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Financial Conflict of Interest Procedures: US Public Health Service

Who is this for?

The financial conflict of interest (FCOI) procedures apply only to those 17cÆð²ÝÉçÇø investigators who apply for or choose to participate in research funded by the United States Public Health Service (USPHS or PHS) sponsoring agencies, such as the National Institutes of Health (NIH), and only to their research activities that are funded by these agencies.

Background

The USPHS, as well as some other US sponsoring agencies, require all awardee universities and investigators, including those outside the US, to comply with the requirements of the US federal PHS regulations on FCOIs (i.e., and ) as a condition of the award.

These regulations require that participating investigators be trained in the regulations and disclose to 17cÆð²ÝÉçÇø their significant financial interests. 17cÆð²ÝÉçÇø is required to:

  • Review disclosed significant financial interests to determine whether they constitute FCOIs.
  • Manage any FCOIs and report them to the sponsoring agency.
  • Monitor and enforce investigator compliance with the regulations.
  • Maintain records and make certain information publicly accessible.

17cÆð²ÝÉçÇø has established procedures for investigators and the institution under 17cÆð²ÝÉçÇøâ€™s Policy on Research Integrity.

Resources

Contact

Please contact researchservices@torontomu.ca if you wish to declare an FCOI in relation to USPHS funding or if you have any questions about 17cÆð²ÝÉçÇøâ€™s FCOI procedures for the USPHS.

When to complete FCOI Training and a Financial Interests Report

The must be completed within the following timeframes:

  • Initially, at the time of any application for NIH funding, whether directly to NIH or through another institution as a co-investigator.
  • Refresher FCOI training is also required every 4 years for active NIH funding recipients.

 (PDF file) Financial Interests Report must be completed and submitted within the following timeframes: 

  • Initially, at the time of any application for NIH funding, whether directly to NIH or through another institution as a co-investigator.
  • At a minimum, annually, within the term of an existing grant or sub-award.
  • Within 30 days of any new significant financial interest or change in status of any investigator’s financial interests within the term of an existing grant or sub-award.

How to complete a Financial Interests Report

  1. Provide a list of all investigators on the project, including any subrecipient(s).
  2. Ensure all investigators at 17cÆð²ÝÉçÇø have signed and submitted a Financial Interests Report.
  3. Ensure an authorized official of the subrecipient has signed and submitted their institution's Subrecipient External Investigator Institutional Declaration form to the OVPRI contact above.
  4. Where a subrecipient external investigator opts to follow 17cÆð²ÝÉçÇøâ€™s FCOI policy, they must submit a Financial Interests Report to the OVPRI.