[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR56.121]
[Page 302]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 56 INSTITUTIONAL REVIEW BOARDS--Table of Contents
Subpart E Administrative Actions for Noncompliance
Sec. 56.121 Disqualification of an IRB or an institution.
(a) 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 Sec. 56.120(a), and the Commissioner of Food and Drugs
determines that this noncompliance may justify the disqualification of
the IRB or of the parent institution, the Commissioner will institute
proceedings in accordance with the requirements for a regulatory hearing
set forth in part 16.
(b) The Commissioner may disqualify an IRB or the parent institution
if the Commissioner determines that:
(1) The IRB has refused or repeatedly failed to comply with any of
the regulations set forth in this part, and
(2) The noncompliance adversely affects the rights or welfare of the
human subjects in a clinical investigation.
(c) 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. The Food and Drug Administration will send notice of the
disqualification to the IRB and the parent institution. Other parties
with a direct interest, such as sponsors and clinical investigators, may
also be sent a notice of the disqualification. In addition, the agency
may elect to publish a notice of its action in the Federal Register.
(d) The Food and Drug Administration will not approve an application
for a research permit for a clinical investigation that is to be under
the review of a disqualified IRB or that is to be conducted at a
disqualified institution, and it may refuse to consider in support of a
marketing permit the data from a clinical investigation that was
reviewed by a disqualified IRB as conducted at a disqualified
institution, unless the IRB or the parent institution is reinstated as
provided in Sec. 56.123.
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