Children who are wards of the state or any other agency, institution, or entity can
be included in research under §46.406 or §46.407 only if such research is:
Related to their status as wards; or
Conducted in schools, camps, hospitals, institutions, or similar settings in which
the majority of children involved as subjects are not wards.
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.