FDA recently issued a new procedural guidance on IRB continuing review of previously approved research. Finalized in February 2012, this guidance supersedes the 1998 Information Sheet guidance on continuing review and reflects an ongoing effort to harmonize FDA’s regulatory requirements and guidance with those of OHRP.
The updated guidance is recommended reading for IRB members and professionals, investigators, research personnel and administrators overseeing human subject research. Look for a more in-depth review in a future edition of the InfoEdge newsletter.
