The Financial Conflict of Interest Policy establishes guidelines for the disclosure of Significant Financial Interests and management of Financial Conflicts of Interests in PHS-funded research by the Institution. Definitions - Disclosure of significant financial interests means an Investigator's disclosure of significant financial interests to the Institution.
- Financial conflict of interest (FCOI) means a significant financial interest that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.
- Financial interest means anything of monetary value, whether or not the value is readily ascertainable.
- Investigator means the project director or principal Investigator 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, which may include, for example, collaborators or consultants.
- 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.
- PD/PI means a project director or principal Investigator of a PHS-funded research project.
- PHS means the Public Health Service of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority involved may be delegated, including the National Institutes of Health (NIH).
- Significant financial interest (SFI)means: A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator's spouse and dependent children) that reasonably appears to be related to the Investigator's institutional responsibilities:
- With regard to any publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. 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;
- With regard to any non-publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator's spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest); or
- Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
- The term significant financial interest does not include the following types of financial interests: salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution, including intellectual property rights assigned to the Institution and agreements to share in royalties related to such rights; any ownership interest in the Institution held by the Investigator, if the Institution is a commercial or for-profit organization; 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; income from seminars, lectures, or teaching engagements sponsored by a Federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education; or income from service on advisory committees or review panels for a Federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.
SFI Review Process Significant financial interests’ disclosure is in place to meet the requirements to promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, or reporting of research funded under PHS grants or cooperative agreements will be free from bias resulting from any conflicting financial interest of an investigator. Disclosure of FCOI is required when a significant financial interest (SFI) directly affects, or could appear to affect, the professional judgment of a researcher when designing, conducting, or reporting research. A "researcher" is someone: The Institution is responsible for: - Maintaining an up-to-date, written, enforced policy on financial conflicts of interest that is publicly accessible the public web site.
- Inform each Investigator of the Institution's policy on financial conflicts of interest, the Investigator's responsibilities regarding disclosure of significant financial interests, and of these regulations, and require each Investigator to complete training regarding the same prior to engaging in research related to any PHS-funded grant and at least every four years, and immediately when any of the following circumstances apply:
- The Institution revises its financial conflict of interest policies or procedures in any manner that affects the requirements of Investigators;
- An Investigator is new to an Institution; or
- An Institution finds that an Investigator is not in compliance with the Institution's financial conflict of interest policy or management plan.
How do I disclose? Significant financial interest (SFI) should be submitted to the Institution to the Executive Director (gabrielle.webster@physicianscientists.org). SFI submissions must include the following elements to complete the FCOI Report: - The name of the investigator with the FCOI
- The name of the entity with which the investigator has an FCOI
- The nature of the Significant Financial Interest (SFI)
- The value of the financial interest
- Description of how the financial interest relates to the NIH-funded research and the financial interest conflicts with such research
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