[Code of Federal Regulations]

[Title 34, Volume 1]

[Revised as of July 1, 2006]

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

[CITE: 34CFR97.409]



[Page 313]

 

                           TITLE 34--EDUCATION

 

PART 97_PROTECTION OF HUMAN SUBJECTS--Table of Contents

 

  Subpart D_Additional ED Protections for Children Who Are Subjects in 

                                Research

 

Sec.  97.409  Wards.



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

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

97.406 or Sec.  97.407 only if that 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 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 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 research and who is not associated in any way (except in the role as 

advocate or member of the IRB) with the research, the investigator or 

investigators, or the guardian organization.



(Authority: 5 U.S.C. 301; 20 U.S.C. 1221e-3, 3474; and 42 U.S.C. 300v-

1(b))