FDA IRB Registration Regulation: Effective Date July 14, 2009

By Anne Marie Murphy –

FDA’s final rule requiring IRBs that review FDA-regulated clinical investigations to register through a system maintained by the Department of Health and Human Services (“HHS”) takes effect on Tuesday, July 14, 2009.  In the Federal Register notice announcing the final rule, FDA explained that the IRB registration will help the agency “identify more precisely those IRBs reviewing clinical investigations regulated by FDA . . . send education information and other information to IRBs . . . [and] identify IRBs for inspection.”  The required registration information includes contact information, the number of active protocols involving FDA-regulated products reviewed during the preceding 12 months, and a description of the types of FDA-regulated products involved in the protocols reviewed. 

Previously, registration was required by HHS through the Office for Human Research Protections (“OHRP”) for IRBs that reviewed federally-funded research.  IRBs that review FDA-regulated studies and that are not already registered with OHRP will now be required to submit an initial registration.  IRBs already registered in the OHRP system must update their registrations to include all of the information required by the new rule.  IRBs have until September 14, 2009 to submit an initial registration or update an existing registration.  The database used by OHRP was modified to accomplish the new registration requirements.  A guidance document on the new registration requirements is expected soon.