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The establishment of the National Research Act and the creation of the Belmont Report were significantly influenced by the Tuskegee Study, which exposed serious ethical violations in research practices. Conducted between 1932 and 1972, this study involved the unethical treatment of African American men who were misled about their diagnosis of syphilis and were denied treatment in order to study the disease's progression. The public outcry and awareness of the ethical breaches revealed in this study highlighted the urgent need for regulatory oversight and ethical standards in research involving human subjects.
This event ultimately prompted the U.S. government to take action, leading to the formulation of ethical guidelines that prioritize the welfare of research participants. The National Research Act of 1974 was a direct response to the fallout from the Tuskegee Study and laid the groundwork for the establishment of Institutional Review Boards (IRBs) and the development of the Belmont Report, which provides essential ethical principles such as respect for persons, beneficence, and justice. The connection between this tragic study and the need for ethical safeguards in research underscores why the Tuskegee Study is seen as the pivotal event in the creation of the National Research Act and the Belmont Report.