Which groups are specifically protected under federal regulations (45 CFR 46), regarding additional protections?

The correct choice highlights the groups specifically recognized as needing additional protections in research under federal regulations, particularly 45 CFR 46. This regulation reflects a commitment to safeguarding populations that may be vulnerable in research contexts.

Pregnant women are included because of the ethical implications associated with research involving them and their potential offspring. When research affects pregnant women, there are unique considerations concerning fetal health and the rights of unborn children, making it essential to ensure their welfare.

Prisoners are identified as a protected group due to their compromised autonomy and the potential for coercion in research settings. The participation of prisoners raises important ethical considerations, particularly regarding informed consent and the influence of an institution's power dynamics.

Children are also recognized as needing additional protections due to their inability to provide fully informed consent and their developing capacity for understanding consequences. Special regulations ensure that any research involving children is conducted with the utmost care to prioritize their welfare.

This combination of groups reflects an understanding that each of these populations faces particular ethical challenges and vulnerabilities, necessitating tailored protections to safeguard their rights and well-being in research contexts.