Institutional Review Boards;Registration Requirements

• Date: November 22, 2009
• Source: www.fda.gov

The Food and Drug Administration (FDA, we) 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). The registration information includes contact information (such as addresses and telephone numbers), the number of active protocols involving FDAregulated products reviewed during the preceding 12 months, and a description of the types of FDA-regulated products involved in the protocols reviewed. The IRB registration requirements will make it easier for FDA to inspect IRBs and to convey information to IRBs

Effective Date:This rule is effective july 14, 2009

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