DOE Openness: Human Radiation Experiments: Roadmap to the Project
Chapter 10: ConclusionThe story of human research conducted in connection with nuclear weapons tests illustrates the difficult questions that are raised when human research is conducted in an occupational setting, especially a setting, such as the military, where exposure to risk is often part of the job. The story illustrates that it may often be difficult to discern whether or not an activity is a human experiment. By the same token, it also illustrates the importance of guarding participants against unnecessary risks, whether or not the activity is a human experiment.
Human experiments at atomic bomb tests were undertaken by the military, which had a long tradition of requiring voluntary consent from participants in biomedical experiments. The need for written consent in experiments related to atomic, biological, and chemical warfare was clearly stated in the secretary of defense's 1953 memorandum. That memorandum also required the approval in writing of the appropriate service secretary and precluded experiments that did not adhere to its further requirements. The 1953 memorandum, however, does not appear to have been transmitted to those involved in human research at bomb tests, although the tenet of voluntary consent was followed in some cases. In addition to consent, the 1953 memorandum contained other significant ethical requirements, including that research be reasonably likely to produce useful scientific results and that proper precautions be taken to minimize risk.
The bomb-test research illustrates the significance of the position that bad science is bad ethics. Unless a research project is scientifically defensible, there is no justification for imposing on human subjects even minimal risk or inconvenience. For example, the DOD's biomedical advisers advocated the conduct of psychological and physiological research on troops participating in bomb tests with an awareness that the likelihood of scientifically useful results was small and that the effort would be part of a larger exercise in indoctrination and training. Having done so, they had an obligation to at least review continued research efforts to determine if the research design was developing useful information. In the case of the psychological and physiological testing, the evidence indicates that early results showed that the research design was not likely to produce useful scientific information, if only because the military, the researchers, and perhaps even the subjects did not view the setting as sufficiently realistic.
At the same time, this question of ethics and science is irrelevant if the HumRRO activities did not entail research involving human subjects. An activity that has a poor research design would not be an ethical human experiment. However, the same activity might be ethical if conducted as a training activity whose essential purpose is to provide reassurance. Similarly, to the extent that research was intended solely to provide reassurance, ethical questions arise that might not be present if the activity were not experimental.
Just what makes something an instance of research involving human subjects? The answer to this question is not discoverable; instead, it is fashioned by people in particular contexts for particular purposes. Today, we would likely consider all the activities reviewed in the first part of this chapter--the HumRRO testing, the "atomic effects experiment," the flashblindness experiments, the cloud flythroughs, and the protective clothing and decontamination tests--to be cases of research involving human subjects to which the current federal regulations and the current rules of research ethics would apply. Some of these activities are, nevertheless, more paradigmatically instances of human research than others. Depending on the context, for example, the protective clothing and decontamination tests might be considered within the normal course of duty for military personnel.
One of the reasons it is important to be able to distinguish research involving human subjects from other activities is that military policy clearly states that service personnel may not be ordered to be human subjects. In contrast to much else in military service, participation in research is a discretionary activity that service personnel are permitted under military policy and federal regulation to refuse. Thus, in the military as elsewhere, human subjects are supposed to be volunteers whose valid consent has been obtained.
Human subject research is not the only activity in the military, however, for which consent is a requirement. The military also often asks for volunteers in settings where the risk is unusually great. For example, the testing of equipment may often be hazardous, may involve the use of volunteers, but may not be considered human research. Thus, in the case of test pilots, there may be significant risk, volunteers may be called for, but the activity might not be considered research with human subjects and thus would not be thought subject to human use research regulations.
Conversely, a requirement of consent may not necessarily mean that subjects have some measure of control over the risks to which they are to be exposed. Even under today's rules, informed consent in the HumRRO tests would be limited to the psychological and physiological testing, and not required for participation in the bomb test itself.
Whether the activity is research involving human subjects or an unusually risky assignment that is not considered human subject research, how free are military personnel to accept or refuse offers (as opposed to orders) put to them? Dr. Crawford, when asked to comment in 1994 on consent in his HumRRO research, responded by observing that "military service people generally do what they're asked to do, told to do." He was speaking of an army that included many conscripts; today's all-volunteer military is doubtless different in many respects that bear on questions of voluntariness. Nevertheless, the culture of the military, with its emphasis not only on following orders but on the willingness to take risks in the interests of the nation, surely influences and in some circumstances may restrict how service personnel respond to such offers.
Because in the military volunteering is often seen as a matter of duty and honor, and the boundaries between experimental and occupational activities may not be clear, the importance of minimizing risk emerges as a central concern. Above all, the activities discussed in this chapter confirm that the ethical requirement that risks to service personnel be minimized should not depend on whether an activity is characterized as an experiment or occupational. In the case of the atomic veterans, the risks run were usually no different for those who were subjects of research and those who were not.
The military took precautions, with great success, to preclude exposure to radiation at levels that might produce acute effects. However, bomb-test participants were exposed to lesser, long-term risks without adequate provision for (l) the creation and maintenance of records that might be needed, in retrospect, to determine the precise measure of risks to which military personnel were exposed; (2) the tracking of those exposed to risk, so that follow-up and assurance, as needed, could be efficiently undertaken.
It might be argued that, at the time, there was no awareness of a potential for long-term risk, or that the potential was understood to be nonexistent. But, while the possibility of long-term risk from low exposures was seen as low, it was not seen as nonexistent. Following the 1946 Crossroads tests, officials and experts connected with the DOD, AEC, and VA thought action was needed to collect data in secret to evaluate potential disability claims.
Since the bomb tests, the Defense Department has come to recognize the importance of providing for an independent risk assessment when service personnel may be exposed to new weapons--regardless of whether the exposure is classed as experimental or occupational.
However, for the numerous atomic veterans (and their family members) who spoke to the Committee, a continuing source of distress is not simply that the government put service personnel at risk but that, having undertaken to do so, the government did not undertake to collect the data and perform the follow-up that might provide them knowledge and comfort in later years. The Advisory Committee agrees. When the nation exposes servicemen and women to hazardous substances, there is an obligation to keep appropriate records of both the exposures and the long-term medical outcomes.
From listening to those who appeared before us, and from reflection on the laws that are already in effect, the Committee came to appreciate that there are several reasons record keeping is important. First, those who served, and their widows and surviving family members, have a great interest in knowing the facts of service-related exposures. We repeatedly heard from veterans and family members whose inquiries into the circumstances and details of exposures has spanned many years. Second, information may provide basis for scientific analysis that may shed light on the relation between exposure to risk and subsequent disability or disease. Third, where disability or disease appears to be a possible result of exposure, data are needed to provide the basis for a fair and efficient system of remedies.
The experience of the bomb-test participants indicates that several different kinds of records or data should be of use. First, of course, there are data about the exposure of individual service personnel to particular potential hazards. In the case of the atomic bomb tests, the potential that radiation would be a hazard was, of course, obvious. In addition, radiation is a phenomenon that is almost uniquely susceptible to measurement. In other settings faced by service personnel, the precise nature of the hazard may not be easily anticipated or, even if anticipated, readily measurable. Second, there are data concerning the location of service personnel. In the case of the bomb tests, as we have seen, data on the identity and location of all test participants (so that their position in relation to the putative hazard can be retrospectively reconstructed, if need be) were not readily available. Even if the hazard cannot be anticipated, such data can be useful in later efforts to reconstruct the nature of the hazard and its effect. Third, the maintenance of complete medical records, including linkages where multiple sets of records exist, is essential. Records suitable for use in epidemiologic studies of long-term medical consequences of military actions would be valuable for both medical science and service members.
But having heard from many atomic vets and their family members, the Advisory Committee does not believe that, but for the inadequate record keeping and lack of follow-up, there would be no anger or disappointment among atomic veterans and their families. The real offense to many is the belief that the risk was unacceptable and that they or their loved ones may suffer illness unnecessarily as a consequence. Proper attention to record keeping should provide some basis for gaining and assuring the trust of those who are exposed to risk in the future and, perhaps, scientific results that may be of real value to them, but it is hardly a guarantee against perceptions of abuse or unfairness.
If nothing else, our experience makes us appreciate the difference between technical, analytic data and the reality of the human experience. The available data, as we have discussed, indicate that the average amount of radiation to which bomb-test participants were exposed was low. But those who believe they have suffered as a consequence of these exposures do not believe these risks to have been as slight as the data indicate. When we review this decades later, we rely on numbers; the atomic veterans and their family members who have appeared before the Committee associate, in a "cause and effect" way, the exposure with some kind of result that they have personally experienced or witnessed. The emotions and concerns expressed to the Committee by these citizens (and those downwind from atomic tests and intentional releases) were very, very real. Both the public and the scientific community must understand that, when data indicate that risks are low, the risks are not necessarily zero; and it is possible for a rare event to occur. The risk analysis may only indicate that it is unlikely that such events will occur with significant frequency or probability.