Among the earliest prosecuted was for horrific procedures performed on concentration camp prisoners in the name of research during World War Two. Twenty-three physicians and scientists stood trial in the Nuremberg War Tribunal in 1947. Between the 1940s and 1970s pregnant women, enlisted soldiers, psychiatric patients, and children were used by the US Government as subjects in the effects of radiation exposure. Under the auspices of the Manhattan Project, participants were injected or exposed to various types of radiation without their consent. The drug thalidomide was used with pregnant women in the 1950s to combat some side effects of pregnancy. While the women knew they were taking the drug, it was not largely disclosed that thalidomide was still experimental and its use with pregnant women had not been established as safe. Approximately 12000 babies were born with severe deformities as a result of their mothers having used the drug.
Events such as these, as well as the Tuskegee Syphilis Study, resulted in regulations protecting human research subjects including the Belmont Report ( 64 KB) (1979), the Nuremberg Code (1948), and the Declaration of Helsinki ( 98 KB) (1964).
Syphilis Study in Tuskegee, GA
Between 1932 and 1972, the US Public Health Service conducted a research study on the effects of syphilis on humans. The researchers recruited 600 low-income African-American males who were infected with syphilis. The men were provided with free medical care, and were under the perception that the medical care was intended to help them become cured of Syphilis. In fact, the researchers interest was in following the men, observing the effects of the disease, and then determining the ultimate effects of syphilis through autopsy after the participants’ death.
Penicillin was determined to be a cure for syphilis in the 1950′s but study participants were denied the medicine. When doctors outside the study offered the men penicillin, Public Health Service researchers intervened and prevented treatment. The study was discontinued in 1973 by the US Department of Health, Education, and Welfare.
In 1974, the National Research Act was passed, requiring the protection for human research participants and creating a committee to determine guidelines for ethical research with humans. That committee published the Belmont Report in 1974.
It was these and other events like them that prompted ethicists to develop standards for human research participants.