[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: 21CFR56.101]

[Page 300]
 
                        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. 56.101  Scope.


    (a) This part contains the general standards for the composition, 
operation, and responsibility of an Institutional Review Board (IRB) 
that reviews clinical investigations regulated by the Food and Drug 
Administration under sections 505(i) and 520(g) of the act, as well as 
clinical investigations that support applications for research or 
marketing permits for products regulated by the Food and Drug 
Administration, including foods, including dietary supplements, that 
bear a nutrient content claim or a health claim, infant formulas, food 
and color additives, drugs for human use, medical devices for human use, 
biological products for human use, and electronic products. Compliance 
with this part is intended to protect the rights and welfare of human 
subjects involved in such investigations.
    (b) References in this part to regulatory sections of the Code of 
Federal Regulations are to chapter I of title 21, unless otherwise 
noted.

[46 FR 8975, Jan. 27, 1981, as amended at 64 FR 399, Jan. 5, 1999; 66 FR 
20599, Apr. 24, 2001]