Financial Conflict of Interest (FCOI)

Throughout the Manage stage Investigators participating in research under a Conflict Management Plan should be ensuring the work performed is being done consistent with any imposed conditions or restrictions. In cases where a Significant Financial Interest (SFI) that represents a Financial Conflict of Interest (FCOI) with PHS-Sponsored research is not reported, an Investigator does not comply with the terms of an issued management plan, or the institution fails to manage a conflict in a timely manner; a Retrospective Review of the research may be required to determine whether bias was introduced in the design, conduct, or reporting of the research as a result of the unmanaged conflict.

 Roles

• Investigators are responsible for completing FCOI training once every four years and for timely reporting of their SFI in the Financial Interest Disclosure System (FIDS).
• Investigators are responsible for complying with the terms of the Conflict Management Plans issued to them and for updating SFI disclosures within 30 days of a new or changed SFI.
• For studies involving Human Subjects, Investigators are responsible for disclosing their FCOI to the relevant IRB. Unsponsored IRB activities may require special review.

 Plan/Act

• If you have been issued a Conflict Management Plan, be sure you understand the terms and can comply with the plan and still fulfill the research aims. If you’re unsure or have questions, work with the Office of Research to establish a management plan that mitigates the risk and doesn’t unduly burden the research.
• Remember to disclose FCOIs in any publication or presentation which cites the funding source for which your conflict has been identified. Contact the Office of Research for details or sample language for these disclosures.
• Implement internal controls or tracking to ensure Investigators with FCOI are participating in research as approved.