Which vulnerable population receives additional protections under HHS regulations besides pregnant women and neonates?

Prisoners are recognized as a vulnerable population that requires additional protections due to their unique circumstances, particularly their limited autonomy and the potential for coercion in research settings. The Department of Health and Human Services (HHS) regulations, specifically under 45 CFR 46 Subpart C, establish special provisions aimed at safeguarding the rights and welfare of prisoners involved in research. This is in response to the ethical concerns regarding the selection of prisoners for research, especially in studies that may pose risks to their health or personal freedoms.

These regulations seek to ensure that prisoners are not unjustly exploited for research purposes and that their participation is purely voluntary, informed, and not influenced by their incarceration status. Consequently, any research involving prisoners must undergo additional scrutiny to provide adequate protections, ensuring that their rights and mental well-being are prioritized.

In contrast, while college students, adults with decisional impairments, and the elderly can be considered vulnerable populations in certain contexts, they do not receive the same specific regulatory protections that are outlined for pregnant women, neonates, and prisoners under HHS regulations.