.

    H. Appeals

    Disputes regarding interpretation of this policy or decisions made by the APB and/or the Biosafety Officer should be referred to the Dean of Research for adjudication.

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    4. Appendix B: The use of recombinant DNA (rDNA) is regulated by the National Institutes of Health

    The use of recombinant DNA (rDNA) is regulated by the National Institutes of Health (NIH); the guidelines can be found in the publication Guidelines for Research Involving Recombinant DNA Molecules; these guidelines are the official guide to all rDNA work done at Stanford. It is important to realize that following these guidelines is the responsibility of all investigators at Stanford University and not solely investigators that are funded by NIH.

    Experiments that are categorized as Exempt do not require approval by the Stanford University Institutional Biosafety Committee (the Administrative Panel on Biosafety (APB). To determine if your experiments are exempt, check Category F in the NIH Guidelines; a short reference guide is presented here.
     
     
    Is your rDNA never going to be in an organism or virus? 

    If Yes

    Exempt (III-F-1)
    Is your rDNA solely from a single non-chromosomal or viral source? If Yes Exempt (III-F-2)
    Is your rDNA solely from a prokaryotic host and propagated in
    the same host or transferred to another host by naturally
    occurring means?
    If Yes Exempt (III-F-3)
    Is your rDNA from a eukaryotic host and propagated in
    the same host?
    If Yes Exempt (III-F-4)
    Is your rDNA from species that naturally exchange DNA? If Yes Exempt (III-F-5)
    Is your rDNA of a type which does not present a significant
    risk to health or the environment,
    as determined by the NIH
    If Yes Exempt (III-F-6)

     

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    7.9 Research Funded by the Department of Energy Through SLAC National Accelerator Laboratory

    Provides clarification about health and safety procedures for campus based research funded through the SLAC National Accelerator Laboratory.

    1. Safety Policy and Procedures

    Stanford University (SU) and the SLAC National Accelerator Laboratory (SLAC) each have the obligation to provide a safe and healthful working and learning environment. The policies and procedures that SU and SLAC use to meet this obligation may differ, since the two organizations are regulated by different government agencies and operate under different requirements. Line managers (including supervisors and Principal Investigators) have the primary responsibility for assuring this obligation is met in areas under their control. 
 


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    2. Research Activity Performed at SLAC

    Those researchers, staff, and students involved with research conducted at SLAC will plan and carry out such work in accordance with SLAC Environment, Safety and Health (ES&H) policy, manual, and processes. Researchers, staff, and students conducting work at SLAC are required to participate in SLAC safety training.  
  


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    3. Department of Energy Funded Research Activity Performed on the Stanford Campus

    Those researchers, staff, and students involved primarily with SLAC funded research conducted on the main SU campus will plan and carry out such work in accordance with SU Environmental Health and Safety (EH&S) policies and procedures, which includes development of laboratory-specific safety plans. (These SU Laboratory Safety Plans may refer to and use SLAC safety policy/procedures for the conduct of such research work to minimize differences in work and safety procedures between SLAC and SU campus laboratories.) Researchers, staff, and students conducting work on the SU campus are required to participate in appropriate SU or equivalent SLAC safety training. 
  


    Emergency response at either SLAC or SU will follow the host institution protocols.  Recovery activities will be coordinated between SLAC and SU emergency and line organization personnel.  
  


    To ensure continued protection of personnel, the public, and the environment during research funded through the SLAC contract and conducted at SLAC and SU, any conflict that may arise shall be resolved between the SU Associate Vice Provost for EH&S and the SLAC ES&H Director.

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    7.10 Operation of Unmanned Flying Vehicles

    Establishes University approval procedures and review committee to facilitate flights of unmanned flying vehicles in a safe and responsible manner. Sets forth flight approval criteria to ensure consistency with the University’s mission to promote the public welfare, advance knowledge, and educate students. Prohibits third party flights from within or above University lands.

    Authority

    Contact

    Ash Chaudhry

    Risk Management Research Consultant

    1. Introduction and Applicability

    This policy applies to Unmanned Flying Vehicle flights. Unmanned Flying Vehicle (or “UFV”), as used in this policy, means any device used, intended to be used, or designed to fly in the air, which is operated without the possibility of direct physical human intervention from within or on the vehicle. UFVs include but are not limited to model aircraft, drones, unmanned aircraft systems (or “UAS”), rockets, and weather balloons, but do not include satellites. 
     
    This policy prohibits Third Party flights from within or above University lands. For the purposes of this policy, current faculty, students, staff, or other persons acting on behalf of the University pursuant to an approved agreement (or “Approved Vendors”) are not “Third Parties,” and may fly UFVs with the approval of the UFV Committee. All other persons or entities are Third Parties and are prohibited from flying UFVs from within or above University lands.  
     
    This policy applies to the following individuals or entities:
    • Third Parties operating or intending to operate UFVs on or above University lands, including hobbyist, recreational, or aerial photography flights. Such flights are prohibited by this policy.
    • Faculty, students, staff, or Approved Vendors flying UFVs on or above University lands, or on behalf of the University at any location. Thus, for example, the policy applies to faculty, students, or staff seeking to pursue the following activities:
    • Research and development or data collection by flying UFVs in the pursuit of their University duties, whether on or off University property;
    • UFV flight as a part of their University courses, or research activities, whether on or off University property;
    • Agreements or other arrangements for Approved Vendors and other persons to fly UFVs on behalf of the University (such as for aerial photography, or for any of the reasons above), whether on or off University property; and
    • Model aircraft or other UFV flight from within or above University property for recreational or hobby purposes (which will require membership in a University sanctioned hobbyist club).
    This policy does not apply to:
    • Anyone flying UFVs if such flight is (1) unrelated to University coursework, research, or employment and (2) such flight is not from within or above University lands.  
     

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    2. Background

    In pursuing its mission to promote the public welfare, advance knowledge, and train its increasingly global student base, the University may seek to utilize UFVs. The University recognizes that UFVs may enable faster, better, cheaper, and safer scientific data gathering, and because of their versatility, may serve as useful learning tools for students. At the same time, these vehicles present unique issues to environmental health, safety, regulatory compliance, and privacy, and these issues must be balanced with the University’s other missions.

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    3. Policy Statement

    A. Third Parties

    UFVs may not be flown from within or above University property by Third Parties.

    B. Stanford Faculty, Staff and Students and Approved Vendors

    UFVs may be flown by faculty, students, staff, and Approved Vendors if and only if the flight is approved in advance by the University’s UFV Committee in addition to any other applicable entities within the University, the flight has a nexus to the University’s mission or community, and the flight adheres to any limits prescribed by the UFV Committee to ensure safety and compliance with all applicable laws. 

    C. Stanford Research Activities

    Research activities involving UFVs must comply with the University’s RPH 1.4 Openness in Research Policy.

    4. UFV Committee

    The UFV Committee will be responsible for reviewing and approving all UFV flights by or on behalf of faculty, students, and staff.  
     
    The UFV Committee will comprise representatives from the following University offices or departments: School of Engineering (Faculty Representative); Humanities and Sciences (Faculty Representative); Dean of Research; Student Affairs; Risk Management; General Counsel; Public Safety; Land, Building, and Real Estate; and Public Affairs.  The UFV Committee may also consult with other University offices or departments as necessary.
     

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    5. UFV Commitee Review and Approval Process

    UFV flights may require Federal Aviation Administration (FAA) approvals and/or permissions from local authorities, other regulatory agencies, or private parties.  Certain FAA approvals take several months to seek and obtain. Further, in some cases, the UFV Committee may need to refer issues to impacted Stanford offices and departments.

    In light of these constraints, the UFV Committee must be notified, using the linked form, at the earliest possible time of a proposed UFV flight governed by this policy. For flights involving hobbyist or recreational activities, refer to the streamlined procedures provided in the linked form. In all other cases, in no event may the notification be submitted fewer than 10 business days before the envisioned

    1. flight,
    2. relevant commitment of funds or resources for the flight, or
    3. binding commitment or proposal relevant to the flight, whichever is earliest. 

    For flights posing new or significant risks or novel questions, additional review time or multiple meetings may be required, and requesters are advised to submit the request well in advance to avoid delays or disapproval. 

    The UFV Committee will determine and communicate whether the proposed UFV flight is permissible, and if so, under what conditions. If the proposed UFV flight is permissible, the UFV Committee will issue an electronic certificate of approval, which will be provided to the requester. If the proposed UFV flight is not permissible, the UFV Committee may provide guidance on whether and how the requester could address deficiencies in the request. No UFV flights may proceed without the certificate of approval.

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    6. General Criteria Considered by UFV Committee

    In determining whether to grant a request, the UFV Committee considers the following issues: 
     
    • Does the flight comport with the University’s scientific research and education mission? 
     
    • Does the flight comply with applicable laws and regulations, such as Federal regulations, privacy laws, and other state and local laws?  
     
    • Does the flight pose safety or privacy concerns for the University, the University community, or the general public? If so, has the requester identified protocols that will adequately address or mitigate potential risks?
     
    • If the flight is conducted by an Approved Vendor, is there an appropriate written agreement in place?
     
    • Is the flight in a permissible location? Among other considerations, specific locations on campus may have use restrictions or local permission requirements, applicable on a case-by-case basis. For example, flights are generally not permissible in locations such as the Oval, Main Quad, Memorial Court, the Central Energy Facility, SLAC National Accelerator Laboratory, in the vicinity of a highway or road, above public venues or thoroughfares, and in the vicinity of hospitals or airports.
     

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    7. Submission and Contact Information

    To request approval for a UFV flight please submit an application to the UFV committee and allow a minimum of 10 business days for routine requests, with additional time for more complex requests.  

    Applications for a UFV flight can be found in the Related Items section in the Documents Tab below. Applications should be sent to ufvcommittee@stanford.edu.

    Supplementary information on Stanford UFV policy and procedures can be found in the Documents Tab below under Frequently Asked Questions.

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    8. Export Controls

    8.1 Applicability and Policy Background, and Regulatory Authority

    Defines requirements for exports of research-related items, information and software code; addresses policies on acceptance of 3rd party export controlled items and data; describes documentation requirements for export control determinations including export license exceptions and exclusions; and establishes compliance with trade sanctions laws as an integral export control policy function.

    Contact

    Steven Eisner

    Director of Export Compliance and University Export Control Officer

    Vice Provost and Dean of Research

    (650) 724-7072

    1. Applicability

    This policy addresses issues related to:

    • shipping tangible items overseas
    • sharing confidential technical information or software source code with foreign nationals wherever located
    • interactions with embargoed or sanctioned countries, organizations, or individuals

    Federal regulations related to these topics are complex and changing. Individuals at Stanford are therefore encouraged to contact Stanford's Export Control Officer whenever they expect to be involved with any of these issues.

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    2. Policy Background

    Export controls, set forth in regulations administered by several federal agencies, impose access, dissemination, and participation restrictions on the transfer of "export controlled" software code and information and on the export and reexport of tangible items. An export is defined as the shipment of tangible items and the transmission or transfer of software code or information to another country, while a "deemed export" is the disclosure of controlled software code or information to foreign nationals in the US. The US Commerce Department must issue an export license or authorize an exception to or exclusion from license requirements before any controlled tangible item, software or information in the US on the Commerce Control List (CCL) may be exported or reexported. Likewise, if a tangible item, software or information is on the US Munitions List (USML), the US State Department must issue an export license or authorize an exception to or exclusion from licensing requirements. Stanford University will comply with all applicable export controls, as established by federal regulations.

    Export controls restricting a foreign national's participation in university research within the United States, i.e., "deemed export" restrictions, generally do not apply to the conduct or results of fundamental research (for more information, see PDF entitled "Reminder -Export Control Requirements" available below in "Related Items") . Stanford conducts only fundamental research as defined by the export control regulations - namely, openly-conducted basic and applied research in science and engineering that is not subject to access, dissemination, or participation restrictions (see Openness in Research policy). Because fundamental research is excluded from export control regulations, research, and other scholarly activities involving foreign nationals at Stanford do not trigger the need to obtain export licenses before they may proceed.

    Of primary concern are transactions involving proprietary or confidential export-controlled information provided to Stanford researchers by third parties, such as corporate vendors, subcontractors, or government collaborators. These may generate disclosure restrictions that may only be acceptable if they fall within the narrow exceptions provided by the Openness in Research Policy and qualify for treatment under an exemption (ITAR) or license exception (EAR) in the export control regulations (see "Accepting a Third Party Party's Controlled Items or Data").

    In the case of international shipments of tangible items, or the export or deemed export of 3rd party export controlled software code or information to foreign countries or their nationals , Stanford has the responsibility to either:

    1. Obtain an export license
    2. Document an express determination that an exception to export licensing requirements applies
    3. Document an express determination that no license is needed

    For detailed guidance on the Stanford community’s responsibilities under University and Federal export control policy, see the Reference Guides available in the Documents tab of the “Related Items” below.

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    3. Regulatory Authority

    A. International Traffic in Arms Regulations 22 CFR 120-130


    The US Department of State, Directorate of Defense Trade Controls (DDTC), is responsible for items and information inherently military in design, purpose, or use. Referred to as "defense articles," such items are found on the US Munitions List, 22 CFR 121. Certain spacecraft and satellites, even if not for military use, are on the Munitions List, along with their associated systems and related equipment. Information related to Defense Articles is referred to as "technical data."

    B. Export Administration Regulations 
15 CFR 700-799 


    The US Department of Commerce, Bureau of Industry and Security (BIS), has export jurisdiction over everything in the United States, although BIS does not require a license for every export. BIS controls goods and information having both civilian and military uses by including them on the Commerce Control List, 15 CFR 774, also known as the "Dual Use List." BIS uses the term "technology" when referring to information about the goods on the Commerce Control List.

    C. Office of Foreign Assets Control CFR 500-599

    The US Department of the Treasury oversees US economic sanctions and embargoes through its Office of Foreign Assets Control (OFAC). Empowered by the Trading with the Enemy Act and the International Emergency Economic Powers Act, OFAC enforces trade, anti-terrorism, narcotics, human rights and other national security and foreign policy based sanctions prohibiting the provision of anything of value, either tangible or intangible, to sanctioned countries, organizations, or individuals. OFAC has broad authority to license block or otherwise regulate "transactions" involving goods, technology and services to restricted destinations or parties.

    8.2 Definitions

    Provides a brief glossary of commonly used export control terms as they apply to Stanford export controls policy.

    Contact

    Steven Eisner

    Director of Export Compliance and University Export Control Officer

    Vice Provost and Dean of Research

    (650) 724-7072

    1. Definitions

    A. Export

    "Export" means to send or take controlled tangible items, software, or information out of the United States in any manner including handcarries, to transfer ownership or control of controlled tangible items, software or information to a foreign person, or to disclose information about controlled items, software or information to a foreign government or foreign person. The controlled tangible item, software or information being sent or taken out of the United States is also referred to as an "export.

    B. Reexport

    "Reexport" means an actual shipment or transmission of controlled tangible items, software or information from one foreign country to another foreign country. The export or reexport of controlled tangible items, software or information that will transit through a country or countries, or will be unloaded in a country or countries for reloading and shipment to a new country, or are intended for reexport to the new country, are deemed to be exports to the new country.

    C. Deemed Export

    "Deemed export" is a term used by the Commerce Department to describe the situation where a foreign national on US soil may be exposed to, or have access in any manner to, an export-controlled item or export-controlled software or information. Although the State Department does not use this term, but rather includes this concept in its definition of export, Stanford University will use the term "deemed export" when discussing access by foreign nationals to controlled information on our soil, without regard to which agency may have cognizance over the transaction.

    D. US Person/Foreign Person

    A "US person" is a citizen of United States, a lawful permanent resident alien of the US, (a "Green Card" holder), a refugee or someone here as a protected political asylee or under amnesty. US persons also include organizations and entities, such as universities, incorporated in the US. The general rule is that only US persons are eligible to receive controlled items, software or information without first obtaining an export license from the appropriate agency unless a license exception or exclusion is available.


    A "foreign person" is anyone who is not a US person. Examples of foreign persons are students, post-doctoral scholars, or research staff in F-1 or J-1 status, and Stanford foreign national employees in H1-B status.  A foreign person also means any foreign corporation, business association, partnership or any other entity or group that is not incorporated to do business in the US.  Foreign persons may include international organizations, foreign governments, and any agency or subdivision of foreign governments such as consulates.

    E. Fundamental Research

    The concept of "fundamental research" was established by National Security Decision Directive 189 (NSDD 189, found below in "Related Items"), which establishes a national policy with regard to how such research shall be treated for purposes of the various export control regimes. 
NSDD 189 defines fundamental research as: 
basic and applied research in science and engineering where the resulting information is to be shared broadly within the scientific community.



    NSDD 189 provides that the conduct, products, and results of fundamental research are to proceed largely unfettered by deemed export restrictions. It also states that the government must determine - before releasing a research opportunity - whether the research should be classified or otherwise kept secret. Research that carries access, participation, or dissemination restrictions will not qualify as fundamental research for purposes of the export control regulations.
 Because export regulations expressly recognize that fundamental research is excluded from deemed export controls, no export license or other authorization is needed to involve foreign nationals in fundamental research activity at Stanford. However, such research may give rise to export issues if the primary research is to be conducted outside of the US or if it requires exposure of foreign nationals to proprietary or confidential export controlled information provided by third parties such as corporations, commercial vendors or government collaborators. Please see RPH: Accepting a Third Party's Export Controlled Items or Information for guidance.

     

    8.3 Export Licenses for International Transfers of Items, Software or Technical Information

    Describes documentation requirements; identifies resources for export control determinations including export license exceptions, exclusions and “No License Required” (NLR) assessments.

    Contact

    Steven Eisner

    Director of Export Compliance and University Export Control Officer

    Vice Provost and Dean of Research

    (650) 724-7072

    1. Export Licenses for International Transfers of Items, Software or Technical Information

    The Commerce Department has export jurisdiction over all tangible items, software and "technology" (technical information) in the United States unless some other agency has expressly been given such authority. However, this does not mean that a license must be obtained before any tangible item, software code or piece of technical information can be shipped. An Export Control Decision Tree is available to assist in determining the applicability of export control regulations in the case of shipments of tangible items or transfers or transmission of software code or technical information to foreign countries and their nationals.

    In order to determine whether it is necessary to obtain an export license from the relevant federal agency to send tangible items or to transfer or transmit software code or technical information outside the United States, the researcher preparing the shipment or transfer needs to consider:

    • whether the software code or information is disclosure-restricted and thus subject to export control, or whether it resulted from fundamental research to which export controls do not apply
    • the technical characteristics and specifications of the tangible item, software or technical information
    • its intended end-use and end-user
    • its destination

    All tangible items, software code and information not on a US export control list may be shipped or transmitted to any country, individual or entity that is not sanctioned, embargoed or otherwise restricted for export. Such items, code, and information may be exported under "No License Required" (NLR) provisions.

    Certain overseas shipments or transmissions being handled on a "No License Required" basis will require an explanation and justification for that classification. Stanford electronic NLR Certification templates for such justifications are available.  Submission of the appropriate Stanford export control Certification is a Stanford Policy requirement. The Documents tab in the “Related Items” section below includes detailed guidance on export certification submission requirements. See RPH: Recordkeeping Requirements for additional information about recordkeeping.

    The University Export Control Officer should be contacted for any international shipment, or international transfer of commercial software code or confidential technical information, identified on an export control list.

    Stanford's preferred export freight forwarder for more complex or sensitive international shipments, or for those shipments for which Stanford personnel would like individualized attention, is Tigers Global Logistics in Hayward, CA. Tigers' Export Manager may be contacted for assistance or to arrange for pickup at (510) 784-8920 ex. 2601. Tigers also serves as an import customs broker on Stanford's behalf and can assist in customs clearance for items purchased through Stanford's Procurement Services Department (650-723-2772). Tigers' Import Manager can be reached at (510) 784-8920 ex. 2616.

    Note also that specific training and documentation is needed whenever you are shipping chemicals, biologicals, or other dangerous materials. See Environmental Health & Safety website for more information.

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    8.4 Accepting a Third Party’s Export Controlled Items or Information

    Addresses policies on acceptance of third party export controlled items and information.

    Contact

    Steven Eisner

    Director of Export Compliance and University Export Control Officer

    Vice Provost and Dean of Research

    (650) 724-7072

    1. A Third Party's Export Controlled Items or Information

    The conduct of fundamental research may proceed openly and its informational results shared freely with foreign nationals without regard to export licensing concerns. Export-controlled items, proprietary software source code, or confidential technical information provided by a third party, however, may not be openly shared with certain foreign nationals, even though those individuals may be important contributors to the performance of the fundamental research. For example, a corporate sponsor or a research collaborator may have to disclose confidential technical information in the form of background intellectual property (IP) such as the proprietary heat and vibration tolerances on a piece of export-controlled hardware it may be providing for use in carrying out a fundamental research experiment. Confidential technical information that is required for the development, production or use of export-controlled equipment is itself export-controlled. It carries with it export control restrictions that must be honored by the researcher who agrees to be a recipient of such information.

    Before a researcher decides to accept such information, he or she must 1) review the conditions of the University's Openness in Research Policy and 2) notify the University Export Control Officer (ECO) of the need to receive the export-controlled information before it is disclosed.  The ECO will review the proposed disclosure to assess potential deemed export licensing requirements. If the ECO concurs that receipt of such information is in compliance with University policy – namely that receipt of the export controlled information does not restrict any foreign national member of the research group ineligible to access that information from participating fully in the intellectually significant portions of the project – the researcher must then complete a Certification on the Handling and Use of Third-Party Export Controlled Information. At that point, the researcher is free to receive the third party’s export controlled information.

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    8.5 Export Controls and Stanford’s Openness in Research Policy

    Expresses Stanford’s commitment to ensure freedom of access to information that is central to the intellectually significant portions of the research; clarifies that Stanford will not accept export controlled information in the conduct of university fundamental research that disadvantages any foreign national member of a research group because of resulting access restrictions.

    Contact

    Steven Eisner

    Director of Export Compliance and University Export Control Officer

    Vice Provost and Dean of Research

    (650) 724-7072

    1. Openness in Research Policy

    Stanford's Openness in Research Policy expresses our institutional commitment to "the principle of freedom of access by all interested persons to the underlying data, to the processes, and to the final results of research." This policy does not forbid nondisclosure agreements, but such a commitment may relate only to such information that is substantially remote from the intellectually significant portions of the research. A promise not to disclose export-controlled information may be appropriate, so long as keeping the confidentiality of that information will not disadvantage any other researchers on the same project and receipt of that information is not conditioned on submitting to restrictions on the right to publish.


    Once it is determined that the nondisclosure commitment does not violate the Openness in Research Policy, it must be determined that the intended recipient is in fact "eligible" under the regulations.

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    8.6 Export Controls and an Individual’s Eligibility as a Recipient of Export Controlled Items, Software Code, or Information

    Identifies the requirement for the original recipient of export controlled articles or data to determine the eligibility of others to access such items or data without an export license; addresses the potential applicability of specific export license exemptions and exceptions; sets forth the requirement that the original recipient of export controlled articles or data document all transfers when export controls apply.

    Contact

    Steven Eisner

    Director of Export Compliance and University Export Control Officer

    Vice Provost and Dean of Research

    (650) 724-7072

    1. Export Controls on Individual Eligibility as a Recipient

    Generally, federal regulations require that only US persons as defined in RPH: Definitions may be provided with export-controlled items, software code or information without having to obtain an export license. Nonetheless, there are some specific exemptions (ITAR) and license exceptions (EAR) available to those within the University community that may be useful. It is extremely important to keep them in mind should it become necessary to share any export-controlled items, software code or information beyond the original recipient.

    In addition, records must be kept in order to demonstrate compliance.

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    8.7 Recordkeeping Requirements

    Describes federal and university export control documentation retention requirements.

    Contact

    Steven Eisner

    Director of Export Compliance and University Export Control Officer

    Vice Provost and Dean of Research

    (650) 724-7072

    1. Record Keeping Requirements

    Each of the relevant export control regulations contain specific recordkeeping requirements that must be satisfied. In addition, the university maintains its own recordkeeping requirements in order to document its commitment to, and compliance with, export control regulations generally.

    Departments or programs must keep soft or hard copies of all export documentation, including Restricted Party Screens, financial records such as purchase orders and shipping documentation (commercial/pro forma invoices, packing lists, FedEx and other international freight forwarder/courier documents), in their research project files for a period of five years from the date of the export, reexport or controlled deemed export.

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    9. Intellectual Property

    9.1 Inventions, Patents, and Licensing

    Establishes policy and procedures for disclosure and assignment of ownership of potentially patentable inventions created in the course of work at Stanford or with more than incidental use of Stanford resources. Extends this requirement to faculty, staff,  graduate students, undergraduate students, post doctoral scholars and visitors.

    Authority

    Stanford Board of Trustees

    Contact

    Karin H Immergluck

    Executive Director

    Office of Technology Licensing (OTL)

    2:(650) 723-0651

    1. Patent Policy

    A. Board Policy

    1. All potentially patentable inventions conceived or first reduced to practice in whole or in part by members of the faculty or staff (including student employees) of the University in the course of their University responsibilities or with more than incidental use of University resources, shall be disclosed on a timely basis to the University. Title to such inventions shall be assigned to the University, regardless of the source of funding, if any.

    2. The University shall share royalties from inventions assigned to the University with the inventor.

    3. The inventors, acting collectively where there is more than one, are free to place their inventions in the public domain if they believe that would be in the best interest of technology transfer and if doing so is not in violation of the terms of any agreements that supported or related to the work.

    4. If the University cannot, or decides not to, proceed in a timely manner to patent and/or license an invention, it may reassign ownership to the inventors upon request to the extent possible under the terms of any agreements that supported or related to the work.

    5. Waivers of the provisions of this policy may be granted by the President or the President's designate on a case-by-case basis, giving consideration among other things to University obligations to sponsors, whether the waiver would be in the best interest of technology transfer, whether the waiver would be in the best interest of the University and whether the waiver would result in a conflict of interest. In addition, the President may expand upon these provisions and shall adopt rules, based on the same factors as well as appropriateness to the University's relationship with inventors, for the ownership of potentially patentable inventions created or discovered with more than incidental use of University resources by students when not working as employees of the University, by visiting scholars and by others not in the University's employ.

    6. This policy shall apply to all inventions conceived or first reduced to practice on or after September 1, 1994.

    B. Additional Provisions

    (promulgated by the University President, reference section 5 of the Board Policy, above)

    1. In addition to faculty and staff (including student employees), the provisions of the University's patent policy will extend to:
    • all graduate students and postdoctoral fellows
    • non-employees who participate or intend to participate in research projects at Stanford (including visiting faculty, industrial personnel, fellows, etc.)

    The Board policy will apply as stated for graduate students and postdoctoral fellows. In the case of non-employees, all potentially patentable inventions conceived or first reduced to practice in whole or in part in the course of their participation in research projects at Stanford, or with more than incidental use of University resources, shall be disclosed on a timely basis to the University, and title shall be assigned to the University, unless a waiver has been approved.

    2. The President's authority to grant waivers of provisions of this policy is delegated to the Vice Provost and Dean of Research.

     

    2. Administrative Procedures

    A. Office of Sponsored Research

    Office of Sponsored Research (OSR) is responsible for reviewing terms and conditions of the University's grants and contracts for compliance with University policies on intellectual property rights and openness in research.

    B. Office of Technology Licensing

    The mission of the Office of Technology Licensing (OTL) is to promote the transfer of Stanford technology for society's use and benefit while generating unrestricted income to support research and education. OTL is responsible for the administration of the University's invention reporting and licensing program, the commercial evaluation of inventions, patent filing decisions, petitions to agencies for greater rights in inventions, and negotiation of licensing agreements with industry.

    C. Patent and Copyright Agreements

    All faculty, staff, student employees, graduate students and postdoctoral fellows must sign the Stanford University Patent and Copyright Agreement (referred to as "SU-18"). In addition, non-employees who participate or intend to participate in research projects at Stanford must also sign a Patent and Copyright Agreement. A variation of this agreement has been created for individuals with prior obligations regarding the disclosure and assignment of intellectual property. See Patent and Copyright Agreement for Personnel at Stanford who have a Prior Existing and Conflicting Intellectual Property Agreement with Another Employer (SU-18A).

    Each department is responsible for getting the Patent and Copyright Agreement signed, normally at the time of the individual's initial association with Stanford.

    D. Invention Disclosures

    An invention disclosure is a document which provides information about inventor(s), what was invented, circumstances leading to the invention, and facts concerning subsequent activities. It provides the basis for a determination of patentability and the technical information for drafting a patent application. An invention disclosure is also used to report technology that may not be patented but is protected by other means such as copyrights.

    Inventors must prepare and submit on a timely basis an invention disclosure for each potentially patentable invention conceived or first actually reduced to practice in whole or in part in the course of their University responsibilities or with more than incidental use of University resources.


    A disclosure form describing the invention and including other related facts should be prepared by the inventor and forwarded to OTL, or to the SLAC Inventions Administrator, as appropriate. Forms may be requested from these offices.

    The following practical considerations relate to invention disclosures:

    1. Individuals covered by this policy are expected to apply reasonable judgment as to whether an invention has potential for commercial marketing. If such commercial potential exists, the invention should be considered "potentially patentable," and disclosed to Stanford.

    2. Individuals may not use University resources, including facilities, personnel, equipment, or confidential information, except in a purely incidental way, for any non-University purposes, including outside consulting activities or other activities in pursuit of personal gain.

    "More than incidental use of University resources" would include:

    • The use of specialized, research-related facilities, equipment or supplies, provided by Stanford for academic purposes
    • Significant use of "on-the-job" time

    The occasional and infrequent use of the following would typically not constitute "more than incidental use of University resources":

    • Routinely available, office-type equipment, including desktop computers and commercially-available software
    • Reference materials or other resources collected on the Stanford campus, and which are generally available in non-Stanford locations.

    E. Alternative Disposition of Rights

    The inventor, or inventors acting collectively when there are more than one, is free to place inventions in the public domain if that would be in the best interest of technology transfer and if doing so is not in violation of the terms of any agreements that supported or governed the work. The University will not assert intellectual property rights when inventors have placed their inventions in the public domain.

    If OTL cannot, or decides not to, proceed in a timely manner to patent and/or license an invention, OTL may reassign ownership to the inventor or inventors upon request to the extent possible under the terms of any agreements that supported or related to the work. In the case of an invention resulting from a government-sponsored project, where OTL cannot or chooses not to retain ownership, rights would then typically be retained by the government. In such cases, the inventor may request and be granted rights by the sponsoring agency to an invention made under such an award, provided that a well-conceived and detailed plan for commercial development accompanies the request.

    3. Licensing

    The University encourages the development by industry for public use and benefit of inventions and technology resulting from University research. It recognizes that protection of proprietary rights in the form of a patent or copyright are often necessary - particularly with inventions derived from basic research - to encourage a company to risk the investment of its personnel and financial resources to develop the invention. In some cases an exclusive license may be necessary to provide an incentive for a company to undertake commercial development and production. Nonexclusive licenses allow several companies to exploit an invention.

    The research and teaching missions of the University always take precedence over patent considerations. While the University recognizes the benefits of patent development, it is most important that the direction of University research not be established or unduly influenced by patent considerations or personal financial interests.

    OTL handles the evaluation, marketing, negotiations and licensing of University-owned inventions with commercial potential. Royalty distribution is as follows:

    1. Cash Royalties

    A deduction of 15% to cover the administrative overhead of OTL is taken from gross royalty income, followed by a deduction for any directly assignable expenses, typically patent filing fees. After deductions, royalty income is divided one third to the inventor, one third to the inventor's department (as designated by the inventor), and one third to the inventor's school. In the case of Independent Laboratories and Independent Research Centers or Institutes, which report directly to the Vice Provost and Dean of Research (who is the cognizant Dean for these research units), the inventor may assign to his or her Independent Laboratory, Center or Institute the department's third of the royalty income or a part thereof, based on support of the work. In these cases, the School's portion goes to the Dean of Research. Similarly, when more than one department is involved, the inventor shall designate the distribution of the department and school thirds based on support of the work. Disagreements involving royalty distribution will be reviewed and resolved by OTL; involved parties may appeal the OTL resolution to the Dean of Research.

    2. Equity

    Stanford may at times accept equity as part of the license issue fee. Net equity, i.e., the value of the equity after the deduction of 15% to cover OTL administrative costs, will be shared between the Inventor(s) and the University, with the University share going to the OTL Research and Fellowship Fund. The University's share of equity will be managed by the Stanford Management Company, and the OTL Research and Fellowship Fund is administered by the Vice Provost and Dean of Research. (All other cash payments, including royalties based on sales, will be distributed in accordance with the provisions of (1) above.)

    See Research Policy Handbook document, Equity Acquisition in Technology Licensing Agreements.

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    4. Background

    A. What is a Patent?

    A U.S. patent is a grant issued by the U.S. Government giving an inventor the right to exclude all others from making, using, or selling the invention within the United States, its territories and possessions for a period of 20 years. When a patent application is filed, the U.S. Patent Office reviews it to ascertain if the invention is new, useful, and nonobvious and, if appropriate, grants a patent - usually two to five years later. Other countries also grant similar patents. Not all patents are necessarily valuable or impervious to challenge.

    B. What is an Invention?

    An invention is a novel and useful idea relating to processes, machines, manufactures, and compositions of matter. It may cover such things as new or improved devices, systems, circuits, chemical compounds, mixtures, etc. It is probable that an invention has been made when something new and useful has been conceived or developed, or when unusual, unexpected, or nonobvious results have been obtained and can be exploited.

    An invention can be made solely or jointly with others as coinventors. To be recognized legally, a coinventor must have conceived of an essential element of an invention or contributed substantially to the general concept. (See section 2.D. for information and procedure regarding the formal disclosure of an invention.)

     

    C. Patentability

    Not all inventions are patentable. Questions relating to patentability are often complex and usually require professional assistance.

    1. General criteria for patentability

      An important criterion of patentability is that an invention must not be obvious to a worker with ordinary skill in that particular field. It must also be novel, in the sense that it not have been previously publicly known or used by others in this country or patented or described in a printed publication anywhere.

    2. Loss of patentability

      Inventions that are patentable initially may become unpatentable for a variety of reasons. An invention becomes unpatentable in the United States unless a formal application is filed with the U.S. Patent Office within 12 months of disclosure in a publication or of any other action which results in the details of the invention becoming generally available.

    3. Circumstantial impairment of patentability

      Many other circumstances may impair patentability, such as lack of "diligence." For example, unless there is a record of continuous activity in attempting to complete and perfect an invention, it may be determined that the invention has been abandoned by the initial inventor, and priority given to a later inventor who showed "due diligence."

    3. International variation of patentability regulations

    Regulation covering the patentability of inventions and application filing procedures vary from country to country and are subject to change. It is important to note that an invention is unpatentable in most foreign countries unless a patent application is filed before publication.

     

    D. Value of Unpatented Inventions

    An invention, although unpatentable for various reasons, may still be valuable and important - for example, trade secrets and technical "know-how" encompassing proprietary information of a valuable and confidential nature.

    Agencies sponsoring research at Stanford usually require reports of all inventions, whether or not they are considered patentable.

    9.2 Copyright Policy

    Establishes Stanford policy on copyright ownership and defines administrative procedures for policy implementation.

    Authority

    Stanford Board of Trustees

    Contact

    Karin H Immergluck

    Executive Director

    Office of Technology Licensing (OTL)

    2:(650) 723-0651

    1. Introduction

    This document describes Stanford policies and associated administrative procedures for copyrightable materials and other intellectual property. Its objectives are:

    • to enable the University to foster the free and creative expression and exchange of ideas and comment

    • to preserve traditional University practices and privileges with respect to the publication of scholarly works

    • to establish principles and procedures for sharing income derived from copyrightable material produced at the University

    • to protect the University's assets and imprimatur

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    2. General Policy Statement

    Copyright is the ownership and control of the intellectual property in original works of authorship which are subject to copyright law. It is the policy of the University that all rights in copyright shall remain with the creator unless the work is a work-for-hire (and copyright vests in the University under copyright law), is supported by a direct allocation of funds through the University for the pursuit of a specific project, is commissioned by the University, makes significant use of University resources or personnel, or is otherwise subject to contractual obligations.

    NOTE: Policy governing patentable software is contained in the Research Policy Handbook document entitled Inventions, Patents and Licensing.

    A. Books, Articles and Similar Works, Including Unpatentable Software

    In accord with academic tradition, except to the extent set forth in this policy, Stanford does not claim ownership to pedagogical, scholarly, or artistic works, regardless of their form of expression. Such works include those of students created in the course of their education, such as dissertations, papers and articles. The University claims no ownership of popular nonfiction, novels, textbooks, poems, musical compositions, unpatentable software, or other works of artistic imagination which are not institutional works and did not make significant use of University resources or the services of University non-faculty employees working within the scope of their employment.

    B. Institutional Works

    The University shall retain ownership of works created as institutional works. Institutional works include works that are supported by a specific allocation of University funds or that are created at the direction of the University for a specific University purpose. Institutional works also include works whose authorship cannot be attributed to one or a discrete number of authors but rather result from simultaneous or sequential contributions over time by multiple faculty and students. For example, software tools developed and improved over time by multiple faculty and students where authorship is not appropriately attributed to a single or defined group of authors would constitute an institutional work. The mere fact that multiple individuals have contributed to the creation of a work shall not cause the work to constitute an institutional work.

    C. Patent and Copyright Agreement: Stanford Form SU-18

    All faculty, staff, student employees, graduate students and postdoctoral fellows, as well as non-employees who participate or intend to participate in research projects at Stanford are bound by this policy. They are also required to sign the Stanford University Patent and Copyright Agreement (referred to as SU-18). See Research Policy Handbook, entitled Inventions, Patents, and Licensing. Except as described in Section 2.A. above, this agreement assigns rights to copyrightable works resulting from University projects to Stanford. This policy applies, and those subject to this policy are deemed to assign their rights to copyrightable works, whether or not a SU-18 is signed and is on file.


    Royalty income received by the University for such works will normally be distributed in accordance with University policy (see RPH 9.3 Section 2B. Royalty Distribution). Physical embodiments of copyrightable works may also be subject to the University's policy on Tangible Research Property, also in the Research Policy Handbook document.

    D. Works of Non-Employees

    Under the Copyright Act, works of non-employees such as consultants, independent contractors, etc. generally are owned by the creator and not by the University, unless there is a written agreement to the contrary. As it is Stanford's policy that the University shall retain ownership of such works (created as institutional rather than personal efforts, as described in Section 2.B, above), Stanford will generally require a written agreement from non-employees that ownership of such works will be assigned to the University.
 Examples of works which the University may retain non-employees to prepare are:

    • reports by consultants or subcontractors

    • computer software

    • architectural or engineering drawings

    • illustrations or designs

    • artistic works

    E. Videotaping and Related Classroom Technology

    Courses taught and courseware developed for teaching at Stanford belong to Stanford. Any courses which are videotaped or recorded using any other media are Stanford property, and may not be further distributed without permission from the cognizant academic dean (or, in the case of SLAC, by the director). Blanket permission is provided for evanescent video or other copies for the use of students, or for other University purposes. Prior to videotaping, permission should be obtained from anyone who will appear in the final program. In this regard, see the University's policy on Consent to Use of Photographic Images, which is found in the Privacy of Student Records section of the Stanford Bulletin.

    F. Contractural Obligations of the University

    This Copyright Policy shall not be interpreted to limit the University's ability to meet its obligations for deliverables under any contract, grant, or other arrangement with third parties, including sponsored research agreements, license agreements and the like. Copyrightable works that are subject to sponsored research agreements or other contractual obligations of the University shall be owned by the University, so that the University may satisfy its contractual obligations.

    G. Use of University Resources

    Stanford University resources are to be used solely for University purposes and not for personal gain or personal commercial advantage, nor for any other non-University purposes. Therefore, if the creator of a copyrightable work makes significant use of the services of University non-faculty employees or University resources to create the work, he or she shall disclose the work to the Office of Technology Licensing and assign title to the University. Examples of non-significant use include ordinary use of desktop computers, University libraries and limited secretarial or administrative resources. Questions about what constitutes significant use should be directed to the appropriate school dean or the Dean of Research.

    H. Reconveyance of Copyright to Creator

    When copyright is assigned to Stanford because of the provisions to this policy, the creator of the copyrighted material may make a request to the Dean of Research that such ownership be reconveyed back to the creator. Such a request can at the discretion of the Dean, be granted if it does not: (i) violate any legal obligations of or  to the University, (ii) limit appropriate University uses of the materials, (III)create a real or potential conflict of interest for the creator, or (iv)otherwise conflict with University goals or principles.

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    3. Explanations of Terms

    A. Copyright

    1. Copyrightable Works

    Under the federal copyright law, copyright subsists in "original works of authorship" which have been fixed in any tangible medium of expression from which they can be perceived, reproduced, or otherwise communicated, either directly or with the aid of a machine or device. These works include:

    • Literary works such as books, journal articles, poems, manuals, memoranda, tests, computer programs, instructional material, databases, bibliographies;

    • Musical works including any accompanying words;

    • Dramatic works, including any accompanying music;

    • Pantomimes and choreographic works (if fixed, as in notation or videotape);

    • Pictorial, graphic and sculptural works, including photographs, diagrams, sketches and integrated circuit masks;

    • Motion pictures and other audiovisual works such as videotapes;

    • Sound recordings.

    2. Scope of Copyright Protection

    Copyright protection does not extend to any idea, process, concept, discovery or the like, but only to the work in which it may be embodied, illustrated, or explained. For example, a written description of a manufacturing process is copyrightable, but the copyright only prevents unauthorized copying of the description; the process described could be freely copied unless it enjoys some other protection, such as patent.

    Subject to various exceptions and limitations provided for in the copyright law, the copyright owner has the exclusive right to reproduce the work, prepare derivative works, distribute copies by sale or otherwise, and display or perform the work publicly. Ownership of copyright is distinct from the ownership of any material object in which the work may be embodied. For example, if one purchases a videotape, one does not necessarily obtain the right to make a public showing for profit.

    The term of copyright in works created on or after January 1, 1978, is the life of the author plus seventy years. Copyright in works-for-hire is for ninety-five years from the date of first publication or one hundred twenty years from creation, whichever period first expires.

    B. Works for Hire

    "Work for hire" is a legal term defined in the Copyright Act as "a work prepared by an employee within the scope of his or her employment." This definition includes works prepared by employees in satisfaction of sponsored agreements between the University and outside agencies. Certain commissioned works also are works for hire if the parties so agree in writing.

    The employer (i.e., the University) by law is the "author", and hence the owner, of works for hire for copyright purposes. Works for hire subject to his principle include works that are developed, in whole or in part, by University employees. For example, under section 1.G of this policy, significant use of staff or student employee programmers or University film production personnel will typically result in University ownership of the copyright in the resulting work. Where a work is jointly developed by University faculty or staff or student employees and a non-University third party, the copyright in the resulting work typically will be jointly owned by the University and the third party. In such instances, both the University and the other party would have nonexclusive rights to exploit the work, subject to the duty to account to each other. Whether the University claims ownership of a work will be determined in accordance with the provisions of this policy, and not solely based upon whether the work constitutes a work-for-hire under the copyright law. For example, copyright in pedagogical, scholarly or artistic works to which the University disclaims ownership under this policy shall be held by the creators regardless of whether the work constitutes a work-for-hire under copyright law. University ownership in a work for hire may be relinquished only by an official of the University authorized to do so by the Board of Trustees.

    4. Attachment A. Policy Clarifications Concerning Online Instruction

    Date: February 19, 2013

    To:   Department Chairs and Program Directors

    From: John Etchemendy, Provost

    Subject:  Policy clarifications concerning online instruction

    Statement on Outside Teaching and Online Course Materials

    The Presidential Advisory Committee on Technology in Higher Education was convened in February 2012 to provide guidance on the use of educational technology both on and off campus. The committee issued a report in June 2012 in which the committee expressed its belief that Stanford’s primary educational mission is to educate students admitted to the University’s programs. At the same time, the committee recognized faculty interest in extending the impact of their scholarship through external distribution of courses. In light of the committee’s findings and recommendations, the following policy clarifications will be made to the Research Policy Handbook and the Faculty Handbook.

    Outside Teaching Activities

    The committee recognized that faculty owe their primary teaching duty to the University and that any teaching outside the University must be consistent with the University’s policies on conflict of commitment and interest. Under longstanding University policy, a faculty member is normally not permitted to accept or hold a regular teaching, research or administrative position at another institution. This is true regardless of whether the faculty member is on regular duty at Stanford, on sabbatical, or on leave without salary. The policy is consistent with the expectations of our students that, through their admission to the University and payment of tuition, they will receive a unique educational experience from exceptional Stanford faculty that is not available elsewhere.

    The committee noted that this policy should apply regardless of whether the teaching is provided in person or through an electronic format. Merely limiting the creation of course materials for another institution to consulting hours, a vacation or an off duty quarter does not address the potential conflict with the faculty member’s obligations to the University and its students. Such outside teaching activities can be at odds with University policies on conflict of commitment and interest by diverting attention from the appointee’s work at Stanford, competing with existing programs offered by the University, or undermining the development of new programs at the University. In addition, such activities may inappropriately rely upon University resources (including its personnel and students) that are funded by tuition payments and by contributions from donors and extramural funders for the non-profit teaching and research activities of the University.

    Accordingly, Faculty, Academic Staff and Other Teaching Staff with a primary employment affiliation with the University, as reflected in an appointment of more than 50% for a year or longer, are not permitted to teach for another institution or otherwise teach extramural courses without the approval of the Provost, except through a Stanford-sponsored program or agreement with that institution.

    Individuals who are employed by the University in an appointment of 50% or less time do not owe their primary teaching duty to Stanford and therefore may teach for another institution, as long as such teaching does not interfere with their duties at Stanford. However, they may not use their Stanford title or affiliation in any way to promote the teaching activity at the other institution or to imply that there is Stanford sponsorship of the activity. The committee noted that the University’s name is a significant University resource and implicates the interests of not only the University, but also the reputation and academic standing of the professoriate. Accordingly individuals who are permitted to teach elsewhere should prevent the other institutions with whom they work from using the Stanford name or its insignias, identifying them as Stanford instructors (as opposed to instructors at the institution in which the courses are offered), or making statements that imply that Stanford sponsors, endorses or otherwise vouches for their courses. In extended biographical descriptions, such individuals may refer to the fact that they have taught at the University.

    This policy does not prohibit the academic tradition of teaching in a visiting capacity at other non-profit educational institutions during sabbatical leaves,  giving occasional guest lectures or presenting a tutorial or short course at a scientific conference. However, approval from the cognizant dean is required before any electronic materials created in connection with such teaching may be used as a course or a significant portion of a course by another institution after the conclusion of the faculty member’s visit.

    Faculty members and other academic appointees are responsible for complying with this policy and should consult with their deans or the Vice Provost for Online Learning before pursuing activities that might be problematic under this policy.

    Distribution of Course Materials

    The committee acknowledged that under existing University policy, courses taught and courseware developed by faculty while employed by the University belong to Stanford. The committee noted that this policy should continue to apply regardless of the form of expression, including courses captured on video or in other digital forms.  However, faculty are permitted to make written course materials they personally create available to peers at other academic institutions for noncommercial academic or personal use outside the University. Additionally, if a faculty member leaves the University, he or she may continue to use, at another non-profit academic institution, course material he or she created at Stanford.

    Faculty creating textbooks that include additional course materials should not allow publishers to assert broad control over derivative works and limit the ability of the faculty member or the University to use and distribute the course materials in the future. Faculty may include course materials owned by the University in textbooks under a free license from the University; however, the faculty member’s contract with a publisher should contain terms acknowledging the University’s ownership interest in the course materials and require prior consent by the University for the creation and distribution of derivative works.

    Compensation for Course Development

    If a department or school specifically commissions the development of course content or courseware, the payment of any supplementary compensation will be consistent with the existing policies set forth in Section 5.1 of the Faculty Handbook and relevant school policies.

    Consistent with the existing University policies regarding the commercialization of inventions, any commercialization of course content and courseware created and taught at Stanford will be undertaken by the University. The University will not, however, undertake any commercialization without the agreement of the faculty-creator and will ensure that any revenue arising from commercialization will be shared with the creators, their departments and schools, as is done with patent income.

    Click here to view Memo from John Etchemendy Provost, dated February 19, 2013.

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    9.3 Administration of Copyright Policy

    Authority

    Stanford Board of Trustees

    Contact

    Karin H Immergluck

    Executive Director

    Office of Technology Licensing (OTL)

    2:(650) 723-0651

    1. Determinations of Ownership and Policy in Unclear Cases

    Questions of ownership or other matters pertaining to materials covered by this policy shall be resolved by the Dean of Research (or his or her designee) in consultation with the Office of Sponsored Research, the Office of Technology Licensing (OTL) and the Legal Office. For academic and research issues, the Dean of Research is the Provost's designee.

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    2. Licensing and Income Sharing

    A. Licensing

    OTL seeks the most effective means of technology transfer for public use and benefit and, toward that end, handles the evaluation, marketing, negotiations, and licensing of University-owned inventions or copyrightable materials with commercial potential. Computer databases, software and firmware, and other copyrightable works owned by the University, are licensed through OTL. Exceptions to this procedure must be approved in advance by the Dean of Research.

    B. Royalty Distribution

    Royalties will normally be allocated in accordance with the University's policy on Inventions, Patents, and Licensing. If copyright protection alone is claimed, royalties normally will be allocated in a similar manner, with the "inventor's share" allocated among individuals identified by the investigator (or department head if not under a sponsored agreement), based on their relative contributions to the work. Where royalty distribution to individuals would be impracticable or inequitable (for example, when the copyrightable material has been developed as a laboratory project, or where individual royalty distribution could distort academic priorities), the "inventor's share" may be allocated to a research or educational account in the laboratory where the copyrightable material was developed. Such determination will be made on a case-by-case basis by the Office of Technology Licensing after consultation with the PI or department head, and is subject to the approval of the Dean of Research.

    C. Assignments

    No assignment, license or other agreement may be entered into or will be considered valid with respect to copyrighted works owned by the University except by an official specifically authorized to do so.

    Question regarding licensing and royalty-sharing should be addressed to the Office of Technology Licensing.

    The following notice should be placed on University-owned materials in order to protect the copyright:
 Copyright © [year] The Board of Trustees of The Leland Stanford Junior University. All Rights Reserved.

 No other institutional or departmental name is to be used in the copyright notice, although the name and address of the department to which readers can direct inquiries may be listed below the copyright notice. The date in the notice should be the year in which the work is first published, i.e. distributed to the public or any sizable audience.
Additionally, works may be registered with the United States Copyright Office using its official forms. Forms may be obtained from the Office of Technology Licensing, to which questions concerning copyright notices and registration also may be addressed.

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    Each department is responsible for getting a Patent and Copyright Agreement (SU-18) signed, normally at the time of the individual's initial association with Stanford.

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    5. Copying of Works Owned by Others

    Members of the University community are cautioned to observe the rights of other copyright owners. Contact the Provost's Office or the Legal Office for University policies pertaining to copying for classroom use. Policies regarding copying for library purposes may be obtained from the Office of the Director of Libraries.

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Contracts and grants frequently contain complex provisions relating to copyright, rights in data, royalties, publication and various categories of material including proprietary data, computer software, licenses, etc. Questions regarding the specific terms and conditions of individual contracts and grants, or regarding rules, regulations and statutes applicable to the various government agencies, should be addressed to the University's Office of Sponsored Research.

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    7. General Advice and Assistance

    The Office of Sponsored Research , the Office of Technology Licensing, the Office of the Dean of Research and the Legal Office are available to advise on questions arising under this policy , and to assist with the negotiation and interpretation of the provisions of proposed formal agreements with third parties, as described earlier in the sections.

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    9.4 Tangible Research Property

    Establishes Stanford policy for ownership and distribution of tangible property resulting as a product or by-product of research activities.

    Contact

    Karin H Immergluck

    Executive Director

    Office of Technology Licensing (OTL)

    2:(650) 723-0651

    1. Introduction

    The following policy and procedures are directed toward the administration and distribution of Tangible Research Property (TRP), which is owned and/or controlled by Stanford. The policy and procedures are subject to Stanford's contractual obligations and are to be interpreted and applied consistent with and complementary to Stanford's other policies affecting the administration of tangible properties

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    2. Definition of Tangible Research Property (TRP)

    TRP is defined for purposes of this Policy as tangible (or corporeal) items produced in the course of research projects supported by Stanford or by external sponsors. TRP includes such items as: biological materials, engineering drawings, computer software, integrated circuit chips, computer databases, prototype devices, circuit diagrams, equipment.


    TRP is separate and distinct from intangible (or intellectual) property such as inventions, patents, copyright and trademarks which are subject to other policies and guidelines (see RPH on Inventions, Patents and Licensing and Copyright Policy). Individual items of TRP may be associated with one or more intangible properties such as copyright or patents.

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    3. Ownership of TRP

    TRP normally is either owned by Stanford or is subject to the ownership and other provisions of contracts and grants. For example, items such as microorganisms produced under a government grant or contract usually belong to Stanford as expendable property, subject to the terms and conditions of the grant or contract. Equipment which is fabricated at Stanford for subsequent off-campus use by a research sponsor (e.g., an instrument for a space satellite fabricated at Stanford under contract with NASA) is usually owned exclusively by the sponsor.

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    4. Control of TRP

    A. Freedom of Access

    The University's Openness in Research Guidelines, adopted by the Senate in 1969, state:

    
"...that the principle of openness in research - the principle of freedom of access by all interested persons to the underlying data, to the processes, and to the final results of research - is one of overriding importance."



    Consistent with these Guidelines, it is Stanford's policy to promote the prompt and open exchange of TRP and associated research data with scientific colleagues outside the investigator's immediate laboratory.

    B. Control Responsibilities

    It is the responsibility of the PI (or laboratory director or department chairperson, if the TRP is not developed as part of a sponsored research project) to control the development, storage, use, and distribution of TRP made in the course of research activity, subject to provisions of applicable grants or contracts and University policy. Such control includes determining if and when distribution of the TRP is to be made beyond the laboratory for others' scientific use.

    C. Commercial Considerations

    Because TRP may have potential commercial value as well as scientific value, the investigator may wish to make TRP broadly available for others' scientific use by means which do not diminish its value or inhibit its commercial development or public use. Although valid non-commercial reasons may exist for the temporary delay of TRP distribution outside the laboratory for other's scientific use (e.g., safety factors or the need to more fully characterize the TRP prior to distribution, etc.) scientific exchanges should not be inhibited due to potential commercial considerations.

    5. Income From TRP

    A. Recoverable Costs

    TRP may not be sold for profit, although licensing agreements which include provision for royalty income may be negotiated for commercial use of the intangible property rights associated with the TRP (see section C below). When distributing TRP to research colleagues outside the laboratory, costs of the raw materials and handling may be recovered from the recipient, with the income returned to the account which funded those costs.

    B. Contractual Obligations

    If any of the initial costs were funded from sponsored agreements, the Office of Sponsored Research (OSR) should be asked to advise on the contractual obligations regarding distribution of the TRP and disposition of the recovered costs. If any costs are charged for TRP distribution, adequate documentation must be maintained for audit purposes.

    6. Purpose of the TRP Procedures

    The following procedures for identification and distribution of TRP are designed to aid the traditional open distribution and exchange of TRP for research purposes, preserve the potential commercial value of TRP, assist the further development of TRP for public use, and protect the University and its employees from liability claims arising from the use of Stanford TRP by others.

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    7. Identification of TRP

    A. Identification System

    Each item of TRP should have an unambiguous identification code and name sufficient to distinguish it from other similar items developed at Stanford or elsewhere. 


    The Office of Technology Licensing (OTL) should be consulted for assistance in developing appropriate identification systems and for information regarding use of existing University systems (e. g., Biological TRP Registry, Trademark Registry, etc.).

    B. Ownership Marks

    Where applicable (e.g. computer software), each item should also carry the name of the TRP owner and such other marks and legends as may be required to meet Stanford's contractual obligations and administrative needs, including notice of copyright, trademark, government right etc.

    Information regarding identification, marks, and legends required under research contracts and grants can be obtained from the OSR.

    8. Distribution of TRP for Research Purposes

    A. Biological TRP

    1. Transmittal Letter

    Each distribution for non-commercial research purposes should be accompanied by a letter of transmittal which includes the following, or equivalent, wording:

    
"For Stanford's records, please indicate your agreement (1) to accept S- (insert Biological Registry No.) to be used only for non-clinical research by you in your research laboratory, and (2) to not distribute S- to any other individual or entity, by signing and returning a copy of this letter to me."

    2. Precautionary Language

    If there is a possibility of biohazard or other risk associated with the transport, storage or use of a particular TRP, or if the recipient is likely to use the TRP for clinical research, (the Office of the University Counsel should be consulted for advice regarding appropriate precautionary language in the TRP distribution agreement), or the OTL can provide standard TRP distribution forms which contain appropriate precautionary language. (Note: For information about regulations regarding transfer of infectious agents or recombinant DNA material, contact the Office of Environmental Health and Safety.)

    B. Software TRP

    TRP 
Distribution, for research purposes only, of computer software owned by Stanford may be made without restrictions if control of subsequent use by the PI is not desired. For example, a PI may wish recipients to follow a specific research protocol. Any such distribution is subject to the applicable contract or grant provisions and an agreement by the recipient that commercial development of the software is not to be undertaken.

    1. Distribution Agreement 


    If software owned by Stanford has commercial value or if it is considered desirable to control subsequent use, distribution for research purposes must be coordinated with OTL and must be accompanied by an appropriate agreement with the recipient. OTL will arrange for trademark and copyright registration as needed. OTL will also provide wording for the distribution agreement as necessary to preserve commercial value and provide coordination with existing or prospective commercial licensing activities.

    2. Distribution Services

    The Software Distribution Center (SDC), operated by OTL, provides a convenient service for distributing software for research use, charging recipients only the cost of distribution. In addition to attending to any legal and other details, including mailing, etc., SDC also makes arrangements for collecting departmental costs associated with providing software for non-commercial use and returning these to the department. Faculty and staff are encouraged to use this service for all software distribution activities.

    3. Contractual Obligations

    When software results from sponsored research, OSR should be consulted regarding contractual obligations and regulations affecting ownership, disposition of various rights, and restrictions on the distribution and use of TRP and any associated income.

    C. Other Forms of TRP

    Distribution of TRP other than biological products should normally follow the procedures outlined above for the example of computer software.

    9. Distribution of TRP for Commercial Purposes

    A. Distribution Agreement

    If TRP developed by Stanford as a result of research activities is to be distributed to outside users for commercial purposes, the distribution agreement must contain provisions negotiated by OTL covering the terms under which the property may be used, limits on the University's liability for the property or products derived therefrom, and disposition of any royalty income to Stanford from licensing of intangible property rights associated with the use of the tangible property.

    B. Income Distribution

    Distribution of any TRP-related royalty income other than patent royalties will be similar to the patent royalty income distribution policy (see "Inventions, Patents and Licensing," Research Policy Handbook document 5.1) except that the "inventor's share" will normally be distributed to a research account in the laboratory which produced the TRP (subject to any contractual obligations regarding distribution of income). Questions regarding distribution of any royalty income to individuals should be referred to OTL. Any distribution to individuals is subject to prior approval of the Vice Provost and Dean of Research.

    C. Contractual Obligations

    If the TRP results from sponsored research, SPO should be consulted regarding contractual obligations  and regulations affecting ownership, notices, acknowledgements, disposition of various rights, and restrictions on the distribution and use of the TRP and any associated income.

    9.5 Other Intellectual Property: Trademarks, Patents and Proprietary Information

    Establishes University policy for Trade and Service Marks and Proprietary Information.

    Authority

    Stanford Board of Trustees

    Contact

    Karin H Immergluck

    Executive Director

    Office of Technology Licensing (OTL)

    2:(650) 723-0651

    1. Trade and Service Marks

    Trade and service marks are distinctive words or graphic symbols identifying the sources, product, producer, or distributor of goods or services. Trade or service marks relating to goods or services distributed by the University shall be owned by the University. Examples include names and symbols used in conjunction with computer programs or University activities and events. Consult the Office of Technology Licensing for information about registration, protection, and use of marks.

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    2. Patents

    See Stanford Policy on Inventions, Patents, and Licensing, in the Research Policy Handbook.

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    3. Proprietary Information

    Proprietary information arising out of University work (e.g., actual and proposed terms of research agreements, financial arrangements, or confidential business information) shall be owned by the University. "Trade secret" is a legal term referring to any information, whether or not copyrightable or patentable, which is not generally known or accessible, and which gives competitive advantage to its owner. Trade secrets are proprietary information.


    NOTE: All research involving proprietary information owned by others is subject to the University's Policy Guidelines on Openness in Research, as adopted by the Senate of the Academic Council.

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    4. Tangible Research Property

    The University encourages the prompt and open exchange, for other's scholarly use, of software, firmware and biological material resulting from research. See Stanford's policy on Tangible Research Property.

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    10. Non-Faculty Research Appointments

    10.1 Policy and Procedures for Appointment and Promotion: Academic Staff - Research

    Establishes Stanford policy for Academic Staff - Research (AS-R), including provisions for appointment and promotion, and Visiting AS-R. Clarification added in July 1996 regarding exception to search requirements in the case of recent Stanford doctorate or completed postdoctoral study. In Summer 2016, the designation of Research Associate was changed to Research Scientist, Research Engineer, and Research Scholar.

     

    Authority

    Senate of the Academic Council

    1. Introduction

    Academic Staff - Research (AS-R) are Stanford employees hired to work on Stanford research activities as defined below. As Stanford employees, Academic Staff-Research are subject to all policies and procedures related to Stanford employment, and receive staff benefits, as applicable.

    Individuals appointed as adjunct faculty or other non-faculty academic ranks who will be or who become involved in research activities must be appointed to a research staff position for an appropriate level of effort by the faculty member who directs the research.  The research activity for AS-R described below is the guideline for the type of activity that should trigger a research appointment.  Appointments made to fulfill a teaching role may be held as a dual appointment with those of research scientist, research engineer or research scholar, or with senior appointments in these categories, when the individual is involved in both education and research activities.

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    2. Definitions/Roles

    A. Research Scientist, Research Engineer, Research Scholar

    Working in a capacity which ordinarily requires a Ph.D. or its equivalent in research skill and subject knowledge, a Research Scientist, Engineer, or Scholar is involved directly in the execution, and frequently the design, of a Principal Investigator's (PI's) research activities. Their primary purpose is to assist the PI in attaining the goals of the PI's sponsored research projects. AS-R may participate in the preparation of proposals, progress, and final reports, and may be the coauthor or sole author of research results,with agreement of the PI. Although not usually engaged in formal classroom teaching, AS-R frequently assist in the guidance of postdoctoral scholars, graduate and undergraduate students in the laboratory.

    B. Senior Positions: Senior Research Scientist, Senior Research Engineer, Senior Research Scholar

    Individuals whose accomplishments reflect professional achievement and recognition considerably greater than that of a Research Scientist, Research Engineer, or Research Scholar may be appointed as Senior Research Scientist, Senior Research Engineer, or Senior Research Scholar, whichever is most appropriate to the nature of the individual's work.

    
Note: In Spring 1990, the Faculty Senate Committee on the Professoriate changed the designation of Senior Research Associate to Senior Research Scientist, Senior Research Engineer, or Senior Research Scholar.  In Summer 2016, the designation of Research Associate was changed to Research Scientist, Research Engineer, or Research Scholar.

    
Senior Research Scientists, Senior Research Engineers and Senior Research Scholars may serve as Co-investigators in association with a faculty PI on those research projects (and on related applications for support) for which they carry a significant role. Designation of Co-investigator is not an entitlement; it requires the permission of the PI.

     

    3. Procedures for Appointment

    A. Selection and Search Procedures

    As a general rule, an appointment to the AS-R requires a search. Searches are initiated with a written vacancy announcement, such as in relevant professional journals or other publications.

    All searches must engage actively in affirmative action in the search process; steps may include contacting professional colleagues to solicit names of female and minority candidates (as well as others who would bring diversity to the academic staff) and encouraging such candidates to apply, and contacting resources such as female and minority professional organizations and journals so that such groups are alerted to the search.


    The text for the announcement must be sent to the Office of the Vice Provost and Dean of Research. Advertisements and letters announcing vacancies must include a statement such as:


    Stanford is an equal employment opportunity and affirmative action employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stanford welcomes applications from all who would bring additional dimensions to the University's research mission.

    The responsibility for affirmative action aspects of the search process rests primarily with the PI. 


    Exceptions to the search requirement may be permitted if the candidate: (1) has just completed their doctorate or program of postdoctoral study at Stanford and completion of all degree requirements is documented; (2) is uniquely qualified for the particular position; or (3) was previously identified by name on a written research proposal submitted by the PI to an external funding agency.

    B. Criteria for the Appointment to Rank of Research Scientist, Research Engineer, or Research Scholar

    After a candidate has been identified and selected for appointment, a recommendation for appointment form through the Faculty and Academic Staff Appointments (FASA) system must be completed, and approved by the Principal Investigator, Department Chair (or Independent Laboratory, Center or Institute Director), the cognizant School Dean, and the Vice Provost and Dean of Research to insure that:

    • the work to be performed is at the level which ordinarily would require a doctoral degree or equivalent research skill and subject knowledge
    • the qualifications of the candidate have undergone careful scrutiny
    • a serious review has been undertaken of the professional qualifications of a candidate for an AS-R position by others in the field besides the PI
    • University-wide equity is being maintained
    • a thorough affirmative action search has been conducted or, if a search was not conducted, that the requirements for an exception have been met

    Recommendations along with a current Curriculum Vitae must be submitted to the Office of the Vice Provost and Dean of Research prior to the date of anticipated employment. The School Dean's or Laboratory Director's office will be notified of the approved appointment form or if further information or clarification is required prior to approval. Depending on the preference of each School, the Department or School Dean will send written confirmation to the employee indicating the terms, length of employment, identity and duration of funding sources contributing to his or her salary. A copy of this confirmation is sent to the Office of the Vice Provost and Dean of Research.

    C. Criteria and Procedures for the Appointment or Promotion to the Rank of Senior Research Scientist, Senior Research Engineer or Senior Research Scholar

    After a candidate has been identified and selected for appointment to a senior Academic Staff-Research position, a Recommendation for Appointment form through FASA must be completed, approved by the Principal Investigator, the Department Chair (or Independent Laboratory, Center or Institute Director), the cognizant School Dean, and the Vice Provost and Dean of Research, following the same procedure as for AS-R (described in 3.B above).

    In many cases, individuals are promoted to senior positions from the ranks of Research Scientists, Research Engineers, or Research Scholars. For both appointments and promotions to senior AS-R positions, the Principal Investigator is responsible for submitting the following four items of documentation to the Department Chair for use in review of the candidate:

    1. Appointment/Promotion Form
    2. Curriculum Vitae
    3. Written evaluations from three referees outside of Stanford who are in positions to judge the professional competence of the candidate.
    4. Covering memorandum from the Principal Investigator to the Department Chair stating the justification for appointment or promotion to Senior Research Staff.

    Such appointments must follow a formal review process by a departmental or Independent Laboratory, Center or Institute ad hoc appointment committee consisting of at least two Academic Council members in addition to the faculty Principal Investigator, and, if practicable, a senior member of the AS-R. The ad hoc committee shall review the documentation and prepare a written report to the Department Chair regarding the qualifications of the candidate for appointment or promotion.

    Candidates for the senior position will ordinarily have completed a minimum of five years at the Research Scientist, Engineer, or Scholar rank (or will have equivalent experience). 

    Some indicators which may help to evaluate the qualifications of a candidate for the rank of Senior Research Scientist, Senior Research Engineer or Senior Research Scholar are the following:

    1. Professional Activities

    Indications of theoretical sophistication and independent research accomplishment, including recent publications, invited presentations of papers at professional meetings, and appointment to review committees in professional societies.

    2. Research Experience

    The knowledge and ability associated with the rank of Senior Research Scientist, Senior Research Engineer or Senior Research Scholar is unlikely to be acquired in less than five years after completion of the Ph.D. or M.D. degree.

    3. Scope of Responsibility

    In addition to demonstrating depth of knowledge and theoretical understanding which surpasses that generally expected of Research Scientist, Engineer, or Scholar in the field, the candidate for Senior Research Scientist, Senior Research Engineer or Senior Research Scholar should be capable of functioning independently at an advanced level in their field under the overall direction of the Principal Investigator. Senior Research staff characteristically should have supervisory responsibility for technical staff. This might include training, guidance in problem definition, performance evaluation or recommendation on salaries, hiring and termination. They may also participate in grant administration, monitoring expenditures, and the drafting of new proposals.

    4. Evaluation by Others in the Field

    Candidates for the rank of Senior Research Scientist, Senior Research Engineer or Senior Research Scholar should have achieved recognition in the scientific community.

     

    4. Compensation and Terms of Employment

    A. Period of Employment

    A member of the Academic Staff - Research is appointed for a fixed, renewable term of up to five years, contingent on continued programmatic need and funding. Senior Research Scientists, Senior Research Engineers or Senior Research Scholars may be appointed on either a fixed-term or a continuing basis.


    Requests for reappointments of fixed-term appointments must be reviewed at the department level and approved by the School Dean's Office. A written notice of either renewal or non-renewal must be given to the employee at least 90 days in advance of the term end date. The conclusion of a fixed term does not constitute layoff nor is it accompanied by layoff benefits (see discussion below).

    B. Compensation

    Although not subject to salary ranges per se, salaries for Academic Staff-Research are subject to the approval of the cognizant Principal Investigator, Department Chair, School Dean and Vice Provost and Dean of Research for purposes of maintaining University-wide equity. Data indicating the distribution of Stanford salaries for each classification of AS-R are supplied to school deans and Independent Laboratory, Institute, and Center directors. This provides a framework from which to review University-wide salaries to insure parity. 

    Due to the relatively uncertain nature of financial support for sponsored projects which support Academic Staff-Research members' salaries (whether on fixed terms or continuing appointments), AS-R members shall be informed of the duration of all funding sources which materially contribute to their salaries. This information must be included in the employment confirmation letter and, subsequently, made available to the AS-R member by the PI upon request.

    C. Termination

    An AS-R member is entitled to 30 days written notice, but not to layoff benefits or reemployment preference, when terminated for unsatisfactory performance or other just cause. In extreme cases of termination for just cause, advance notice of termination may be waived with the approval of the Office of the Vice Provost and Dean of Research.

    D. Layoffs

    A layoff (as opposed to end of fixed-term appointment or dismissal for just cause) occurs when a position is eliminated as a result of lack of funds or changing programmatic needs prior to the scheduled end of a fixed-term appointment or at any time during a continuing appointment. If a layoff is a result of lack of available financial support, the AS-R member must be given at least 30 days written notice. Selection of the individual(s) to be laid off is a judgment of the Principal Investigator. These individuals are eligible for layoff benefits and reemployment preference.

    Occasionally, a Principal Investigator chooses to change the direction of their research activities in ways that are not commensurate with the skills or research interests of the AS-R member. When this occurs, layoff is considered on programmatic grounds, not due to lack of available financial support. In these cases, the AS-R member shall always be given at least three months written notice of layoff. They are eligible for the same layoff benefits and reemployment preferences as are applicable for other exempt staff.

    E. Additional Compensation

    With approval of their faculty supervisor, full-time members of the academic staff may perform a variety of services for the institution apart from those normally considered to be their own regular job duties. Academic staff members may be assigned these tasks either within their department or for another area within the University. Further, it is understood that academic staff may often be expected to work in excess of 40 hours a week. Because the foregoing situations are considered to fall within normal expectations for these staff, they would not constitute grounds for payment of additional compensation.

    Academic Staff - Research may be eligible for additional compensation when, on a one-time or infrequent basis, they teach in established University programs or University-hosted conferences that: (a) clearly fall outside the boundaries of their regular responsibilities, (b) require a significant amount of time in excess of the normal work schedule and (c) normally provide additional payment to other participants. This exception does not cover appointments to teach regular University courses in degree-granting programs, in which cases salary offsets would be appropriate.

    Examples for which additional compensation might be appropriate include:

    • teaching in the Continuing Studies Programs;
    • teaching in the Stanford Center for Professional Development;
    • teaching in the Vice Provost for Undergraduate Education Programs;
    • teaching in the Postgraduate Medical Education Program;
    • teaching in the Graduate School of Business Executive Education Programs;
    • teaching in a special event, such as a conference.

    An academic staff member who teaches in these Stanford programs must be appointed, where relevant, through the regular appointment process of the program. Their compensation for the activity is limited by the established rates for the particular program. AS-R, employed on a full-time basis, owe their primary commitment of time and intellectual energies to the programs on which they are working. The faculty supervisor is responsible for assuring that this activity does not adversely impact that obligation.

    For activities of the type described above, specific approval for additional compensation is required in advance of the service being performed. Faculty supervisor, the cognizant school Dean and the Vice Provost and Dean of Research must approve all additional compensation involving Academic Staff-Research. Failure to obtain such approval will in all likelihood result in forfeiture of payment.

    5. Right, Privileges and Responsibilities

    A. Academic Staff - Research Members

    Academic Staff - Research members appointed for terms of six months or longer (at 50% time or more) are entitled to staff benefits available to other regular exempt staff, including vacation and sick leave accrual, with some exceptions related to layoff as outlined above and grievance process, see Academic Staff Grievance Procedure in RPH 10.2.

    With approval of their faculty sponsor, members of the Academic Staff may engage in outside consulting activities.  Permission for members of the AS-R to consult, including the reasons for such permission, must be in writing, normally on a prospective basis, by the faculty principal investigator. Principles that govern outside activities and applicable conflicts of commitment and interest policies can be found at RPH 4.4.

    1. Limitations of Academic Staff - Research Positions

    While the highly professional nature of these positions allows PIs to delegate considerable independence and authority to members of the AS-R in support of the PI's research objectives, there are also limitations inherent in these positions. Individuals in the AS-R ranks are not members of the Academic Council; they are not eligible to act as PIs on sponsored projects (Senior Research staff may act as Co-investigators with the permission of the faculty PI, but may not serve as Co-PI); they are not eligible for sabbatical leaves nor in any way are considered to be on a tenure track. Their positions are coterminous with externally-sponsored support and programmatic need. Appointments from the AS-R to the non-tenure line or tenure-line faculty ranks at Stanford may occur, but such promotions are rare and should not be expected as part of an AS-R member's typical path at the University.

     

    6. Visiting Academic Staff - Research

    A. Definitions/ Roles

    Visiting AS-R and Visiting Senior AS-R positions differ from regular AS-R ranks in that the visitor's primary purpose in coming to the University is to collaborate with the Stanford Principal Investigator on research projects of mutual interest, rather than to provide the ongoing staff assistance normally associated with regular AS-R positions. They also differ from Visiting Scholar positions, which are courtesy appointments without Stanford salary support.

     

    B. Procedures for Appointment

    Visiting AS-R or Visiting Senior AS-R appointments may be made for periods not to exceed twelve months for individuals who are permanently employed by another institution at a level at least equivalent to the AS-R at Stanford. If the individual ceases to hold a regular position elsewhere prior to or during the Stanford appointment, they are not eligible to continue as a Visiting AS-R. Rather, the person may be recommended for a regular Academic Staff-Research appointment. Formal searches for the visiting appointments are not required as Stanford does not constitute the primary employment commitment to the individual.

    A recommendation for appointment of Visiting AS-R or Visiting Senior AS-R form, accompanied by a resume of the candidate and applicable visa information, must be completed through FASA and approved by the Principal Investigator, Department Chair or Independent Laboratory, Center or Institute Director, the cognizant School Dean, and the Vice Provost and Dean of Research. 

     

    C. Compensation and Terms of Employment

    Stanford salary support for Visiting AS-R and Visiting Senior AS-R normally is funded from sponsored research projects, typically at a level based on the individual's salary from their home institution. In any event, minimum full-time equivalent salaries for Visiting AS-R and Senior Research staff are established annually by the Office of the Vice Provost and Dean of Research.

    D. Rights, Privileges and Responsibilities

    Visiting AS-R and Visiting Senior AS-R are eligible for staff benefits, including vacation and sick leave, if employed at 50% time or more for an anticipated length of six months or more. Regular staff policies for fixed-term appointments apply except that the Academic Staff Grievance Procedures, rather than the staff procedures, are applicable. University courtesies and privileges commensurate with the visitors' rank at their home institutions may be granted by the Provost on an exception basis.

    10.2 Grievance Procedure: Academic Staff

    Defines grievance procedure for Academic Staff.

    Authority

    Senate of the Academic Council

    Contact

    Office of the Provost: Academic Staff-Teaching

    Office of the Vice Provost and Dean of Research: Academic Staff-Research

    1. Definitions and Coverage

    A. Grievance

    A grievance is a complaint in writing made to an administrative officer of the University concerning a decision, made by a person or group of persons acting in an official University capacity, that directly or adversely affects the grievant as an individual in his or her professional academic capacity. A grievance does not include dissatisfaction with a University policy of general application challenged on the ground that the policy is unfair or inadvisable.

    B. Coverage

    A grievance may be filed and the appeal procedure hereunder may be utilized by any member of the Academic Staff-Teaching or Academic Staff-Research as defined in Chapter 6 of the Stanford University Faculty Handbook and in the Research Policy Handbook.

    2. Grievance Structure

    The Grievance Structure consists of an Administrative Structure.

    The Administrative Structure includes, in order and as applicable, the following administrative officers of the University: head of administrative unit; department chair; dean of school; Provost and President.

    The President shall devise a set of standing rules of procedure which will govern proceedings for the filing and appeal of grievances in the Administrative Structure, provided that:

    1. The set of standing rules of procedure, and any amendments thereof, shall be valid upon promulgation.
    2. The rules shall provide that any communication or material solicited and received with the understanding that it would be kept in confidence shall be kept confidential and shall not be revealed to any person, including the grievant, who was not a party to the confidential communication or material, except that such communication or material may be revealed to any person(s) consulted by the administrative officer for guidance on that grievance.

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    3. Grievance Procedures

    Filing of Grievance

    1. A grievance arising out of a decision at the administrative unit or department level shall be filed with the dean of the school.
    2. A grievance arising out of a decision at the dean's level shall be filed with the Provost.
    3. A grievance arising out of a decision at the Provost's level shall be filed with the President.
    4. A grievance arising out of a decision at the President's level shall be filed with the President. The President shall make a determination on the grievance, and such determination shall be final. The decision of the President, with the reasons therefor, shall be given to the grievant in writing.

    The grievant shall file his or her complaint in writing, setting forth a statement of the decision that constitutes the subject matter of the grievance and all ground(s) on which it is being challenged. The written grievance shall also include the grievant's statement that he or she has made informal efforts to resolve the dispute at each administrative level (including, as applicable, with his or her principal investigator and with the department chair) below the level at which the grievance is filed, and shall describe those efforts in detail.

    The administrative officer with whom the grievance is filed shall consider the grievance. The administrative officer may attempt to resolve the matter informally or make whatever disposition of the grievance he or she deems appropriate. The administrative officer may refer the grievance, or any issue therein, to any person(s) who shall consider the matter and report to the administrative officer as the latter directs. The administrative officer may also, in appropriate cases, remand the grievance to a lower administrative level (including to the original decision maker) for further consideration. The administrative officer shall notify the grievant in writing of the disposition made of the grievance.

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    4. Appeal Procedure

    A grievant who is dissatisfied with the disposition of the grievance by the administrative officer with whom the grievance was filed may appeal the decision in order to each of the higher administrative officers within the Administrative Structure as follows:

    1. For a grievance filed with and decided by the dean, a grievant may appeal the decision in writing to the Provost. The Provost will follow the procedure for appeals set forth below.
    2. For a grievance (or an appeal) filed with and decided by the Provost, a grievant may appeal the decision in writing to the President. The President will follow the procedure for appeals set forth below.
    3. No appeal shall be available for a grievance (or an appeal) filed with the President. (See Section (4) above.)

    The determination by any administrative officer of any grievance appealed to him or her shall be appealable by the grievant to the next higher administrative officer within the Administrative Structure, except that the determination of the President shall be final.

    An appeal shall be made in writing and shall contain the following information:

    • A statement of the decision that constitutes the subject matter of the grievance and all ground(s) on which it is being challenged
    • The names and positions of all administrative officers with whom the grievance has been filed or appealed and a copy of the determination made by each of those administrative officers

    Each administrative officer within the Administrative Structure who considers a grievance appealed to him or her shall make a determination on the matter and shall inform the grievant in writing of the determination.

    The administrative officer may attempt to resolve the matter informally, or refer the appeal, or any issue thereof, to any person(s) who shall consider the matter and report to the administrative officer as the latter directs. The administrative officer may also, in appropriate cases, remand the matter to a lower administrative level (including to the original decision maker) for further consideration.

    In considering a grievance that arises out of a negative decision on appointment, reappointment, or promotion, an administrative officer may consult with the same body, if any, that makes recommendations on decisions involving appointment, reappointment, or promotion.

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    5. Standards for Review and Procedural Matters

    The review of a grievance or of an appeal by the dean, the Provost or the President shall usually be limited to the following considerations:

    1. Were the proper facts and criteria brought to bear on the decision? Were improper or extraneous facts or criteria brought to bear that substantially affected the decision to the detriment of the grievant?
    2. Were there any procedural irregularities that substantially affected the outcome of the matter to the detriment of the grievant?
    3. Given proper facts, criteria, and procedures, was the decision one which a person in the position of the decision maker might reasonably have made?

    Standing rules of procedure, seen below in "Related Items", for the handling of grievances under the Statement on Academic Staff Grievance Procedures, which include time limitations for the filing of grievances and appeals, as well as other procedural matters, are available in the Office of the Academic Secretary, the Office of the Provost and online. Note that a delay in filing a grievance may, taking all circumstances into account, constitute grounds for rejection of the grievance by the administrative officer with whom it is filed. Similarly, appeals should be filed without delay.

    Questions concerning the filing and appeal of grievances should be directed to the Office of the Provost or to the Office of the Vice Provost and Dean of Research.

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    6. Attachment A: Standing Rules of Procedure Governing the Filing and Appeal of Grievances (under the Statement on Academic Staff Grievance Procedures)

    Date: Promulgated December 10, 1975; Amended April 9, 1998

    These Standing Rules of Procedure for grievances brought under the Statement on Academic Staff Grievance Procedures have been devised by the President. They shall apply to the filing and appeal of all grievances pursuant to the Statement.

    These procedures are meant to be invoked only when persistent efforts at informal resolution of significant differences have failed; thereafter, further informal resolution efforts may be undertaken at any stage of the process. The time frames set forth in these rules are guidelines. They may be extended by the relevant administrative officer in his or her discretion for good cause.

    I. FILING OF GRIEVANCE

    1. The grievant shall file his or her grievance in writing, setting forth a statement of the decision that constitutes the subject matter of the grievance, all grounds on which it is being challenged, and all reasons why the grievant believes that the decision was improperly taken. The grievance shall specifically address the matters set forth in the Standards for Review in Section V of the Statement. The written grievance shall include allegations of any and all adverse effects on the grievant, known to the grievant at the time of filing, which arise from the decision being challenged.

    2. The written grievance shall also include the grievant's statement that he or she has made informal efforts to resolve the dispute at each administrative level (including, as applicable, with his or her principal investigator and with the department chair) below the level at which the grievance is filed, and shall describe those efforts in detail. That description shall include the grievant's statement that he or she notified in writing the original decision maker of the grievant's intention to file a grievance, and gave that decision maker 10 days to reconsider the decision.

    3. The grievance shall be filed at the earliest practicable date after the grievant receives notice of the decision that is the subject matter of the grievance and after reasonable efforts have been made at informal resolution. Such filing shall normally be made within 90 days after the grievant receives such notice. A delay in filing a grievance may, taking all circumstances into account, constitute grounds for rejection of the grievance by the administrative officer with whom it is filed.

    II. RESPONSE TO GRIEVANCE

    1. The administrative officer with whom the grievance is filed shall consider the grievance. The administrative officer may attempt further to resolve the matter informally or make whatever disposition of the grievance he or she deems appropriate. The administrative officer may refer the grievance, or any issue therein, to any person(s) who shall consider the matter and report to the administrative officer as the latter directs.

    2. The administrative officer shall inform the grievant in writing of any referral of the matter and shall specify the matters referred, the directions to the person or persons to whom the referral is made (including the time frame within which the person or persons is/are to report back to the administrative officer), and the names of those persons.

    3. Should attempts to resolve the matter informally not be successful, the administrative officer with whom the grievance is filed shall decide the grievance, and shall notify the grievant in writing of the disposition made of the grievance and all grounds for the disposition at the earliest practicable date after the officer's receipt of the grievance.

    4. Normally no more than 60 days should elapse between the filing of a grievance and the disposition by the administrative officer. Unreasonable delay in processing a grievance can in itself be grounds for a grievance. If, because of absence of key persons from the campus or other circumstances or exigencies, the officer decides that prompt disposition is not possible, he or she shall inform the grievant of that fact in writing, giving the grounds therefor and an estimate of when a disposition can be expected.

    III. FILING OF APPEAL

    1. An appeal shall be made in writing and shall contain the following:

      1. A copy of the original grievance, any other documents submitted by the grievant in connection therewith, and copies of any previous appeals and supporting documents.

      2. The names and positions of all administrative officers with whom the grievance was filed or appealed and a copy of the determination made by each of those administrative officers.

      3. A statement of why the reasons for the determination or determinations of the administrative officer(s) who previously heard the matter are not satisfactory to the grievant. This statement should specifically address the matters set forth in the Standards for Review in Section V of the Statement.

    2. The grievant shall file his or her appeal at the earliest practicable date after the grievant's receipt of the determination by the administrative officer with whom the grievance has been filed or appealed. Normally no more than 30 days should elapse between the transmittal of the administrative officer's decision on the grievance and the filing of the appeal. A delay in filing an appeal may, taking all circumstances into account, constitute grounds for rejection of the appeal by the administrative officer with whom it is filed.

    IV. RESPONSE TO APPEAL

    1. The administrative officer may attempt to resolve the matter informally, or refer the appeal, or any issue thereof, to any person(s) who shall consider the matter and report to the administrative officer as the latter directs.

    2. The administrative officer shall inform the grievant in writing of any referral of the matter and shall specify the matters referred, the directions to the person or persons to whom the referral is made (including the time frame within which the person or persons is/are to report back to the administrative officer), and the names of those persons.

    3. The administrative officer to whom the grievance is appealed shall decide the appeal, and shall notify the grievant in writing of the disposition made of the grievance and all grounds for the disposition at the earliest practicable date after the officer's receipt of the appeal.

    4. Normally no more than 60 days should elapse between the filing of the appeal and the disposition by the administrative officer. Unreasonable delay in processing a grievance can in itself be grounds for a grievance. If, because of absence of key persons from the campus or other circumstances or exigencies, the officer judges that prompt disposition is not possible, he or she shall inform the grievant of that fact in writing, giving the grounds therefor and an estimate of when a disposition can be expected.

    V. GRIEVANT'S RIGHT TO ADVISOR

    The grievant shall have a right to be accompanied by a member of the professoriate or the academic staff at Stanford University as his or her advisor in any conference or discussion with the administrative officer hearing the grievance or the appeal, or at any appearance before any person(s) to whom the matter or any issue therein has been referred by the administrative officer. As a general proposition, the role of the advisor is to advise the grievant, not to address the administrative officer or the person(s) to whom the grievance or appeal has been referred.

    VI. CONFIDENTIALITY

    Any communication or material solicited and received with the understanding that it would be kept in confidence shall be kept confidential and shall not be revealed to any person, including the grievant, who was not a party to the confidential communication or material, except that such communication or material may be revealed to any person(s) consulted by the administrative officer for guidance on that grievance.

     

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    10.3 Postdoctoral Scholars

    This document sets forth policies and procedures related to the appointment, roles, requirements and responsibilities of Postdoctoral Scholars at Stanford.

    Contact

    Sofie Kleppner

    Associate Dean for Postdoctoral Affairs

    Office of Postdoctoral Affairs

    (650) 725-5075

    1. Definition

    A Stanford postdoctoral scholar is a non-matriculated trainee, in graduate student status, in residence at Stanford University pursuing advanced studies beyond the doctoral level in preparation for an independent career. Postdoctoral Scholars are appointed for a limited period of time and may participate on Stanford research projects and/or may be supported by external awards or fellowships. In all cases, their appointment at Stanford is for the purpose of advanced studies, research, and training under the mentorship of a Stanford faculty member.

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    2. Terms of Appointment

    Postdoctoral Scholars are appointed on a full-time basis for a minimum of nine months for the primary purpose of receiving advanced research, clinical, and/or academic training at Stanford University.

    
In advance of the initial appointment, the terms and conditions of that appointment should be discussed and agreed upon by the Postdoctoral Scholar and the Faculty mentor(s), e.g., sponsoring faculty. This should include agreement on the anticipated length of appointment, scope of work and training goals, expectation of an annual research progress and mentoring, sources and amount of support, and possibly other details such as plans to submit fellowship applications, office space, lab, and supporting equipment such as computers.

    
A postdoctoral appointment at Stanford brings with it certain defined benefits, including insurance and leave benefits. These defined levels of benefits may not be modified or diminished by individual agreement with the department or the faculty mentor(s)/PI. 


    All Postdoctoral Scholars must be registered at Stanford during every academic quarter of their appointment. Registration entails payment of a quarterly postdoctoral fee by the appointing academic department or school on behalf of the Scholar. 


    If a Postdoctoral Scholar wishes to take courses for credit, which are not required by Stanford, the Scholar is responsible for the payment of any tuition and additional fees.

    A. Eligibility and Term Limits

    Initial appointments are generally restricted to those who have received their Ph.D. within the last three years or their M.D. within the last six years; exceptions to this restriction are permitted in cases when the candidate has been away from research activity after a doctoral degree and wishes to start a training program. 
Individuals are eligible to be in postdoctoral scholar status at Stanford for a period that does not exceed a total of five years for all combined years of institutional research training/activity, at Stanford and elsewhere.  The following periods are not included in such determination:

    • Up to one year spent in postdoctoral research carried out in the same dissertation lab/research group as doctoral work
    • Period of unpaid leaves

    Extensions beyond five years are possible only upon submission of a request to the Office of Postdoctoral Affairs, and after review by a Subcommittee of faculty on postdoctoral term exceptions as described below (see Section 2.G.). All requests for such extensions must be reviewed and approved by the Associate Dean for Postdoctoral Affairs.

    B. Appointment Processing

    Individuals interested in a postdoctoral appointment should make their inquiries directly to the appropriate academic department or faculty member. Faculty members respond to correspondence regarding possible postdoctoral research, to determine whether the area of interest is appropriate for study at Stanford, and whether there is sufficient office/laboratory space and other resources needed to support the Scholar. 


    The sponsoring faculty mentor initiates the offer of appointment to the Scholar, with departmental approval. A standard offer letter is generated by the department, and communicated electronically and either accepted or rejected electronically by the Scholar. Offers of appointment are contingent upon final approval by the Office of Postdoctoral Affairs.

    Departments wishing to appoint a Postdoctoral Scholar must follow the University’s online process and provide complete documents (including visa requests) to the Office of Postdoctoral Affairs as early as possible and no later than two weeks in advance of the proposed start date for the appointment (longer period may be required for international scholars due to visa processing).

    C. Joint Degree Appointees

    In the case of candidates who are pursuing joint/dual MD-PhD degrees where one of the two degrees is conferred first, a postdoctoral appointment on the basis of the conferred degree is possible while the second degree is in progress if the postdoctoral training is unrelated to the ongoing degree in progress.
Individuals who hold doctoral degrees, who are enrolled in a graduate degree program at another institution, and are at Stanford to pursue research activities that are pertinent to their ongoing graduate degree in progress should be appointed as Visiting Student Researchers rather than as postdoctoral scholars. 
In the case of postdoctoral appointees who are pursuing a graduate degree program at Stanford, the dual-status policy, Postdoctoral Scholars in Degree Programs (GAP 5.11), applies.

    D. Full-Time Appointment

    Stanford University maintains that effective and meaningful training for postdoctoral scholars requires full-time commitment by the scholar and the University. As such, postdoctoral scholars at Stanford are appointed in full-time status, or the equivalent of 100% Full Time Equivalent (FTE). Reduction in effort is not allowed in order to offset a funding shortfall, reduce the training expectations, or accommodate inadequate performance. 
However, University policy allows appointment of postdoctoral scholars on a part-time basis in limited circumstances relating to medical and family leave, or as described in the circumstances listed below. The University understands that family- or health-related needs may warrant granting temporary reductions in effort, such as for a new parent, or in the case of trainees undergoing significant medical procedures or treatments, in accordance with the following guidelines:

    • A reduction to a minimum of 50% FTE for new mothers or fathers for up to three months following the return from leave related to the birth or placement (adoption or fostering) of a child.
    • Consistent with applicable laws, in the event of a serious health condition of the scholar or one of their immediate family members, a reduction to a minimum of 50% FTE for scholars for a limited period of time not to exceed 12 weeks, intermittent or taken together, in a one-year period. This provision applies to postdoctoral scholars, regardless of whether they meet the legal eligibility requirements under the California Family Medical Leave Act (FMLA) or the California Family Rights Act (CFRA).
    • A reduction to a limit of 80% FTE in order to facilitate an appointment at the School of Medicine in a 20% Clinical Instructor position. The common configuration for these combined Postdoctoral scholar/clinical instructor appointees are 90/10 or 80/20. A revised offer letter must be made and signed articulating the expectations for both the postdoctoral and clinical portions of the effort and the total compensation.

    If necessary, and as required by applicable federal and state medical leave laws, postdoctoral scholars may elect to request unpaid leave of absence in accordance with the leave policy described in Section 6 below. Requests for temporary reductions in effort are subject to review and approval by the Assistant Dean for Postdoctoral Affairs. Considerations include funding agency restrictions, research program needs and available resources in the lab, and applicable laws. Any reductions in effort may require a signed waiver of certain benefits and privileges.

    E. Appointment Continuation and Extensions/Renewals

    Postdoctoral Scholars are appointed at Stanford for fixed terms, by issuance of re-appointment notifications that may total up to five years. Faculty sponsors may request an extension beyond the five-year total (see sections 2.F and 2.G, below). 
During its term, an appointment is contingent upon satisfactory performance and the existence of funding. At the end of the term and subject to the limits set forth in this policy, the appointment may be eligible for renewal, based on satisfactory performance, the existence of funding, programmatic need and continuing visa eligibility (for international Scholars). International Scholars should note that postdoctoral appointments are not guaranteed to match the length of visa eligibility.

    F. Standard Extensions Beyond the Five-Year Term Limit

    Postdoctoral training programs at Stanford are intended to be limited in duration and to prepare postdoctoral scholars for research careers in academia and elsewhere. Consistent with this philosophy, the university sets a five-year limit on the total term of postdoctoral appointments, at Stanford and elsewhere, in an effort to facilitate such transition. Those who wish to remain in research at Stanford beyond the term limits of a postdoctoral scholar appointment should be moved, as warranted, to more appropriate classifications at the University. 
In the two circumstances listed below, faculty mentors may request an exception to the term limit policy in order to extend the current appointment of a postdoctoral scholar at Stanford beyond five years of total research experience.

    • The Scholar has been offered, and has accepted a position with a defined starting date, and an extension of the Stanford appointment would bridge a short period of time (less than 1 year) to the start of that position.
    • The extension would allow for the completion of a nationally or internationally competitive postdoctoral research fellowship.

    An administrative approval may be granted in these circumstances upon submission of supporting documentation to the Office of Postdoctoral Affairs. Examples of appropriate documentation include: award or job offer letters, rationale from the faculty sponsor outlining the details of the case, and the scholar's curriculum vitae. 
Any other exceptions are rare, as described in Section 2.G, below.

    G. Rare Exceptions to Postdoctoral Eligibility and Term Limits

    In circumstances other than noted in section 2.F above, a faculty mentor may wish to request an initial appointment or an extension of an individual who has been actively researching for five years after the doctoral degree. Such cases require formal review as described below.

    A sixth year of a new appointment or an extension of an existing appointment may be granted upon submission to the Office of Postdoctoral Affairs of:

    • A request from the PI (form available here)
    • A training plan from the scholar (form available here)
    • The scholar's updated curriculum vitae
    • A copy of the PI’s complete IDP training record (available here) If there are gaps in the recorded IDP meetings, an explanation should be provided.

    Scholars who accept a second postdoctoral training position at Stanford in a new field representing a major change in research direction may receive up to six total years of training. In this circumstance, the request will be reviewed by a faculty committee. To grant approval, that committee will review the following:

    • The record of annual Individual Development meetings that is filed with the Office of Postdoctoral Affairs. See IDP policy here.
    • The scholar’s updated  curriculum vitae
    • A clear description by the faculty mentor of the distinctions between the previous and proposed new research fields.

    Other requests for new appointments or extensions of scholars beyond a fifth year of training where none of the criteria noted above, or in Section 2.F, are met will undergo a more detailed review by the faculty committee. In the case of extensions of existing appointments, the following are required:

    • Detailed account of ongoing mentoring by the faculty member of the postdoctoral scholars towards reaching the scholar's research goals, from the first year of appointment at Stanford. Such account may be demonstrated through the submission of the annual mentoring progress meeting notes and summaries.
    • A written description of an agreed-upon transition plan for the postdoctoral scholar and the faculty member to pursue during the extension period
    • Optional: A second letter of support from a faculty member who has been actively mentoring the postdoctoral scholar.

    The committee will consider the merits of the case based on required supporting evidence:

    • Review of the career transition plans including timeline and resources that will be or have been accessed.
    • Review of the postdoctoral scholar's research activity during all years of postdoctoral training.
    • Review of the faculty sponsor's trainee history and outcomes.
    • A rationale outlining the reasons for the appointment or extension in a postdoctoral scholar status – which is a training period – rather than pursuing an Academic Staff Researcher or other staff position.
    • If the scholar has a significant family obligation, the committee will consider it favorably in the extension request.

    The committee formulates a recommendation to the Vice Provost for Graduate Education in each case. The final determination is made by the Vice Provost for Graduate Education.

    H. Early Termination by Appointing Department

    The postdoctoral appointment is contingent upon programmatic need, satisfactory performance, and the existence of funding. There is no guaranteed or implied renewal at the end of the term; the faculty mentor and postdoc should discuss renewal well before the end date, a minimum of 3 months if a visa is required. International postdocs may be eligible for up to five full years of a J-1 visa program, but there is no guarantee that the appointment will be renewed. Subject to the limits set forth in university policy, the appointment may be subject to early termination or non-renewal.

    A postdoctoral appointment may be ended prior to the agreed-upon appointment end date as a result of funding shortfall, change in programmatic need, or lack of sufficient research progress or inadequate performance. Early termination may also be made following a determination that misconduct by the scholar has occurred.

    Where termination is based upon misconduct or cause (including for disclosure or misuse of confidential information, conflict of interest, misuse of University resources, or any other misconduct or acts detrimental to University operations or violating University policy) advance notice of termination may be waived with the approval of the Associate Dean for Postdoctoral Affairs.

    In all cases of possible early termination, the faculty sponsor must contact the department’s postdoctoral administrator, who may also recommend discussion of the case with the Assistant Dean for Postdoctoral Affairs.

    Faculty sponsors should give the postdoc an early termination notice 30-60 days before the early termination date, with a copy to the Associate Dean for Postdoctoral Affairs. In cases of funding shortfall, 90 days’ notice is typical. If the postdoc is on a visa, the faculty sponsor must also provide a written/e-mail notice of the early termination date to the Bechtel International Center.

    Any terminations due to inadequate academic or research progress must follow a process by which progress discussions and written evaluation by the faculty mentor are made. This process must note the specific steps to be taken in order to remedy any deficiencies, and the possibility of early termination if those deficiencies remain by a specific date. Such process takes place several weeks/months in advance of taking this early termination action.

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    3. Visas for International Postdoctoral Scholars

    Stanford University appoints international Postdoctoral Scholars in a J-1 (Research Scholar) status. J-1 Scholars who are transferring from another appointment must maintain continuous active status (breaks in J-1 program eligibility are not permitted). When appointing an international Postdoctoral Scholar, the department must request a visa through the Stanford's International Center (Bechtel). Visa requests may be approved only in conjunction with the review of an appointment request to the Office of Postdoctoral Affairs. 

    
In the event that an international Scholar is approved for an H-1B (or other employment) visa status, those Scholar must be paid salary. See below, Attachment B: Policy on H-1B (and other employment visas) for Postdoctoral Scholars at Stanford University .

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    4. Levels and Sources of Financial Support

    Postdoctoral Scholars must be supported either by Stanford grants and contracts, training grants, departmental or School fellowship funds, or external fellowships, or by a combination of these sources. Postdoctoral Scholars may not be self-supporting. Benefits for Postdoctoral Scholars are defined in Attachment D, see below. 

    All Postdoctoral Scholars, regardless of their source of funding, must be paid at least the minimum level based on years of experience established annually by Stanford University at the time of the appointment, and on October 1 of each subsequent year. A school may also establish a higher minimum salary level for Postdoctoral Scholars paid within that school.


    Postdoctoral scholars appointed in the School of Medicine in standard or advanced clinical training programs must be paid based on established Stanford Hospital and Clinics (SHC) Postgraduate year (PGY) levels in effect and in agreement with SHC Graduate Medical Education requirements.


    Funding is not limited by the university's academic calendar, and may start and stop on the appointment start and end dates as established by the department. All financial support for Postdoctoral Scholars, whether paid as salary or as stipends, must be entered and recorded through Stanford's Graduate Financial Support (GFS) System.

    A. Appointment on Sponsored Projects

    Payments from Stanford research contracts and grants, or from other sources where services by the scholar are rendered in return for wages, such as on-call duty, will be processed in the form of assistantship appointments in the university's GFS system. Salary payments to Postdoctoral Scholars are made through the University Payroll Office where appropriate taxes will be withheld and the negotiated fringe benefit rate will be applied.See below in Section 6.

    If a Postdoctoral Scholar is receiving salary for less than 50% FTE (for example, if most of the Scholar's support is in the form of fellowship stipends, with supplemental salary), the salary will be charged the "contingent" fringe benefit rate.

    B. Fellowship Support

    A Postdoctoral Fellowship is a competitive award of financial support to an individual Postdoctoral Scholar, providing a stipend and, in some cases, Stanford registration fees or other expenses. Although Postdoctoral Fellowships may be awarded on the basis of a proposed research program, they are not awarded to accomplish a specific statement of work, and they do not lead to an employer-employee relationship. Postdoctoral Fellowships are awarded on a merit basis to assist a Scholar in his or her professional training and development.


    Stipend support may also be provided from department funds, gift accounts, and school fellowships where available, as well as from training grants and other external sources, where the financial assistance is not being provided as salary for work performed.


    Postdoctoral Fellowships may not be awarded to international Scholars on an H-1B (employment) visa. Individual Postdoctoral Fellowships may specify other restrictions related to citizenship. Scholars on an H-1B visa may apply for fellowship support, but, if awarded, they will not be able to accept the funding without changing their visa status.

    
Applications for postdoctoral fellowships are processed in the same manner as sponsored projects, i.e., applications must be routed and approved through either the Office of Sponsored Research (OSR) or, in the School of Medicine, to the Research Management Group (RMG). Applications must be accompanied by a signed Proposal Development and Routing Form (PDRF) and should be submitted to either OSR or RMG at least three days before the proposal is due at the funding agency.

    See below in Related Items: Checklist 
for Determining Whether is a Postdoctoral Fellowship or a Sponsored Project.

    If a Postdoctoral Scholar is receiving salary for less than 50%, or is completely funded through fellowship support, the following sequence applies to determine the appropriate method of paying for the Scholar's insurance benefits:

    • If the Scholar is supported by a fellowship or an institutional training grant which provides funds to pay for the recipient's benefits, then those funds should be used for that purpose. For example, the NIH NRSA awards and training grants include an "institutional allowance" to be used to pay additional expenses, including health insurance, on behalf of the recipient of the award. Those funds may be used to pay the cost of benefits for Postdoctoral Scholars.
    • If no fellowship or training grant funds are available to pay the cost of a Scholar's benefits, then the cost must be borne by a departmental or other unrestricted account. Under no circumstances may the costs of the benefits be directly charged to sponsored projects.

    Fellowship applications will be processed only for individuals with approved Postdoctoral appointments. If the Scholar has not yet arrived and begun the appointment, a copy of the offer letter must accompany a fellowship application

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    5. Eligibility to Work Regulations: I-9 Requirement

    Postdoctoral Scholars, regardless of citizenship, may not receive salary without a valid I-9 Form. A valid I-9 form is required by the Immigration Reform Control Act of 1987.
 Support from a fellowship or training grant does not require an I-9 Form. Other forms may be required, particularly for international Scholars.

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    6. State and Federal Tax Compliance

    All Postdoctoral Scholars must have a Social Security number on file with Stanford.  All funds received by Postdoctoral Scholars, except from foreign sources to non-resident aliens as noted below, are subject to U.S. federal income tax. Reimbursement for travel expenses incurred to support the Scholar's education (e.g., to attend a conference as a student) may be reportable income. 

    Note: Income from a foreign source going to a non-resident alien is not taxable. Income from a foreign source going to a U.S. citizen or to a resident alien is subject to U.S. tax.


    A. Payments from Stanford Research Contracts and Grants

    Payments from Stanford research contracts and grants will be subject to withholding (a W-4 form should be filed at Payroll). This applies to Postdoctoral Scholars who are U.S. citizens and those who are resident or non-resident aliens. Foreign citizens from countries which have a tax treaty with the United States may qualify under that treaty by filing a Form 8233 prior to receipt of their first salary payment.

    B. Stipend Payments

    Stipend payments (from fellowship funds or training grants) for Postdoctoral Scholars who are US citizens or resident aliens are not subject to withholding. These Scholars will pay quarterly estimated taxes via the IRS Form 1040-ES and California Form 540-ES. Any fellowship stipends to foreign citizens (except from a foreign source going to a non-resident alien, as noted above) will be withheld for tax at the rate of 14% unless they are a qualifying resident of a country which has a tax treaty with the U.S. All non-resident aliens that qualify under such treaties must file a Form W-8 BEN with the Payroll Office prior to the first stipend payment if they wish to claim exemption. 


    Note that rules and policies will be modified as needed to accommodate changes in the tax laws. Contact Stanford University Payroll Office for additional information regarding taxes.

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    7. Registration Fees

    Each academic quarter, a postdoctoral registration fee will be charged by Stanford University and is paid on behalf of the Postdoctoral Scholar. This fee may be charged directly to a grant or contract from which the Scholar is being paid, or to a Fellowship supporting the Scholar. Where neither of these funding sources is available, the fee will be paid by the faculty sponsor/department in which the Scholar is appoin