Issued in 1974, 45 CFR 46 raised to regulatory status

Subject : Business

Question: Issued in 1974, 45 CFR 46 raised to regulatory status:

A) The 1974 National Research Act

B) US Public Health Service Policy

C) The Nuremberg Code

D) Kefauver-Harris Drug Amendments to the Federal Food, Drug & Cosmetics Act

Expert Verified Answer:

Issued in 1974, 45 CFR 46 raised to regulatory status:

The 1974 National Research Act

Explanation:

45 CFR 46 refers to the Code of Federal Regulations Title 45, Part 46, which sets forth regulations for the protection of human subjects in research. This regulation was established under the authority of the National Research Act of 1974.

The 1974 National Research Act was pivotal in the development of these regulations. It mandated the creation of institutional review boards (IRBs) to oversee and ensure the ethical conduct of research involving human subjects.

US Public Health Service Policy, The Nuremberg Code, and Kefauver-Harris Drug Amendments to the Federal Food, Drug & Cosmetics Act are related to the ethical conduct of research and drug regulation but were not directly established by 45 CFR 46.