[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR50.52]

[Page 294]
 
                        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. 50.52  Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects.

    Any clinical investigation within the scope described in Secs. 50.1 
and 56.101 of this chapter in which more than minimal risk to children 
is presented by an intervention or procedure that holds out the prospect 
of direct benefit for the individual subject, or by a monitoring 
procedure that is likely to contribute to the subject's well-being, may 
involve children as subjects only if the IRB finds and documents that:
    (a) The risk is justified by the anticipated benefit to the 
subjects;
    (b) The relation of the anticipated benefit to the risk is at least 
as favorable to the subjects as that presented by available alternative 
approaches; and
    (c) 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.