The document outlines the processes and requirements for the timing and submission of Financial Conflict of Interest (FCOI) disclosures and reports in connection with NIH funding. It details that institutions must implement FCOI policies for each new grant or cooperative agreement after the compliance date, with the option to coordinate implementation across all Public Health Service (PHS) funded awards. Investigators are required to disclose significant financial interests (SFI) to their institutions, which must then review these disclosures, determine if an FCOI exists, and report any identified FCOIs to the NIH in a timely manner. These reports are mandated at several key points: initially prior to funding, within 30 days of acquiring or discovering a new SFI, within 60 days of identifying an FCOI, and annually in coordination with progress reports or extensions, all via the eRA Commons FCOI Module.
The institution’s reporting obligations extend to both initial and ongoing submissions. Initial disclosures pertain to any investigator SFI related to institutional responsibility at the time of application, with required public accessibility of FCOI information. For ongoing projects, newly participating investigators or newly disclosed SFIs must be assessed, managed, and reported within specified timeframes. The document also emphasizes procedures in scenarios involving non-compliance, such as untimely disclosures or failures in review, which necessitate retrospective reviews and, if necessary, mitigation actions and reports to the NIH. Additional requirements cover the handling of subrecipient disclosures and reporting, ensuring synchronized timelines for compliance. Annual FCOI reports must be submitted for previously reported conflicts, and institutions may need to update reports based on subsequent findings or reviews. Overall, the document underscores a comprehensive and structured FCOI management process to support transparency and integrity in NIH-funded research.
