Federal (PHS) Financial Conflict of Interest Disclosure/Certification Form
The U.S. Department of Health and Human Services (HHS) has issued a final rule in the Federal Register amending the Public Health Service (PHS) regulations on Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 CFR Part 50, Subpart F) and Responsible Prospective Contractors (45 CFR Part 94). An Institution applying for or receiving NIH (and other PHS agency*) funding from a grant, cooperative agreement, or contract must be in compliance with all of the revised regulatory requirements.
*Other PHS agencies include the Centers for Disease Control and Prevention (CDC), the Health Resources and Services Administration (HRSA), the Substance Abuse and Mental Health Services Administration (SAMHSA), the Food and Drug Administration (FDA) and the Agency for Healthcare Research and Quality (AHRQ), Administration for Children and Families, Administration on Aging, Agency for Toxic Substances and Disease Registry, Federal Occupational Health, and Indian Health Service.
It is mandatory that Principal Investigators, Co-Principal Investigators, Project Directors, and any other individuals with responsibility for the design, conduct, or reporting of research (“Investigators”) disclose Significant Financial Interests (“SFI”) of themselves, their spouse, and dependent children that reasonably appear to be related to the Investigator’s institutional responsibilities. Completion of the form is required prior to a PHS proposal being submitted.
(Note that this disclosure is separate from any disclosure required under the State of Florida Disclosure of Financial Interests, and the Florida State University Outside Employment Activity form).
Definitions:
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, including collaborators or consultants.
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:
1. With regard to a publically traded entity, a 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 for a single entity, exceeds $5,000. Remuneration in this section includes salary and any payment for services not otherwise identified as salary (such as 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 measure of fair market value;
2. With regard to any non-publically traded entity, a SFI exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated for a single entity, 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).
The term “significant financial disclosure” 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, 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, lecture, 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.
3. Intellectual property rights and interests (e.g. patents, copyrights), upon receipt of income related to such rights and interests, which exceed $5,000 from a single entity.
4. 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, an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education. The $5000 threshold applies for the reporting of travel.
Institutional Responsibilities means an Investigator’s professional responsibilities on behalf of the Institution such as research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Board or Data and Safety Monitoring Boards.
An Investigator’s SFI is related to PHS-funded research when the SFI could be affected by the PHS-funded research; or is in an entity whose financial interest could be affected by the research.