[Code of Federal Regulations]

[Title 21, Volume 1]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR56.121]



[Page 300-301]

 

                        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.



[[Page 301]]



    (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.