National Research Act

Great Seal of the United States (obverse)

National Research Act

The National Research Act of 1974 is a pivotal piece of legislation in the history of United States biomedical ethics. Enacted on July 12, 1974, this act was a response to growing ethical concerns about the conduct of research involving human subjects. Notably, it was influenced by public revelations of unethical research practices, such as the Tuskegee Syphilis Study, which ran from 1932 to 1972 and involved the non-treatment of African-American men with syphilis without their informed consent.

Background

Prior to the National Research Act, there was no comprehensive federal policy in the United States that governed the ethics of research involving human subjects. The Tuskegee Syphilis Study, among other unethical research practices that came to light in the early 1970s, highlighted the need for greater oversight and ethical guidelines in biomedical and behavioral research.

Provisions

The National Research Act established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The commission was tasked with identifying the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and developing guidelines to ensure such research is conducted in accordance with those principles.

One of the most significant outcomes of the National Research Act was the development of the Belmont Report. Published in 1979, the Belmont Report outlines three fundamental ethical principles for conducting research involving human subjects: respect for persons, beneficence, and justice. These principles have since become the cornerstone of ethical guidelines for human subject research in the United States and have influenced ethical standards internationally.

Impact

The National Research Act and the subsequent Belmont Report have had a profound impact on the conduct of research involving human subjects. They have led to the establishment of Institutional Review Boards (IRBs) at institutions where research is conducted, which review research proposals to ensure that they comply with ethical standards. The act has also influenced international ethical guidelines, such as the Declaration of Helsinki, and has played a crucial role in shaping public policy and legislation on biomedical and behavioral research ethics around the world.

Controversies and Challenges

While the National Research Act has been instrumental in promoting ethical research practices, it has also faced criticism and challenges. Some researchers argue that the regulations and oversight it mandates can be overly burdensome and stifle scientific innovation. Others have raised concerns about the adequacy of protections for research subjects, particularly in light of evolving research methodologies and technologies that pose new ethical dilemmas.

Conclusion

The National Research Act of 1974 represents a landmark in the evolution of research ethics. By establishing the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and leading to the creation of the Belmont Report, it has laid the foundation for the ethical conduct of research involving human subjects. Despite ongoing debates and challenges, the act's legacy continues to influence the ethical framework within which research is conducted, ensuring respect for the dignity and rights of research participants.