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Public Health Service (PHS) Financial Conflict of Interest Regulations

Mandate: The federal FCOI regulations require that USA 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.
    
    

• PHS-Funded Sub-award COI Management
  • View procedures and forms relating to COI management for PHS-funded sub-awards issued by the ºÚÁÏÌìÌà to another institution.
    
    
• USA COI in Research Policy
  • complies with PHS FCOI regulations
    
    
• USA COI in Research Procedures
  • complies with PHS FCOI regulations
    
    
• Guidance Documents
  • Guidance for determining if a financial COI is related to PHS-funded sponsored projects
    
  • Notification letter informing students/staff of potential conflict of interest
  • PHS Requirement to Disclosure Sponsored/Reimbursed Travel
    
    
• PHS Financial Conflict of Interest Certification Form - This certification form must be uploaded at the time of grant proposal via Cayuse. The form shall be updated any time additional individuals are identified at the time of proposal award or thereafter.
  
  
• FAQs:  National Institutes of Health has issued