The Tuskegee Syphilis Study (1932-1972)

The Tuskegee Syphilis Study (1932-1972)

To secure the cooperation of the black subjects, the participation of black physicians was seen as essential. A local nurse who had trained at the Tuskegee Institute was hired to be the on-site representative. More than 400 black men with syphilis participated, and about 200 men without syphilis served as controls.  The men were recruited without informed consent and, in fact, were misinformed that some of the procedures done in the interest of research (e.g., spinal taps) were actually "special free treatment."

By 1936, it was apparent that many more infected men than controls had developed complications, and 10 years later, a report of the study indicated that the death rate among those with syphilis was about twice as high as it was among the controls.  In the 1940s, penicillin was found to be effective in the treatment of syphilis. However, during WWII, to keep the syphilis research participants from receiving treatment, it was arranged with the local draft board to exempt them from the military. By 1951, penicillin was widely available as the treatment for syphilis, but it continued to be withheld from the study participants. Actually, the availability of penicillin was used by the study investigators as justification for continuing the study because it made the protocol a ‘never-again’ scientific opportunity. Neither the ethical issues nor the fact that the supposedly untreated participants had received some minimal treatment were addressed. No connection was made between the Syphilis Study and the Nazi experiments.
The first accounts of this study appeared in the New York Times and the Washington Star on July 25, 1972 by investigative reporter Jean Heller from the Associated Press.  The resulting public outrage led to the appointment of an ad hoc advisory panel by the Department of Health, Education and Welfare to review the study and advise on how to ensure that such experiments would never again be conducted.  By 1973, Senator Edward Kennedy held hearings on experimentation using human participants in research. In March 1973 the Syphilis Study was stopped, treatment was given, and by 1975 the government extended treatment to the wives and children who had been born with congenital syphilis. In 1997, President Clinton apologized to study participants and their families and called for renewed emphasis on research ethics.

In 1974, Congress passed the National Research Act. The Act required regulations for the protection of human participants that included requirements for informed consent and review of research by institutional review boards (IRBs). This Act also created the National Commission for the Protection of Human Subjects of Biomedical and Behavior Research, who in 1979 wrote the “Belmont Report.”