After the U.S Public Health Service’s (USPHS) Syphilis Study at Tuskegee, the government changed its research practices.
In 1974, the National Research Act was signed into law, creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Researchexternal icon. The group identified basic principles of research conduct and suggested ways to ensure those principles were followed.
In addition to the Commission’s recommendations, regulations were passed in 1974 that required researchers to get voluntary informed consent from all persons taking part in studies done or funded by the Department of Health, Education, and Welfare (DHEW). They also required that all DHEW-supported studies using human subjects be reviewed by Institutional Review Boards, which decide whether research protocols meet ethical standards.
The rules and policies for human subjects research have been reviewed and revised many times since they were first approved and efforts to promote the highest ethical standards in research are ongoing.
An Ethics Advisory Board was formed in the late-1970s to review ethical issues of biomedical research. As a result of their work, the 1979 publication commonly known as The Belmont Reportexternal icon summarized the three ethical principles that should guide human research: respect for persons; beneficence; justice. From 1980-1983, the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Researchexternal icon reported “every two years on the adequacy and uniformity of the Federal rules and policies, and their implementation, for the protection of human subjects in biomedical and behavioral research.” In 1991, federal departments and agencies (16 total) adopted the Federal Policy for the Protection of Human Subjectsexternal icon.
In October 1995, President Bill Clinton created a National Bioethics Advisory Commissionexternal icon, funded and led by the Department of Health and Human Services. The commission’s task was to review current regulations, policies, and procedures to ensure all possible safeguards are in place to protect research volunteers. It was succeeded by the President’s Council on Bioethicsexternal icon, which was established in 2001, and then the Presidential Commission for the Study of Bioethical Issuesexternal icon established in 2009.
In 1932, the USPHS, working with the Tuskegee Institute, began a study to record the natural history of syphilis. It was originally called the “Tuskegee Study of Untreated Syphilis in the Negro Male” (now referred to as the “USPHS Syphilis Study at Tuskegee”). The study initially involved 600 Black men – 399 with syphilis, 201 who did not have the disease. Participants’ informed consent was not collected. Researchers told the men they were being treated for “bad blood,” a local term used to describe several ailments, including syphilis, anemia, and fatigue. In exchange for taking part in the study, the men received free medical exams, free meals, and burial insurance.
1932
The U.S. Public Health Service (USPHS) engages the Tuskegee Institute in Macon, AL in the USPHS Tuskegee Syphilis Study.2
1972
First news article about the study.
The study ends, on recommendation of an Ad Hoc Advisory Panel convened by the Assistant Secretary for Health and Scientific Affairs.
By 1943, penicillin was the treatment of choice for syphilis and becoming widely available, but the participants in the study were not offered treatment.
In 1972, an Associated Press story about the study was published. As a result, the Assistant Secretary for Health and Scientific Affairs appointed an Ad Hoc Advisory Panel to review the study. The advisory panel concluded that the study was “ethically unjustified”; that is, the “results [were] disproportionately meager compared with known risks to human subjects involved.” In October 1972, the panel advised stopping the study. A month later, the Assistant Secretary for Health and Scientific Affairs announced the end of the study. In March 1973, the panel also advised the Secretary of the Department of Health, Education, and Welfare (HEW) (now known as the Department of Health and Human Services) to instruct the USPHS to provide all necessary medical care for the survivors of the study.1 The Tuskegee Health Benefit Program (THBP) was established to provide these services. In 1975, participants’ wives, widows and children were added to the program. In 1995, the program was expanded to include health, as well as medical, benefits. The last study participant died in January 2004. The last widow receiving THBP benefits died in January 2009. Participants’ children (10 at present) continue to receive medical and health benefits.
Later in 1973, a class-action lawsuit was filed on behalf of the study participants and their families, resulting in a $10 million, out-of-court settlement in 1974.
On May 16, 1997, President Bill Clinton issued a formal Presidential Apology for the study.