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QRTI Newsline --- Wednesday September 8, 2010

Institutional Review Boards Registration Requirements

By Phyllis B. Kent

The Food and Drug Administration (FDA) is issuing a final rule to require institutional review boards (IRBs) to register through a system maintained by the Department of Health and Human Services (HHS).

FDA has never compiled a comprehensive list of IRBs involved in reviewing clinical investigations. Existing FDA regulations have required some, but not all, clinical investigators or sponsors to provide IRB names and addresses to FDA, and the requirements differ slightly among the different types of products regulated by FDA

FDA's goals in requiring IRB registration are to

Enable identification of those IRBs reviewing clinical investigations regulated by FDA;
Enable FDA to send educational information and other information to IRBs;
Help us identify IRBs for inspection;
Create a simple, electronic registration system that all IRBs, regardless of whether they review clinical investigations regulated by FDA or federally supported research, can use; and
To allow for voluntary registration by foreign IRBs and by any domestic IRB that is not otherwise required to register.

The registration information includes contact information (such as addresses and telephone numbers), 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. This rule is effective July 14, 2009. All IRBs must comply with the initial registration requirement and, if necessary, make required revisions to their registrations by September 14, 2009.

FOR FURTHER INFORMATION CONTACT: Erik Mettler, Office of Policy, Planning and Preparedness, Food and Drug Administration, WO1, rm. 4324,

Silver Spring, MD 20993-0002, 301-796-4830.