Research Policy Handbook

PHS and NSF Requirements Regarding Financial Disclosures and Agency Notifications (RPH 4.2)

Current version: April 2006

Summary:

Establishes guidelines for implementation of agency requirements related to financial disclosures by faculty members submitting proposals and notifications to agencies in the event a potential conflict is identified.

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

In addition to requirements for an institutional policy on conflict of interest, several federal agencies have their own requirements for disclosures related to their sponsored research projects; these include the Public Health Service (PHS), which includes the National Institutes of Health (NIH), and the National Science Foundation (NSF). This memo provides guidance related to the requirements of those agencies.

INVESTIGATOR DISCLOSURES

PHS and NSF require that, for each proposal submitted to that agency, the PI certify that he or she has appropriately disclosed any significant financial interests related to that proposal. Before an award can be accepted, Stanford must determine how any potential conflict will be managed, reduced or eliminated. At Stanford, each School will handle this responsibility for its own PIs, relying on the annual and ad hoc disclosures submitted by faculty as required by Stanford's Faculty Policy on Conflict of Commitment and Interest.

These agencies require that each investigator disclose to a designated representative of the institution all significant financial interests of the investigator:

1. that would reasonably appear to be affected by the research; or
2. in entities whose financial interests would reasonably appear to be affected by the research.

The term "investigator" means the principal investigator, co-principal investigators, and any other person responsible for the design, conduct, or reporting of research funded or proposed for funding by the sponsor. For purposes of financial disclosures, "investigator" includes the investigator's spouse and dependent children.

The term "significant financial interest" means anything of monetary value, including, but not limited to, salary or other payments for services (e.g., consulting fees or honoraria); equity interests (e.g., stocks, stock options or other ownership interests); and intellectual property rights (e.g., patents, copyrights and royalties from such rights). As defined by these agencies, the term "significant financial interest" does not include:

• an equity interest that, when aggregated for the investigator, spouse and dependent children, does not exceed $10,000 in value as determined through reference to public prices or other reasonable measures of fair market value, and does not represent more than a five percent 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 $10,000 over a twelve-month period.

STANFORD UNIVERSITY IMPLEMENTATION

Principal Investigators must complete a Proposal Routing Form (SU-42 form) in order to document that all requirements related to the submission of that proposal have been met. The Proposal Routing Form includes the following question:

Do you or anyone involved in this research with responsibility for the design, conduct or reporting of the research (including spouses/domestic partners and dependent children) have a financial or professional relationship with, or receive payment from, or have stock or stock options in the proposed sponsor, vendor(s) or subrecipient(s), or in a company that would be interested in the study results (but is not sponsoring the study)? If yes, an appropriate disclosure must be made.

In addition, all proposals being submitted to any sponsor from faculty appointed in the School of Medicine must be accompanied by a separate form, Disclosure of Financial Interests Related to Research, signed by the Principal Investigator.

All disclosures of such financial interests will be reviewed by the appropriate mechanism as established by each school dean, as required by Stanford's Faculty Policy on Conflict of Interest and Commitment.

AGENCY NOTIFICATIONS (PHS ONLY)

Upon receipt of an award from the Public Health Service, Stanford is obligated to notify the sponsoring institute or agency, prior to any expenditure of project funds, if a potential conflict has been identified in regard to THAT award. In addition, if a potential conflict is identified subsequent to the initial award of the project, Stanford will notify the sponsoring institute or agency within sixty days of that identification.

If a potential conflict of interest is identified at the time a proposal is submitted, and that proposal is subsequently awarded, or if a potential conflict is identified subsequent to the award of the project, the cognizant School Dean's office must prepare a brief notification to the administrative officer for the awarding agency. That notification is to consist of the following:

Re: Agency award number

Stanford University has identified a potential conflict of interest in regard to the subject proposal, and has taken appropriate action to manage, reduce or eliminate that conflict.

The Public Health Service does not require, nor does it want, any explanation of the details of the potential conflict situation.

The notification should be signed and transmitted by the Contract Officer in the Office of Sponsored Research, or by the appropriate administrator in a School Research Administration Office. A copy of the notification must be kept with the project records.

Note that this notification requirement applies only to the Public Health Service, including the National Institutes of Health (NIH).