Prior to World War II, medical research was performed without appreciable constraints or formal guidance on the protection of the human participants in this research. However, Nazi research atrocities starkly revealed the need to develop basic ethical principles for the protection of human subjects in research and to ensure their oversight. The Tuskegee syphilis study, in which African American men were enrolled without informed consent and were not treated when treatment was available, has further illustrated this need.
Following the Nuremberg Trials, the Declaration of Helsinki was issued. This represented a formal embodiment of ethical principles for the conduct of medical research. It was not until 1966, however, that the U.S. government initiated actions to regulate the performance of human research in this country. On July 1 of that year, William H. Stuart, M.D., Surgeon General, issued Public Health Service Policy and Procedure Order #129, requiring submissions of formal assurances by all institutions conducting human research and thereby establishing the Institutional Review Board (IRB) as a mechanism for ensuring the protection of human research subjects. The National Institutes of Health (NIH) approved the first institutional assurance of the University of Miami on November 1, 1966. In this assurance, the University agreed to establish committees to review all human research studies, and to abide by federal scientific and administrative guidelines and procedures. This Federal Wide Assurance (FWA) has continued to the present day.
Regulations protecting human subjects first became effective on May 30, 1974. Promulgated by the Department of Health, Education and Welfare (DHEW), those regulations raised to regulatory status the National Institutes of Health’s (NIH) 1966 Policies for the Protection of Human Subjects. In 1979 the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research issued the Belmont Report, another important document pertaining to human subjects protections.
The current U.S. system of protection for human research subjects is heavily influenced by the Belmont Report. This Report outlines the basic ethical principles in research involving human subjects. In 1981, with this report as foundational background, the Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA) revised and made as compatible as possible—under their respective statutory authorities—their existing human subject regulations. With leadership from DHHS, the Federal Policy for the Protection of Human Subjects or the “Common Rule” was published in 1991 and codified in separate regulations by 15 Federal departments and agencies (c.f. Policy 2.3).
The Office for Human Research Protections (OHRP) now oversees any IRBs that review federally funded research involving human subjects while the FDA also oversees IRBs that review studies under its jurisdiction. Knowledge and awareness of human subjects research protections continue to increase; and federal regulations continue to be refined. This is necessary in order to meet the many challenges resulting from the scientific and technological developments that are constantly occurring.