[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR50.51]

[Page 293]
 
                        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. 50.51  Clinical investigations not involving greater than minimal risk.

    Any clinical investigation within the scope described in Secs. 50.1 
and 56.101 of this chapter in which no greater than minimal risk to 
children is presented may involve children as subjects only if the IRB 
finds and documents that adequate provisions are made for soliciting the 
assent of the children and the permission of their parents or guardians 
as set forth in Sec. 50.55.