The Tuskegee syphilis experiment (also known as the Tuskegee syphilis study or Public Health Service syphilis study) was a clinical study conducted between 1932 and 1972 in Tuskegee, Alabama, by the U.S. Public Health Service. Investigators recruited 399 impoverished African-American sharecroppers with syphilis for research related to the natural progression of the untreated disease, in hopes of justifying treatment programs for blacks.
The 40-year study was controversial for reasons related to ethical standards, primarily because researchers failed to treat patients appropriately after the 1940s validation of penicillin as an effective cure for the disease. Revelation of study failures led to major changes in U.S. law and regulation on the protection of participants in clinical studies, including the necessity for informed consent, communication of diagnosis, and accurate reporting of test results.
When the study began in 1932, standard medical treatments for syphilis were toxic, dangerous, and of questionable effectiveness. Part of the study goal was to determine if patients were better off not being treated with such toxic remedies. Additionally, researchers wanted to understand each stage of the disease in hopes of developing suitable treatments for each.
By 1947 penicillin had become the standard treatment for syphilis. Rather than treat all syphilitic subjects and close the study, or split off a control group for testing penicillin, the Tuskegee scientists continued the study, withholding penicillin and information about it. Participants were prevented from accessing syphilis treatment programs available to others in the area. The study continued until 1972, when a leak to the press resulted in its termination. Victims included numerous men who died of syphilis, wives who contracted the disease from them, and children born with congenital syphilis.
The Tuskegee Syphilis Study, cited as "arguably the most infamous biomedical research study in U.S. history," led to the 1979 Belmont Report and the establishment of the Office for Human Research Protections (OHRP). It also led to federal regulation requiring Institutional Review Boards for protection of human subjects in studies involving human subjects. The Office for Human Research Protections (OHRP) manages this responsibility within the US Department of Health and Human Services (HHS)