[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: 21CFR50.54]



[Page 288]

 

                        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.