Which group requires additional HHS regulations due to past research abuses?

The correct answer is that prisoners require additional HHS (Department of Health and Human Services) regulations due to historical research abuses. Throughout the history of biomedical research, there have been significant ethical violations involving prisoners, including coercive practices where incarcerated individuals were exploited for research without proper consent or consideration of their vulnerable status. This led to a recognition of the need for enhanced protections for this group to ensure that they are treated fairly and ethically in research contexts.

In response to these past abuses, the federal government's regulations, notably Subpart C of the HHS regulations (45 CFR 46), were established specifically to provide additional protections for prisoners involved in research. These regulations aim to safeguard their rights and well-being, ensuring that their participation is truly voluntary and that they are not subjected to undue manipulation or coercion due to their incarceration status.

The other groups mentioned do not have the same historical precedent of abuses in research that prompted the creation of such specific regulations. While the elderly and mentally disabled persons have their own protections in place, particularly through various laws and ethical guidelines addressing informed consent and capacity, the specific focus on prisoners arises directly from a response to historical systemic issues that highlighted their unique vulnerabilities. Men, as a demographic group, do not fall into a category requiring