Policy on Conflict of Interest and Conflict of Commitment

I.  Policy Statement

Stanford University is an institution of public trust. Stanford Personnel (Faculty, Staff, and Postdoctoral scholars) must conduct their affairs in ways that will not compromise the integrity of the University or that trust.

Personnel owe their primary professional allegiance to Stanford University, and their primary commitments of time and intellectual energy shall be to the educational, research, clinical, and service programs of the University in support of the University's mission. 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.

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; such conflicts of commitment usually involve issues of time allocation.  A conflict of interest occurs when there is a divergence between an individual’s private interests and professional obligations to the University, such that individual's professional actions or decisions are or may be perceived to be determined by considerations of personal gain.  To avoid such conflicts, Personnel should avoid any engagement, interaction, or use of University resources that creates or appears to create a Conflict of Interest or Conflict of Commitment, as defined in this policy.

Good judgment is essential.  No list of rules can provide direction for all the varied circumstances that may arise. If a situation raises questions of Conflict of Interest or Conflict of Commitment, Personnel should discuss the situation with the Designated Official in their School, their School Dean or decanally designated faculty member, or the Designated Official in the Office of the Vice Provost and Dean of Research.

II.      Purpose

This policy establishes standards and requirements regarding Outside Professional Activities and Financial Interests that are designed to protect Personnel, Stanford's reputation, and financial well-being and meet legal obligations.  This policy outlines requirements for disclosure of Outside Professional Activities and Financial Interests; provides the framework for managing, reducing, or eliminating such conflicts; endeavors to protect the interests of Students, Postdoctoral Scholars and others whose work depends on Faculty and Staff direction; and describes situations that require prior approval or are prohibited.

III.    Applicability

This policy applies to all Stanford Personnel, as defined herein. All Personnel should become familiar with and abide by the provisions of this policy.

IV.    Definitions

Conflict of Commitment.  A Conflict of Commitment usually involves an issue of time allocation that creates a risk of divided loyalty between Stanford and an outside entity. At Stanford, a conflict of commitment arises when Personnel engage in Outside Professional Activities that exceed the permitted limits as defined in RPH 4.3 Consulting and Other Outside Professional Activities by Members of the Academic Council and University Medical Line Faculty (normally thirteen days per quarter) or when Personnel's Outside Professional Activities, paid or unpaid, interfere with their professional obligation and commitment to Stanford.

Conflict of Interest.  A Conflict of Interest arises when an individual's financial, professional, or other personal interests may directly or indirectly affect - or have the appearance of affecting -the individual's professional judgment in exercising Stanford Responsibilities.

Consulting.  Consulting is an Outside Professional Activity related to Personnel’s field or discipline where there is a fee-for-service or equivalent relationship with a third party, and Personnel act as an independent contractor (hereafter referred to as Consultant).  There are many types of consulting relationships, and the precise form may vary. However, in general, when consulting, Personnel agree to use their professional capabilities to further the agenda of a third party in return for an immediate or prospective gain. See RPH 4.3 Consulting and Other Outside Professional Activities by Members of the Academic Council and University Medical Line Faculty for more details on Consulting.

Designated Official.  The Designated Official is appointed by each Stanford school Dean to implement this policy, including School Procedures.  A Designated Official is also appointed by the Vice Provost and Dean of Research (VPDoR) to implement this policy for the units under the VPDoR’s oversight.

Financial Conflict of Interest (FCOI). An FCOI is a form of Conflict of Interest regulated by some funding agencies as defined in RPH 4.2 Federal Requirements Regarding Financial Disclosures and Agency Notifications.   

Financial Interest. A Financial Interest exists when Personnel (or their spouse/domestic partner or dependent child) have a financial relationship with an outside entity that involves anything of monetary value, whether or not such value is readily ascertainable.  A Financial Interest does not include:

1. Salary, royalties, or other remuneration paid by Stanford or its affiliated hospitals, medical centers, or research institutes to Personnel if they are currently employed or otherwise appointed by Stanford, including intellectual property rights assigned to Stanford and agreements to share in royalties related to such rights.
2. Income from or value of investment vehicles, such as mutual funds and retirement accounts, if Personnel does not directly control the investment decisions made in those vehicles. 
3. Income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency in the United States, or by a United States public or non-profit institution of higher education (as defined at 20 USC 1001(a)) or its affiliated hospital, medical center or research institute.
4. Income from service on advisory committees or review panels for a federal, state, or local government agency in the United States, or a United States institution of higher education (as defined at 20 USC 1001(a)) or its affiliated hospital, medical center, or research institute.

It is important to note that federal agencies may define a financial interest or a significant financial interest differently from the above.  Investigators should ensure they are familiar with these definitions, as applicable.  Additional federal sponsor requirements can be found in RPH 4.2 Federal Requirements Regarding Financial Disclosures and Agency Notifications.

Investigator.  An Investigator is anyone named as a principal investigator, co-investigator, or senior/key personnel on a sponsored award.  Investigators are subject to this policy and  RPH 4.2 Federal Requirements Regarding Financial Disclosures and Agency Notifications, as applicable.  

Outside Professional Activity.  When Personnel undertake an activity at an outside entity, and the activity relates to their Stanford Responsibilities but is not part of their Stanford Responsibilities, the activity is an Outside Professional Activity. Outside Professional Activities include Consulting and Professional Services.  These activities may be paid or unpaid, part-time or full-time, voluntary relationships, positions, or appointments at any entity other than Stanford, including for-profit, not-for-profit, governmental, domestic or international organizations.  These activities do not include activities undertaken for, with, or at Stanford University, its affiliated hospitals, clinics, or research institutes.  (See RPH 4.3 Consulting and Other Outside Professional Activities by Members of the Academic Council and University Medical Line Faculty for additional examples of Outside Professional Activities.)

Personnel. Personnel refers to people covered under this policy, including:

1. Faculty – including all Academic Council members and University Medical Line Faculty.
2. Staff – including all Full-time or part-time Academic, Teaching, and Research Staff, and all Clinical Educators.
3. Postdoctoral Scholars –full-time trainees in residence, pursuing advanced studies beyond the doctoral level in preparation for an independent career.

Professional Service. Professional Service is a form of Outside Professional Activity that both is remunerated by no more than a modest honorarium or equivalent and involves service to:

1. United States (US) national commissions, US governmental agencies and boards; peer review panels and speaking engagements for agencies or state and local governmental entities within the US.
2. US based philanthropic organizations or charities, US professional societies, visiting committees or advisory groups to other US universities, and analogous domestic bodies.

Because professional service activities are not undertaken for personal financial gain, they do not fall within the definition of Consulting under Stanford policy.

Publication. Publication and scholarly works as defined in RPH 4.3 Consulting and Other Outside Professional Activities by Members of the Academic Council and University Medical Line Faculty for additional examples of Outside Professional Activities.

Related Entity. A Related Entity is any domestic or international, public or private, for-profit, non-profit or governmental organization at which Personnel have Outside Professional Activities, or in which Personnel or their spouse, domestic partner, or dependent children, hold a Financial Interest related to Personnel’s Stanford Responsibilities.

School Procedures.  School Procedures refer to the written school-based procedures for evaluating and managing Conflicts of Interest and Conflicts of Commitment, including procedures for disclosing activities, reviewing and approving activities, and other related guidance for Personnel from local departments and programs. [FUTURE Hyperlink to School Procedures Webpage]

Stanford Responsibilities.  Stanford Responsibilities are Personnel's professional responsibilities at Stanford, including research and other scholarly activities, clinical care activities, teaching or educational activities, and administrative activities. The precise nature of Personnel’s responsibilities vary and are specified by schools and departments.  Stanford Responsibilities are usually performed at Stanford but sometimes involve work in other places (e.g., field work, archival research at an external institution, invited lectures, dissemination of research findings.)

Stanford Rider. The Stanford Rider is the “Stanford Required Addendum to Consulting or Related Agreement”, which is provided as an Addendum to this Policy.  The Stanford Rider must be provided to the outside entity when Personnel enter into agreements to perform certain Outside Professional Activities or other collaboration agreements.

Students.  Students are full-time or part-time, undergraduate and graduate students, and other trainees.

V. Roles and Responsibilities

A. Personnel

All Personnel should conduct their affairs so as to avoid or minimize conflicts of interest, and must respond appropriately when conflicts arise.  Personnel are required to disclose all Financial Interests, including those of their spouses and dependent children, and Outside Professional Activities (excluding Professional Services) that could reasonably appear to be related to their Stanford Responsibilities. Details of these disclosure obligations are specified in section VI(B), below. Personnel may need to seek prior written approval from their Designated Official before engaging in certain Outside Professional Activities, in accordance with this policy and School Procedures.  Additionally, Personnel who enter agreements to perform certain Outside Professional Activities must provide to the outside entity the Stanford Required Addendum to Consulting or Related Agreement (Stanford Rider). Copies of these agreements must be provided to Designated Officials upon request. Personnel who have a Conflict of Interest or Conflict of Commitment must work with their Designated Official and follow the management plan requirements as set forth by the Dean to ensure that the conflict is managed and monitored or eliminated for as long as the conflict exists.

B. Dean

Each Stanford School is responsible for the oversight of the Conflict of Interest and Conflict of Commitment program for its Personnel.  Deans interpret, educate, and define processes for oversight, management, and monitoring of conflicts, as required by the policy.  Deans must ensure that their School develops School Procedures to facilitate implementation of the policy.  School Procedures may be more but not less restrictive than Stanford policy.  The Dean is also responsible for appointing and consulting with the School’s Designated Official, assisting in determining appropriate management strategies, and for monitoring the management of conflicts. 

A School may establish its own internal conflict of interest review committee to assist with the Designated Official responsibilities set forth below.  With the approval of the VPDoR, Deans may elect to delegate reviews of Outside Professional Activity disclosures and the creation of management plans to the VPDoR's Designated Official. If a Dean so elects, the Dean will provide appropriate resources for accepting the delegation and provide the names of faculty representatives to be considered for appointment by the VPDoR to a conflict of interest review committee convened by the VPDoR (VPDoR Committee).

Where a conflict involves Stanford’s reporting obligations to an external entity, the School is responsible for notifying the VPDoR and providing the information needed to enable the filing of any required reports with the external entity.

C. Designated Official

Designated Officials are responsible for implementing School Procedures; providing guidelines and resources for disclosure review; approving or denying requests for Outside Professional Activities; reviewing disclosures of Financial Interests and Outside Professional Activities to determine whether conflicts exist, and developing management plans that reduce, eliminate, or manage any identified conflicts. Designated Officials are also responsible for assisting Personnel in complying with this policy.

D. Vice Provost and Dean of Research

The VPDoR is responsible for maintaining this Conflict of Commitment and Conflict of Interest Policy in adherence with applicable laws and regulations.  The VPDoR supports the Deans by providing interpretation, education, and systems to enable reporting, oversight, and management of Conflicts of Interest and Commitment, as required by this policy.  The VPDoR is responsible for reviewing and approving School Procedures for implementing this policy, consulting with School Deans to determine appropriate strategies for managing conflict situations and reporting annually to the Committee on Research on the effectiveness of the policy. 

The VPDoR is responsible for appointing a Designated Official to review the Provost and President disclosures, School Dean disclosures, disclosures from Personnel in units that report to VPDoR, and disclosures Schools elect to have managed by the VPDoR. The VPDoR hears appeals of decisions made by Schools in relation to Conflicts of Interest and Commitment. The VPDoR also ensures that reporting of Financial Conflicts of Interest to external entities and sponsors occurs as needed.

The VPDoR may form a conflict of interest review committee, which shall be comprised of faculty representatives from Schools that have opted to use this committee.  This committee shall review Outside Professional Activities and Financial Interests, assess potential conflicts, and recommend appropriate actions to eliminate, reduce or manage conflicts.

E. Designated Official for the VPDoR

VPDoR’s Designated Official implements, manages, and supports the University's Conflict of Interest and Conflict of Commitment program and associated software systems; regularly reviews, maintains, and revises this policy; acts as a subject matter expert supporting the School Designated Officials; provides regular education to the Schools; coordinates the VPDoR's approval process for reviewing and approving School Procedures for implementation of this policy; and will serve as the administrator of a VPDoR Committee, should one be formed.

F. Conflict of Interest Committees

A conflict of interest committee may be established by a School (School Committee) or by the VPDoR (VPDoR Committee).  The role of these committees is to assist Designated Officials by reviewing Outside Professional Activities and Financial Interests, identifying potential Conflicts of Interest, determining when a conflict exists, and recommending appropriate actions to eliminate, reduce, or manage such conflicts. The School Committee performs this responsibility for a particular School.  The VPDoR Committee may perform this function for one or more Schools, in accordance with requests to do so by the relevant School Dean.

VI.Policy Implementation

A. Prior Approvals for Outside Professional Activities

Personnel must request prior approval for the following paid or unpaid Outside Professional Activities:

1. Employment at any outside entity, including during leave periods, where the Personnel’s responsibilities may be similar to their Stanford Responsibilities.
2. Appointment or affiliation at any outside entity where Personnel will undertake activities similar to their Stanford Responsibilities.
3. Formation of a new entity, or acquisition of an ownership interest of 5% or more either in an outside entity related to Personnel’s Stanford Responsibilities or in an entity that licenses Stanford intellectual property.
4. Service on the board of directors, science advisory board, or other board of an outside entity, unless such service constitutes Professional Service.
5. For Faculty, Consulting activities that substantially overlap with Stanford Responsibilities (e.g., outside teaching commitments, same or similar research. activities); for Academic Staff and Other Teaching Staff, all Consulting activities.
6. Participation in a foreign government-sponsored talent program
7. Other activities specified in School Procedures as requiring prior approval

Requests for prior approval must include details of the proposed Outside Professional Activity and describe measures to ensure the Outside Professional Activity will not adversely impact Personnel’s Stanford Responsibilities or subject the University to financial or reputational risk. All relevant approvals must be obtained prior to the commencement of any Outside Professional Activity.

Requests from Staff for prior approval to undertake Outside Professional Activities, including Professional Service, should be routed first through the appropriate supervisor or the principal investigator on their research.  Requests that do not involve Professional Service should then be routed for approval to the relevant department/program chair, dean, or director of the library, in accordance with School Procedures.  The Designated Official has final approval authority.  

Requests from Postdoctoral Scholars for prior approval to undertake Outside Professional Activities, including Professional Service, should be routed first through the appropriate Faculty advisor.  Requests that do not involve Professional Service should then be routed to the Designated Official, who has final approval authority.  See RPH 10.6 Relationships Between Students (Including Postdoctoral Scholars) and Outside Entities.

If final approval is granted, Personnel and the Designated Official may develop an appropriate management plan outlining the details of the relationship, providing an analysis of how the activity relates to Personnel’s Stanford Responsibilities and specifying the appropriate steps to implement and maintain the plan.

Personnel must ensure that the Stanford Rider is provided in all Consulting agreements with an outside entity.  Upon request, Personnel must provide copies of such agreements to Designated Officials.

B. Disclosure of Outside Relationships

Personnel should err on the side of disclosure if there is any doubt related to disclosing a Financial Interest or an Outside Professional Activity. Disclosure protects both Stanford and its Personnel.

Individual schools, deans, Designated Officials, and the VPDoR’s Designated Official may request additional information or disclosure from Personnel, as needed, to evaluate Financial Interests and Outside Professional Activities for conflicts.

On an annual basis, and at any time when a situation that requires disclosure occurs, Personnel must certify to their School Deans their compliance with Stanford's policies related to Conflict of Commitment and Conflict of Interest.

1. Faculty and Investigators

All Faculty, as well as Staff and Postdoctoral Scholars who are Investigators, must disclose their Outside Professional Activities (excluding Professional Service) and all Financial Interests, including the Financial Interests of their spouse/domestic partner or dependent children, that would reasonably appear to be related to their Stanford responsibilities. Such disclosures must be made through the Outside Professional Activities Reporting Dashboard (OPACS) at the following times:

• upon hire,
• at least every 12 months,
• within 30 days of acquiring or becoming aware of a new Financial Interest, 
• before beginning a new Outside Professional Activity that requires prior approval, pursuant to this policy,
• within 30 days of a significant change in interests in or activities for an already reported Outside Professional Activity or Financial Interest.

Faculty and Investigators may need to file additional disclosures to Stanford and to sponsors, particularly federal sponsors (e.g., RPH 4.2).

2. Staff and Postdoctoral Scholars

Staff and Postdoctoral Scholars who are not Investigators must disclose their Financial Interests and Outside Professional Activities, according to processes defined by School Procedures.​​​​​

3. Transactional Disclosures

Personnel must disclose any Outside Professional Activities or Financial Interests that relate to sponsored awards, gifts, technology licensing arrangements, materials transfers, collaboration agreements, animal or human subject research, stem cell transfer research, or specific procurements from a Related Entity (e.g., sole-source procurements), or any other transactions related to Personnel’s Stanford Responsibilities     ​​​​​​

4. Disclosure of Outside Professional Activities with International Entities

Notwithstanding rules and requirements related to Professional Services as stated in this policy, Faculty and Investigators must disclose Outside Professional Activities -- paid and unpaid -- related to and Financial Interests in any international entity (that is, any non-U.S. entity), including but not limited to international institutions of higher education (private or public) and the government of another country (including local, provincial, state, parastatal organizations, and any other quasi-governmental organization).

This disclosure requirement does not apply if the activity meets all of the following three criteria: (1) is clearly part of the Stanford Responsibilities of the Faculty or Investigator, (2) is “one off” or ad hoc in nature (e.g., visiting lecture, review of student paper), and (3) does not result in receipt of resources or compensation (monetary or in-kind).

5. Disclosures Associated with Visiting Scholars

At the time of requesting an appointment for Visiting Scholars (faculty or other qualified individuals, appointed or employed at another institution, who are invited by a Stanford faculty member and formally appointed to visit Stanford for an extended period), Faculty must disclose any Outside Professional Activity or Financial Interest they have in relation to the home institution of the Visiting Scholar.  

Visiting Scholars who are expected to be supported by or contribute to a sponsored program, or whose appointment is related to a Transactional Disclosure, may be required to make disclosures. See RPH 10.5 Visiting Scholars.

C. Disclosure Review

Designated Officials will review disclosures and determine whether the Outside Professional Activity or Financial Interest is related to Personnel's Stanford Responsibilities or presents an actual or perceived Conflict of Interest or Conflict of Commitment under this policy.

When a potential conflict involves Personnel from more than one School, or when Personnel hold an appointment in more than one School, the Designated Officials from the relevant Schools will coordinate on the review and determination of conflicts.  At the discretion of the School Deans, disclosures may also be shared with and reviewed by Department chairs, school-based committees, and others.

Outside Professional Activities and Financial Interests that may be related to Personnel's Stanford Responsibilities will be further reviewed to determine if those activities or interests could directly and significantly impact or influence those responsibilities. If a conflict exists, it will need to be eliminated, reduced, or managed. The School Dean or the VPDoR has responsibility for ensuring these actions occur.

D. Relationships and Transactions with Related Entities

Personnel may not engage in any of the following activities with a Related Entity:

1. Negotiate with Stanford on behalf of the Related Entity or negotiate with the Related Entity on behalf of Stanford.
2. Receive gifts, industrial affiliation memberships, or sponsored research funding from a Related Entity (except as provided in this policy, VI.F.3 “Integrity and Prevention of Bias in Research and Scholarly Activities”).
3. Involve Stanford employees in activities at a Related Entity or enable Related Entity’s personnel to be affiliated with the University.
4. Involve Related Entity’s personnel in Stanford research, teaching, or other Stanford Responsibilities.
5. Involve junior faculty that they mentor in Personnel’s activities with a Related Entity.
6. Use Stanford facilities for a Related Entity’s purposes.
7. Undertake human subjects research as that is expected to affect a Related Entity's financial position.
8. Supervise investigators on human subject research when studies could significantly impact a Related Entity.
9. Select a Related Entity as a Stanford contractor, subcontractor, consultant or vendor.
10. Promote the use of products or services of a Related Entity.

Personnel may not involve current Students, Postdoctoral Scholars, or other trainees in a Related Entity’s activities.  

• If a Student seeks to take a leave of absence to participate in an activity with a Related Entity, the Student should be referred to the School Dean, who will review the request and offer independent advice.
• If a Postdoctoral Scholar seeks to take a leave of absence to participate in an activity with a Related Entity, the Postdoctoral Scholar should discuss plans with their faculty sponsor and the Office of Postdoctoral Affairs and must adhere to the postdoctoral leave of absence policy (RPH 10.3 Postdoctoral Scholars).

E. Standards for Conflict of Commitment

1. Physical Presence

Personnel must maintain a significant physical presence on campus (main or overseas) throughout each quarter they are on active duty, consistent with their scope of employment.  Personnel with responsibility for overseeing, training or mentoring Staff, Students or      Postdoctoral scholars must be accessible and available to interact with individuals and other Stanford colleagues, throughout each quarter they are on active duty. Any modification in the requirement to maintain a significant physical presence on campus (e.g., extended or frequent absences from campus) should be specifically approved by the relevant department chair and/or School Dean.

2. Research / PI’ship

Personnel on active duty normally are prohibited from serving as principal investigators on sponsored projects submitted and managed through other institutions. This rule 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 restrict access to specialized facilities not available at Stanford. Additionally, Stanford recognizes that Personnel may receive special approval for concurrent appointments with other research organizations where they may serve as principal investigators.  These exceptions will be maintained by the VPDoR in guidance documents.

3. Limits On Outside Professional Activities and Outside Employment

1. Outside Professional Activities should normally be carried out as a Consultant or temporary provider of advice or service.
2. Except as provided for under Section VI.E.2 “Research/PI’ship” full-time Personnel may not accept a position as an employee at another organization.  On the rare occasion where an exception to this prohibition on outside employment is granted, Personnel would likely be required to take a leave of absence from Stanford, and such circumstances will be documented under a management plan.
3. Part-time Faculty and Staff may engage in paid or unpaid work activities, provided that those activities are separate and distinct from their Stanford Responsibilities, do not make use of Stanford personnel or resources, and do not sum to greater than full-time employment (100% effort) when considered alongside Stanford employment.  A management plan may be needed to document the separation between outside work activities and Stanford Responsibilities.  Part-time Faculty and Staff must exercise good judgment in assessing and engaging in these activities.
4. Postdoctoral Scholars are full-time. A reduction in effort is only permitted in limited and temporary circumstances as described in University policy and with the approval of the Office of Postdoctoral Affairs.  See RPH 10.3 Postdoctoral Scholars.
5. Under no circumstances may Outside Professional Activities of Full-time Staff and Postdoctoral Scholars exceed the time limits imposed by RPH 4.3 Consulting and Other Outside Professional Activities or RPH 10.6 Relationships Between Students and Outside Entities and RPH 10.3 Postdoctoral Scholars. Internships and externships arranged or authorized by Stanford as part of a Postdoctoral Scholar programs are not Outside Professional Activities subject to these limitations.
6. Full-time Personnel may not accept line management or significant managerial responsibilities.

4. Appropriate Use of Stanford Personnel and Resources

To avoid questions about their appropriate use of resources and attributions of products of their work, Personnel must establish clear boundaries that separate their obligations to Stanford from their obligations to outside entities.

Personnel must not engage University employees, Students, or Postdoctoral Scholars in their Outside Professional Activities (except for Professional Services) or in any activities unrelated to the education, research, scholarship, or public service missions of Stanford.

Only incidental use may be made of Stanford resources. Personnel must not use Stanford resources for personal gain, for purposes outside the University's mission, as an offering of inappropriate favors to outside entities, or for any other non-Stanford purposes.  Stanford resources include:

1. Facilities, equipment, and services.
2. Knowledge gained from government-sponsored contracts, including knowledge regarding possible new sites for government operations or information about forthcoming programs or selection of contractors or subcontractors in advance of official announcements.
3. Stanford confidential information (including, but not limited to, medical, personnel, or security records of individuals) or confidential information provided to Stanford by third parties.

5. Titles & Appointments at External Organizations

Full-time Personnel may not accept line management or significant managerial responsibilities, or titles that suggest or connote such responsibilities, as part of their Outside Professional Activities.  To avoid implying line management or significant managerial responsibilities, Personnel must not accept roles or titles such as CEO, COO, CIO, “director”, “officer” or “vice-president.” Personnel may agree to roles or titles such as 'advisor' or 'consultant,' e.g., “Chief Scientific Advisor,” or “Chief Technical Consultant.” Normally it will be necessary for full-time Personnel to take a full leave of absence from their University responsibilities to take on a significant management role in an outside entity; doing so while on sabbatical is not permitted.

6. Intellectual Property

1. Personnel are subject to Stanford's Patent and Copyright Agreement (SU-18) and associated policies.
2. Outside Professional Activities should not conflict with SU-18 or associated policies. Personnel may not promise or assign 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 any third party, including entities where they are engaged in Outside Professional Activities or Professional Service.
3. Stanford research or academic work should not be used or shared in Outside Professional Activities, such that a third party could receive early, preferential or exclusive access to Stanford research results.
4. Distribution and use of teaching materials developed by Personnel while they are employed by Stanford University must conform to the rules set forth in RPH 9.2 Copyright Policy.

7. Use of Stanford Name/Affiliation

When Personnel are involved in Outside Professional Activities not directly associated with Stanford, use of Stanford's name and marks is limited to identification of the individual by generic title (e.g., Associate Professor, Senior Lecturer), and place of work (Stanford University) and must be consistent with the guidance provided in the Stanford Administrative Guide 1.5.4. The title may be used only during the term of their appointment at Stanford.

8. Authorship

If Personnel are listed authors on any Publication resulting from the performance of Outside Professional Activities, a disclosure should be included in the Publication clearly stating that their contribution to the Publication was as a paid consultant (or another role) and was not part of Personnel’s Stanford University duties or responsibilities. Personnel should provide the same disclosure in presentations and speaking engagements conducted as Outside Professional Activities. In the course of Outside Professional Activities Personnel may not publish articles or other forms of scholarly communication that are written in whole or material part by employees of an outside entity (i.e., “ghost written”).  See Publications in RPH 4.3: Consulting and Other Outside Professional Activities for more information.

F. Standards for Conflict of Interest

1. Appropriate Use of University Resources

Personnel should follow the highest ethical and legal standards by avoiding Conflicts of Interest and taking measures to (a) ensure openness in carrying out Stanford Responsibilities to protect Students, Postdoctoral Scholars and Staff, (b) ensure integrity and prevent bias in research and scholarly activities, (c) protect human subjects in research, (d) appropriately manage Intellectual Property, (e) appropriately use teaching and education resources (f) ensure clinical care is free from bias, and (g) ensure transparency and oversight of global collaborations and affiliations.

Examples of specific Conflicts of Interest can be found in Appendix 1. 

2. Openness in Carrying out Stanford Responsibilities to Protect Students and Staff

The results of research or scholarship undertaken at Stanford must be disseminated on an open and timely basis to the broader scholarly community and public in keeping with Stanford's RPH 1.4 Openness in Research Policy.  All Personnel must foster an atmosphere of academic freedom by promoting the open and timely exchange of results of scholarly activities.  To achieve this:

1. Personnel are responsible for informing other Personnel, and colleagues about any Outside Professional Activities that might influence the free exchange of scholarly information among them.  Academic activities must be free from the influence of the personal or commercial interests of Stanford Personnel.
2. Faculty should take particular care to ensure that their advising of Students and Postdoctoral Scholars, supervision of employees, and selection and assignment of Students and employees to participate in research projects is not influenced by personal financial interests or unwarranted external influence.  Advancing the scholarly field and addressing educational needs are the sole considerations appropriate for the selection and assignment of Students, Postdoctoral Scholars  and Staff to research projects.
3. Faculty must be open with their Students, Postdoctoral Scholars, employees, and colleagues about their Outside Professional Activities and their involvement with and obligations to third parties who could benefit from their work or ideas. Students, Postdoctoral Scholars and Staff should have access to information about the sources of funds that support the research they participate in.
4. Students, Postdoctoral Scholars, employees, and collaborators must not be used to support Personnel's Outside Professional Activities. In rare cases, it may be acceptable for Personnel to involve a Student, Postdoctoral Scholar, or Staff in their Outside Professional Activities.  Such participation requires prior written approval from the school Dean and department chair.
5. Personnel’s Outside Professional Activities should not impede Students’, Postdoctoral Scholars’ or collaborators’ ability to pursue topics of interest, access to information and facilities, and ability to communicate the results of their work to other scholars and the public.

3. Integrity and Prevention of Bias in Research and Scholarly Activities

Stanford strongly encourages Personnel to participate in scholarly activities that may benefit study participants, the University, and the public. Researchers are expected to carry out such activities consistent with high ethical and legal standards.

External research sponsors, whether governmental or private, often promulgate conflict of interest regulations. The purpose of such regulations is to promote objectivity in research and to provide a reasonable expectation that the design, conduct, and reporting of research will be free from bias arising from Personnel’s Financial Interests and commitments to outside parties. As a recipient of external funding from governmental and nongovernmental sponsors, the University must comply with these regulations. To the extent that any external research sponsor's rules, policies, or guidelines are more stringent than this policy, the sponsor's requirements will take precedence.

The following requirements serve to promote integrity and mitigate bias associated with financial gain or conflicting commitments:

1. Personnel on active duty must not act as principal investigator or project director on sponsored projects submitted and managed at another institution when the project could be conducted by Stanford University.
2. Personnel must not provide early, preferential, or exclusive access to their Stanford research results or other works as part of their Outside Professional Activities or to a Related Entity, nor should the dissemination of research results be withheld for personal gain.
3. Personnel may not accept sponsored funding, gifts, or directed disbursements from industrial affiliate memberships at Stanford from a Related Entity if Personnel:
4. are on the board of directors of a Related Entity that is a small business
5. hold an ownership interest in the Related Entity of 5% or more
6. are the inventor of intellectual property licensed to the Related Entity, or
7. engage in an Outside Professional Activity at or in connection with the Related Entity.

There are two potential exceptions to this requirement, which, if approved, would require a robust management plan approved by the VPDoR. 

• Stanford researchers may accept research funding in their labs from a Related Entity under a Phase I SBIR/STTR grant, or
• In rare circumstances, the significance of the research to Stanford combined with the potential benefits of research outcomes to the world may exceed the potential risks of accepting financial support for research from a Related Entity.

The management plan should be prepared by the relevant Designated Official and include scientific, programmatic oversight and financial management provided by a non-conflicted institutional official(s).  Alternatively, the conflicted individual may divest from the outside interests before conducting such research. 

d. Notwithstanding the restrictions specified in (c) above, Personnel may receive sponsored funding, gifts, and directed disbursements from industrial affiliates memberships when the Related Entity is a publicly traded company, provided that Personnel do not have any role in the Related Entity’s decision to provide the funds, the work that the funds will support is separate and distinct from any Outside Professional Activities Personnel may be engaged in at the Related Entity, and the funding arrangement is documented in a management plan.

4. Protection of Human Subjects in Research

1. A Conflict of Interest will be presumed to exist for Personnel conducting Human Subject Research related to their Outside Professional Activity or Financial Interest, where the value of the Outside Professional Activity or Financial Interest is $10,000 or more, the interest is any amount of stock/stock option in a privately held company, or Personnel hold a leadership role in an outside entity that is funding the research, or has a Financial Interest in an entity that could be impacted by the outcome of the study.
2. Personnel with such a presumed Conflict of Interest may provide to the department chair, School Dean, or VPDoR a request to proceed that includes a compelling justification for why the research is critical.  In addition to the compelling justification, the request must include plans to manage the Conflict of Interest, reduce any potential bias to the research, and minimize risks to human subjects. The Stanford Institutional Review Board (IRB), which is responsible for ensuring that the interests of research participants are protected, has the final authority in determining the conditions under which such research is allowable.
3. If the justification is accepted and the request to proceed is approved by the relevant department chair, School Dean, the VPDoR, and the IRB, the Designated Official must develop an appropriate written management plan to minimize or reduce potential risks to human subjects and ensure the objectivity of the research.
4. If such an application is not submitted and approved, Personnel will be required to reduce their financial interest in the outside entity to a level below $10,000, or the work may not be done at Stanford or by Personnel at another location. See COI: Conflicts of Interest Overview.

5. Clinical Care, Free from Bias

Personnel who provide clinical care may be required to file additional disclosures with Stanford and through the health system with which they are employed. 

Stanford School of Medicine has a policy on Conflicts of Interest in Clinical Care which recognizes that physicians have a unique opportunity to improve patient care through collaboration with industry. However, these interactions must take place in an atmosphere of high integrity and transparency so that collaborations with industry can optimally benefit patients and improve human health and well-being. Accordingly, Stanford physicians are expected to fully disclose financial relationships with companies that produce, manufacture, or provide medical devices, implants, pharmaceuticals, biologics, diagnostics, or other medical care related products that may be used in the care of their patients. A financial interest in a company could create a conflict of interest if:

• The physician prescribes pharmaceuticals made or supplied by this entity for FDA-approved or non-FDA-approved indications
• The physician uses a medical device or implant made or supplied by this entity
• The physician refers patients to a health care facility with which he/she has a financial relationship
• The physician is involved in evaluating products made or supplied by this entity

Clinical care conflicts need to be reviewed by the Senior Associate Deans for Clinical Affairs.

6. Intellectual Property

Stanford encourages personnel to become involved in transferring knowledge from the University to the public and private sectors. 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. To ensure intellectual property is protected, Personnel must disclose, on a timely basis, the creation or discovery of all potentially patentable inventions created or discovered in the course of their Stanford activities or in the course of activities with more than incidental use of University resources. If intellectual property rights are to claimed by Personnel, ownership of inventions is assigned to the University regardless of the source of funding.

When participating in Outside Professional Activities or Professional Services, Personnel may not:

1. promise or assign intellectual property conceived, or first reduced to practice, in whole or in part, in the course of Stanford activities or activities that have more than incidental use of Stanford resources, to any third party, including entities where they are engaged in Outside Professional Activities or Professional Services. 
2. use or share Stanford research in Outside Professional Activities, such that a third party could receive early or exclusive access to Stanford research results.
3. use teaching or research materials generated as part of their Stanford employment in their Outside Professional Activities.
4. provide preferential access to research results, materials, or products generated from Stanford teaching or research to an outside entity for personal financial gain.
5. agree to nondisclosure or confidentiality terms or enter into agreements that delay or prohibit Publications resulting from Stanford research or scholarship.

7. Outside Teaching

Under longstanding University policy, Faculty are 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 are 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.  This policy applies whether the teaching is provided in person or through an electronic format. For additional details regarding permissible teaching activities outside Stanford, see RPH 9.2 Copyright Policy.

8. Transparency and Oversight of Global Collaborations and Affiliations

International collaboration and engagement are encouraged and supported by Stanford University. However, Stanford's open research environment also provides opportunities for outside entities to take advantage of Stanford's intellectual property, ideas, and resources in a manner that may not comport with the ethical norms of research and scholarly activities. Therefore, Personnel must exercise vigilance in these circumstances to ensure that the fundamental norms of research integrity are preserved. Investigators engaged in federally sponsored research must be particularly careful to disclose all collaborations, gifts, sponsored research, affiliations, appointments, and activities related to their Stanford Responsibilities to both Stanford and to sponsors in proposals and progress reports in accordance with sponsor requirements. Additionally, as mentioned elsewhere in this policy, Personnel who enter Consulting agreements with an outside entity must provide the outside entity with the Stanford Rider.

G. Conflict Management and Oversight

A conflict may be eliminated by divesting a Financial Interest, terminating the relationship or sponsored project that gives rise to the Financial Interest, abandoning the project, or similar measures.

If Personnel does not want to eliminate the real or perceived conflict and the Designated Official or Dean or Conflict of Interest Committee determines that it can be managed in accordance with this policy, Personnel and the School or Conflict of Interest Committee (as delegated in implementation procedures) will work together to develop a written management plan.

Managing a conflict means taking actions to ensure Outside Professional Activities are separate and distinct from Stanford activities and, to the extent possible, free from bias.  Management plans will include a description of the activity that gave rise to the Conflict of Interest or Conflict of Commitment, an analysis of how the activity relates to the individual's Stanford Responsibilities, steps Personnel will take to mitigate any bias or risk, and an agreement to update the plan if circumstances change.  Management plans must be reviewed at least annually for as long as the conflict exists.

The VPDoR’s Designated Official will assist the School and the Office of the VPDoR on policy interpretation and development of conflict management plans, as necessary. Where the School or VPDoR Committee provides recommendations to manage a conflict, those recommendations will be considered by the Dean.  Personnel may appeal the Dean’s final determination, as described below.

All management plans must be approved and signed by Personnel and the dean of the School or the Dean's delegate.  Where Personnel are appointed in more than one School, the plan must be co-signed by each of the relevant School Deans or their delegates.  Personnel may not commence or participate in the activity that gave rise to the conflict until all approvals are obtained.

Schools are responsible for maintaining management plans and monitoring adherence to approved plans at least annually, but more often if required by the management plan.  Personnel are responsible for updating their disclosures and must work with their School to update management plans at least annually and when circumstances or relationships in the plan change.

The School Designated Official is responsible for working with the VPDoR, the Research Management Group, and the Office of Sponsored Research, as necessary, to ensure proper reporting of conflicts to research sponsors in accordance with applicable rules and Stanford procedures.

H. Appeals

Should Personnel wish to appeal a decision of their School made pursuant to this policy, they may appeal to the VPDoR.  Appeals of a decision of the VPDoR made pursuant to this policy are to the Provost, who will consider the case in consultation with the Advisory Board of the Academic Council.

VII. Confidentiality and Disclosures to Third Parties

Disclosures will generally be treated as confidential information, except as required for review management, and oversight by the cognizant School Dean, the VPDoR, Designated Officials, the department chair, senior administrative staff, and University officials in Internal Audit and the Office of the General Counsel. Disclosures and management plans will be kept confidential from outside parties except as may be required by law or by conditions imposed by a sponsor of research to report conflicts of interest and/or any failure to report a conflict of interest to the affected project sponsors. Disclosures that are identified by the review as financial conflicts of interest (FCOI) related to federally-funded research must be reported and the federal funding agencies may require Stanford to make this information available to the public.

VIII. Training

Personnel must complete Conflict of Interest and Conflict of Commitment training in accordance with University and sponsor requirements.

IX. Record Retention

Each School will retain all disclosures, conflict management plans, and related documents for a period of at least three years following the expiration of the term of the management plan.  If the conflict is connected to a sponsored program, the School will maintain records for at least three years following the submission of the final expenditure report to the sponsor for the project that gave rise to the Financial Conflict of Interest, unless any litigation, claim or negotiation, audit, or other action involving the records commences before the expiration of the three years, in which case, records must be retained for three years following the completion of the action and resolution of all issues, or three years after the submission of the final expenditure report, whichever is longer.

X. Consequences of Violating this Policy

Failure to comply with this policy -- including failure to disclose information required by this policy; disclosure of incomplete, erroneous, or misleading information; or failure to comply with prescribed management plans or monitoring procedures -- will be handled under Stanford disciplinary policies and procedures.

Appendix 1: Examples of Conflicts of Interest

The following activities are examples of situations that constitute apparent or real Conflicts of Interest:

1. Greater than incidental use or unauthorized use of Stanford’s time, resources, or non-public information to benefit Personnel or for use in their Outside Professional Activities.
2. Personnel’s use of Students or Postdoctoral Scholars for private gain or involvement of Students, Postdoctoral Scholars, or subordinates in their Outside Professional Activities.
3. Unfair access by an outside party to Stanford programs, services, information, or technology.
4. Compromised design, conduct, or reporting of research due to overlap of Stanford research with Personnel's Outside Professional Activities or Financial Interests.
5. Personnel’s selection of a Related Entity as a University contractor, subcontractor, consultant, or vendor.
6. Acceptance of a gift or favor from an outside party conducting (or seeking to conduct) business with Stanford, when Personnel are in a position to influence or inform Stanford decision–making in relation to the engagement of the outside party.
7. Withholding research results or providing research results on a preferential basis for personal gain.
8. Receiving gifts, industrial affiliate memberships, or sponsored funds at Stanford from a Related Entity.
9. Negotiating with Stanford on behalf of a Related Entity or negotiating with a Related Entity on behalf of Stanford.
10. Diverting research or teaching opportunities to a Related Entity when those opportunities are more appropriately undertaken by Personnel at Stanford.
11. Promoting the use of products or services of a Related Entity.
12. Engaging in research, particularly research involving human subjects, that could reasonably appear to impact the financial condition of a Related Entity.