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Historical Examples of Exploitation of Human Subjects
Nazi Medical War Crimes
During World War II, Nazi physicians conducted experiments on thousands of concentration camp prisoners which were unprecedented in their scope and the degree of harm and suffering to which human beings were subjected. "Medical experiments" included deadly studies and tortures such as injecting people with gasoline and live viruses, immersing people in ice water, and forcing people to ingest poisons. More information about the Nuremberg trials against the physicians is available at the U.S. Holocaust Memorial Museum web site.
In December 1946, 23 physicians and administrators were indicted before the War Crimes Tribunal at Nuremberg for their willing participation in the systematic torture, mutilation, and killing of prisoners in experiments. Despite the arguments from German physicians that the experiments were medically justified, the Nuremberg Military Tribunals condemned the experiments as "crimes against humanity." In the 1947 verdict, the judges included a section called "Permissible Medical Experiments." This section became known as the Nuremberg Code and has formed the basis for ethics codes internationally.
In December 1946, 23 physicians and administrators were indicted before the War Crimes Tribunal at Nuremberg for their willing participation in the systematic torture, mutilation, and killing of prisoners in experiments. Despite the arguments from German physicians that the experiments were medically justified, the Nuremberg Military Tribunals condemned the experiments as "crimes against humanity." In the 1947 verdict, the judges included a section called "Permissible Medical Experiments." This section became known as the Nuremberg Code and has formed the basis for ethics codes internationally.
The Tuskegee Syphillis Study
The most notorious example in the United States of prolonged and knowing violations of the rights of a vulnerable group of research participants was the long-term study of black males conducted at Tuskegee by the United States Public Health Service. This study was initiated in the 1930s as an examination of the natural history of untreated syphilis; it continued until 1972.
More than 400 black men with syphillis participated, and about 200 men without syphilis served as controls. The men were recruited without informed consent and, in fact, were misinformed that some of the procedures done in the interest of research (e.g., spinal taps) were actually "special free treatment."
By 1936, it was apparent that many more infected men than controls had developed complications, and 10 years later, a report of the study indicated that the death rate among those with syphilis was about twice as high as it was among the controls. In the 1940s, penicillin was found to be effective in the treatment of syphilis. The study continued, however, and the men were neither informed nor treated with the antibiotic.
The first accounts of this study appeared in the national press in 1972. The resulting public outrage led to the appointment of an ad hoc advisory panel by the Department of Health, Education and Welfare to review the study and advise on how to ensure that such experiments would never again be conducted. Among the recommendations was the request that Congress establish a "permanent body with the authority to regulate, at least, all federally supported research involving human subjects."
In acknowledgement of its responsibility, the Government continues to compensate surviving participants and the families of deceased participants.
Additional information can be found at these web sites:
Tuskegee Syphilis Experiment
How Tuskegee changed research practices
An Apology to survivors of the Tuskegee Study
More than 400 black men with syphillis participated, and about 200 men without syphilis served as controls. The men were recruited without informed consent and, in fact, were misinformed that some of the procedures done in the interest of research (e.g., spinal taps) were actually "special free treatment."
By 1936, it was apparent that many more infected men than controls had developed complications, and 10 years later, a report of the study indicated that the death rate among those with syphilis was about twice as high as it was among the controls. In the 1940s, penicillin was found to be effective in the treatment of syphilis. The study continued, however, and the men were neither informed nor treated with the antibiotic.
The first accounts of this study appeared in the national press in 1972. The resulting public outrage led to the appointment of an ad hoc advisory panel by the Department of Health, Education and Welfare to review the study and advise on how to ensure that such experiments would never again be conducted. Among the recommendations was the request that Congress establish a "permanent body with the authority to regulate, at least, all federally supported research involving human subjects."
In acknowledgement of its responsibility, the Government continues to compensate surviving participants and the families of deceased participants.
Additional information can be found at these web sites:
Tuskegee Syphilis Experiment
How Tuskegee changed research practices
An Apology to survivors of the Tuskegee Study
Jewish Chronic Disease Hospital Study
In 1963, studies were undertaken at New York's Jewish Chronic Disease Hospital to undestand whether the body's inability to reject cancer cells was due to cancer or debilitation. Previous studies had indicated that healthy persons reject cancer cells promptly, and the researchers allegedly believed that the debilitated patients would also reject the cancers but at a substantially slower rate when compared to healthy participants.
These studies involved the injection of live cancer cells into patients who were hospitalized with various chronic debilitating diseases. Consent had been given orally, but did not include discussion on the injection of cancer cells, and consent was not documented. The researchers felt that documentation was unnecessary because it was customary to undertake much more dangerous medical procedures without the use of consent forms.
Patients were not told that they would receive cancer cells, because the researchers felt it would unnecessarily frighten them. Researchers defended this view with the assertation that they had good cause to predict that the cancer cells wre going to be rejected.
In subsequent review proceedings conducted by the Board of Regents of the State University of New York, it was found that th study had not been presented to the hospital's research committee and that the physicians responsible for the pateints' care had not been consulted. The researchers were found guilty of fraud, deceit, and unprofessional conduct.
These studies involved the injection of live cancer cells into patients who were hospitalized with various chronic debilitating diseases. Consent had been given orally, but did not include discussion on the injection of cancer cells, and consent was not documented. The researchers felt that documentation was unnecessary because it was customary to undertake much more dangerous medical procedures without the use of consent forms.
Patients were not told that they would receive cancer cells, because the researchers felt it would unnecessarily frighten them. Researchers defended this view with the assertation that they had good cause to predict that the cancer cells wre going to be rejected.
In subsequent review proceedings conducted by the Board of Regents of the State University of New York, it was found that th study had not been presented to the hospital's research committee and that the physicians responsible for the pateints' care had not been consulted. The researchers were found guilty of fraud, deceit, and unprofessional conduct.
The Willowbrook Study
The vulnerability of children, especially institutionalized children, as participants in research is demonstrated in a series of studies conducted from 1963 to 1966 at the Willowbrook State School, a New York institution for "mentally defective" children. In order to gain an understanding of the natural history of infectious hepatitis under controlled circumstances, newly admitted chidlren were deliberately infected with the hepatitis virus. Researchers defended the deliberate injection of these children by pointing out that the vast majority of them would acquire the infection anyway while at Willowbrook, given the crowded and unsanitary conditions, and because only children whose parents had given consent were included.
During the course of these studies, Willowbrook closed its doors to new patients, claiming overcrowded conditions. However, the hepatitis program, because it occupied its own space at the institution, was able to continue to admit new patients. Thus, in some cases, parents found they were unable to admit their children to Willowbrook unless they agreed to their participation in the studies.
This controversial case raised important questions about the adequacy and freedom of consent, inadequate disclosure of the child's risk of later developing chronic liver disease, and the lack of information given to parents about access to doses of gamma globulin for their children.
During the course of these studies, Willowbrook closed its doors to new patients, claiming overcrowded conditions. However, the hepatitis program, because it occupied its own space at the institution, was able to continue to admit new patients. Thus, in some cases, parents found they were unable to admit their children to Willowbrook unless they agreed to their participation in the studies.
This controversial case raised important questions about the adequacy and freedom of consent, inadequate disclosure of the child's risk of later developing chronic liver disease, and the lack of information given to parents about access to doses of gamma globulin for their children.
Note: much of this information is derived from the National Institutes of Health Tutorial. The full tutorial is available at http://cme.cancer.gov/clinicaltrials/learning/humanparticipant-protections.asp