[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR50.54]

[Page 317]
 
                        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.