What regulatory guideline was issued in 1974 to elevate the protection of human subjects in research?

The correct answer is 45 CFR 46, which refers to the Code of Federal Regulations Title 45, Part 46. This set of regulations was established specifically to protect the rights and welfare of human subjects involved in research. It outlines requirements for informed consent, the assessment of risks and benefits, and the oversight of Institutional Review Boards (IRBs). The regulations were developed in response to historical unethical research practices and aim to ensure that research conducted with human subjects is ethical and respects their dignity and autonomy.

The significance of 45 CFR 46 lies in its comprehensive framework that mandates ethical considerations and procedural safeguards in research studies, making it a foundational regulatory guideline in the field of research ethics. This regulation has undergone revisions and updates since its inception, reflecting the evolving understanding of ethical research practices.

Other options pertain to important aspects of human research protection but are not the primary regulatory guideline issued in 1974. The US Public Health Service Policy, the Belmont Report, and FDA Regulations all contribute to the broader context of research ethics but do not specifically represent the foundational regulatory framework established in that year. The Belmont Report, for example, which was published in 1979, outlines ethical principles and guidelines for the protection of human subjects, while FDA Regulations serve