What does Subpart E of the HHS regulations for the protection of human subjects in research entail?

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Subpart E of the HHS regulations specifically addresses additional protections for children, pregnant women, and prisoners involved in research. It outlines the unique considerations and requirements that researchers must follow to ensure the safety and ethical treatment of these vulnerable populations. This subpart recognizes that certain groups may have diminished autonomy or may be at increased risk of harm in research settings, therefore necessitating more stringent protections.

The other options refer to different aspects of human subjects research regulation. The basic protections for research subjects generally are described in other parts of the regulations, while the requirements for registration of Institutional Review Boards (IRBs) and managing financial conflicts of interest fall under different regulatory requirements, not specifically under Subpart E.

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