DISCLAIMER The following is a staff memorandum or other working document prepared for the members of the Advisory Committee on Human Radiation Experiments. It should not be construed as representing the final conclusions of fact or interpretation of the issues. All staff memoranda are subject to revision based on further information and analysis. For conclusions and recommendations of the Advisory Committee, readers are advised to consult the Final Report to be published in 1995. TAB H PART 1A þþþDRAFTþFOR DISCUSSION PURPOSESþþþ MEMORANDUM TO: Members of the Advisory Committee on Human Radiation Experiments FROM: Advisory Committee Staff DATE: November 9, 1994 RE: Discussion Points on the Ethics of Intentional Releases An ethical analysis of intentional releases should consider many of the same issues considered in biomedical experiments. With intentional releases, however, the considerations must be reinterpreted. In discussing these issues we shall mirror the memorandum from the last briefing book that suggested a framework for the ethical analysis of historical case studies. We should emphasize, however, that this discussion is preliminary. We have tried to provide questions rather than answers, and these questions may not capture the full range of relevant issues. I. FAVORABLE BALANCE OF HARMS AND BENEFITS Did the intentional release cause more benefit than harm? Intentional releases normally spread the likelihood of harm over a large population (and perhaps over several generations if the release produces long life contaminants or genetic effects), but they also may cause significant harm to specific individuals. For example, specific individuals might contract cancer from an intentional release even though the release may pose only a negligible likelihood of harm to each individual in the exposed population. If we focus only on the statistical likelihood of harm posed to individuals we may underestimate the real harm. This does not mean that we should not be concerned about the likelihood of harm posed to individuals in a group; in some cases the likelihood of harm may be large enough to merit individual attention. However, in many cases it will be more telling to estimate the harm to health in terms of the exposed population as a whole. We also face difficult questions because intentional releases often engage starkly different kinds of harms and benefits, raising questions about the commensurablilty of competing goods and values. Intentional releases may harm human health, but they also may harm livestock, wildlife, crops, and the ecosystem. Each of these concerns is instrumentally important for humans. Many environmentalists, however, would argue that we should treat these concerns as more than instrumentally important. They would reject the view that morality should only be concerned with the effects on humans, a view often called anthropocentrism. Some claim that any effect on life is morally significant--biocentrism. Others claim that all life is interconnected and all effects on ecosystems are morally significant--ecocentrism. In addition, intentional releases may protect national security or advance scientific knowledge, or both. Green Run, for example, may have helped the United States develop a long range detection system for plutonium production. This benefit, however, is difficult to weigh against risk or actual harm to the public's health. How do we compare benefits of national security with harms to public health? Is there any rational or reasonable way to adjudicate conflicts between these values or are they incommensurable? Adjudication may be especially difficult in the case of national security. Some would argue that we can adjudicate most conflicts in social values through democratic means. Through public debate and democratic procedures we can collectively decide what weight we should give to each social value. National security, however, may require secrecy, and secrecy limits public debates and democratic solutions. II. SELECTION OF SITE AND QUESTIONS OF JUSTICE In releasing radiation into the environment did the government unjustly burden any individuals or groups in the society? Intentional releases might unjustly distribute harms because they distribute them disproportionately. Proportionality as a feature of justice is often considered as a comparison of the distribution of harms with the distribution of benefits expected from a given act or policy. Disproportionality in distribution results when the individuals or groups that bear the harms or risks of harm are not the group that stands to benefit, or when the entire society stands to benefit but only a subset of the society bears the risk or harm. Intentional releases only benefit the individuals they harm in this latter sense, providing general benefits to harmed individual that the whole society enjoys. And even these general social benefits may not reach individuals harmed by a release. This raises basic questions of distributive justice. When should the government be permitted to harm individuals for the benefit of society? Intentional releases also can raise questions of intergenerational justice--how are benefits to be enjoyed by those presently living to be balanced by the potential for harm to those who come after us in the event of long term environmental or genetic compromise? Intentional releases might also unjustly distribute harms if they distribute harms in a manner that is inegalitarian. Harms may be distributed in an inegalitarian manner if the individuals or groups who bear the harms are among the less advantaged members of society. This might occur by exacerbating preexisting inequalities rather than directly distributing harms unequally. An intentional release, for example, might cause a treatable illness. And even if this illness is randomly distributed in the population it will cause more harm to those who lack access to health care. Even though an intentional release may randomly distribute an illness in the population the harms from those illnesses may be unevenly felt by the impoverished. In such a case the intentional release would contribute to inequality. Similarly, if as some studies suggest, hazardous waste is more likely to be located near minority communities than non-minority communities, this both exploits and contributes to social inequality. Experts currently debate whether this pattern is primarily caused by impoverished minorities moving to these communities to capture the benefits of low land values or by government officials locating dump sites near minority communities because they are least likely or able to offer political resistance. Other "vulnerable" populations may be uniquely burdened by an environmental release. Children and the frail elderly, for example, might face significant risks from intentional releases not faced by the general population. III. LEGITIMACY, AUTHORIZATION, AND CONSENT If the government required individual consent from every individual possibly affected by an intentional release, intentional releases would be impossible. Invariably someone would refuse. Thus, if intentional releases are ever permissible we must rely on a less stringent standard for authorization than individual consent. The most likely standard would be some kind of "consent of the governed" obtained through democratic and fair procedures. Procedures for implementing policies, however, can be more or less democratic. When the burdens fall heavily on specific individuals or groups, some might argue that the procedural requirements of democracy should be stricter than normal. For example, public officials could be required to consult with the affected public in an open setting. Several issues are relevant here. Does both the affected and the general public know about the release and its potential hazards so that it can hold its representatives accountable? Is the group that is most affected by the release adequately represented? Is there a reliable means for considering public input? Is public input considered seriously? Does the public have any effective method of challenging government decisions? IV. DISCLOSURE AND SECRECY Closely tied to questions of authorization are issues of public disclosure and duties to warn, on the one hand, and justifications for withholding otherwise relevant information from the public and for secrecy, on the other hand. By what standards should the adequacy of information provided to the public be judged? Was information kept secret? Were affected persons and the general public informed about the release? If they were, then what information were they given and was it effective? Were they informed about possible harms that might result from the release? Were members of the public consulted before the proposed release was finalized? What actions, if any, were recommended to the public to minimize potential harm? If information was withheld and secrets kept, was this a justified infringement of the public's right to know? How was the secret kept? (For example, did the government lie in order to conceal information?) Why did they keep them? (For example, did officials keep secrets in order to protect national security?) Did the culture of secrecy negatively affect decision making? (For example, did the culture of secrecy encourage unethical research?) Did any secret retard scientific progress? Did any secret compromise democratic values? Did any secret increase the risk of harm to affected persons or groups? V. PRIOR REVIEW AND AGENCY REVIEW Also closely tied to questions of legitimate authorization and secrecy are the questions of who should review and evaluate proposed releases. A central issue is whether the impact and propriety of proposed releases should be reviewed by a unit or agency of government other than the unit or agency sponsoring the proposed release. But who qualifies for this role of "third party" reviewer? Intentional releases raise several different questions that an adequate review might have to answer. Can the intentional release achieve its proposed goal? Are there any alternatives which could limit unwanted side effects? Do the side effects constitute an unacceptable cost? If there are attached studies, are they conducted in an ethical manner? Because these questions require several different kinds of expertise to adequately answer they may require several different reviewers. Also, must third party reviewers be "disinterested," and what does this mean? Even if an outside agency reviews a proposal the outside agency may have a promotional interest in the data collected from the intentional release. Opening the review to the public may help attain this goal. Agencies may be more careful about conflicts of interests if the public is watching. What happens to the review and decision-making process, however, when these evaluations occur in secret? Finally, an adequate review requires a third party that has authority to affect an agency's proposal. If an agency can ignore a review of its proposal then the review may be pointless. VI. ATTACHMENTS: 1. International Ethical Guidelines for Biomedical Research Involving Human Subjects, Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO). 2. International Guidelines for Ethical Review of Epidemiological Studies, CIOMS.