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

Subpart A of the HHS regulations outlines the basic general protections for research subjects involved in studies. It establishes fundamental ethical principles, including respect for persons, beneficence, and justice. This section sets the groundwork for informed consent, emphasizing that participants should be adequately informed about the research and voluntarily consent to participate without coercion. These protections are crucial for ensuring the ethical conduct of research involving human subjects and provide a framework that all research involving human participants must follow, thus safeguarding their rights and welfare.

The other options focus on specific populations or administrative aspects of research governance—such as additional protections for vulnerable groups or requirements for Institutional Review Board (IRB) registration—rather than the foundational principles established in Subpart A.