[Code of Federal Regulations]

[Title 45, Volume 1]

[Revised as of October 1, 2006]

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

[CITE: 45CFR46.409]



[Page 133-134]

 

                        TITLE 45--PUBLIC WELFARE

 

                    SUBTITLE A--DEPARTMENT OF HEALTH

                           AND HUMAN SERVICES

 

PART 46_PROTECTION OF HUMAN SUBJECTS--Table of Contents

 

 Subpart D_Additional Protections for Children Involved as Subjects in 

                                Research

 

Sec.  46.409  Wards.



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

institution, or entity can be included in research approved under Sec.  

46.406 or Sec.  46.407 only if such research is:

    (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 research is approved under paragraph (a) of this section, 

the IRB shall require appointment of an advocate for each child who is a 

ward, in addition to any other individual acting on behalf of the child 

as guardian or in loco parentis. One individual may serve as advocate 

for more than one child. The advocate shall be an individual who has the 

background and experience to act in, and agrees to act in, the best 

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

the research and who is not associated in any way (except in the role as 

advocate or member of the IRB) with the research,



[[Page 134]]



the investigator(s), or the guardian organization.