Are there special regulatory requirements for research involving children as subjects who are also wards?
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: • research approved by an IRB under 45 CFR 46.406; or • 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: • 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 • the IRB must require appointment of an advocate for eac
