Human Subjects |  | Chronology of Cases Involving Unethical Treatment of Human Subjects |
|  |  | Nazi Atrocities During World War II, Nazi researchers, many of whom were highly esteemed physicians, conducted inhumane experiments on concentration camp prisoners -- men, women, and children. Subjects were deliberately mutilated and systematically dissected as part of experiments that included the deliberate infliction of gunshot wounds, traumatic amputations without anesthesia, limb and bone transplants, exposure to biological and chemical agents, sterilization, and exposure to sub-freezing temperatures. No attempt was made to relieve the tremendous pain and suffering that resulted, and high mortality rates were tolerated. The atrocities, many of which were conducted “in the name of science,” came to light during the 1946 Nazi Doctors Trial in Nuremberg (United States v. Karl Brandt). Tuskegee Syphilis Study At the beginning of the 1900's, syphilis was a problem for the military and was also at epidemic levels in areas of the rural South. The treatment at that time was toxic and involved the use of poisonous substances such as mercury and arsenic. Severe reactions, including death, were not uncommon. The United States Public Health Service (PHS) was interested in finding new methods to treat and understand the disease. In 1932, PHS initiated the Tuskegee Syphilis Study to document the natural history of syphilis. The research subjects were 399 poor African American male sharecroppers from Macon County, Alabama, with latent syphilis and 201 men without the disease who served as controls. Researchers did not disclose the nature of the study to the participants (no informed consent); subjects were deceived by investigators as they were told that they were being treated for "bad blood." In addition, subjects were coerced to participate through inducements of free transportation, free meals, free medical treatment for minor ailments, and burial insurance. Subjects were given a thorough medical exam and were to be followed for six to eight months during which time their disease would not be treated. Initially, there was no intent to deny anyone treatment on a long-term basis. Penicillin was accepted as the treatment for syphilis in 1943; however, it was deliberately withheld from study subjects. In addition, subjects were actively prevented from obtaining other treatments for syphilis. None of the subjects knew that they were involved in an experiment nor that effective treatment existed. Although the original study was projected to be six months long, it continued for forty years. Out of the original 400 subjects, 100 died as a direct result of untreated, late stage neurosyphilis No one questioned the ethical issues although the study was published in several medical journals. In 1972 the public learned about the study through the press, resulting in outrage. Wichita Jury Bugging In the 1950s, a series of studies conducted on a Ford Foundation grant by University of Chicago researchers involved the taping of jury deliberations in criminal cases to study how juries made decisions. The study was in response to concerns that juries were being unduly influenced by showmanship rather than the facts of the case. Though the judge and the attorneys involved were aware of the taping, the juries were not informed as researchers believed it would affect their behavior. Milgram Obedience Study Social psychology researcher Stanley Milgram wondered why defendant after defendant at the Nuremberg Trials justified their unethical actions by saying they were just following orders. Thus, he executed a series of experiments at Yale in the early 1960s to find out when and how people would defy authority in the face of a clear moral imperative. Milgram recruited subjects using deception; he called the experiments “a study of learning and memory,” though really he was studying conditions of obedience and disobedience to authority. In these experiments, naïve subjects believed they were applying punishment to a "learner" in the form of escalating electric shocks in response to incorrect answers to word-pair matching questions. In reality, the “learner” was a confederate in the study and was not being shocked. At the end of the session the "deception" was revealed, but the study was criticized for the extreme psychological stress experienced by some of the subjects, and for the fact that, due to the deceptive nature of the study, informed consent was not obtained. Tearoom Trade Study In this study, conducted in the mid-1960s, a researcher wanted to study the motivations of men who have anonymous sex in public restrooms. He befriended the men by acting as a “lookout” for them. He then proceeded to identify some of the participants by tracing their car license plates, and disguising himself as a healthcare worker, visited them at home. Jewish Chronic Disease Hospital In 1963, chronically ill and debilitated non-cancer patients at the Jewish Chronic Disease Hospital in New York were injected with live human cancer cells . Physicians did not inform the patients so as not to scare them, since it was believed that the cells would be rejected. Willowbrook State School Between 1963 and 1966 at the Willowbrook State School, a New York State institution for mentally retarded children, residents were deliberately infected with the hepatitis virus. The study was intended to study to follow the course of viral hepatitis, and to study the effectiveness of an agent for inoculating against hepatitis. Consent was obtained from parents, but the procedures were presented as vaccinations. In addition, there is evidence that only children enrolled in the study were admitted to the school (coercion). Stanford Prison Experiment The Stanford Prison Experiment was a psychological study conducted at Stanford University in 1971. The planned two-week investigation into the psychology of prison life had to be ended prematurely after only six days because of what the situation was doing to the college students who participated. In only a few days, subjects acting as guards became sadistic, and subjects playing the role of prisoners became depressed and showed signs of extreme psychological stress. Gene Therapy Study at University of Pennsylvania In the September 1999, Jesse Gelsinger died while a participant in a gene therapy research study at the University of Pennsylvania. After his death, information divulged led Jesse's father to believe that Jesse and his family were not fully informed of the risks involved in the research. Death of a Health Volunteer at Johns Hopkins On May 4, 2001, a 24 year old healthy female employee at Johns Hopkins Asthma and Allergy Center inhaled hexamethonium as a volunteer in a research study. She became ill within days, and died on June 2, 2001. The ensuing investigation revealed that the consent document failed to adequately describe the research procedures to be followed, or failed to identify procedures which were experimental, and failed to adequately describe the reasonably foreseeable risks and discomforts associated with the research. In addition, the researchers failed to follow the approved research protocol, failed to report unanticipated problems in an initial subject, and continued to involve additional subjects before the symptoms in the first subject were resolved and reported to the appropriate entities.
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