Good Clinical Practice (GCP) Practice Exam

Which subpart of the HHS regulations provides additional protections for children?

1. Subpart A

2. Subpart B

3. Subpart C

4. Subpart D

The correct answer is: Subpart D

Subpart D of the HHS regulations specifically addresses additional protections for children involved in research. This subpart is crucial because children are considered a vulnerable population, and as such, they require enhanced safeguards to ensure their rights and welfare are protected throughout the research process. Subpart D outlines the requirements for institutional review boards (IRBs) when evaluating research that involves children. It includes stipulations related to the informed consent process, which must thoughtfully consider the children's developmental levels and capacities to provide assent. The regulations mandate that any research involving minors must adhere to ethical principles that prioritize their safety and benefit, reflecting the unique considerations necessary when working with this demographic. In this context, while other subparts may touch on various general protections and ethical considerations related to human subjects research, only Subpart D explicitly focuses on and delineates the additional protections necessary for children.