THE TUSKEGEE EXPERIMENT

CLINICAL RESEARCH ETHICS: THE TUSKEGEE EXPERIMENT

The Tuskegee syphilis experiment (/tʌsˈkiːɡiː/) 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 in Alabama. They were told that they were receiving free health care from the U.S. government

The Public Health Service started working on this study in 1932 during the Great Depression, in collaboration with the Tuskegee Institute, a historically black college in Alabama. Investigators enrolled in the study a total of 600 impoverished sharecroppers from Macon County, Alabama. Of these men, 399 had previously contracted syphilis before the study began, and 201 did not have the disease. The men were given free medical care, meals, and free burial insurance for participating in the study. None of the men infected was ever told he had the disease, nor was any treated for it with penicillin after this antibiotic became proven for treatment. 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 in 1972 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  communication of diagnosis, and accurate reporting of test results.

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; they withheld penicillin and information about it from the patients. In addition, scientists prevented participants from accessing syphilis treatment programs available to other residents in the area. The study continued, under numerous US Public Health Service supervisors, until 1972, when a leak to the press resulted in its termination on November 16 of that year. The victims of the study included numerous men who died of syphilis, 40 wives who contracted the disease, and 19 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 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 USDepartment of Health and Human Services (HHS)

Dr. Nicholas Herten-Greaven lectures about the Tuskegee syphilis experiment as part of the Ethics in Clinical Research course at Oxford College