The national research act of 1974

General
1

the national research act of 1974

2

What is the National Research Act of 1974?

Answer:
The National Research Act of 1974 is an important legislative piece in the history of human research protections in the United States. This Act was a pivotal response to unethical research practices that had come to light during this period, most notably the Tuskegee Syphilis Study. Below, I will delve into the details, implications, and outcomes of this Act:

  1. Historical Context:

    • Before 1974, there had been numerous instances of unethical research practices, including the syphilis experiments conducted from 1932 to 1972 in Tuskegee, Alabama, where African American men were left untreated for syphilis without their informed consent in order to study the disease’s natural progression.
    • Public awareness and outrage over these abuses, especially the Tuskegee Study, led to demands for better regulation and protection of human subjects involved in medical and scientific research.

  2. Purpose and Provisions of the Act:

    • Establishment of Institutional Review Boards (IRBs):
      • The National Research Act required the establishment of Institutional Review Boards (IRBs) at institutions that conduct human subject research. These boards are responsible for reviewing research protocols to ensure they comply with ethical standards and federal regulations.
    • Development of Ethical Guidelines:
      • The Act mandated the creation of guidelines for the ethical treatment of human subjects. This led to the establishment of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
    • Informed Consent:
      • The Act emphasized the necessity of obtaining informed consent from research participants, ensuring they are fully aware of the nature of the research, potential risks, and their right to withdraw without penalty.

  3. The Belmont Report:

    • As part of its mandate, the National Commission developed key ethical principles for conducting research involving human subjects. This effort culminated in the Belmont Report, published in 1979. The Belmont Report outlines three fundamental ethical principles:
      • Respect for Persons: Treating individuals as autonomous agents and protecting those with diminished autonomy.
      • Beneficence: Maximizing potential benefits while minimizing potential harms.
      • Justice: Ensuring equitable distribution of research benefits and burdens.

  4. Impact and Legacy:

    • The National Research Act of 1974 and the subsequent Belmont Report significantly shaped the landscape of human subject research. These regulations and guidelines became the foundation for the Common Rule (Code of Federal Regulations Title 45 Part 46), which governs federally funded research in the U.S.
    • The Act also led to greater awareness and implementation of ethical standards across all types of research, not just federally funded studies, promoting a culture of ethical responsibility.

Final Answer:
The National Research Act of 1974 was a landmark piece of legislation that fundamentally transformed human subject research in the United States. By establishing Institutional Review Boards, emphasizing informed consent, and leading to the creation of the Belmont Report, the Act set the groundwork for ethical practices and protections that continue to govern research today.