Which of the following regulations was raised to regulatory status by 45 CFR 46 in 1974?

In 1974, the United States implemented the National Research Act, which resulted in the establishment of regulations to protect human subjects in research, specifically through the creation of the Institutional Review Board (IRB) framework. This act led to the formalization of ethical principles outlined in 45 CFR 46, which primarily addresses the protection of human subjects in research settings.

The correct answer highlights the increased regulatory importance of policies governing human subjects, emphasizing the ethical considerations in conducting research. While the Nuremberg Code set essential ethical standards after World War II for conducting research on human subjects, it did not have the regulatory authority that emerged later. The Kefauver-Harris Drug Amendments focus on drug approval processes and do not specifically address the broader context of human subject protection in research. The US Public Health Service Policy covers specific aspects of public health research but does not represent the regulation raised to the same broader authority under 45 CFR 46 as established through the National Research Act. Thus, the reference to the US Public Health Service Policy as a significant regulatory framework correctly points to the influence of 45 CFR 46 in shaping how research ethics and human subject protections are governed in the U.S.