The
Tuskegee syphilis experiment[1] was an infamous
clinical study conducted between 1932 and 1972 by the
U.S. Public Health Service to study the natural progression of untreated
syphilis in rural African American men who thought they were receiving free health care from the U.S. government.
[1]
The Public Health Service, working with the
Tuskegee Institute, began the study in 1932. Investigators enrolled in the study a total of 600 impoverished
sharecroppers from
Macon County,
Alabama; 399 who had previously contracted syphilis before the study began, and 201
[2] without the disease. For participating in the study, the men were given free medical care, meals, and free burial insurance. They were never told they had syphilis, nor were they ever treated for it. According to the
Centers for Disease Control, the men were told they were being treated for "bad blood", a local term for various illnesses that include syphilis, anemia, and fatigue.
The 40-year study was controversial for reasons related to
ethical standards; primarily because researchers knowingly failed to treat patients appropriately after the 1940s validation of
penicillin as an effective cure for the disease they were studying. Revelation of study failures by a
whistleblower led to major changes in U.S. law and regulation on the protection of participants in clinical studies. Now studies require
informed consent (with exceptions possible for U.S. Federal agencies which can be kept secret by Executive Order),
[3][
not in citation given] communication of
diagnosis, and accurate reporting of test results.
[4]
By 1947, penicillin had become the standard treatment for syphilis. Choices available to the doctors involved in the study might have included treating all syphilitic subjects and closing the study, or splitting off a
control group for testing with penicillin. Instead, the Tuskegee scientists continued the study without treating any participants and withholding penicillin and information about it from the patients. In addition, scientists prevented participants from accessing syphilis treatment programs available to others in the area.
[5] The study continued, under numerous US Public Health Service supervisors, until 1972, when a leak to the press eventually resulted in its termination on November 16.
[6] The victims of the study included numerous men who died of syphilis, wives who contracted the disease, and children born with
congenital syphilis.
[7]
The Tuskegee Syphilis Study, cited as "arguably the most infamous biomedical research study in U.S. history,"
[8] led to the 1979
Belmont Report and the establishment of the
Office for Human Research Protections (OHRP).
[9] It also led to federal laws and regulations requiring
Institutional Review Boards for the 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).
[10]