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 þþþDRAFTþFOR DISCUSSION PURPOSE ONLYþþþ MEMORANDUM TO: Members of the Advisory Committee on Human Radiation Experiments FROM: Advisory Committee Staff DATE: December 12, 1994 RE: For Discussion: Ethical Standards and Government Culpability [This memorandum was prepared by the staff in order to help facilitate a Committee discussion. This draft is not intended to represent the views of the Committee or any Committee member. Rather it is to provide one possible approach for the Committee's consideration.] I. INTRODUCTION The purpose of this memo is to move from consideration of a general framework for ethics criteria, retrospective judgment, and guidelines for remedies, to an assessment of the government's culpability in light of available historical evidence. The position put forth in this memo for consideration by the Committee is that there is sufficient evidence of at least some government culpability where morally wrong actions occurred in the conduct of government-sponsored human radiation research. II. GOVERNMENT CULPABILITY Specifically, we contend: 1. The government acted with full knowledge that the use of citizens to serve the ends of government raises basic ethical questions. In 1947, on behalf of his nomination to become the first chairman of the newly created Atomic Energy Commission, David Lilienthal told the United States Senate that: . . . all Government and all private institutions must be designed to promote and protect and defend the integrity and the dignity of the individual. . . . Any forms of government. . . which make men means rather than ends in themselves. . . are contrary to this conception: and therefore I am deeply opposed to them. . . . The fundamental tenet of communism is that the state is an end in itself, and that therefore the powers which the state exercises over the individual are without any ethical standards to limit them. That I deeply disbelieve. [McCullough, David, Truman, (Simon & Schuster: NY, 1992), pp 537-538.] 2. The government had ethical standards to govern human radiation research. These standards date back at least to the 1930's (Department of the Navy), World War II (the Committee on Medical Research), and the post-War era (the Atomic Energy Commission). In the early and mid-1950's the Department of Defense adopted the Nuremberg Code and the Clinical Center of the National Institutes of Health created a system of prior peer review. There was also at least one relevant professional code, that of the American Medical Association in 1946. 3. Even compared to current rules, these standards were respectable. They included the notion that subjects must give consent and that they should not be exposed to serious harm. Although these ideas were perhaps vaguely understood and minimal from a modern standpoint, they were surely better than no standards at all. The Nuremberg Code-based policy adopted by the Department of Defense in 1953 might be said to be more protective than today's standard. 4. Though one may quarrel with the adequacy of the standards as written, it appears that even those standards were not followed by the government in at least some cases. 5. The government is culpable for its failure to ensure that human radiation experiments conducted with Federal support followed its own ethical standards. 6. Neither of two obvious defenses for this failure of government is persuasive. The first defense is that the norms of the day permitted the use of human research subjects in ways that would not be permitted today. But the government need not be judged by present day norms. For the purpose of this memorandum it may be judged only by those represented in its own past ethical standards. The second defense is that national security considerations "trumped" research ethics. But there is little or no evidence that the government's own ethics policies either contemplated national security or identified national security considerations as justified exceptions, to ethical standards for human experiments. To the contrary, the 1953 Defense Department Nuremberg Code policy was clearly effected in the immediate context of national security concerns, and did not include any recognized national security exception. We will return to the subject of national security later. This argument goes to government culpability and the need for remedies, but not to the degree of government culpability or the nature or extent of remedies. Those issues require a more refined evaluation according to specific fact situations. A framework for those questions is found in the staff memorandum on "Remedies." III. TWO SCENARIOS In light of what the Advisory Committee has learned so far, two scenarios may be relevant characterizations of the past. We believe that Scenario 1 best represents the situation during the period of interest to the Advisory Committee: Scenario 1. There were officially sanctioned ethical standards, but these standards were not widely disseminated, implemented or practiced. (Note this interpretation of the historical state of affairs corresponds to positions 3-4 on Ruth Faden's proposed schema for assessing degree of culpability.) Some may not be prepared to adopt Scenario 1 as an accurate description of the past research environment. But the following more modest construction also has important implications for remedies: Scenario 2. There were articulated but not widely accepted standards at the time. (Note: This corresponds to positions 2-3 on Ruth Faden's proposed schema.) Each of these states of affairs can be "unpacked" in terms of its implications for remedies. Scenario 1. The Advisory Committee's work suggests that there were officially sanctioned ethical standards for research involving human subjects, but that these standards were not widely disseminated, implemented or practiced. By "officially sanctioned" is meant that persons in authority adopted or enacted ethical standards on behalf of an institution (e.g., in a policy directive). Failure of dissemination or recognition is a partial explanation for the failure of subordinates to implement these standards. Specific reasons for these kinds of failures will depend on the case at hand but could include the level of classification of the document, different ways of interpreting the standards, or ambiguity about the assignment of responsibility for ensuring that the standards are enforced. Those who have the authority to promulgate ethical standards have a correlative responsibility to make a good faith effort to see that they are implemented. Individuals and institutions are therefore culpable for the failure to implement such standards. Those who were wronged as a result of failed implementation of standards that should, by the terms of those standards, have applied to them, are entitled to the full panoply of remedies. Subordinates who failed to operate according to standards about which they were not given reasonable notice cannot be held blameworthy (e.g., obtaining a subject's consent in writing), unless the standards spoke to moral norms of which they should have been aware from other contexts (e.g., the arbitrary use of vulnerable people in dangerous medical experiments against their will). Then they are culpable on other grounds. Scenario 2. Instead of Scenario 1, perhaps it should be said that standards were articulated but not widely accepted. Under this interpretation, standards were expressed by some individuals but did not receive official sanction. Although we do not subscribe to this description of the relevant period, it still has implications for culpability and remedies. If acts were performed in violation of articulated standards then remedies should be provided to those who were harmed or wronged but the agent may not be morally culpable. Judgments about agents' culpability for a violation of articulated but not widely accepted ethical standards depend on a number of considerations. In particular, in order to be held to the highest level of culpability the agent must have been in a position not only to evaluate, but also to implement the articulated ethical standard. In other words, agents may be criticized for failing to appreciate the ethical standard, but the degree of their culpability for failing to act in accord with that standard is limited unless they were demonstrably in a position to have considered and acted on a standard that was not yet widely accepted, and the wrongs that resulted were significant by today's standards. This scenario also goes to institutions that could be held to collective responsibility for failure to accept a superior ethical standard. Arguably, it is the burden of institutions--and especially governmental institutions--to submit their current policies to constant review in light of the continual societal conversation about normative questions. In some cases, including instances that are relevant to the work of the Advisory Committee, it may be transparent that articulated ethical standards that were not widely accepted were relevant to the institutions' functions. IV. CONCEPTIONS OF THE GOVERNMENT How one understands what "the government" is may be crucial to one's interpretation of the arguments in this memorandum. There are at least two ways of conceptualizing "the government." On one, the government is a unified corporate person, a singular entity. There are discrete units within government and administrations may come and go, but "the government" persists. On the other view, what we call "the government" is simply the grossest manifestation of the aggregate, though often inharmonious, actions of its individual entities (e.g., the Department of Defense, the Department of Energy, the Department of Veterans Affairs, etc.) or of individual human agents who are in some official capacity with regard to the government. But most Americans do not think of government in this atomized way. Rather, we are mainly accustomed to thinking of government in the first sense, as itself an agent, and as one that is indivisible. We adopt this way of thinking of government for the remainder of this memorandum. V. NATIONAL SECURITY CONSIDERATIONS Again, there is no evidence that the government's own ethical standards created an exception for national security considerations. Yet the Advisory Committee has documented instances of non-disclosure that an experiment was being conducted, or of limited disclosure of its details. For example, a plain example of complete non-disclosure in the Advisory Committee's purview seems to be the plutonium injections conducted under the auspices of the Manhattan Project. In those cases there is generally no evidence of disclosure to the subject of what was being done, and some evidence that what was being done was deliberately not disclosed. Examples of limited disclosure (concerning why some experiments were being done) likely abound in the cases within the Advisory Committee's mission. In these instances certain information that might have been relevant to the subjects was not provided. But even if not all of the purposes of an experiment could be disclosed to a patient on national security grounds, at least the general nature of the experiment, its potential harms and the funding source may be disclosed without generating national security concerns. Of course, difficult questions could be raised, e.g., the extent in which no disclosure at all would be acceptable (and the need for special protections, if any, in such case). However, these questions, while critical as prospective issues, do not appear to be addressed by the policies we have found in the past, which do not, on their face, provide for "national security" exceptions to the rules of consent they state. VI. REMEDIES FOR HARMS WITHOUT WRONGS Perhaps some past actions that resulted in harms will not be judged as wrong in the present. Even though they were not wronged, if some individuals were harmed in the past they may be considered as due remedial action. None of the positions on judging the ethics of past actions reviewed in this memorandum applies to such cases, nor do any of them place limits on remedies that may be judged as due to individuals who were harmed but not wronged. Although the philosophical bases of remedies for harms without wrongs differ from those discussed in this memorandum, they are familiar from other contexts. These contexts include the military ] (benefits for those widowed or orphaned by a service-related death), and certain dangerous industries (compensation for work-related injury). One important rationale for such remedial action is that these individuals have shouldered especially weighty burdens in activities that benefit the rest of society, and they or their loved ones should not be penalized for this service. Another rationale is forward-looking: society's future needs in these relatively high-risk areas may not be served unless candidates for such jobs believe that their interests are going to be cared for. In any case, remedies for past wrongs should not be hostage to doubts about the specific grounds for the wrongfulness of an historic incident.