Question

The provisions of Subpart D, of the HHS regulations, Additional Protections for Children Involved as Subjects in Research apply to:

All research involving children


All research that is more than minimal risk


All research funded by any federal agency


All research funded by HHS

Answer 1

All research funded by HHS

Step-by-step explanation:

The provisions of Subpart D must be applied to all research funded by the HHS (which includes NIH). However, not all federal agencies that have adopted the Common Rule have also adopted Subpart D. In addition to HHS, only the U.S. Food and Drug Administration and the Department of Education have adopted it. Institutions may elect to apply the subpart to all research, regardless of the source of funding.

Answer 2

The correct answer is A) "All research involving children".

The HHS (Office for Human Research Protections) is a regulatory entity of the US government. The provisions presented in subpart D of the mentioned regulations divide all research involving children in 3 categories:

1. Research not involving greater than the minimal risk to the children.
2. Research involving greater than minimal risk but presenting the prospect of direct benefit to the child involved in the research.
3. Research involving greater than minimal risk and presenting no prospect of direct benefit to the child involved in the research.