Financial Conflict of Interest Procedures: US Public Health Service
Who is this for?
The financial conflict of interest (FCOI) procedures apply only to those TMU 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., Promoting Objectivity in Research (external link) and Responsible Prospective Contractors (external link) ) as a condition of the award.
These regulations require that participating investigators be trained in the regulations and disclose to TMU their significant financial interests. TMU 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.
TMU has established procedures for investigators and the institution under TMU’s Policy on Research Integrity.
Resources
Contact
Please contact Sanja Obradovic if you wish to declare an FCOI in relation to USPHS funding or if you have any questions about TMU’s FCOI procedures for the USPHS.
When to complete FCOI Training and a Financial Interests Report
The FCOI Training Tutorial (external link) 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.
A (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
- Provide a list of all investigators on the project, including any subrecipient(s).
- Ensure all investigators at TMU have signed and submitted a Financial Interests Report.
- 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.
- Where a subrecipient external investigator opts to follow TMU’s FCOI policy, they must submit a Financial Interests Report to the OVPRI.