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  6. Institutional Review Boards – Restrictions Imposed Letters and Disqualification Proceedings
  1. Clinical Investigations Compliance & Enforcement

Institutional Review Boards – Restrictions Imposed Letters and Disqualification Proceedings

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.

Restrictions Letter. When, during an inspection, FDA has observed apparent noncompliance by an IRB with the applicable regulations, FDA may notify the IRB and the parent institution in writing of the noncompliance (e.g., Warning Letter, Restrictions Letter) and require that the IRB or parent institution respond to the letter within a time period specified by FDA and describe the corrective actions that will be taken by the IRB, the institution, or both to achieve compliance with the regulations. (21 CFR 56.120(a)) In addition, until the IRB or institution takes appropriate corrective action, FDA may impose restrictions on the IRB. (21 CFR 56.120(b)) An Institutional Review Board – Restrictions Imposed Letter (Restrictions Letter) is a noncompliance letter issued under 21 CFR 56.120(a) that imposes such restrictions on the IRB. See 21 CFR 56.103, 56.110(d), and 56.120(b).

Based on information provided by the IRB or institution, FDA may remove the restrictions imposed in the Restrictions Letter.

Whenever the IRB or the institution has failed to take adequate steps to correct the noncompliance stated in the letter sent by the agency under 21 CFR 56.120(a), and the Commissioner determines that this noncompliance may justify the disqualification of the IRB or the parent institution, the Commissioner will institute disqualification proceedings in accordance with the requirements for a regulatory hearing set forth in 21 CFR part 16. (21 CFR 56.121(a))

Notice of Opportunity for Hearing (NOOH).The NOOH provides the IRB with the opportunity for a regulatory hearing on the proposed disqualification action before a presiding officer designated by the Commissioner, as described in 21 CFR part 16. The IRB or institution may request a hearing or decline the opportunity for a hearing. In declining the hearing, the IRB or institution may request in writing that the agency make a determination based on the available information.

Disqualification of an IRB. The Commissioner may disqualify an IRB or the parent institution if the Commissioner determines, per 21 CFR 56.121(b), that:

  1. The IRB has refused or repeatedly failed to comply with any of the applicable regulations, and
  2. The noncompliance adversely affects the rights or welfare of the human subjects in a clinical investigation.

If the Commissioner determines that disqualification is appropriate, the Commissioner will issue an order that explains the basis for the determination and that prescribes any actions to be taken with regard to ongoing clinical research conducted under the review of the IRB. FDA will send notice of the disqualification to the IRB and the parent institution. (21 CFR 56.121(c))

The table below lists the dates that actions were taken by the FDA for each IRB listed. Clicking on these dates will allow the user to view the regulatory correspondence issued to the IRB by the FDA. 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 Name Status & Date Restrictions Imposed Restrictions Removed NOOH Presiding Officer's Report Commissioner's Decision Disqualification Order
Advanced Magnetic Research Institute Restricted 07/10/2017 07/10/2017 N/A N/A N/A N/A N/A
American Association of Acupuncture and Bio-Energetic Medicine (AAABEM)
c/o Institute of Bio-Energetic Medicine		 Restricted 11/14/2013 11/14/2013 N/A N/A N/A N/A N/A
Burzynski Research Institute – Institutional Review Board (BRI IRB) Restrictions removed 04/11/2014 09/23/2013 04/11/2014 N/A N/A N/A N/A
Inland Institute of Aesthetic Dentistry IRB Restricted 05/13/2015 05/13/2015 N/A N/A N/A N/A N/A
Texas Applied Biomedical Services (TABS) Research Review Committee (RRC) IRB Disqualified 02/29/2016 09/25/2012
(Issued as a Warning Letter)		 N/A 09/16/2014 N/A 02/29/2016 02/29/2016

 

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