Chapter 2: IntroductionIn chapter 1, we explored government discussions of research involving human subjects in the 1940s and 1950s. We found that, at several junctures, government officials exhibited an awareness of the Nuremberg Code, the product of an international war crimes tribunal in 1947. If a requirement of voluntary consent of the subject was endorsed by the Nuremberg judges and was recognized at the highest reaches of the new Cold War bureaucracy, then how, a citizen might now ask, could there be any question about the use of this standard to judge experiments conducted during this time in the United States? And yet precisely this question has been raised in connection with human radiation experiments. Did American medical scientists routinely obtain consent from their subjects in the 1940s and 1950s, including those who were patients, and if not, how did these scientists square their conduct with the demands of the Nuremberg Code?
This chapter describes the Advisory Committee's efforts to answer these questions and what we learned. We begin with an examination of what, in fact, was argued at Nuremberg. We focus particularly on the testimony of Andrew Ivy, the American Medical Association's (AMA) official consultant to the Nuremberg prosecutors, and on the AMA's response to the report Dr. Ivy prepared about the trial for the organization.
We turn next to an analysis of the actual practices of American medical scientists during this period. In addition to reviewing contemporary documentation and present-day scholarship, the Advisory Committee conducted interviews with leading medical scientists and physicians who were engaged in research with human subjects in the 1940s and 1950s. These sources suggest a different, more nuanced picture of the principles and practices of human research than that presented at Nuremberg.
Of particular importance in this picture are the practical and moral distinctions that many researchers made between investigations with healthy subjects and those with sick patients. Those working with healthy subjects could cite a tradition of consent that dated, at least, to Walter Reed's turn-of-the-century experiments; those working with sick patients were in a clinical context that was conditioned by a tradition of faith in the wisdom and beneficence of physicians, a tradition that was dominant until at least the 1970s. Closely related to these distinctions was the tension between being a scientist and being a physician. This tension confronted members of a new, and rapidly growing, breed of medical professionals in the United States working to make careers in clinical research. The chapter goes on to explore whether these distinctions and tensions were reflected in the Nuremberg Code and why the trial may not have had much impact on the treatment of patient-subjects.
The rest of the chapter explores the emerging awareness of the moral complexities of research at the bedside and the limitations of the Nuremberg Code to address them. We close with a brief discussion of the Declaration of Helsinki, the international medical community's attempt to produce a code of conduct compatible with the realities of medical research.