The Belmont Report was written by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Commission, created as a result of the National Research Act of 1974, was charged with identifying the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and developing guidelines to assure that such research is conducted in accordance with those principles. Informed by monthly discussions that spanned nearly four years and an intensive four days of deliberation in 1976, the Commission published the Belmont Report, which identifies basic ethical principles and guidelines that address ethical issues arising from the conduct of research with human subjects. Show
 READ THE BELMONT REPORT
WATCH A VIDEO ABOUT THE BELMONT REPORT This video describes the basic ethical principles that underlie research involving human subjects and demonstrates how they can help resolve ethical conflicts in research
VIEW 25th ANNIVERSARY INTERVIEWS This collection of videos includes interviews with members and staff of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research from the 25th anniversary of publication in 2004
READ OTHER REPORTS BY THE NATIONAL COMMISSION Explore a compilation of related reports published by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research between 1974 and 1978 Prior to 1906, when the Pure Food and Drug Act was passed, there were no regulations regarding the ethical use of human subjects in research. There were no consumer regulations, no Food and Drug Administration (FDA), no Common Rule, and no Institutional Review Board (IRB). What follows is a brief discussion of why federal rules and regulations were established and why the IRB became a necessity. Nuremberg CodeA well-known chapter in the history of research with human subjects opened on December 9, 1946, when an American military tribunal opened criminal proceedings against 23 leading German physicians and administrators for their willing participation in war crimes and crimes against humanity. Among the charges were that German physicians conducted medical experiments on thousands of concentration camp prisoners without their consent. Most of the subjects of these experiments died or were permanently crippled as a result. As a direct result of the trial, the Nuremberg Code was established in 1948, stating that "The voluntary consent of the human subject is absolutely essential," making it clear that subjects should give consent and that the benefits of research must outweigh the risks. Although it did not carry the force of law, the Nuremberg Code was the first international document which advocated voluntary participation and informed consent. ThalidomideIn the late 1950s, thalidomide was approved as a sedative in Europe; it was not approved in the United States by the FDA. The drug was prescribed to control sleep and nausea throughout pregnancy, but it was soon found that taking this drug during pregnancy caused severe deformities in the fetus. Many patients did not know they were taking a drug that was not approved for use by the FDA, nor did they give informed consent. Some 12,000 babies were born with severe deformities due to thalidomide. U.S. Senate hearings followed and in 1962 the so-called "Kefauver Amendments" to the Food, Drug and Cosmetic Act were passed into law to ensure drug efficacy and greater drug safety. For the first time, drug manufacturers were required to prove to FDA the effectiveness of their products before marketing them. Tuskegee Syphilis Study (1932-1972)An equally well known chapter in history occurred during a research project conducted by the U.S. Public Health Service. Six hundred low-income African-American males, 400 of whom were infected with syphilis, were monitored for 40 years. Free medical examinations were given; however, subjects were not told about their disease. Even though a proven cure (penicillin) became available in the 1950s, the study continued until 1972 with participants being denied treatment. In some cases, when subjects were diagnosed as having syphilis by other physicians, researchers intervened to prevent treatment. Many subjects died of syphilis during the study. The study was stopped in 1973 by the U.S. Department of Health, Education, and Welfare only after its existence was publicized and it became a political embarrassment. In 1997, under mounting pressure, President Clinton apologized to the study subjects and their families. Declaration of HelsinkiIn 1964, the World Medical Association established recommendations guiding medical doctors in biomedical research involving human subjects. The Declaration governs international research ethics and defines rules for "research combined with clinical care" and "non-therapeutic research." The Declaration of Helsinki was revised in 1975, 1983, 1989 and 1996 and is the basis for Good Clinical Practices used today. Issues addressed in the Declaration of Helsinki include:
National Research Act (1974)Due to the publicity from the Tuskegee Syphilis Study, the National Research Act of 1974 was passed. The National Research Act created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which was charged to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and to develop guidelines which should be followed to assure that such research is conducted in accordance with those principles. The Commission drafted the Belmont Report, a foundational document in for the ethics of human subjects research in the United States. Which study is linked to the National Research Act?National Research Act (1974): due to the publicity from the Tuskegee Syphilis Study, the National Research Act of 1974 was passed.
What study is linked to the Belmont Report?What is the Belmont Report? The Belmont Report was written in response to the infamous Tuskegee Syphilis Study, in which African Americans with syphilis were lied to and denied treatment for more than 40 years.
What was one of the requirements of the National Research Act of 1974?The Tuskegee Syphilis Study is probably the worst case of unethical human subjects research in the history of the United States. The National Research Act codified the requirement that human subjects in research must be protected and set the stage for the issuance of the Belmont Report.
Which of the following most directly contributed to the establishment of the National Research Act and the creation of the Belmont Report?Which of the following most directly contributed to the establishment of the National Research Act and the creation of the Belmont Report: The Tuskegee Study.
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