Events that brought research ethics to public attention
Ideas about research ethics formed in response to significant events involving unethical behavior by researchers. Below are some of the historically significant occurrences. More occur each year, raising suspicion among the public. Although the most dramatic examples of unethical research involve medical interventions, the social and behavioral investigations that often accompany Praxis courses can also carry serious risk.
Nazi scientists and physicians performed many horrific experiments on humans without consent. For instance, they inflicted wounds and infections to observe the effects. They also administered experimental drugs without permission. Many of these experiments were made public in the Nuremberg trials (1945-1949).
Tuskegee Syphilis Study
"The Tuskegee Syphilis Study, carried out in Macon County, Alabama, from 1932 to 1972, is an example of medical research gone wrong. The United States Public Health Service, in trying to learn more about syphilis and justify treatment programs for Blacks, withheld adequate treatment from a group of poor Black men who had the disease, causing needless pain and suffering for the men and their loved ones.”
“In the late 1950s, thalidomide was approved as a sedative in Europe; it was NOT approved in the United States by the FDA. The drug was originally taken because it was believed to control sleep and nausea throughout pregnancy, but it was soon found that taking this drug during pregnancy caused severe deformities in the fetus. Many patients did not know they were taking an experimental drug nor did they give informed consent. Some 12,000 babies were born with severe deformities due to thalidomide.” (Thalidomide Experiments)
Death of Jesse Gelsinger in University of Pennsylvania Gene Therapy Experiment
Gelsinger, a research participant, died in 1999. His family sued the researchers and bioethicists involved in the experiment. The trial and subsequent hearings in the United States Senate questioned whether Gelsinger was properly informed of the risks involved in the experiment. They also raised questions about whether the researchers and bioethicists stood to profit from approving the experiment, which would be a conflict of interest.
Major Responses to Ethics Violations
The Nuremberg Code (1949)
Produced in response to the Nuremburg trials, this international guideline specifies responsibilities of medical researchers.
Another important international document specifying rules for medical research.
This is a part of the Code of Federal Regulations. It specifies the government requirements for researchers using government funds for research involving human beings.
The Belmont Report (1978)
Legislation in 1974 created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Following a four day meeting at the Smithsonian Institution’s Belmont Conference Center in February 1976 and monthly meetings over a period of about four years, the deliberations of the Commission were summarized in the Belmont Report. The report provides the basic ethical principles that should be applied to research with human participants, as well as guidelines for addressing ethical problems in human subjects research. The Belmont Report is not a legal document, but provides the most important ethical guidelines for human subjects research in the US.