[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: 21CFR50.56]



[Page 289]

 

                        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.  50.56  Wards.



    (a) Children who are wards of the State or any other agency, 

institution, or entity can be included in clinical investigations 

approved under Sec.  50.53 or Sec.  50.54 only if such clinical 

investigations are:

    (1) Related to their status as wards; or

    (2) Conducted in schools, camps, hospitals, institutions, or similar 

settings in which the majority of children involved as subjects are not 

wards.

    (b) If the clinical investigation is approved under paragraph (a) of 

this section, the IRB must require appointment of an advocate for each 

child who is a ward.

    (1) The advocate will serve in addition to any other individual 

acting on behalf of the child as guardian or in loco parentis.

    (2) One individual may serve as advocate for more than one child.

    (3) The advocate must be an individual who has the background and 

experience to act in, and agrees to act in, the best interest of the 

child for the duration of the child's participation in the clinical 

investigation.

    (4) The advocate must not be associated in any way (except in the 

role as advocate or member of the IRB) with the clinical investigation, 

the investigator(s), or the guardian organization.