Who may be advocates for children involved in research that are wards and how should they be appointed?
Each institution is likely to rely on a different process for appointing an advocate. In some cases it might be a member of the Institutional Review Board (IRB), a representative from an institution’s health advocacy or ombudsman’s office, or a case worker, social worker, or counselor responsible for the child’s rights and welfare. In some cases, state law or local practice might dictate who is responsible for appointing the advocate. In any case, the appointment should be made by a party or individual with no interest in or affiliation with the research being conducted. Investigators and IRBs should consult with their institution to determine the policies in procedures in place locally. IRBs should review and approve the process for appointing advocates.