Is it True That There are Special Requirements for Addressing FCOI in Clinical Research?

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Yes. In any case in which HHS determines that an NIH-funded clinical research project’s purpose is evaluating the safety or effectiveness of a drug, medical device, or treatment, and that intervention has been designed, conducted, or reported by an investigator with a conflicting interest that was not managed or reported by the grantee organization as required by the regulation, then the grantee organization must require the investigator(s) involved to disclose financial conflict of interest in each public presentation of the results of the research, and by requesting an addendum to previously-published presentations. Your grantee organization’s financial conflict of interest policy may contain additional requirements, so be sure to check with the appropriate official at your institution for additional guidance.

For more information on financial conflict of interest, visit the FCOI web page and our list of frequently asked questions about FCOI.

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