[Code of Federal Regulations] [Title 45, Volume 1] [Revised as of October 1, 2003] From the U.S. Government Printing Office via GPO Access [CITE: 45CFR46.409] [Page 128] TITLE 45--PUBLIC WELFARE 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, the investigator(s), or the guardian organization.