Part IV

Part IV: Overview

In chapter 17, findings are presented in two parts, first for the period 1944 through 1974 and then for the contemporary period. These parts, in turn, are divided into findings regarding biomedical experiments and those regarding population exposures.

We begin our presentation of findings for the period 1944 through 1974 with a summation of what we have learned about human radiation experiments: their number and purpose, the likelihood that they produced harm, and how human radiation experimentation contributed to advances in medicine. We then summarize what we have found concerning the nature of federal rules and policies governing research involving human subjects during this period, and the implementation of these rules in the conduct of human radiation experiments. Findings about the nature and implementation of federal rules cover issues of consent, risk, the selection of subjects, and the role of national security considerations.

Our findings about government rules are followed by a finding on the norms and practices of physicians and other biomedical scientists for the use of human subjects. We then turn to the Committee's finding on the evaluation of past experiments, in which we summarize the moral framework adopted by the Committee for this purpose. Next, we present our findings for experiments conducted in conjunction with atmospheric atomic testing, intentional releases, and other population exposures. The remaining findings for the historical period address issues of government secrecy and record keeping.

There is an asymmetry in our findings on human radiation experiments and intentional releases. In both cases, we discuss their number and purpose, the likelihood that they produced harm, and what is known about applicable government rules and policies. In the case of human radiation experiments, we also have a finding on the benefits to medicine--and thus to all of us--that human radiation research during this period produced. We do not, however, have a corresponding finding on the benefits of the intentional releases of the period, benefits that would presumably have been to the national defense and, thus again, to all of us. Although the members of the Committee are positioned to comment on contributions to medicine and medical science, we do not have the expertise to evaluate contributions to the national defense and thus could not speak to this issue.

Our findings for the contemporary period summarize what we have learned about the rules and practices that currently govern the conduct of radiation research involving human subjects, as well as human research generally, and about the status of government regulations regarding intentional releases.

Chapter 18 presents the Committee's recommendations to the Human Radiation Interagency Working Group and to the American people. The Committee's inquiry focused on research conducted by the government to serve the public good--the promotion and protection of national security and the advancement of science and medicine. The pursuit of these ends--today, as well as yesterday--inevitably means that some individuals are put at risk for the benefit of the greater good. The past shows us that research can bear fruits of incalculable value. Unfortunately, however, the government's conduct with respect to some research performed in the past has left a legacy of distrust. Actions must be taken to ensure that, in the future, the ends of national security and the advancement of medicine will proceed only through means that safeguard the dignity, health, and safety of the individuals and groups who may be put at risk in the process.

The needed actions are in four dimensions:

First, the nation must provide for appropriate remedies as it comes to grips with the past.

Second, the nation must provide improved means to better ensure that those who conduct research involving human subjects act in a manner consistent with the interests and rights of those who may be put at risk and consistent with the highest ethical standards of the practice of medicine and the conduct of science.

Third, the nation must ensure that special care is taken to prevent abuses in the conduct of human subject research and environmental releases in a context where these activities must occur in secret.

Fourth, the nation must ensure that records are kept so that a proper accounting can be made to those who are asked to bear risks, particularly when any or all of the risk taking involves secrecy. Moreover, these records should be made available to the public at large on a timely basis consistent with legitimate national security requirements.

The Committee's recommendations address these four areas--remedies for the past, practices to govern the future of biomedical experimentation, practices to govern the future exposure of citizens to biomedical research or environmental releases from secret activities, and provisions for record keeping and public access to records.

We wish to note here the limits of our framework for remedies for past harms or wrongs for subjects of human radiation experiments.[*] First, we are addressing questions of remedies from the perspective of what, ethically, ought to be done. We recognize that some of the remedies we propose, including financial compensation, may not be available under current federal law. To the extent that such remedies are not available under current law, we encourage the administration to work with Congress to develop such remedies through legislation or other appropriate means.

* In accordance with our charter, these recommendations apply to human radiation experiments conducted from 1944 to 1974 that were supported by the government, whether the support was in the form of funding (including funding for data gathering in conjunction with exposure of patient-subjects to radiation) or other means, such as the provision of equipment or radioisotopes, and regardless of whether the research was performed by federal employees or nonfederal investigators. Although we focus here on human research involving exposure to ionizing radiation, the moral justification for these recommendations is not specific only to experiments involving radiation.

Second, the Committee has focused on past experiments in which there was no possibility that subjects could derive medical benefit from being in the research or in which the potential for this benefit is in dispute. These were the experiments that raised the greatest public concern. They were also the experiments that raised the greatest concern for most members of the Committee when we considered the 1944-1974 period. This was a time, as noted throughout this report, when it was common for physicians to use patients as research subjects without the patients' knowledge or consent. It was also a time, however, when physicians were ceded considerable moral authority both by patients and by society to decide for patients what medical treatments they should receive. This authority extended, as well, to deciding whether a patient should be a subject in therapeutic medical research, provided that this decision was based on a good faith judgment by the physician that it was in the patient's medical best interest to be a subject in the research and thus that any risks of the research were acceptable in light of the possibilities for medical benefit. Even at the time, however, physicians did not have the moral authority to use patients, without their knowledge or consent, as subjects in research in which there was no expectation that they could benefit medically.

The Committee appreciates that simply because the moral context of the doctor-patient relationship during the 1944-1974 period was different from today's, this does not mean that all therapeutic research was always or even often conducted in an ethical fashion. We also appreciate that the risks of therapeutic research were often considerable and that it is likely that some patient-subjects were harmed unnecessarily as a consequence. However, the moral problems presented when people in the 1944-1974 period were used as subjects of research from which they could not benefit medically are both more straightforward and more compelling. We therefore felt obligated to expend our limited resources on historical and moral analysis of these kinds of experiments. We do not address whether or under what conditions remedies should be provided for injuries or offenses related to research that offered a plausible prospect of medical benefit to subjects and we leave that work to others.

Third, even in those experiments where there was no prospect of medical benefit, limited Committee resources, and the overall Committee mandate, precluded the type of fact-intensive individual investigation that would give rise to a recommendation of compensation in individual cases. The Committee did not have the ability to locate and evaluate the research and medical records of countless individual subjects. As a consequence, for example, we were not able to make judgments about whether, in individual cases, subjects had suffered physical harm attributable to their involvement in research.

Fourth, we note that the Committee was not unanimous in its decision to make a recommendation for remedies for people who were subjects in experiments that offered them no prospect of medical benefit but who were not physically harmed as a consequence (recommendation 3). Three Committee members elected not to support this recommendation.

The entire Committee believes that people who were used as research subjects without their consent were wronged even if they were not harmed. Although it is surely worse, from an ethical standpoint, to have been both harmed and wronged than to have been used as an unwitting subject of experiments and suffered no harm, it is still a moral wrong to use people as a mere means. Although what we know about the practices of the time suggests it is likely that many people who were subjects in nontherapeutic research were used without their consent or with what today we would consider inadequate consent, in most of these cases, we have almost no information about whether or how consent was obtained. Moreover, in most of these cases, the identities of the subjects are not currently known; even if considerable resources were expended, it is likely that most of their identities would remain unknown. The Committee is not persuaded that, even where the facts are clear and the identities of subjects known, financial compensation is necessarily a fitting remedy when people have been used as subjects without their knowledge or consent but suffered no material harm as a consequence; the remedy that emerged as most fitting was an apology from the government.

The Committee struggled with and ultimately was divided on the issue of whether to recommend that the government extend an apology under the circumstances just described. While all members agreed that a goal of all the Committee's recommendations is, in the words of one member, to "bind the nation's wounds," we disagreed about how best to accomplish that end when debating whether we should recommend such an apology. Our deliberations were complicated by what we all agreed was a murky historical record. In the case of some experiments, there was evidence of some disclosure or some attempt to obtain consent, and the issue emerged as to how poor these attempts must be for an apology still to be in order. In other cases, there was simply too little documentary evidence to draw any conclusions about disclosure or consent. In most cases, as noted above, the identities of subjects are unknown and are unlikely to be uncovered even with an enormous expenditure of resources.

The Committee members who concluded that it was not appropriate to recommend that a government apology be extended did not all reach this conclusion for the same reasons. Among the reasons put forward were that it would be impossible to craft a recommendation for an apology in such a way as to avoid the divisiveness that could result from apologizing to some but not all of those who view themselves as victims of this kind of human radiation experiment. There was concern that if the criteria for who should receive an apology were too narrow, some people would resent not qualifying for an apology; conversely, if the criteria were too broad and included large numbers of people, the generality of the apology would diminish its meaningfulness. It was also argued that a recommendation for an apology should not be made because of the difficulties in crafting the criteria for eligibility in the face of an incomplete historical record. Another reason for not recommending an apology was that during the 1944-1974 period many people were used as subjects of research that did not involve radiation, for which there was no prospect of medical benefit and consent was not obtained from them, and these people would not be included in a recommendation from us for an apology.

The Committee members who favored an apology took the position that justice requires that an apology from the government is due in research that it sponsored, where it can be determined that an apology is deserved and the identities of subjects who were wronged can be known. They do not believe that the recommendation to apologize rests on the likelihood that it will lead to more healing than divisiveness. Rather, these Committee members hold that an apology is a just remedy for those who were wronged and that it should not be withheld only because there are other cases that are likely to have been morally similar but for which a recommendation of an apology could not be made because the evidence was unclear or unavailable. Making a specific apology in those cases where the facts are clear today would not for these Committee members preclude apologies being extended to other subjects in the future, should new information come to light.

All Committee members agreed that it was appropriate that the subjects of the experiments at the Fernald State School in Massachusetts receive an apology, but divisions within the Committee arose when we tried to determine how to differentiate them from the subjects of studies similar to those conducted at Fernald about which less is known in relation to disclosure and consent.

Fifth, the Committee notes that our recommendations for remedies are directed solely to the executive and legislative branches of the federal government; they are not recommendations for exclusive remedies intended to bar the opportunity to seek redress from other parties or the courts. Those who believe they or their family members have been wronged or injured should be free also to seek relief from appropriate institutions or from individuals; the Committee does not intend to suggest the limiting of any rights to do so.

Finally, the framework for remedies for former subjects of human radiation experiments that the Committee proposes in our recommendations limits the availability of compensation from the federal government to what is likely to be a small number of people. In developing the framework we were concerned about the impact of recommending criteria that would result in compensation in some cases but not in others. The Committee sought and heard testimony from hundreds of witnesses, over months of deliberation, many of whom were emotional and heart-rending in sharing their experiences. Often these witnesses expressed considerable anguish over the pain that they and their families suffer because of their belief that they have been or might yet be harmed, and some advanced the view that compensation is appropriate. It was very painful for the Committee to recognize that often we had neither the resources nor the mandate to investigate all these compelling stories. The Committee concluded that an appropriate service we could render was to shed light on this dark period in our history by articulating the historical record to the best of our ability. But it is equally important that, the historical record having been spelled out, we as a nation move forward. The most fitting way to acknowledge the wrongs and harms that were done to others in the past, and to honor their contributions to the nation, is for the government to take steps to ensure that what they experienced will not happen again.

Thus, many of our recommendations are directed not to the past but toward the future. The Committee calls for changes in the current federal system for the protection of the rights and interests of human subjects. These include changes in institutional review boards; in the interpretation of ethics rules and policies; in the conduct of research involving military personnel as subjects; in oversight, accountability, and sanctions for ethics violations; and in compensation for research injuries. Unlike the 1944-1974 period, in which the Committee focused primarily on research that offered subjects no prospect of medical benefit, our recommendations for the future emphasize protections for patients who are subjects of therapeutic research, as many of the contemporary issues involving research with human subjects occur in this setting. We also call for the adoption of special protections for the conduct of human research or environmental releases in secret, protections that are not currently in place.

We realize, however, that regulations and policies are no guarantee of ethical conduct. If the events of the past are not to be repeated, it is essential that the research community come to increasingly value the ethics of research involving human subjects as central to the scientific enterprise. We harbor no illusions about the Pollyanna-ish quality of a recommendation for professional education in research ethics; we call for much more. We ask that the biomedical research community, together with the government, cause a transformation in commitment to the ethics of human research. We recognize and celebrate the progress that has occurred in the past fifty years. We recognize and honor the commitment to research ethics that currently exists among many biomedical scientists and many institutional review boards. But more needs to be done. The scientists of the future must have a clear understanding of their duties to human subjects and a clear expectation that the leaders of their fields value good ethics as much as they do good science. At stake is not only the well-being of future subjects, but also, at least in part, the future of biomedical science. To the extent that that future depends on public support, it requires the public's trust. There can be no better guarantor of that trust than the ethics of the research community.

Finally, our examination of the history of the past half century has helped us understand that the revision of regulations that govern human research, the creation of new oversight mechanisms, and even a scrupulous professional ethics are necessary, but are not sufficient, means to needed reform. Of at least equal import is the development of a more common understanding among the public of research involving human subjects, its purposes, and its limitations. Furthermore, if the conduct of the government and of the professional community is to be improved, that conduct must be available for scrutiny by the American people so that they can make more informed decisions about the protection and promotion of their own health and that of the members of their family. It is toward that end that we close our report with recommendations for continued openness in government and in biomedical research. It is also toward that end that this report is dedicated. Some of what is regrettable about the past happened, at least in part, because we as citizens let it happen. Let the lessons of history remind us all that the best safeguard for the future is an informed and active citizenry.