The document summarizes key requirements and considerations related to Financial Conflict of Interest (FCOI) disclosures at the time of grant application, particularly focusing on the roles and responsibilities of investigators, subrecipients, and prime institutions in compliance with NIH regulations. It emphasizes the necessity for all investigators, including those from subrecipient organizations, to disclose Significant Financial Interests (SFI) at the application stage. The responsibilities for SFI disclosure and FCOI reporting can depend on whether the subrecipient or the prime institution’s policy prevails, which should be clarified through written agreements. If a subrecipient lacks an FCOI policy at application, disclosures are made to the prime institution, but the subrecipient’s policy can take precedence if developed before the award is granted. For foreign subrecipients without policies, the prime institution’s policy governs. Additionally, the document clarifies that preaward costs may be incurred; however, an FCOI report must be submitted to NIH before any expenditure of funds authorized under the award, specifically after issuance of the Notice of Award but before costs are charged. These provisions are aimed at ensuring regulatory compliance and transparency in NIH-funded research collaborations.
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