Conflict of Interest for Public Health Service Agencies (NIH, CDC, FDA)

Researchers, who are funded by a Public Health Services Agency (PHS) (see 42 C.F.R. §50.603) must comply with detailed, strict financial conflict of interest regulations. The Department of Health and Human Services enacted the regulations in 2011 to promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under PHS grants, cooperative agreements, or contracts will be free from bias resulting from Investigator financial conflicts of interest.

The PHS agencies are (1) the Agency for Healthcare Research and Quality (AHRQ), (2) the Agency for Toxic Substances and Disease Registry (ATSDR), (3) the Centers for Disease Control and Prevention (CDC), (4) the Food and Drug Administration (FDA), (5) the Health Resources and Services Administration (HRSA), (6) the Indian Health Service (IHS), (7) the National Institutes of Health (NIH), and (8) the Substance Abuse and Mental Health Services Administration (SAMHSA).

The financial conflict of interest (FCOI) regulations are applicable to each Institution that is applying for, or that receives, PHS research funding by means of a grant, cooperative agreement, or contract and, through WHOI’s implementation of these regulations, applies to every project director or principal investigator and any other person, regardless of title or position, who is involved in the design, conduct or reporting of the PHS research project, or is proposed for such funding, which may include, for example, collaborators or consultants.

WHOI’s  COI/COC Policy and Addendum to COI for PHS research  incorporate the standards and requirements of the regulations in mandatory disclosures. WHOI’s COI/COC Disclosure System incorporates all disclosure requirements and elements the regulations establish. Complete disclosure made in compliance with these policies and entered into WHOI’s COI/COC Disclosure System enables WHOI and Investigators to meet the responsibilities imposed under the regulations. Elements of the regulations implemented and required under WHOI’s policies include, among others:

• Mandatory conflict of interest training and periodic renewal.
• Broad mandatory disclosure of all financial interests that relate to an individual’s institutional responsibilities, including remuneration from nonprofit entities and sponsored travel.
• A threshold of $5,000 for “financial interests” as defined in WHOI’s COI/COC Policy and policy addendum, “WHOI Addendum to COI for PHS research”.
• Prior to submitting each PHS proposal, disclose the Investigator’s (and Close Relatives’) financial interests and update the disclosure annually or within 30 days of changes.
• Prior to expenditure of any funds under a PHS-funded research project,  WHOI reviews and manages with a management plan as necessary any financial conflict of interest and reports any financial conflict of interest and the associated management plan to the PHS agency.
• Identification, review, management, and reporting to the PHS agency of any financial conflict of interest not timely disclosed or not timely reviewed, managed, and reported.