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FDA Institutional Review Board Inspections Guidance For IRBs, Clinical Investigators, and Sponsors January 2006

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 provide information about FDA inspections of Institutional Review Boards (IRBs) conducted under FDA’s Bioresearch Monitoring (BIMO) Program. This document supersedes another document, "FDA Institutional Review Board Inspections," issued in September 1998, by the former Office of Health Affairs, FDA. This document has been revised to provide updated information and is being issued in accordance with the Agency’s regulations on Good Guidance Practices (21 CFR 10.115).

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.

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