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

Under HHS regulations, prisoners are recognized as a vulnerable population that requires additional protections due to the unique ethical and procedural concerns associated with conducting research involving them. This recognition is grounded in the potential coercion and diminished autonomy that individuals in incarceration may experience, making it imperative to establish safeguards to ensure their rights and welfare in research settings.

The regulations (specifically 45 CFR 46, Subpart C) are designed to protect their interests by mandating additional review processes and stipulations when research involves prisoners. This means that researchers must demonstrate that the risks of the research are reasonable in relation to the anticipated benefits, not only for the prisoners themselves but also for the broader community.

This focus on protecting prisoners as a vulnerable group complements the existing protections for other populations, such as pregnant women and neonates. Collectively, these protections ensure that ethical considerations are prioritized when engaging with groups that might have limited capacity to consent or understand the implications of their participation in research.