Wards

(a)

Children who are wards of the state or any other agency, institution, or entity can be included in research approved under ... [these regulations] 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 ... 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. (sec. 45 CFR 46.409)

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