Financial Conflicts of Interest (FCOI)

Financial Conflicts of Interest (FCOI)

The Public Health Service (PHS) issued updated conflict of interest regulations applicable to existing and new PHS-funded investigators in effect August 24, 2012 (click here) note: All Faculty and Staff must also be in compliance with the OU Board of Regents Conflict of Interest policy which can be found here.

Applies to:

  • PHS investigators include the Project Director/Principal Investigator, key personnel and anyone designated by the PD/PI as critical to the design, conduct, and reporting of research.
    • the PD/PI are responsible for identifying all Investigators as defined by the PHS guidelines
    • may include support staff
  • Applies to sub-investigators, sub-recipients, sub-grantees, collaborators, subcontractors, or consortium members and includes state flow-through.
  • PHS agencies include: HHS, NIH, CDC, FDA, AHRQ, HRSA, IHS, SAMHSA, ATSDR, ACF, & CMS

Critical changes:

  • Training requirements
    • All current PHS investigators must complete the financial conflict of interest training initially and repeat every 4 years.
    • The mandatory OUHSC training may be accessed here.
    • PHS regulations require that in order for spending to continue on active grants, all training must be completed by all investigators before the next Notice of Award for that project.
  • Travel Reporting:  If an outside organization reimburses you for travel expenses or pays your travel expenses directly, you must disclose the travel to the Office of Research
    • Note:  NIH travel is exempted and there are many other exceptions that are covered in the online training.
  • Subcontracts (Subrecipients)
    • Subrecipients must certify they are in compliance with PHS regulations.
  • Disclosure thresholds.  All Investigators must:
    • Disclose ALL outside Signficant Financial Interests (SFI) related to OUHSC responsibilities based on PHS SFI criteria
    • Disclose new interest/changes within 30 days to the Office of Research.
    • Significant financial interest threshold lowered to $5,000.
    • Note:  Investigators must disclose all Significant Financial Interests.  The Office of Research determines whether it’s a Conflict of Interest.
  • Reporting & Public Accessibility
    • All Financial Conflict of Interests must be made publicly available within 5 days of request.
    • Financial conflict of interests and management plans will be reported to the PHS Agency.

For more detailed information, click here.

If you have any questions, please don’t hesitate to contact us