[Code of Federal Regulations]

[Title 21, Volume 1]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR50.53]



[Page 287]

 

                        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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