[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: 21CFR50.50]

[Page 294]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 50--PROTECTION OF HUMAN SUBJECTS--Table of Contents
 
Subpart D--Additional Safeguards for Children in Clinical Investigations
 
Sec. 50.50  IRB duties.

    Source: 66 FR 20598, Apr. 24, 2001, unless otherwise noted.


    In addition to other responsibilities assigned to IRBs under this 
part and part 56 of this chapter, each IRB must review clinical 
investigations involving children as subjects covered by this subpart D 
and approve only those clinical investigations that satisfy the criteria 
described in Sec. 50.51, Sec. 50.52, or Sec. 50.53 and the conditions of 
all other applicable sections of this subpart D.