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 responsibility to conduct continuing review under 21 CFR 56.108(a) and 56.109(f) by providing recommendations regarding the criteria, process, and frequency of continuing review to ensure the protection of the rights and welfare of research participants enrolled in clinical investigations.
FDA has been working with the Office for Human Research Protections (OHRP) to harmonize their respective guidance documents. This guidance document was developed as a part of these efforts.
The document is now available here.
Their guidelines should be made clear and be regulated strictly. Their FDA consultants should also be very well knowledgeable with new rules and guidelines that they come up.
ReplyDelete