(a) Children who are wards of the state or any other agency, institution, or
entity can be included in research approved under §46.406 or §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.