How the Tuskegee Experiments Changed Clinical Trials

In 1932, 600 African American men from Macon County, Alabama were told they were receiving treatment for bad blood. Unbeknownst to them, they were enlisted in what became a tragic 40-year study to observe untreated syphilis in black populations. Withholding not only their diagnosis but also treatment cost the lives of some of these men and drastically impacted their families. Officially known as the Tuskegee Study of Untreated Syphilis in the Negro Male, it birthed the development of modern medical ethics.

Clinical trials, also known as clinical research studies, are studies in volunteers that try to answer specific health questions. Some measure the safety and effectiveness of potential new treatments, and others observe health issues and behaviors in large groups of people.

The unethical Tuskegee Study and America’s long history of medical exploitation of black people understandably caused black patients to distrust the medical system. This poses a challenge because patients of color can respond differently to treatments, so treatments need to be tested in individuals of all backgrounds.

In 2020, London-based medical student Malone Mukwende created Mind the Gap, a handbook of images and descriptions of clinical signs and symptoms in Black and Brown skin to raise awareness of how these signs and symptoms can present differently on darker skin. Unfortunately, while many illnesses such as sickle cell anemia, asthma, diabetes, heart disease, HIV/AIDS, and cancer affect African Americans disproportionately, little is known about how BIPOC respond to treatment. An increase in African American volunteers — and an increase in diversity in clinical trials as a whole — will help improve the health of all people and provide a greater understanding of health disparities.

In 1972, Peter Buxtun leaked information about the study to the New York Times, sparking a mass outrage. In 1974, following the National Association for the Advancement of Colored People’s lawsuit against the United States Public Health Service, Congress passed the National Research Act, creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Regulations were passed requiring 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). All DHEW-supported studies using human subjects must be reviewed by Institutional Review Boards (IRB), which read study protocols and decide whether they meet ethical standards.

Federal guidelines and codes of ethics have continued to be reviewed, revised, and implemented since then. In the late 1970s, an Ethics Advisory Board was formed to review ethical issues of biomedical research. In 1991, federal departments and agencies adopted the Federal Policy for the Protection of Human Subjects.

Historically, clinical trials were done on white men only. Groups such as African Americans, women, and other minorities were not included. Today, clinical trials welcome the participation of all people, and those clinical trials are closely monitored for their safe and ethical treatment of volunteers.

Many are concerned about history repeating itself and wonder if something like the Tuskegee Experiment could happen today. Because of the federal guidelines and codes of ethics in place to protect all volunteers, regardless of skin color, the answer is no. Committees review the balance of potential risks and benefits for each study before approving them to proceed. The Informed Consent discloses all known information about those potential risks and benefits to the patient so they can decide whether they want to participate. The process emphasizes body autonomy, and participation in clinical trials is strictly voluntary. Participants can drop out at any time for any reason.

Before enrolling in a clinical trial, it is recommended to learn as much as one can about it. There are different kinds of clinical trials; some need healthy volunteers while others seek volunteers needing treatment.

A clinical trial is conducted according to a plan called a protocol, which describes:

The investigational treatment studied in a clinical trial may or may not benefit you personally, but the potential benefits of participating include:

Clinical trials study investigational treatments; therefore, not all is known about those treatments yet. Some risks include:

The Tuskegee Study eroded trust and contributed to health disparities. The 1972 whistleblower disclosed an inhumane and unethical practice prompting a significant change. From reforms that established medical ethics and policies that protect all patients, regardless of skin color, clinical trials now place emphasis on patient safety and providing access to innovative healthcare.