In addition to pregnant women and neonates, which vulnerable population is provided additional protections under HHS regulations?

Prisoners are recognized as a vulnerable population and are provided additional protections under the Department of Health and Human Services (HHS) regulations. This is largely due to their unique circumstances and potential for coercion, making them more susceptible to risks in research. The regulations entail specific requirements to ensure that prisoners are not exploited and that their participation in research is genuinely voluntary. When research involves prisoners, guidelines are established to protect their rights and welfare, acknowledging that they may not have the same level of autonomy as the general public, given their incarceration status.

Other groups, while certainly vulnerable and deserving of ethical considerations, do not have the same specific regulatory protections in place under HHS as prisoners do. While children, individuals with disabilities, and the elderly are also recognized as vulnerable, the specific regulations that exclusively address the protection of prisoners highlight the additional layers of ethical concern in research involving this population.