No expenditures of sponsored research funds will occur unless the COI disclosure has been reviewed and determined that no FCOI exists or that any identified FCOI is managed under a conflict of interest management plan.
If a FCOI is discovered that is related to PHS-funded research and is not timely identified or managed, or if an investigator fails to comply with a management plan, the member’s COI Official or designee must, within 120 days after determining noncompliance:
- Complete a retrospective review of the investigator’s research activities and any PHS-funded research project to determine if any PHS-funded research, or portion thereof, conducted during the period of noncompliance, was biased in the design, conduct or reporting of such research; and
- Implement any measures necessary, including but not limited to halting the investigator’s participation in any affected research project, to remediate the noncompliance between the date the noncompliance was identified and the date the retrospective review is completed.