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The HHS regulations at 45 CFR part 46, subpart D provide additional protections for children who are also wards of the State or any other agency, institution, or entity. These special protections for wards apply to two categories of research:

1. research approved by an IRB under 45 CFR 46.406; or
2. research approved in accordance with the requirements of 45 CFR 46.407 that requires a special level of HHS review beyond that provided by the Institutional Review Board (IRB).

As set out in 45 CFR 46.409, before children who are wards of the State or any other agency, institution, or entity can be included in either of the two categories of research referenced above, the research must meet the following conditions:

1. the research must be either related to the children’s status as wards; or conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children involved as subjects are not wards; and
2. the IRB must 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, and must 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. The advocate should represent the individual child subject’s interests throughout the child’s participation in the research. The HHS regulations further require that the advocate not be 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.

Last Reviewed: 01/20/2011

• 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?
• Who may be advocates for children involved in research that are wards and how should they be appointed?
• Are the exemptions different for research involving children?
• What is parental permission in the context of research involving children?

• Research with Children