[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR50.50]
[Page 288]
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.
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