Ethical human research: The role of the journal of parenteral and enteral nutrition and its authors

摘要

The Nuremberg "doctors," the Tuskegee Syphilis Study, the human radiation experimentswe forget these abuses at our peril and at the risk of crippling the advance of human well-being through ethical human investigations. These atrocities were committed within the purported context of medical science, but they were neither scientific, nor did they help advance the state of medicine. A high point in medical ethics and in human civilization is the response to these abuses. The Nuremberg doctors trials and the resultant Nuremberg Code (1946-1947), the Declaration of Helsinki Recommendations Guiding Physicians in Biomedical Research Involving Human Subjects (1964), and the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (Belmont Report, 1978) laid the framework for the current conduct of ethical human investigations in the United States.1 The Nuremberg Code is extraordinary in that it went beyond the mere judgment of the physician torturers and murderers of the Nazi regime to create a detailed legal and ethical framework to guide human research worldwide. This code states unequivocally the principle of informed consent: "The voluntary consent of the human subject is absolutely essential."2 The absoluteness of this statement makes it somewhat problematic,3 which led to reformulations in the Declaration of Helsinki and the Belmont Report that are now embodied in U.S. regulations concerning the conduct of human research. A major contribution of the Belmont Report, fully embraced and implemented in U.S. regulations and guidelines, was the creation of institutional review boards (IRBs) to directly and locally oversee human studies and the informed consent process.