[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR50.56]
[Page 290]
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.
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