Evaluation in Today’s World. Veronica G. Thomas
an important issue. Research ethics are core professional behaviors and institutional and federal standards by which every researcher is guided to protect the dignity, rights, and welfare of research participants. However, there have not always been explicit ethical codes and principles to guide the behavior of researchers. In the 1900s, no regulations existed regarding the ethical use of human participants in research. The field of research ethics has largely been built upon disastrous and egregious treatment of research participants, particularly when those individuals were poor or from minority or other vulnerable populations. The sections that follow provide a brief history of research ethics. More detailed historical perspectives can be found elsewhere (e.g., Kitchener & Kitchener, 2009; National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1978).
The Nuremberg Code of 1947
The origins of our present-day approach to research ethics can be traced back to the Nuremberg Code established in 1947. This code, including a set of 10 research ethics principles, followed the December 1946 criminal proceedings against 23 leading German physicians and administrators for their willing participation in war crimes and crimes against humanity. Horrifying procedures, such as the breaking and rebreaking of bones to see how many times they could be broken before healing, were conducted for research purposes on thousands of concentration camp prisoners without their informed consent; most of these prisoners either died or were permanently disabled as a result. The first principle of the Nuremberg Code, which was a radical idea at the time, was that voluntary, active consent of the human participant is absolutely essential. Two other principles included the rights of people to withdraw from research and to protect themselves. The Nuremberg Code also included a principle articulating that it is the duty of researchers to act in the best interests of those who take part in research for the good of society.
The Tuskegee Syphilis Study of 1932–1972
Despite the Nuremberg Code being given status of an international code for the ethical conduct of research and its substantial influence on international documents such as the Universal Declaration of Human Rights (adopted by the United Nations General Assembly in 1948), for many years after the introduction of these documents, researchers continued with unethical practices. In the United States, one of the most infamous biomedical research abuse cases, the Tuskegee Syphilis Study, involved experiments, over a 40-year period, on low-income African American males in Tuskegee, Alabama. As part of a research project conducted by the U.S. Public Health Service, 600 low-income (mostly illiterate) African American males were recruited, 399 of whom were infected with syphilis and 201 of whom served as a control group not infected with the disease. The researchers advertised for “colored” participants with the slogan “Last Chance for Special Free Treatment” by the Macon County Health Department and government doctors. Researchers never obtained informed consent from the men and did not inform the men with syphilis that they were not being treated but were simply being monitored and left to suffer with syphilis long after a cure (penicillin) became available in 1947. By the end of the study in 1972, only 74 of the test subjects were still alive. It was not until May 16, 1997, that President Bill Clinton issued a formal apology for the Tuskegee Syphilis Study, denoting that it destroyed the trust many African Americans had for medical institutions. The following activity provides readers with an opportunity to reflect on the lasting impact of the Tuskegee Syphilis Study.
Reflect and Discuss: The Tuskegee Timeline
Review the timeline of the Tuskegee Syphilis Study and then reflect on and discuss the questions that follow.
The Study Begins
In 1932, the Public Health Service, working with the Tuskegee Institute, began a study to record the natural history of syphilis in hopes of justifying treatment programs for [B]lacks. It was called the “Tuskegee Study of Untreated Syphilis in the Negro Male.”
The study initially involved 600 Black men—399 with syphilis, 201 who did not have the disease. The study was conducted without the benefit of patients’ informed consent. 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 truth, they did not receive the proper treatment needed to cure their illness. In exchange for taking part in the study, the men received free medical exams, free meals, and burial insurance. Although originally projected to last 6 months, the study actually went on for 40 years.
What Went Wrong?
In July 1972, an Associated Press story about the Tuskegee Study caused a public outcry that led the Assistant Secretary for Health and Scientific Affairs to appoint an Ad Hoc Advisory Panel to review the study. The panel had nine members from the fields of medicine, law, religion, labor, education, health administration, and public affairs.
The panel found that the men had agreed freely to be examined and treated. However, there was no evidence that researchers had informed them of the study or its real purpose. In fact, the men had been misled and had not been given all the facts required to provide informed consent.
The men were never given adequate treatment for their disease. Even when penicillin became the drug of choice for syphilis in 1947, researchers did not offer it to the subjects. The advisory panel found nothing to show that subjects were ever given the choice of quitting the study, even when this new, highly effective treatment became widely used.
The Study Ends and Reparation Begins
The advisory panel concluded that the Tuskegee Study was “ethically unjustified”—the knowledge gained was sparse when compared with the risks the study posed for its subjects. In October 1972, the panel advised stopping the study at once. A month later, the Assistant Secretary for Health and Scientific Affairs announced the end of the Tuskegee Study.
In the summer of 1973, a class-action lawsuit was filed on behalf of the study participants and their families. In 1974, a $10 million out-of-court settlement was reached. As part of the settlement, the U.S. government promised to give lifetime medical benefits and burial services to all living participants. The Tuskegee Health Benefit Program (THBP) was established to provide these services. In 1975, wives, widows and offspring were added to the program. In 1995, the program was expanded to include health as well as medical benefits. The Centers for Disease Control and Prevention was given responsibility for the program, where it remains today in the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention. The last study participant died in January 2004. The last widow receiving THBP benefits died in January 2009. There are 11 offspring currently receiving medical and health benefits.
Source: National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, U.S. Department of Health and Human Services. (2020, March 20). U.S. Public Health Service syphilis study at Tuskegee: The Tuskegee timeline. Retrieved from https://www.cdc.gov/tuskegee/timeline.htm
Now, reflect on and discuss the interplay of ethics and social justice issues raised in the Tuskegee Syphilis Study.
Guiding Questions
Do you think the Tuskegee Syphilis Study has current and/or lasting societal impact? If so, what?
Might certain individuals or groups still be suspicious of evaluators and other researchers because of experiments like the Tuskegee Syphilis Study? Elaborate your response.
Courtesy of the Center for Disease Control
The Radiation Studies of 1940–1960
Another example of unethical research practice includes the abuse of human participants during World War II and the early Cold War when U.S. officials studied the effects of radiation through experiments on hospital patients,