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Public Health Service (PHS) Financial Conflict of Interest Regulations

Mandate: The federal FCOI regulations require that Â鶹´«Ã½ take action to address all financial conflicts of interest, which can including 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 inappropriate bias  (42 C.F.R. §50.603)

  • Applicability:
    • PHS Proposed or Funded Research - The NIH  establish standards to be followed by each institution "that is applying for, or that receives PHS research funding by means of a grant or cooperative agreement and [that apply] to each Investigator who is planning to participate in, or is participating in, such research." PHS "Research" includes any activity "for which research funding is available from a PHS Awarding Component through a grant or cooperative agreement... such as a research grant, career development award, center grant, individual fellowship award, infrastructure award, institutional training grant, program project, or research resources award." (42 C.F.R. §§50.602-50.603)
    • List of PHS Agencies.
    • Exemptions. Phase I Small Business Innovation Research (SBIR) Program and Phase I Small Business Technology Transfer (STTR) Program applications are exempt from the PHS FCOI Regulations. (42 C.F.R. §§50.602-50.603)
    • Other Sponsor Funding.  Various non-governmental foundations and entities have adopted the PHS FCOI Regulations and/or used the PHS FCOI Regulations in their award terms.