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U.S. Department of Health and Human Services

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Institutional Review Boards – Restrictions Imposed Letters

Institutional Review Boards (IRBs) review clinical investigations regulated by the Food and Drug Administration (FDA) under sections 505(i) and 520(g) of the Federal Food, Drug, and Cosmetic Act, as well as clinical investigations that support applications for research or marketing permits for products regulated by the FDA.  FDA’s regulations in 21 CFR parts 50 and 56 set forth certain requirements for IRBs regarding their oversight of those clinical investigations.  An IRB’s compliance with the regulations is intended to protect the rights and welfare of human subjects involved in such investigations. 

When FDA has observed serious noncompliance by an IRB with the applicable regulations under 21 CFR 56.120, FDA may notify the IRB in writing of the noncompliance and require that the IRB respond.  In addition, until the IRB takes appropriate corrective action, FDA may impose restrictions on the IRB.  An Institutional Review Board – Restrictions Imposed Letter (Restrictions Letter) is a noncompliance letter issued under 21 CFR 56.120(a) that imposes restrictions on the IRB in accordance with 21 CFR 56.103 and 56.120(b). 

When FDA concludes, based on information available to FDA, that the IRB or institution has adequately addressed the noncompliance described in the Restrictions Letter, FDA will notify the IRB in writing that the restrictions have been lifted.

To search for previously posted letters in which FDA has imposed restrictions in accordance with 21 CFR 56.103 and 56.120(b), see the Warning Letters webpage.

IRB Restrictions Imposed Letters

 IRBCenterDate IRB Restrictions Imposed Letter IssuedIRB Restrictions LetterIRB Restrictions Lifted
Burzynski Research Institute – Institutional Review Board (BRI IRB)
9432 Katy Freeway, Suite 105
Houston, Texas  77055
 CDER 09/23/2013 Letter (PDF - 160KB)April 11, 2014
 Texas Applied Biomedical Services
12101 Cullen Boulevard, Suite A
Houston, Texas 77048
CBER 09/24/2012
(issued as a Warning Letter)
Letter