The FDA recently put into place a new regulation that all IRBs within the U.S. reviewing FDA regulated studies be required to register with the FDA.
The following guidance is intended to assist IRBs in complying with the new requirement for IRB registration under amended 21 CFR 56.106, which is effective July 14, 2009. All IRBs should have been in compliance by September 14, 2009. Registration is accomplished through a modified version of the Internet-based registration system used by OHRP for registration of IRBs that are designated by institutions under FWAs. This guidance document addresses basic information, such as why FDA issued the new rule, which IRBs are subject to the new regulation, the type of information to be provided when registering, and implications of non-compliance.
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