U.S. Department of Health & Human Services
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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.
Last Reviewed: 12/01/2010
Related Questions:
- When must an advocate be appointed to oversee a child’s enrollment in research?
- What is the role of an advocate in research involving children?
- What categories of research involving children can an Institutional Review Board approve?
- What research involving children may an Institutional Review Board refer to the HHS Secretary for special review under 45 CFR 46.407?
- What should investigators do when considering changes to an exempt study that could make it nonexempt?
