[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: 21CFR56.103]



[Page 295]

 

                        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 A_General Provisions

 

Sec.  56.103  Circumstances in which IRB review is required.



    (a) Except as provided in Sec. Sec.  56.104 and 56.105, any clinical 

investigation which must meet the requirements for prior submission (as 

required in parts 312, 812, and 813) to the Food and Drug Administration 

shall not be initiated unless that investigation has been reviewed and 

approved by, and remains subject to continuing review by, an IRB meeting 

the requirements of this part.

    (b) Except as provided in Sec. Sec.  56.104 and 56.105, the Food and 

Drug Administration may decide not to consider in support of an 

application for a research or marketing permit any data or information 

that has been derived from a clinical investigation that has not been 

approved by, and that was not subject to initial and continuing review 

by, an IRB meeting the requirements of this part. The determination that 

a clinical investigation may not be considered in support of an 

application for a research or marketing permit does not, however, 

relieve the applicant for such a permit of any obligation under any 

other applicable regulations to submit the results of the investigation 

to the Food and Drug Administration.

    (c) Compliance with these regulations will in no way render 

inapplicable pertinent Federal, State, or local laws or regulations.



[46 FR 8975, Jan. 27, 1981; 46 FR 14340, Feb. 27, 1981]