[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR50.53]

[Page 286]
 
                        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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