[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: 21CFR50.50]



[Page 287]

 

                        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.