PHS Requirement to Disclose Significant Financial Interest
The Public Health Service (PHS) requires disclosure of significant financial interests by investigators who participate in PHS-funded research either directly or via subaward. Other funding entities, e.g., Administration for Children and Families, Alliance for Lupus Research, American Cancer Society, American Heart Association, American Lung Association, Arthritis Foundation, Juvenile Diabetes Research Foundation, Lupus Foundation of America, Susan G. Komen for the Cure, and CurePSP, have also adopted the PHS requirements.
What is filed: A PHS Financial Disclosure (Form 1), completed and signed by each member of the research team who meets the PHS definition of investigator, submitted with the proposal to the Sponsored Projects Office.
Who Files: All Principal Investigators, project directors, senior/key personnel, and any others, e.g. postdocs, who are responsible for the design, conduct or reporting of PHS-funded research in a substantive, measurable way, whether or not they receive salary or other remuneration.
When are disclosures filed: A PHS Financial Disclosure (Form 1) is filed at the time a proposal is submitted to the Sponsored Projects Office, at least annually at the time of submission of the progress report/non-competing continuation, and within 30-days of acquiring or discovering a new significant financial interest; a PHS Financial Disclosure (Form 2) is filed at the time of a JIT request or progress report/non-competing continuation by those with “yes” responses on the Form 1; a PHS Financial Disclosure (Form 3) is filed by any investigator who is requested to do so by the COI Coordinator. The Form 1 disclosure must accompany the proposal submitted to the Sponsored Projects Office.
What is disclosed: All investigators must disclose the value of any remuneration from a publicly-traded entity in the 12 months preceding financial disclosure and any equity interest owned or acquired as of the date of disclosure which exceeds $5000 when aggregated for the investigator, spouse, registered domestic partner or dependent children; the value of any remuneration received from a non publicly-traded entity which when aggregated exceeds $5,000; any equity interest held in a non publicly-traded entity by the investigator, spouse, registered domestic partner or dependent children regardless of value; any payments exceeding $5,000 received within the past 12 months for any intellectual property interests assigned or licensed to any party other than the UC Regents; any travel reimbursement or payment in excess of $5,000 per entity made by any entity other than a U.S. Federal, state, or local government agency, institution of higher education, academic teaching hospital, medical center, or research institute affiliated with a U.S. institute of higher education, regardless of value.
Managing related significant financial interest: The UCB faculty Conflict of Interest (COI) Committee reviews all positive financial disclosures where the disclosed financial interest is related to the PHS research and takes any necessary steps to manage, reduce or eliminate any conflicts of interest before approval is granted. The COI Coordinator is responsible for reporting financial conflicts of interest to PHS in accordance with the regulations. Approval of the COI Committee is required before any awards are set up by the Sponsored Projects Office.