[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: 21CFR50.54]
[Page 289]
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. 50.54 Clinical investigations not otherwise approvable that present an
opportunity to understand, prevent, or alleviate a serious problem affecting
the health or welfare of children.
If an IRB does not believe that a clinical investigation within the
scope described in Sec. Sec. 50.1 and 56.101 of this chapter and
involving children as subjects meets the requirements of Sec. 50.51,
Sec. 50.52, or Sec. 50.53, the clinical investigation may proceed only
if:
(a) The IRB finds and documents that the clinical investigation
presents a reasonable opportunity to further the understanding,
prevention, or alleviation of a serious problem affecting the health or
welfare of children; and
(b) The Commissioner of Food and Drugs, after consultation with a
panel of experts in pertinent disciplines (for example: science,
medicine, education, ethics, law) and following opportunity for public
review and comment, determines either:
(1) That the clinical investigation in fact satisfies the conditions
of Sec. 50.51, Sec. 50.52, or Sec. 50.53, as applicable, or
(2) That the following conditions are met:
(i) The clinical investigation presents a reasonable opportunity to
further the understanding, prevention, or alleviation of a serious
problem affecting the health or welfare of children;
(ii) The clinical investigation will be conducted in accordance with
sound ethical principles; and
(iii) Adequate provisions are made for soliciting the assent of
children and the permission of their parents or guardians as set forth
in Sec. 50.55.
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gpo.gov/cfr_2007/aprqtr/21cfr50.54.htm
