What do Subpart B, C and D of the HHS regulations for the protection of human subjects in research entail?

Subpart B, C, and D of the HHS regulations specifically outline additional protections for vulnerable populations engaged in research, including children, pregnant women, and prisoners. These regulations recognize that these groups may be at increased risk of coercion or undue influence and therefore require special considerations to ensure their welfare and rights are respected in the research process.

Subpart B focuses on the protections for children, establishing the necessity of ensuring that assent from children is obtained when appropriate, along with parental permission. Subpart C provides guidelines for research involving prisoners, emphasizing that this population must be treated ethically and justly, given their unique circumstances. Subpart D addresses pregnant women, fetuses, and neonates, outlining requirements to protect their rights and welfare within research contexts.

This framework exists to enhance the ethical conduct of research and uphold the rights of those who are often considered vulnerable or at-risk participants, ensuring that their involvement in research is both voluntary and informed. The other options, while relevant to human subject protections, do not specifically address the additional protections designated for these particular groups.