PHS and NSF Requirements Regarding Financial Disclosures and Agency Notifications

Establishes policy for implementation of agency requirements related to financial disclosures by faculty members and other Investigators involved with submitting proposals and notifications to agencies in the event a financial conflict of interest (FCOI) is identified.  This policy will be modified as necessary to maintain compliance with the requirements of external agency.

1. Introduction

Stanford's Faculty Policy on Conflict of Commitment and Interest (RPH 4.1) establishes requirements for faculty disclosures (on both an annual and an ad hoc basis) of financial interests and professional relationships in outside entities that would reasonably appear to be related to institutional responsibilities, and for annual certifications of policy compliance. In addition, Stanford's policy requires that faculty members seeking funding from an external sponsor comply with any financial disclosure or notification requirements of that sponsor.

Certain federal agencies have specific requirements for disclosure and management of personal financial interests related to their sponsored research projects.  The focus of these requirements is to ensure responsible stewardship of federal funds and to promote research free from bias resulting from Investigator financial conflicts of interest.  Agencies with such requirements 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), the Food and Drug Administration (FDA)as well as the National Science Foundation (NSF). This policy provides specific guidance related to the requirements of PHS and NSF.

2. PHS Requirements

A. Definitions

1. Designated Official means the individual(s) designated by each Stanford School Dean to review disclosures of significant financial interests and determine whether there is a financial conflict of interest. For School Deans, the Vice Provost and Dean of Research, or their designee may review disclosures and determine whether there is a financial conflict of interest.
2. Financial conflict of interest (FCOI) means a significant financial interest (SFI) that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.
3. Financial interest means anything of monetary value, whether or not the value is readily ascertainable. 
4. Institutional Responsibilities means an Investigator’s professional responsibilities on behalf of Stanford, including research and other scholarly activities; clinical care activities; teaching or educational activities; and administrative activities.
5. Investigator means the project director (PD) or principal investigator (PI) any Stanford faculty contributing effort to a PHS funded project and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the PHS, or proposed for such funding, designated by the PI/PD or Stanford Faculty.  These individuals may include, for example, academic or teaching staff. 
6. Manage means taking action to address a financial conflict of interest, which can include reducing or eliminating the financial conflict of interest, to ensure, to the extent possible, that the design, conduct, and reporting of research will be free from bias.
7. PD/PI means a project director or principal investigator of a PHS-funded research project; the PD/PI is included in the definitions of senior/key personnel and Investigator.
8. Senior/key personnel means the PD/PI and any other person identified as senior/key personnel by Stanford in the grant application, progress report, or any other report submitted to the PHS by Stanford under this policy.
9. Significant Financial Interest means: 
   1.  Financial Interests Related to a Faculty Member’s Institutional Responsibilities: A Significant Financial Interest (SFI) is a financial interest consisting of one or more of the following interests of the Investigator.  The Investigator (and those of the Investigator’s spouse and dependent children) must disclose any such SFI that reasonably appear to be related to the Investigator’s institutional responsibilities:
      1. With regard to any publicly traded entity, an SFI 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. For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value; 
      2. With regard to any non-publicly traded entity, an SFI 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 (e.g., stock, stock option, or other ownership interest); or
      3. Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
   2. Reimbursed or sponsored travel that reasonably appears related to the Investigator’s Institutional Responsibilities may be an SFI.  Investigators must disclose the occurrence of any reimbursed or sponsored travel, $5,000 or more (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available), related to their institutional responsibilities; provided, however, that this disclosure requirement does not apply to travel that is reimbursed or sponsored by a Federal, state, or local government agency in the United States, or a United States public or non-profit institution of higher education (as defined at 20 U.S.C. 1001(a)) or its affiliated hospital, medical center or research institute.  The Investigator’s disclosure must include the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration.
   3.  The term significant financial interest does not include the following types of financial interests: salary, royalties, or other remuneration paid by Stanford to the Investigator if the Investigator is currently employed or otherwise appointed by Stanford, including intellectual property rights assigned to Stanford and agreements to share in royalties related to such rights.
   4.  SFI also does not include income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles; and
   5. SFI also does not include income from seminars, lectures, or teaching engagements sponsored by a Federal, state, or local government agency in the United States, a United States public or non-profit institution of higher education (as defined at 20 U.S.C. 1001(a)) or its affiliated hospital, medical center or research institute; or 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.

B. Policy

1. Disclosure

Regular Disclosure Requirements

All Stanford faculty who are planning to participate or who are participating in PHS-funded research at Stanford must disclose all financial interests, including those of the their spouse and dependent children, that could reasonably be related to the Investigator’s Institutional Responsibilities.  As described above, Institutional Responsibilities include research and other scholarly activities; clinical care activities; teaching or educational activities; and administrative activities.  Such disclosures must be made in the Outside Professional Activities Certification System (OPACS) on an annual basis or within thirty days of discovering or acquiring (e.g. through purchase, marriage, or inheritance) a new SFI. SFIs disclosed will be identified and reviewed in accordance with this policy.  

PHS-Funded Research Disclosure Requirements

For each project proposed to or funding by PHS, the following people are considered Investigators for purposes of this policy:

• the Principal Investigator (PI), and
• all Stanford faculty contributing effort to a PHS sponsored project, and 
• any other person that the PI or a contributing faculty member designates as responsible for the design, conduct, or reporting of research.

The OPACS system will prompt all these Investigators (faculty and non-faculty alike) to complete a disclosure in OPACS for the proposal. All disclosed financial interests of the Investigators, including those of their spouses or dependent children, are reviewed to identify SFIs that may reasonably appear to be related to the proposed research project, and a determination is made whether there is an FCOI.  All FCOI  are eliminated or managed, in accordance with this policy, to ensure compliance with PHS requirements prior to expenditure of PHS funds. In addition to fulfilling disclosure requirements, all Investigators complete training, as described below, before expenditure of PHS funds.

2. Review of Disclosures by the Designated Official

Each School Dean will identify and appoint a Designated Official (usually a faculty senior associate dean and/or COI program administrator) to assume the review responsibility for its own Investigators.  Designated Officials will review annual disclosures in OPACS and transactional/ad hoc disclosures submitted by faculty as required byStanford's Faculty Policy on Conflict of Commitment and Interest in RPH 4.1, and for academic and teaching staff as required by RPH 4.4 Conflict of Commitment and Interest for Academic Staff and Other Teaching Staff.  The Vice Provost and Dean of Research, or their designee, will review disclosures and act as the Designated Official, with regard to disclosures made by the School Deans.

All financial interests of the Investigator are reviewed by the Designated Official.  Any financial interest that qualifies as an SFI and that may reasonably appear to be related to the proposed research project is further reviewed by the Designated Official to determine whether there is an FCOI and, if so, the FCOI is eliminated or managed and reported to PHS, as applicable, in accordance with this policy and in compliance with PHS requirements regarding conflict of interest. All FCOI identified that are specifically related to PHS-funded research are eliminated or managed prior to expenditure of PHS funds. 

3. Determining if an SFI is Related to PHS-funded Research

An SFI is related to the PHS-funded research when the Designated Official reasonably determines that the SFI could affect PHS-funded research. Stanford may involve the Investigator in the Designated Official’s determination of whether an SFI is related to the PHS-funded research. An SFI with an Entity would be reasonably considered related to an Investigator's research study in circumstances such as the following:

• Entity is a collaborator on or provider of materials, products, data or trainee support for the PHS-funded research or is a licensee with improvement rights to technology likely to arise out of the PHS-funded research. 
• Investigator or Entity has financial interests that could reasonably be considered to have a potential influence on the design, conduct or reporting of the PHS funded research
• Entity has a reasonable possibility of being financially affected by the PHS funded research
• Entity sponsors research at Stanford in which the Investigator is directly involved
• Entity makes gifts to Stanford that benefit Investigator's research/scholarship (including equipment gifts or loans)
• Entity sponsors or makes a product that is under study in research in which Investigator is involved
• Entity sponsors or makes a product that is under study in human subjects in which Investigator is directly or indirectly involved 
• Entity licenses Stanford intellectual property in which Investigator has a financial interest
• Entity owns intellectual property, materials, or data that may be used in research at Stanford
• Entity has a Materials Transfer Agreement, Human Tissue Agreement (MTA/HTA), or Data Transfer and Use Agreement (DTUA) to provide materials or data used in Investigator's research or for materials provided by Investigator to the company/organization
• Entity is the sole-source provider of materials or services or of procurements required for the Investigator to carry out research 
• Entity provides financial support for the faculty member's trainees (including graduate students and postdoctoral fellows)

4. FCOI Determination

A financial conflict of interest (FCOI) exists when the Designated Official reasonably determines that the SFI could directly and significantly affect the design, conduct, or reporting of the PHS-funded research.

Timing of Review and Requirements

1. Newly Funded Project

Prior to Stanford’s expenditure of any funds under a PHS- funded research project, the Designated Official(s) shall review all Investigator SFI disclosures and:

• determine whether the SFI relates to PHS-funded research; 
• determine whether a financial conflict of interest (FCOI) exists; 
• if there is an FCOI, either take steps to eliminate the conflict or develop and implement a management plan that shall specify the actions that have been, and shall be, taken to manage such FCOI; and 
• If an FCOI is not eliminated and a management plan is implemented, Stanford must file an FCOI report with the appropriate PHS awarding component.

2. Ongoing Project (Timely Disclosure)

In the course of an ongoing PHS-funded research project (timely disclosure), should an Investigator who is new to participating in the research project disclose a SFI or should an existing Investigator disclose a new SFI to Stanford, the Designated Official shall, within sixty days, review the disclosure of the SFI and:

• determine whether the SFI relates to PHS-funded research; 
• determine whether a financial conflict of interest (FCOI) exists; 
• if there is an FCOI, either take steps to eliminate the conflict or develop and implement, on at least an interim basis, a management plan that shall specify the actions that have been, and shall be, taken to manage such FCOI. Depending on the nature of the SFI, Stanford may determine that additional interim measures are necessary with regard to the Investigator’s participation in the PHS- funded research project between the date of disclosure and the completion of Stanford’s review; and
• if an FCOI is not eliminated and a management plan is implemented, Stanford must file an FCOI report (or update an existing one) with the appropriate PHS awarding component within 60 days.

3. Ongoing Project (Failure to Timely Disclose or Review)

In the course of an ongoing PHS-funded research project, should Stanford identify an SFI that was not disclosed timely by an Investigator or, for whatever reason, was not previously reviewed by Stanford during an ongoing PHS-funded research project, the Designated Official shall, within sixty days, review the SFI and: 

• determine whether the SFI relates to PHS-funded research; 
• determine whether a financial conflict of interest (FCOI) exists; 
• if there is an FCOI, either take steps to eliminate it or develop and implement, on at least an interim basis, a management plan that shall specify the actions that have been, and will be, taken to manage such financial conflict of interest going forward;
• if there is an FCOI, complete a retrospective review, within 120 days. Depending on the nature of the FCOI, Stanford may determine that additional interim measures are necessary with regard to the Investigator’s participation in the PHS-funded research project between the date that the financial conflict of interest or the Investigator’s noncompliance is determined and the completion of Stanford’s retrospective review; and
• If an FCOI is not eliminated and a management plan is implemented, Stanford must file an FCOI report (or update an existing one) with the appropriate PHS awarding component within 60 days.

5. FCOI Management and Monitoring

Management of an identified FCOI requires development and implementation of a management plan and, if necessary, a retrospective review and a mitigation report (described below).  Examples of conditions or restrictions that Stanford may impose to manage a FCOI include, but are not limited to: (i) Public disclosure of FCOI (e.g., when presenting or publishing the research); (ii) For research projects involving human subjects research, disclosure of FCOI directly to participants; (iii) Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the FCOI; (iv) Modification of the research plan; (v) Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research; (vi) Reduction or elimination of the financial interest (e.g., sale of an equity interest); or (vii) Severance of relationships that create financial conflicts. 

The management plan should include: (A) A description of the SFI and the FCOI (B) Role and principal duties of the conflicted Investigator in the research project; (C) Specific conditions of the management plan; (D) A description of how the management plan is designed to safeguard objectivity in the research project; (D) Confirmation of the Investigator’s agreement to the management plan; (F) How the management plan will be monitored to ensure Investigator compliance.  The appropriate Investigator shall sign and certify each manage plan, along with the cognizant (department or center head, or both), and the Designated Official.  

The Investigator will provide an update to the details of the management plan at least annually, and more often if circumstances related to the SFI change.  Such plans shall remain in effect until the completion of the PHS-funded research project, or until the FCOI is eliminated, whichever comes first. 

6. FCOI Reports to PHS

Prior to Stanford’s expenditure of any funds under a PHS-funded research project, Stanford shall provide to the PHS awarding component, through the NIH eRA Commons, an FCOI report regarding any Investigator’s SFI found by Stanford to be conflicting and ensure that Stanford has implemented management plan in accordance with the PHS regulations. In cases in which Stanford identifies an FCOI and eliminates the conflict prior to the expenditure of PHS-awarded funds, Stanford will not submit an FCOI report.

For any SFI that Stanford identifies as conflicting subsequent to Stanford’s initial FCOI report and during an ongoing PHS-funded research project (e.g., upon the participation of an Investigator who is new to the research project), Stanford shall provide an FCOI report to the PHS Awarding Component, within sixty days,. 

Where an FCOI report involves a SFI that was not disclosed timely by an Investigator or, for whatever reason, was not previously reviewed or managed by Stanford (e.g., was not timely reviewed or reported by a subrecipient), in addition to providing an FCOI report, Stanford also is required to complete a retrospective review (see below) to determine whether any PHS-funded research, or portion thereof, conducted prior to the identification and management of the financial conflict of interest was biased in the design, conduct, or reporting of such research. If bias is found, Stanford is required to notify and promptly and submit a mitigation report to the PHS Awarding Component.

After initial submission of an FCOI report, Stanford shall provide the PHS Awarding Component an annual FCOI report that addresses the status of the FCOI and any changes to the management plan for the duration of the PHS-funded research project. The annual FCOI report shall specify whether the financial conflict is still being managed or explain why the financial conflict of interest no longer exists. Stanford shall provide annual FCOI reports to the PHS Awarding Component for the duration of the project period (including extensions with or without funds) in the time and manner specified by the PHS Awarding Component.

The FCOI report shall include sufficient information to enable the PHS Awarding Component to understand the nature and extent of the financial conflict and to assess the appropriateness of Stanford’s management plan. Elements of the FCOI report shall include, but are not necessarily limited to, the following: (i) Project number; (ii) PD/PI or Contact PD/PI if a multiple PD/PI model is used; (iii) Name of the Investigator with the financial conflict of interest; (iv) Name of the entity with which the Investigator has a financial conflict of interest; (v) Nature of the financial interest (e.g., equity, consulting fee, travel reimbursement, honorarium); (vi) Value of the financial interest (dollar ranges are permissible: $0–$4,999; $5,000–$9,999; $10,000–$19,999; amounts between $20,000– $100,000 by increments of $20,000; amounts above $100,000 by increments of $50,000), or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value; (vii) A description of how the financial interest relates to the PHS-funded research and the basis for Stanford’s determination that the financial interest conflicts with such research; and (viii) A description of the key elements of Stanford’s management plan, including: (A) Role and principal duties of the conflicted Investigator in the research project; (B) Conditions of the management plan; (C) How the management plan is designed to safeguard objectivity in the research project; (D) Confirmation of the Investigator’s agreement to the management plan; (E) How the management plan will be monitored to ensure Investigator compliance; and (F) Other information as needed.

7. Retrospective Review

Whenever an FCOI is not identified or managed in a timely manner, including failure by the Investigator to timely disclose a SFI that is later determined by Stanford to constitute a FCOI; failure by Stanford to timely review or manage such an FCOI; or failure by the Investigator to comply with a FCOI management plan, Stanford shall, within 120 days of Stanford’s determination of noncompliance, complete a retrospective review of the Investigator’s activities and the PHS-funded research project to determine whether any PHS-funded research, or portion thereof, conducted during the time period of the noncompliance, was biased in the design, conduct, or reporting of such research. 

Under PHS policy, Stanford is required to document the retrospective review; such documentation shall include, but not necessarily be limited to, all of the following key elements: (1) Project number; (2) Project title; (3) PD/PI or contact PD/PI if a multiple PD/PI model is used; (4) Name of the Investigator with the FCOI; (5) Name of the entity with which the Investigator has a financial conflict of interest; (6) Reason(s) for the retrospective review; (7) Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed); (8) Findings of the review; and (9) Conclusions of the review. 

Based on the results of the retrospective review, if appropriate, Stanford shall update the previously submitted FCOI report, specifying the actions that will be taken to manage the FCOI going forward. 

If bias is found, Stanford is required to notify the PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component. The mitigation report must include, at a minimum, the key elements documented in the retrospective review, above, and a description of the impact of the bias on the research project and Stanford’s plan of action or actions taken to eliminate or mitigate the effect of the bias (e.g., impact on the research project; extent of harm done, including any qualitative and quantitative data to support any actual or future harm; analysis of whether the research project is salvageable). 

Thereafter, Stanford will submit FCOI reports annually, as specified elsewhere in this policy. 

8. Remedies for Non-Compliance

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, including those described in the Statement on Faculty Discipline. Violation by academic or teaching staff may result in disciplinary action.  

Whenever an FCOI is not identified or managed in a timely manner, including failure by the Investigator to disclose a SFI that is determined by Stanford to constitute a FCOI; failure by Stanford to review or manage such a FCOI; or failure by the Investigator to comply with a FCOI management plan, Stanford shall, within 120 days of Stanford’s determination of noncompliance, complete a retrospective review of the Investigator’s activities and the PHS-funded research project to determine whether any PHS-funded research, or portion thereof, conducted during the time period of the noncompliance, was biased in the design, conduct, or reporting of such research.

If the failure of an Investigator to comply with Stanford’s financial conflicts of interest policy or a FCOI management plan appears to have biased the design, conduct, or reporting of the PHS-funded research, Stanford shall promptly notify the PHS Awarding Component of the corrective action taken or to be taken. 

The PHS Awarding Component will consider the situation and, as necessary, take appropriate action, which may include directing Stanford on how to maintain appropriate objectivity in the PHS-funded research project, requiring Stanford to submit records, submit to on site review, accept special award conditions, suspension of funding, or other enforcement actions until the matter is resolved.

Should HHS determine that a PHS-funded project of clinical research whose purpose is to evaluate the safety or effectiveness of 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 by Stanford as required by this policy, Stanford shall 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.

C. Additional PHS Requirements

1. Public Accessibility

This PHS Policy is available on a publicly accessible website and has been made available to PHS via its NIH eRA Commons.

Information concerning FCOIs held by senior/key personnel is made publicly accessible by a written response to anyrequester within five business days of a request or as required by law.  Requests can be made using the form found here. This information provided 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 publiclyaccessible for at least three years from the date that it was most recently updated.

2. Investigator Training

Each Investigator must complete training regarding Stanford’s policy on financial conflicts of interest, the Investigator’s responsibilities regarding disclosure of significant financial interests, and of these specific PHS requirements.  Training must be completed prior to engaging in research related to any PHS-funded grant and refreshed at least every four years.  The Stanford OPACS system has been designed to be a training tool as well as a disclosure tool, so all Investigators receive annual training through the disclosure process.

Additional training must be completed when (1) Financial conflict of interest policies are revised in a manner that changes researcher requirements; (2) A researcher is new to the organization; and (3) A researcher is non-compliant with financial conflict of interest policies and procedures.

3. Subawards

When Stanford carries out PHS-funded research through a subrecipient (e.g., subcontractors or consortium members), Stanford, as the awardee Institution, will take reasonable steps to ensure that all subrecipient Investigators comply with PHS FCOI policy.  Stanford will incorporate, as part of a written agreement with the subrecipient, terms that establish that (1) the subrecipient’s financial conflicts of interest policy is compliant with PHS FCOI policy, (2) all subrecipient’s Investigators must comply with the subrecipient’s financial conflicts of interest policy, and (3) there is a specified time period for the subrecipient to report all identified conflicts of interest to Stanford, where this time period is sufficient to enable Stanford to provide timely FCOI reports to the PHS as required.  The subrecipient shall certify that its policy complies with PHS FCOI policy. 

4. Records

Stanford will maintain records relating to all Investigator disclosures of financial interests and Stanford’s review of and response to such disclosures (whether or not a disclosure resulted in Stanford’s determination of a financial conflict of interest) and all actions under Stanford’s policy for PHS COI review or retrospective review, as applicable, for at least three years from the date the final expenditures report is submitted to the PHS or, where applicable, from other dates specified in PHS regulations.

3. NSF Requirements

The National Science Foundation (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.

A. Definitions

1. Investigator means the principal investigator (PI), project director (PD), a co-PI or co-PD, any Stanford faculty contributing effort to an NSF funded project and any other person designated by the PI/PD or other Stanford faculty, who is responsible for the design, conduct, or reporting of research or educational activities funded by, or proposed for funding by NSF.
2. 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).

SFI does NOT include:

• salary, royalties, or other remuneration from Stanford
• 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.

3. Responsible Representative means the individual identified and appointed by the School Dean  (usually a faculty senior associate dean and/or COI program administrator) to assume the  review 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 4.1 and for academic and teaching staff as required by RPH 4.4 Conflict of Commitment and Interest for Academic Staff and Other Teaching Staff.  For School Deans, the Vice Provost and Dean of Research, or their designee will review disclosures and act as the Responsible Representative.

B. Policy

1. Disclosure

As required by NSF, and in accordance with Stanford’s Faculty Policy on Conflict of Commitment and Interest, RPH 4.1, and Stanford’s Policy on Conflict of Interest and Commitment for Academic and Teaching Staff,  RPH 4.4, Stanford requires each Investigator to disclose all SFIs 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. 

Investigators must provide all required financial disclosures to Stanford’s responsible representative through OPACS at the time the proposal is submitted to NSF. Investigators must ensure their disclosures are updated during the period of the award, either on an annual basis, or as new reportable SFI are obtained.

2. Overview of Review, Management, Reporting and Remedies for Non-Compliance

Review

Stanford designates a responsible representative to review financial disclosures, determine whether a conflict of interest exists, and determine what conditions or restrictions, if any, should be imposed by the Stanford to manage, reduce or eliminate such conflict of interest. 

A conflict of interest exists when the responsible representative(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.

Management

When a conflict of interest is identified, efforts must be made to manage, reduce or eliminate the conflict.  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

If the responsible representative, in consultation with the Dean and the Dean of Research, determines that imposing conditions or restrictions would be either ineffective or inequitable, and that the potential negative impacts that may arise from a significant financial interest are outweighed by interests of scientific progress, technology transfer, or the public health and welfare, then the reviewer(s) may allow the research to go forward without imposing such conditions or restrictions.

If it is decided that there is no way to satisfactorily manage a conflict of interest and if Stanford finds that research will proceed without the imposition of conditions or restrictions when a conflict of interest exists, Stanford must notify NSF through Stanford’s AOR representative using NSF’s electronic systems. The responsible representative should also coordinate with Stanford’s Office of General Counsel to keep NSF’s Office of the General Counsel appropriately informed.

Remedies for Non-Compliance

The Vice Provost and Dean of Research is responsible for interpretation and overall coordination of the policy. Violation of any part of this policy, including failure to appropriately manage a conflict of interest, may result in sanctions or disciplinary action against a faculty or academic or teaching staff member. In such cases, the responsible representative should also coordinate with Stanford’s Office of General Counsel to keep NSF’s Office of the General Counsel appropriately informed.

C. Additional NSF Requirements

1. Subawards

When Stanford carries out NSF-funded research through subawardees, contractors or collaborators, Stanford, as the awardee Institution, will take reasonable steps to ensure that all subawardee, contractor or collaborator Investigators comply with NSF COI requirements.  Stanford will incorporate, as part of a written agreement with the subawardees, contractors, or collaborators, terms that establish that (1) their conflicts of interest policy is compliant with NSF COI requirements, (2) all their Investigators must comply with the their conflicts of interest policy.

2. Records

Stanford will 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.

4. References

NSF PAPPG 2020 (This should be reviewed on an annual basis to ensure continued compliance)

42 CFR Part 50 Subpart F  

PHS Checklist