Chapter 1: Conclusion

ACHRE Report

Part I

Chapter 1

Conclusion

Chapter 1: Conclusion

Records now available show that at the highest reaches of Cold War bureaucracies officials discussed conditions under which human experimentation could take place. These discussions took place earlier and in greater, although by today's standards uncritical and less searching, detail than might have been assumed. Nonetheless, the stated positions that resulted were often developed in isolation from one another, were neither uniform nor comprehensive in their coverage, and were often limited in their effectuation. Several interrelated factors seem to have been prominent in causing these discussions to take place and in determining the scope of the requirements that were declared and the efforts that were undertaken to implement them. We summarize these key factors below.

Administrative and Legal Circumstance

The creation of new programs, or the qualitative expansion of old ones, impelled officials, lawyers, and researchers to reflect on the rules to govern them. While these rules were sometimes cast as "legal" or "financial" requirements, they often included provisions, such as a requirement for written consent, that appear similar to statements in requirements that govern the conduct of research today. The language used to describe these rules was often that of law or administration, such as "waiver" or "release" forms, or it may have had particular meaning to researchers at the time, such as "clinical testing." As a result, it is often hard to compare these rules to current requirements, which have benefited from intervening decades of linguistic and conceptual refinement.

Professional Cultures

Differing professions brought their own tools and perspectives to discussions of conditions under which human subjects research could proceed. For example, lawyers were likely to insist on obtaining documented evidence of patient consent, while medical professionals emphasized the importance of the trust that underlay the relationship between doctor and patient; they sometimes objected to the use and implications of written consent forms.

If consent procedures were a source of disagreement, the need to minimize risk to subjects was not. In creating and administering the AEC's radioisotope distribution program, physician investigators and other researchers placed a premium on controlling and minimizing risk in the "human use" of radioisotopes. This emphasis on the establishment of administrative and educational procedures to control risk, the details of which are discussed in chapter 6, embodied an essential principle of ethical research.

The requirement for prior review included in the isotope distribution program was, as we have seen, also present elsewhere. Even before 1944, approval of the secretary of the Navy was required for research with human subjects. The secretary of the Army required prior approval of research related to atomic, biological, and chemical warfare in 1953. In the Air Force, secretarial approval of human experiments was codified in 1952. At NIH, prior group review was employed as a policy from 1953 on. The VA, whose program developed under the eye of AEC experts and advisers, relied on local isotope committees.

The Nature of the Subjects

While voluntary consent was acknowledged as a condition of human research by some government agencies well before 1944, it was not as broadly applied as it is today. Requirements of voluntary consent were asserted most clearly and consistently where the subjects were healthy. As a practical matter, healthy subjects are not likely to participate in experiments without specific request, and as a legal matter the invasion of a person's body in the absence of a prior relationship that might justify it has long been unacceptable. Still more important, the arbitrary use of people in experiments is incompatible with respect for human dignity.

The use of patients in medical research appeared in a different historical context from that of healthy subjects, and the agencies appear to have responded accordingly. From the perspective of the medical profession, the age-old tradition of the doctor-patient relationship, as we shall see in the next chapter, provided a justification for research with the potential to benefit patients, but not, of course, for healthy subjects who were not under medical care. There is little evidence that the agencies questioned whether research with patients that did not offer a prospect of benefit warranted a different response. An exception is the position articulated by the AEC's general manager in 1947, which made the possibility of benefit to the patient-subject a condition of permissible research, at least where the research involved "poisonous or harmful" substances. However, there is little indication that this provision was ever implemented.

The period we reviewed in this chapter led to considerable public disquiet about the use of healthy subjects and about the use of ill and institutionalized people in research from which they could not possibly benefit. It was this disquiet, in the wake of several well-publicized incidents, that formed the basis of the mid-1960s reforms of federal policy governing research with human subjects (see chapter 3). The focus on the way that patient-subjects were used in clinical research that offered some prospect of benefit, and particularly on consent issues, came much later. The latter discussion is one that continues today, as is evident from the Advisory Committee's work on current research regulation that is described in part III.

The Degree of Risk

To the extent that there was discussion in the 1940s and the 1950s of consent for patient-subjects, it seemed to arise mainly in circumstances in which those who were ill would be put at unusual risk from the research.

As we have seen, the AEC's radioisotope distribution division concluded that consent was required where patients were being subjected to "larger doses for investigative purposes" that apparently posed unusually hazardous or unknown risks. Similarly, from its establishment at midcentury, the AEC's hospital at Oak Ridge, which focused on new and potentially risky experimental cancer treatment, did have routine requirements for consent. Likewise, from its 1953 birth, the NIH's Clinical Center established a policy that recognized that patient choice was important for all kinds of research with patients, and written consent was required when an experiment involved an unusual hazard.

Formal Policies and Public Morality

It is important not to get lost in the details of the various documents we have cited in this chapter. What is most significant about the discussions that took place in federal agencies from the mid-1940s through the 1950s is the fact that so many of the ideas and values with which we are familiar were apparent then. That does not mean that the same words were used or that when they were used they had the same meaning as they do for us today. But it does mean that there were certainly more or less rough ideas about voluntary consent and minimization of risk. As we have seen in this chapter, these ideas were very much in play in the culture of the time.