The Public Health Service (PHS) Study of Untreated Syphilis in the Male Negro (1932-72) is the most infamous American example of medical research abuse. Commentary on the study has often focused on the reasons for its initiation and for its long duration. Racism, bureaucratic inertia, and the personal motivations of study personnel have been suggested as possible explanations. We develop another explanation by examining the educational and professional linkages shared by three key physicians who launched and directed the study. PHS surgeon general Hugh Cumming initiated Tuskegee, and assistant surgeons general Taliaferro Clark and Raymond A. Vonderlehr presided over the study during its first decade. All three had graduated from the medical school at the University of Virginia, a center of eugenics teaching, where students were trained to think about race as a key factor in both the etiology and the natural history of syphilis. Along with other senior officers in the PHS, they were publicly aligned with the eugenics movement. Tuskegee provided a vehicle for testing a eugenic hypothesis: that racial groups were differentially susceptible to infectious diseases.
There is currently no public policy that provides guidance concerning whether and when physicians infected with hepatitis B virus (HBV), hepatitis C virus (HCV), and/or human immunodeficiency virus (HIV) can safely perform invasive procedures. A committee of experts in the fields of medicine, law, and biomedical ethics and 1 community member, aided by an advisory board, was established to produce recommendations for policy reform. An extensive literature review was conducted for these 3 infectious diseases, medicine, surgery, epidemiology, law, and bioethics to gather all relevant data. Special recommendations are made regarding the management of physicians who are infected with HIV, HBV, and/or HCV. This policy proposal includes a list of exposure-prone procedures and a decision chart that indicates under what conditions infected physicians can practice beyond the need for disclosure of their serological status.
The U.S. Public Health Service’s sexually transmitted disease (STD) experiments in Guatemala are an important case study not only in human subjects research transgressions but also in the response to serious lapses in research ethics. This case study describes how individuals in the STD experiments were tested, exposed to STDs, and exploited as the source of biological specimens—all without informed consent and often with active deceit. It also explores and evaluates governmental and professional responses that followed the public revelation of these experiments, including by academic institutions, professional organizations, and the U.S. federal government, pushing us to reconsider both how we prevent such lapses in the future and how we respond when they are first revealed.
The STD experiments in Guatemala from 1946-1948 have earned a place of infamy in the history of medical ethics. But if the Guatemala STD experiments were so "ethically impossible," how did the U.S. government approve their funding? Although much of the literature has targeted the failings of Dr. John Cutler, we focus on the institutional context and research ethos that shaped the outcome of the research. After the end of WWII, Dr. Cassius Van Slyke reconstructed the federal research contracts process into a grant program. The inaugural NIH study section recommended approval of the Guatemala STD experiments at its first meeting. The funding and oversight process of the Guatemala research was marked with serious conflicts of interest and a lack of oversight, and it was this structure, as opposed to merely a maleficent individual, that allowed the Guatemala STD experiments to proceed. We conclude that while current research regulations are designed to prevent the abuses perpetrated on the subjects of the Guatemala STD experiments, it takes a comprehensive understanding of research ethics through professional education to achieve the longstanding ideal of the responsible investigator, and ensure ethical research under any regulatory scheme.
Over the past thirty years, the doctrine of informed consent has become a focal point in discussions of medical ethics. The literature of informed consent explores the evolution of the principle of autonomy, purportedly emerging from the mists of 19th Century medical practice, and finding its earliest articulation in legal cases where wronged citizens asserted their rights against medical authority. A commonplace, if not obligatory, feature of that literature is a reference to the case of Mary Schloendorff and the opinion written by Judge Benjamin Cardozo by which the case is remembered. Commentators today applaud the prescience of Cardozo for an early articulation of what eventually would become bioethical orthodoxy concerning informed consent and its place as a bulwark of patient autonomy. They inevitably quote Cardozo's famous statement, “Every human being of adult years and sound mind has a right to determine what shall be done with his own body.”
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