Ethical Considerations

Chapter 9: Introduction

This concern provides some of the context for a brace of almost identical experiments carried out between 1963 and 1973 in which 131 prisoners in Oregon and Washington submitted to experimental testicular irradiations with national security and other societal goals, but no potential for therapeutic benefit for the subjects. The studies were directed by Carl G. Heller, M.D., a leading endocrinologist of his day, and by Dr. Heller's protégé, C. Alvin Paulsen, M.D. Perhaps because they involved irradiation of the testicles, they have caused great public concern. They were also noted briefly among the thirty-one experiments Representative Edward J. Markey of Massachusetts publicized in his 1986 report on radiation research on human subjects.[2] Both studies were funded solely by the Atomic Energy Commission. Drs. Heller and Paulsen were interested in the effects of radiation on the male reproductive system, especially the production of sperm cells. The government was interested in the effects of ionizing radiation on workers, astronauts, and other Americans who might be exposed, in a nuclear attack for example.

Both doctors viewed prisoners as ideal subjects. They were healthy, adult males who were not going anywhere soon. In 1963 few if any researchers had moral qualms about using them as subjects, although there seems to have been a consensus in the research community on the rules that should govern such experimentation. By 1973, however, some ethicists, researchers, and others, such as the investigative journalist Jessica Mitford, pointed out that incarcerated people were not well placed to make voluntary decisions. In 1976, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research recommended the banning of almost all research on prisoners. Prison experimentation effectively came to an end in this country a few years after the commission offered its recommendations.

The Heller and Paulsen experiments were groundbreaking scientifically, and they were conceived as having an important government purpose--protecting Americans engaged in building the nation's high-priority nuclear and space programs. But looking back through the lens of history, there appears to be an inconsistency between the way human subjects were treated in this research and the standards intended to govern their treatment. Although both Dr. Heller and Dr. Paulsen showed sensitivity to some ethical issues, in both cases the researchers themselves and some of those charged with oversight at both the federal and state levels did not completely live up to what appear to have been well-understood standards applicable to their research. In this failure they were no different from many if not most of their contemporaries. Times were changing, however, and in the end, state officials shut down both sets of experiments, bringing practice more into line with the standards already on the books of some government agencies and private research organizations.

Among researchers who used prisoners as subjects, as early as 1958 the Nuremberg Code was recognized as a model set of rules for conducting human subject research.[3] It is equally clear that the work in the Oregon and Washington prisons did not carefully follow all these rules. Moreover, the funding agency, the Atomic Energy Commission, had its own rules for the conduct of research with human volunteers, which were not fully observed in these experiments. As discussed in chapter 1, in 1956 the AEC's Isotope Division program provided that where healthy subjects were used for research, they needed to be volunteers "to whom the intent of the study and the effects of radiation have been outlined." A 1966 memorandum from the AEC's office of general counsel to the director of the Division of Biology and Medicine sheds some light on the agency's standards at that time, and why it had them. The specific experiments referred to in the memo--plutonium and promethium injections or ingestion--appear not to have been carried out, but the "use of human volunteers in experiments" is addressed in general terms. The memo calls for "volunteer[s]" to sign a written, witnessed agreement attesting to their sound mental state and free will, to their understanding of the purposes and risks of the planned experimentation, and that the experiment was not being done for their benefit. The relevant paragraph concludes: "Assuming complete understanding and no unequal bargaining factors (e.g. pressure on prisoners to submit), such an agreement would protect against liability for unauthorized invasion of the person."[4]

Finally, those attending a 1962 conference on research using prisoners as subjects reached a consensus on a higher standard for subject selection and informed consent than was typically observed in Oregon and Washington. For example, the conferees argued that potential prisoner subjects should have enough information to avoid their being deceived and that inducements to prisoners should not be so high as to invalidate consent.

The surviving researchers disagree somewhat about the genesis of the testicular irradiation experiments, which the available documentary evidence does not completely resolve. What follows is a version based on and consistent with both the Heller and Paulsen accounts.

Early in 1963 the AEC held a conference in Fort Collins, Colorado, for investigators who were using radiation in studies of reproduction in animals. Dr. Heller was invited. In a bedside deposition taken after he suffered a stroke in 1976, he recounted what happened:

The whole conference finally focused on man. A given group at Fort Collins was working on mice and another group was working on bulls, and then they concluded, what would happen to man[?] They extrapolated the data from bulls or mice to man. I commented one day to Dr. [Paul] Henshaw, who was then . . . with the AEC, that if they were so interested in whether it was happening to man, why were they fussing around with mice and beagle dogs and canaries and so on? If they wanted to know about man, why not work on man[?][5]

According to Dr. Heller, that remark stimulated the AEC to solicit a research proposal from him to study the effects of radiation on the male reproductive system.

Dr. Paulsen, however, recalled a different scenario in a 1994 interview by Committee staff at his office in Seattle.[6] He said he was invited to the AEC's Hanford, Washington, facility in 1962 to act as a consultant after three workers were accidentally exposed to radiation. Like Dr. Heller, Dr. Paulsen had no previous experience with radiation exposure. He said he was brought in because of a chapter he had written on the testes in an endocrinology text. As a result of that experience, Dr. Paulsen said, he became interested in doing work on the effects of radiation on testicular function, discussed his idea with colleagues, and contacted the AEC to see if the agency would be interested in funding his work.

Whether or not Drs. Heller and Paulsen initiated their projects separately, the practical result was that both received AEC funding and carried out their research projects during the 1960s and early 1970s in the Oregon and Washington state prisons, respectively. Although the two studies were very much alike in their methods and objectives, there were small differences. They used different consent forms, different levels and means of irradiation, and different subject-selection procedures.

This chapter provides accounts of the Washington and Oregon experiments that focus on the failure of these two research projects to live up fully to ethical standards of their time; the Committee's analysis of the risk to subjects in the two experiments; capsule descriptions of a number of other radiation experiments using prisoners as subjects; and a general ethical analysis of radiation experiments using prisoners as subjects.