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GUIDANCE DOCUMENT

Frequently Asked Questions - IRB Registration Guidance for Institutional Review Boards (IRBs) July 2009

Final
Docket Number:
FDA-2009-D-0312
Issued by:
Guidance Issuing Office
Office of the Commissioner,Office of Clinical Policy and Programs,Office of Clinical Policy,Office of Good Clinical Practice

This guidance is intended to assist institutional review boards (IRBs) in complying with the new requirement for IRB registration.  (See 74 FR 2358 (Jan. 15, 2009))  This requirement is an amendment to Part 56, Institutional Review Boards, (21 CFR 56.106), that requires each IRB in the United States (U.S.) that reviews FDA-regulated studies to register.  IRB registration information is entered into an Internet-based registration system maintained by the Department of Health and Human Services (HHS).  This system is a modification of the one used by the Office for Human Research Protections (OHRP) for registration of IRBs that are designated by institutions under Federalwide Assurances (FWAs).  OHRP has issued a similar rule requiring IRBs designed under FWAs to register or update their registration information at this modified site.  (See 74 FR 2399 (Jan. 15, 2009))


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2009-D-0312.

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