[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: 21CFR50.51]



[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.  50.51  Clinical investigations not involving greater than minimal 

risk.



    Any clinical investigation within the scope described in Sec. Sec.  

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.