The provisions of Subpart D, of the HHS regulations, Additional Protections for Children Involved as Subjects in Research apply
to: a. All research that is more than minimal risk b. All research involving children c. All research funded by HHS d. All research funded by any federal agency
When you take a look at the HHS Regulation, 45 CFR part 46, in the provisions of subpart D, Additional Protections for Children Involved as Subjects in Research, this applies to every study that involves children and are supported or conducted by HHS, and requires an IRB review which is in line with the provision of subpart D in the about regulation.
