U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Frequently Asked Questions - IRB Registration
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

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

Download the Final Guidance Document
Final
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

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

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 comments should be identified with the title of the guidance.

Back to Top