[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: 21CFR50.53]
[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. 50.53 Clinical investigations involving greater than minimal risk and
no prospect of direct benefit to individual subjects, but likely to yield
generalizable knowledge about the subjects' disorder or condition.
Any clinical investigation within the scope described in Sec. Sec.
50.1 and 56.101 of this chapter in which more than minimal risk to
children is presented by an intervention or procedure that does not hold
out the prospect of direct benefit for the individual subject, or by a
monitoring procedure that is not likely to contribute to the well-being
of the subject, may involve children as subjects only if the IRB finds
and documents that:
(a) The risk represents a minor increase over minimal risk;
(b) The intervention or procedure presents experiences to subjects
that are reasonably commensurate with those inherent in their actual or
expected medical, dental, psychological, social, or educational
situations;
(c) The intervention or procedure is likely to yield generalizable
knowledge about the subjects' disorder or condition that is of vital
importance for the understanding or amelioration of the subjects'
disorder or condition; and
(d) Adequate provisions are made for soliciting the assent of the
children and permission of their parents or guardians as set forth in
Sec. 50.55.
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