TheBelmontReport-Research.ppt

The Belmont Report Presentation for IRB Members Historical Perspective Nuremberg War Tribunal (1947) - Criminal proceedings against 23 leading German physicians and administrators for their willing participation in war crimes and crimes against humanity. Horrifying procedures were conducted for research purposes on thousands of concentration camp prisoners without their informed consent. Syphilis Study in Tuskegee, GA (1932-1972) – As part of a research project conducted by the U.S. Public Health Service, 600 low-income African-American males, 400 of whom were infected with syphilis, were monitored for 40 years. Free medical examinations were given; however, participants 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 participants were diagnosed as having syphilis by other physicians, researchers intervened to prevent treatment. Many participants 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. Historical Perspective Thalidomide use - Thalidomide was used in the 1950s to combat unpleasant symptoms associated with pregnancy. At the time it was being used it was not usually disclosed to patients that the drug was investigational and still in the testing phase of the regulatory process. After women in Europe, Canada, and the U.S. were treated with the drug it was discovered that the drug had teratogenic effects, causing severe deformities in the fetus. Thalidomide was soon banned worldwide. Unfortunately, approximately 12,000 babies were born with severe deformities due to thalidomide. Radiation experiments (1940s – 1960s) - U.S. officials studied the effects of radiation through experiments on hospital patients, pregnant women, mentally disabled children, and en