Conclusion

Chapter 1: Introduction

By contrast to DHEW, much less was known about the history of research rules for other agencies also involved in research with human subjects during this period, including the Department of Defense (DOD), the Atomic Energy Commission (AEC), and the Veterans Administration (VA). From the perspective of the charge to the Advisory Committee, these agencies were at least as important as DHEW. It was known that in 1953 the secretary of defense issued, in Top Secret, a memorandum on human subjects based on the Nuremberg Code.[3] In 1947 an international tribunal had declared the Nuremberg Code the standard by which a group of doctors in Nazi Germany should be judged for their horrific wartime experiments on concentration camp inmates. However, the actual impact of the Nuremberg Code on the biomedical community in the United States, both inside and outside of government, is a matter of some disagreement (see chapter 2). The general view was that, despite some developments in the 1940s and 1950s, there was little activity within the federal government on issues of human subjects research before the 1960s.

But while scholars have known of the 1953 secretary of defense memorandum, which was declassified in 1975, other relevant Department of Defense documents remained classified or had lain buried in archives. Moreover, relevant records of the Atomic Energy Commission were largely unexplored and in some cases still classified. These records are important because, from its creation in 1947, the AEC distributed radioisotopes that would be used in thousands of human radiation experiments, and it was a funding source for many other experiments (see Introduction). Along with the DOD, also created in 1947, the AEC was searching for biomedical information needed to understand the effects of radiation as it prepared for the possibility of atomic warfare. Although the AEC was thus the catalyst for a considerable amount of human experimentation after World War II, there has been literally no scholarship on the AEC's position on the use of human beings in radiation-related research.

Now that previously obscure, even classified, records are being made public, it appears that in the first years of the Cold War, officials and experts in the AEC and DOD did discuss the requirements for human experiments. In this chapter we tell what we have learned about those discussions.

We begin by telling the story of the AEC general manager's early declarations on human research, which included a requirement that consent be obtained from patient-subjects. This story requires a careful look at a series of letters and memorandums exchanged in the late 1940s. Together these documents paint a clearly important but nonetheless confusing picture of a new agency's attempts to come to grips with the complexities of human experimentation. We consider not only what these documents say, but what we can piece together about what they meant in the context of the times. Central questions include the precise scope of the activities covered by the requirements and whether and how these 1947 statements were communicated and put into effect in the AEC's burgeoning contract research and radioisotope distribution programs.

We turn next to the Department of Defense, where we trace the history of rules on the use of healthy "normal volunteer" subjects in military research from the time of Walter Reed through the secretary of defense's 1953 memorandum, and beyond. This memorandum is the earliest known instance in which a federal agency that sponsored human experiments adopted the Nuremberg Code. What is known about how the memorandum was interpreted and implemented by the military establishment takes up much of the rest of this chapter. Here, as in the case of the AEC, key questions concern the scope of the activities covered by requirements and the extent to which they were put into effect.

Finally, we briefly discuss how research involving human subjects was addressed at the National Institutes of Health and the Veterans Administration in the 1950s. The evolution of policies governing human research at DHEW has been well documented and is only summarized here.[4] We now know that NIH's 1953 policy was not the earliest federal requirement that consent be obtained from patients as well as healthy subjects. However, in contrast with the 1940s declarations by the AEC, it was a far more visible statement issued by an agency that was emerging as the leading sponsor of human subjects research. In contrast with what is known about NIH, the extent to which there were research rules at the VA in the 1940s and 1950s remains unclear.

A recurring theme in this chapter is the uncertainty about the significance within government agencies of many of the official statements that are discussed. While these statements emanated from high and responsible officials and committees, often they cannot be linked to fuller expressions of commitment by the agencies. Some of these statements were not widely disseminated, and there were no implementing guidelines or regulations and no sanctions for failures to abide by them. Thus, it is sometimes unclear what formal, legal significance these statements had. We are no less interested, however, in what these statements can tell us about how government officials and advisers saw human research at the time and how they understood the obligations surrounding it.