Wards. (a) Children who are wards of the State or any other agency, institution, or entity can be included in clinical in- vestigations approved under § 50.53 or § 50.54 only if such clinical investiga- tions are: (1) Related to their status as wards; or (2) Conducted in schools, camps, hos- pitals, institutions, or similar settings in which the majority of children in- volved as subjects are not wards. (b) If the clinical investigation is ap- proved under paragraph (a) of this sec- tion, the IRB must require appoint- ment of an advocate for each child who is a ▇▇▇▇. (1) The advocate will serve in addi- tion to any other individual acting on behalf of the child as guardian or in loco parentis. (2) One individual may serve as advo- cate for more than one child. (3) The advocate must be an indi- vidual who has the background and ex- perience to act in, and agrees to act in, the best interest of the child for the duration of the child’s participation in the clinical investigation. (4) The advocate must not be associ- ated in any way (except in the role as advocate or member of the IRB) with the clinical investigation, the investi- gator(s), or the guardian organization.
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Sources: Agreement on Mutual Recognition, Agreement on Mutual Recognition Between the United States of America and the European Community