Which vulnerable population, in addition to pregnant women and neonates, is provided extra protections under HHS regulations?

Prisoners are recognized as a vulnerable population that requires additional protections under HHS regulations. This acknowledgment stems from the unique challenges and risks associated with conducting research involving incarcerated individuals. Historically, prisoners are a group susceptible to coercion and exploitation due to their confinement and the inherent power imbalance in the researcher-participant dynamic. As a result, HHS regulations establish specific safeguards to ensure that prisoners' rights, autonomy, and welfare are upheld in the context of research participation.

These protections are designed to mitigate risks of coercion and ensure that participation is voluntary and informed. This is crucial since prisoners may feel pressured to participate in research for various reasons, including possible benefits like access to medical care or other privileges. Hence, the regulations implement additional review and oversight procedures to protect this population adequately.

While children, individuals with disabilities, and the elderly do have specific protections under various regulations and ethical standards, the particular designation of prisoners as a separate vulnerable group requiring extra safeguards is explicitly outlined in federal regulations, highlighting the need for enhanced ethical scrutiny in research involving this population.