Minority Health and Health Equity Archive

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    Eighty Years of Bad Blood: The Evolution of Human Research after the Tuskegee Study
    (2012) Cook, Brett D.; Jackson, Tahmika Ruth
    The year 2012 marks the eightieth anniversary of the beginning of the U.S. Public Health Service’s (PHS) study on the effects of untreated syphilis in Tuskegee, AL, which lasted from 1932 to 1972. The research continued after penicillin became widely available and was known to be an effective treatment for syphilis. To justify the experiments, the PHS argued that the study was a never-to-be-repeated opportunity. Did the U.S. government continue to take advantage of never-to-be-repeated opportunities in medical research by using unethical justifications? This manuscript will explore how America’s growing understanding of human research and the rights of human subjects have mirrored the growth of regulatory law and jurisprudence since the Tuskegee Study. We will examine PHS human research experiments in Guatemala from 1946 to 1948, as well as the U.S. Department of Justice’s decision not to prosecute members of the Japanese Army despite having received information on human experiments they conducted on World War II Prisoners of War (POWs). We recognize that numerous events have contributed to current human research practices and it would be impossible to discuss every significant topic. We submit that society’s ethical considerations regarding human research have progressed over the past eighty years. In this article we concentrate on the growing protections of the right to informed consent. We contend that constant and consistent oversight by the three branches of U.S. government is necessary to ensure human rights protection of those classes least able to protect themselves and prevent another Tuskegee Study.
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    The Origins of Informed Consent: The International Scientific Commission on Medical War Crimes, and the Nuremburg Code
    (2001) Weindling, Paul
    The Nuremberg Code has generally been seen as arising from the Nuremberg Medical Trial. This paper examines developments prior to the Trial, involving the physiologist Andrew Conway Ivy and an inter-Allied Scientific Commission on Medical War Crimes. The paper traces the formulation of the concept of a medical war crime by the physiologist John West Thompson, as part of the background to Ivy's code on human experiments of 1 August 1946. It evaluates subsequent responses by the American Medical Association, and by other war crimes experts, notably Leo Alexander, who developed Ivy's conceptual framework. Ivy's interaction with the judges at Nuremberg alerted them to the importance of formulating ethical guidelines for clinical research.
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    Historical background of clinical trials involving women and minorities.
    (1994) McCarthy, C R
    The author provides a historical context for the difficult ethical and clinical issues associated with the inclusion of women and members of minority groups in clinical research. He cites as a point of departure the Nuremberg Code of the late 1940s, which declared the fundamental dignity of human beings involved as research subjects, a principle that was quickly endorsed worldwide. From the period following World War II through the 1970s, the prevailing attitude--not always practiced--toward research subjects in the United States was that they should be protected from exploitation. That attitude was reflected in the first broad federal policy on research subjects, created in 1966. During those years, research was widely regarded by the public as dangerous and of little value to individual participants; it is remarkable that so many men and women consented to participate in clinical studies at that time. Furthermore, during the 1970s, for reasons explained by the author, various events--the abortion debate, disclosures from the infamous Tuskegee syphilis study, Nixon's "war on cancer," new federal regulations in 1974 and 1975 (the latter providing additional protection for pregnant women in research), the broad interpretation of the FDA's 1977 policy excluding pregnant or potentially pregnant women from clinical trials, and the tendency of blacks and persons from other minority groups to shun participation in research--tended to deter participation of women and members of minority groups in clinical research.(ABSTRACT TRUNCATED AT 250 WORDS)
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    Steps still being taken to undo damage of America's Nuremberg
    (1997) Wolinsky, Howard
    The year 1947 was a watershed for medical ethics and medical care. Fifty years ago, the Nuremberg Code, created in response to the atrocities of Nazi medicine, called for the informed consent of participants in human research. That same year, penicillin was recognized as the standard of care for syphilis. Researchers from the U.S. Public Health Service failed to connect these two milestones. They continued to conduct a long-running study in Tuskegee, Alabama, on the course of syphilis in untreated African-American men and chose not to provide penicillin to study participants. Today, some researchers attribute problems in recruiting African Americans for clinical trials, at least in part, to the Tuskegee study.