Ethics in Human Subjects Research

History

The contemporary approach to the ethical conduct of research grew out of a history of abuses and scandals. The abuses of human subjects that surfaced during the trial at Nuremberg of Nazi physicians and scientists who had experimented on concentration camp victims led to the first significant 20th-century changes in human subjects’ protections. The necessity of these protections was demonstrated not only because the often fatal experiments conducted by the Nazis were [Page 342]made known, but also because as part of their defense, the Nazi defendants spoke of studies conducted by the victorious powers that shared some parallels to their experiments, including the failure to obtain consent.

The Nuremberg Code was developed as part of the judgment against the Nazi physicians and scientists. The Code consists of 10 principles that the court said should be followed when using humans in research, including the obligations to (1) obtain subjects’ voluntary consent; (2) allow subjects to withdraw and end their participation at any time; (3) ensure that it is necessary to conduct the proposed research to obtain the information sought and that the research is expected to be beneficial to society; (4) minimize the risks to and suffering of subjects; and (5) ensure that the expected benefits outweigh the anticipated risks.

The publication of Henry Beecher's 1966 article in the New England Journal of Medicine was a pivotal event in the history of research ethics. Beecher described 22 biomedical studies that he believed were unethical. In the Jewish Chronic Disease Hospital study conducted in 1963, liver cancer cells were injected under the skin of elderly patients to study immune responses. Most of the subjects suffered from dementia, were not told the truth about the study, and were not asked for permission to participate. At the Willowbrook State School for the Retarded in New York City, where children typically developed hepatitis while living in the institution, children were infected with hepatitis on admission to study the progress of the disease and possible methods of treatment. The study raised a range of issues, including the use of undue influence to obtain parental permission by putting children who would participate in the study on a fast track for admissions and the failure to take basic precautions to prevent the spread of hepatitis in the institution.

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