Kennedy Institute of Ethics Journal

Human subjects research in the United States has only recently emerged as an important area of historical investigation. Over the last quarter century, scholars have begun the process of grounding within an historical context both the complex relationship between researchers and subjects and the processes by which biomedical knowledge is produced. Their studies examine topics ranging from the impact of the anti-vivisectionist movement on human experimentation in the early twentieth century (Lederer 1995) to the development of the discipline of bioethics in the 1960s and 1970s (Rothman 1991) and the emergence of the legal concept of informed consent for human research (Katz, Glass, and Capron 1972). Many of the discussions focus on isolated incidents of scandal, such as the Tuskegee Syphilis Study (Jones 1993; Brandt 1978) and the Willowbrook School hepatitis study (Rothman and Rothman 1984). In doing so, they attempt to explain how such clearly unethical research could have been initiated and what consequences have resulted from public knowledge of such research.

Nonetheless, the broader historical contexts and implications of human subjects research have yet to be fully delineated. This project will be of crucial importance, not only for historians, but also for those concerned with research policy and medical ethics. The historical examination of human subjects research will provide further insight into the details of research methods, the construction of protocols, and the historically specific interest in certain diseases. In addition, scholars will better understand the relationships of power and authority between researcher and subject, as well as the social and scientific mechanisms for the production of new biomedical knowledge. The process of enlisting research subjects illuminates the significance of class, gender, ethnicity, and race in science, in biomedicine, and in society. The fact that, historically, much research has employed research subjects from vulnerable populations, who participated in coercive contexts, has exposed powerful social assumptions embedded in the research enterprise. [End Page 239]

The revelation of new documents indicating past abuses has sparked much of the investigation into human subjects research and the recent investigation of human radiation experiments during the Cold War era. One of the most important achievements of the Advisory Committee on Human Radiation Experiments was the uncovering of thousands of documents, a remarkable mine of archival data, that had been previously inaccessible to researchers. Jonathan Moreno and Susan Lederer’s article on the history of Cold War research ethics in this issue of the Kennedy Institute ofEthics Journal represents the first attempt since the publication of the Committee’s Final Report to analyze the Committee’s findings in a serious historical context.

Historical accounts of the emergence of bioethics traditionally have left a great void in their discussions of human experimentation, generally ignoring the period between the writing of the Nuremberg Code in 1947 and the publication of Henry Beecher’s 1966 New England Journal ofMedicine article condemning systematic, unethical practices in human experimentation (Rothman 1991). The period from 1946 to 1966, however, was a time of vigorous research characterized by a fragmented community of medical researchers who applied inconsistent ethical standards and employed highly variable research practices. Both military and civilian medical researchers were intensely interested in radiation and thus conducted human subjects research along those lines, including examinations of the effects of plutonium injections and of total body irradiation, the use of trace radioisotopes to study various body processes, and observations of the effects of radiation intentionally released into the environment. The U.S. Government sponsored several thousand such studies (ACHRE 1995 [GPO, pp. 227–31; Oxford, pp. 135–38]), some of which were conducted on hospital patients, institutionalized children, military personnel, and prisoners. The Cold War scientific culture that produced this research must be examined from an historical ethical perspective.

A central aspect of the culture of biomedical science after World War II was its insularity. Increasingly high standards of admission and challenging training had come to ensure that only a select group of individuals was admitted to the professions of medicine and research science. In this culture of experts, trustworthiness and ethical judgment were considered to be dependent upon expertise...