[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2001]
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.