Issued in 1974, 45 ?CFR 46 ?raised to regulatory status:
The 1974 ?National Research Act
Kefauver-Harris Drug Amendments to the Federal Food, Drug & Cosmetics Act
The Nuremberg Code
US Public Health Service Policy
The Correct Answer and Explanation is :
The correct answer is: The 1974 National Research Act.
Explanation:
In 1974, the National Research Act was signed into law in the United States, marking a pivotal moment in the ethical oversight of research involving human subjects. This Act led to the establishment of the regulatory framework codified in 45 CFR 46, which raised ethical principles to regulatory status. Here is a breakdown of its significance:
- Historical Context:
- The Act was a direct response to egregious ethical violations in research, such as the Tuskegee Syphilis Study, where participants were misled and harmed. Public outrage and ethical concerns spurred the need for regulatory measures to protect research participants.
- Creation of the National Commission for the Protection of Human Subjects:
- The National Research Act established this commission, tasked with identifying basic ethical principles to guide human research. These principles were later articulated in the Belmont Report (1979).
- Introduction of 45 CFR 46:
- This section of the Code of Federal Regulations outlines the federal policy for the protection of human subjects. It introduced key concepts such as:
- Institutional Review Boards (IRBs): Committees to review research protocols for ethical compliance.
- Informed Consent: Ensuring participants are fully informed about the research and voluntarily agree to participate.
- Special Protections: Additional safeguards for vulnerable populations like pregnant women, prisoners, and children.
- Broader Implications:
- The regulatory framework established under the Act applies to federally funded research but has influenced ethical standards in all human research domains, including private and international studies.
Other Options:
- The Kefauver-Harris Drug Amendments (1962) focused on drug safety and efficacy but did not establish broad ethical research guidelines.
- The Nuremberg Code (1947) was an ethical guideline, not a regulation.
- The US Public Health Service Policy pertains to research animals, not human subjects.
Thus, the National Research Act is the cornerstone of modern research ethics in the U.S.