FDA has issued the final guidance, "IRB Continuing Review after Clinical Investigation Approval." This guidance is intended to assist institutional review boards (IRBs) in carrying out their continuing review responsibility under 21 CFR 56.108(a) and 56.109(f) by providing recommendations regarding the criteria, process, and frequency of continuing review to assure the protection of the rights and welfare of human subjects enrolled in clinical investigations. This guidance should also help clinical investigators and sponsors better understand their responsibilities related to continuing review.
To enhance human subject protection and reduce regulatory burden, the Department of Health and Human Services (HHS), Office for Human Research Protections (OHRP) and FDA have been actively working to harmonize the agencies’ regulatory requirements and guidance for human subject research. This guidance document was developed as a part of these efforts.
The document is now available using the following web link: