[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR56.103]

[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 A--General Provisions
 
Sec. 56.103  Circumstances in which IRB review is required.

    (a) Except as provided in Secs. 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 Secs. 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]