DOE Openness: Human Radiation Experiments: Roadmap to the Project
Chapter 9: Ethical ConsiderationsIt is quite clear that all of the radiation experiments that have come to the Advisory Committee's attention in which prisoners were employed as research subjects would have been in violation of federal standards as they exist today. Federal regulation stipulates an extremely limited range of permissible medical research in prison populations. Only four types of investigations can currently receive approval: (1) low-risk studies of "the possible causes, effects, and processes of incarceration, and of criminal behavior"; (2) low-risk studies of "prisons as institutional structures or of prisoners as incarcerated persons"; (3) "research on conditions particularly affecting prisoners as a class (for example, vaccine trials and other research on hepatitis which is much more prevalent in prisons than elsewhere . . .)"; and (4) research that has "the intent and reasonable probability of improving the health or well-being of the subject." Almost certainly, none of the various episodes of radiation research on prisoners treated in this chapter would have fallen into any one of these categories.
But as noted above, widespread concern about coercion and exploitation of prisoner-subjects--which brought about these restrictive federal regulations--arose relatively recently in this country. For the period before roughly 1970, it is almost certainly unfair to condemn, in retrospect, a research project as unethical solely because researchers employed prisoners as subjects; historical sensitivity demands some appreciation for what seems to have been a genuine lack of widespread professional or public concern for the ethical problems of prison research that came to the fore during the 1970s. Only in the case of the Washington and Oregon testicular irradiation experiments do we know enough to make any legitimate claims about the extent to which researchers conformed with reasonable contemporary standards for the ethical conduct of prison experimentation. And, even for these relatively well-known studies, the individual complexities of each series of experiments have grown hazier with time.
One of the first known efforts to examine the ethics of using prisoners as research subjects was organized by the Law-Medicine Research Institute (LMRI) of Boston University. The conference was called "The Participation of Prisoners in Clinical Research," and it opened on February 12, 1962. The conference was part of a larger LMRI project to study and report on "the actual practices, attitudes, and philosophies currently being applied in the legal and ethical aspects of clinical investigation" (see chapter 2). LMRI's conference on prison research was one of several "invitational work conferences" organized to gather information on several important topics in human experimentation (other conferences were devoted to "the concept of consent," pediatric research, and pharmaceutical testing). The participants at each conference received an agenda and briefing book in advance of the meetings, but discussions tended to be free-ranging. Those who attended the conferences understood that their words were being recorded, but they tended to speak in a frank and revealing fashion because LMRI pledged to preserve their anonymity when reporting on the meetings.
A copy of the list of participants at the conference on "The Participation of Prisoners in Clinical Research," which survives at Boston University, confirms the following characterization of those who attended:
[T]he thirty-six invited participants comprised two main categories. The first was composed of clinical research administrators and clinical investigators with a variety of academic, commercial, and governmental affiliations, who have had experience in conducting medical studies with prisoners as subjects. The second category consisted of prison administrators and prison medical officers with various federal, state, and municipal correctional programs. Also participating in the conference were representatives of various related fields such as behavioral science, criminal law, organized medicine, pharmaceutical manufacturing, and the military services.
Unfortunately, a copy of the actual meeting transcript has not survived. However, the lengthy unpublished "Analytic Summary," which contains many (anonymous) transcript excerpts, seems to be a fair representation of the daylong meeting. It is relatively easy to extract several important points of agreement about the proper conduct of experimentation in prisons from this report. And, given the broad cross section of those involved in prison experimentation who attended this 1962 conference, it seems reasonable to employ the standards enunciated at this conference as evidence of prevailing interpretation of ethical standards for prisoner experiments that began in 1963.
First, the "conferees generally agreed that experimental risks must be balanced against benefits." In the case of research that was not intended to be of potential direct benefit to the subject, which was generally the case in prison experiments, most meeting participants believed that the social or scientific value of new knowledge that might result from an experiment should be weighed as a benefit. However, when "confronted with the direct question of whether or not a relatively high degree of risk can ever constitute a legitimate reason for the use of prisoner subjects, the conferees were almost unanimous in rejecting this position." Interestingly, those at the conference believed that the general public was less inclined to worry about subjecting prisoners to high levels of experimental risk. Two brief transcript excerpts are revealing:
When the public hears that inmates are [participating in a seemingly very hazardous study], they rationalize, "Well, I wouldn't do it, but it's all right with prisoners."
The conferees spent a large portion of their day together discussing the matter of consent. They reached agreement that meaningful consent should be both voluntary and informed, provided the reach of these terms is carefully circumscribed. The report stated,
[T]he legal prerequisites of consent are, first, not absolute free will, but sufficient free choice to avoid coercion or duress; and, second, not absolutely perfect knowledge, but enough information to avoid fraud or deceit.
The conference participants "unanimously agreed that rewards offered to prisoner volunteers should not be so high as to invalidate their consent to participate as research subjects." There seems to have been considerable disagreement about exactly where to draw the line between ethically acceptable and unacceptable rewards to prisoners for service as experimental subjects, but there was a general desire to "minimize rewards" because it was "consistent with the penological desirability of maximizing prisoners' 'opportunity for altruism.'" As for sentence reductions, some thought that small amounts of "good time" credits were appropriate, but all agreed that "maximum rewards of this type, i.e., definite promises of pardon or parole, should not be given." There seems to have been little discussion of the possibility that the authoritarian structure of prison life was in itself coercive and therefore limited a prisoner's ability to make an autonomous decision.
The disclosure component of consent received extensive attention at the conference. The following was offered as a summation of what the conferees perceived as the "essential content and emphasis" of the information that should be conveyed to "prospective prisoner-subjects":
The explanation of a clinical research project . . . should describe completely the procedures entailed and should stress the possible consequences of these procedures. Even though it may be necessary to "stop somewhere short of full revelation when you reach intricacies a layman would never comprehend," there should be no omission of any adverse consequences, detriments, or risks.
To strive toward this level of communication, the conference participants cited procedures that were "usually" followed in most prison experiments: a general announcement of the research project to the inmates (usually by notices posted on bulletin boards or printed in prison newsletters); a general explanation of the project (often in an auditorium) to groups of prisoners who expressed initial interest in an experiment; and, finally, one-on-one meetings between prospective participants and research personnel. Conferees who had administered or conducted prison experiments also reported that prisoner-subjects "usually sign[ed] some type of 'consent agreement.'" (Generally speaking the provisions specified above were followed in the Washington and Oregon experiments, but the information provided was often inadequate.)
Even with all of these measures, some meeting participants asserted that the "ideals of comprehension, evaluation, and decision on the part of prisoners were seldom attained in practice." They pointed to two general difficulties in achieving these ideals. First, "the lack of intelligence, education, or 'medical sophistication' among many prisoners." Second, they cited "various 'motives or pressures which so often stand in the way of objective understanding.'" The participants in the conference also recognized that the consent forms used in prison experiments were often less than perfect. They understood that the "waiver or release" components of many forms were probably inappropriate. They also recognized that reasonably predictable risks of an experiment were not always carefully listed on consent forms, but at the same time they "agreed that 'no serious' risk should ever be disguised or concealed" on these forms.
In sum, the records from this conference suggest that even apart from formal, federal rules for experimentation on prisoners, ethical conditions for the conduct of prison research were articulated in the early 1960s. Now, with these conditions in mind, let us turn to a more detailed analysis of the Washington and Oregon testicular irradiation experiments.
As we have noted, the Committee's ability to assess the quality of consent obtained from a research subject thirty or forty years earlier can be confounded in a thousand ways. To begin with, the records are invariably incomplete; then, the investigators are either no longer alive or their memories have grown hazy or selective with time; the same is true of subjects; and, of course, there are confidentiality considerations, which limit the availability of records, the concern of researchers for their reputations, and so on. All of these considerations, to greater or lesser degrees, apply to the Oregon and Washington experiments.
With respect to these experiments, however, we believe we have a clear-enough picture of the standards and practices of the time to evaluate the conduct of the research against them without reference to the standards and practices of today.
In both Oregon and Washington, some subjects were not warned, warned only after enrolling in the experimental program, or inadequately warned that there was potential risk, albeit small, of testicular cancer. While it might not have been uncommon at the time for physicians to avoid using the word cancer with sick or even terminally ill patients for paternalistic reasons, such avoidance is harder to justify, even by the standards of the time, in the case of healthy subjects who are participating in research that offers them no direct benefit.
As far as acute effects are concerned, the pain of testicular biopsy may have been understated in both programs, and the risk of orchitis from repeated biopsies seems to have been ignored. Some former subjects have complained of long-term pain, sexual dysfunction, and skin rashes. It is not clear whether these conditions were caused by the experiments, nor is it certain that long-term medical follow-up can answer this question.
Subjects in both sets of experiments were required to have a vasectomy at the end of the program because of concerns about possible chromosomal damage. In both cases the vasectomy consent forms signed by the subjects, and their wives if they were married, adequately described the procedure, its consequences, and the small possibility it could be reversed. However, appropriate questions have been raised about the reasons inmates might agree to vasectomy in the circumstances of prison research, and the possibility, as actually occurred in a number of cases, that in the end the subject would refuse to undergo the procedure.
Finally, there appears to be little doubt that the financial incentives offered for participation were the main reason most inmates volunteered. Payments totaling more than $100 could be seen as unduly influencing the judgment of potential volunteers. While money also is a powerful incentive for research participation outside prison walls, we believe that the conditions of confinement can magnify the perceived value of the reward. Whether the payments offered to participants in these programs constitute an unfair inducement to participate in research may vary from inmate to inmate.
While the prison experiments were unethical with respect to current requirements for disclosure of risk and noncoercion, the researchers functioned during a period of rapid evolution of the interpretation of ethical principles in the prison context. Their actions, however, were less than fully consistent with the existing AEC requirements, especially concerning the information the prisoner-subjects were provided.