[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: 21CFR50.51]
[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. 50.51 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.
http://a257.g.akamaitech.net/7/257/2422/26mar20071500/edocket.access.
gpo.gov/cfr_2007/aprqtr/21cfr50.51.htm
Should the health and future of anyone's sick child be left to the whims of some cold Review Board, stacked with proProfits power types? I can't think of a worse situation. This is so sad it's downright sickening.
Sec. 50.51 Clinical investigations not involving greater than minimal risk