Financial conflict of interest policy to meet U.S. Dept of Health and Human Services and Public Health Services Regulations
The PolicyThis policy consists of a set of requirements to be followed by senior and key personnel participating in research funded by a Public Health Service (PHS) funder, most notably the National Institutes of Health (NIH).
The policy applies to any institution (foreign or U.S. domestic) that is applying for or receives research funding from a PHS funder through a grant or cooperative agreement (either directly or via another institution as a sub-awardee) and, consequently, any investigator planning to or who is already participating in such research.
- All Investigators must disclose any Significant Financial Interest (SFI) with respect to their Institutional Responsibilities to the Institute Director who will determine whether such interest constitutes a Financial Conflict of Interest (FCOI).
- Where an SFI is determined to be an FCOI, a management plan will be drawn up to help manage, reduce or eliminate the FCOI.
- A disclosure of the FCOI and management plan must be submitted to the PHS-funder.
- Adherence to the management plan must be monitored.
- All PHS-funded Investigators are required to take training on conflicts of interest
- Annual (and in some circumstances more regular) reporting of FCOIs to the PHS-funder is required.
- Before any expenditure of PHS funds, information concerning any disclosed SFI which has been determined to be an FCOI relating to PHS-funded research, must be made publicly accessible by written response within 5 working days of request.
- See also Key Definitions below
This policy is drawn from the original HSS regulations:
Title 42 – Public Health, Part 50– Policies of General Applicability, Subpart F – Promoting Objectivity in Research
- Investigator is defined as 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. To ensure personnel are correctly identified for the purpose of policy compliance, consider the role of those involved rather than their title and the degree of independence with which they work.
- Institutional Responsibilities are defined as an Investigator's professional responsibilities on behalf of the institution, e.g. research, research consultancy, teaching, professional practice, University committee memberships, service on panels such as ethical review boards.
- A Financial Conflict of Interest exists when the institution, through its Designated Official (see below) reasonably determines that an Investigator's Significant Financial Interest is related to a PHS-funded research project and could directly and significantly affect the design, conduct or reporting of the PHS-funded research.
- A Significant Financial Interest is:
- 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:
(i) 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;
(ii) 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
(iii) Intellectual property rights and interests (e.g. patents, copyrights), upon receipt of income related to such rights and interests.
- Investigators also must disclose the occurrence of any reimbursed or sponsored travel (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, 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. The Institution's FCOI policy will specify the details of this disclosure, which will include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. In accordance with the Institution's FCOI policy, the institutional official(s) will determine if further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes an FCOI with the PHS-funded research.
- 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