PRO-U4520.06A Reporting Financial Conflict of Interest By Public Health Services-Funded (PHS) Investigators
Action By:
Investigator
- New Investigators disclose Significant Financial Interests (SFI) prior to submission of Public Health Services-funded (PHS) proposals.
- Investigators disclose SFIs to RSP by January 15th of each calendar year.
RCO
- The RCO reviews all SFIs within 30 days of disclosure and determines whether the Significant Financial Interest constitutes a Financial Conflict of Interest (FCOI).
- If the RCO determines a FCOI exists, the RCO reports the FCOI to the Financial Conflict of Interest Committee (FCOI Committee).
FCOI Committee
- The FCOI Committee reviews the research, the financial interests in question, and the areas of conflict and create a management plan. The management plan may include conditions or restrictions to manage, reduce or eliminate the FCOI. The plan may include (but are not limited to) monitoring the research by independent reviewers, modification of the research plan, disqualification of participation in the portion of the federally-funded research that would be affected by FCOI, divestiture of the Significant Financial interest, severance of relationships that create conflicts, or public disclosure of the FCOI.
- The FCOI Committee reports its determination and the management plan to the Investigator and the RCO.
- The FCOI Committee consults with Investigator as to implementation of the management plan; the Investigator must agree to the plan before the research can proceed.
Investigator
- Implements management plan or appeals committee determination to the Institutional Official (IO).
- Investigator may appeal the finding to the IO, if Investigator objects to the findings of financial conflict of interest or objects to the management plan proposed by the FCOI Committee. The Investigator must file the appeal within 15 days of the FCOI Committee’s finding.
IO
- IO reviews the evidence, the RCO’s determination of a FCOI and the FCOI Committee’s management plan and determines whether to uphold the finding or reverse it.
Investigator
- Implements management plan upheld by the IO or continues research if no financial conflict of interest is found.
RSP
- RSP will report all financial conflicts of interest to NIH within 60 days of discovery. The disclosure will include the name of the Investigator, the source of the FCOI, the amount of the FCOI, and the management plan.
- RSP will post all FCOIs on the Institution’s website within 5 days of the finding of the Committee. The posting will include the Investigator’s name, the source of the FCOI, the amount of the FCOI, and the management plan.
Investigator
- Investigator reports all newly acquired SFIs that may relate to their field of research and their obligations to the Institution to the RCO within 30 days of acquisition.
Procedure Information
Approved By:
Vice President for Academic Affairs
Effective Date:
August 4, 2012
Procedure Contact
Research and Sponsored ProgramsPhone: (360) 650-3220