The FDA regulations governing disclosure of individual conflicts of interest (COIs) require applicants submitting marketing applications for drugs, biologics, or devices to disclose financial COIs of researchers who conducted clinical studies covered by the regulation. These disclosures must be made to ensure transparency and maintain integrity in the clinical research and approval process. Failure to disclose such financial interests can lead to the FDA refusing to file the application or other legal consequences. The disclosure is intended to assess and mitigate any risks to the rights, safety, or well-being of human subjects involved in research.
Specifically, organizations must disclose any financial COIs to the FDA no later than the time of submission of the Investigational New Drug (IND) application. Applicants must certify either the absence of certain financial interests or disclose these interests if they exist. These regulations apply to researchers, sponsors, and applicants involved in the drug approval process.
In summary, the key points of FDA regulations for individual COI disclosure are:
- Disclosure of financial conflicts by researchers conducting clinical studies.
- Disclosure required at the time of IND application submission or marketing application.
- The FDA may refuse to file applications lacking proper COI disclosures.
- The purpose is to protect human subjects and ensure research integrity.
