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 F - PART II þþþDRAFTþ FOR DISCUSSION PURPOSES ONLYþþþ MEMORANDUM TO: Members of the Advisory Committee on Human Radiation Experiments FROM: Advisory Committee Staff DATE: August 31, 1994 RE: Draft of Possible Ethical and Policy Questions Regarding Potential Experimentation in Connection with Atom Bomb Tests 1. A number of conceptual questions arise in connection with the idea of experiments or research involving human subjects. "Experiment" versus "research": In the first instance, what is meant by the terms "experiment" and "research"? Is an experiment involving human subjects different from research involving human subjects? Technically, an experiment is usually taken to require the control of the "independent variable," while research includes not only experimental but also observational studies. But in ordinary language there is no such distinction. In ordinary language to experiment means to try something new in order to see what happens. Experiments/research or occupational risk assessments: A separate but related question concerns whether bomb test activities should be considered experiments with human subjects (or research with human subjects), rather than, say, assessments of occupational risk exposure or risk measurement (military exercises). Put another way, how can experimentation be distinguished from other kinds of activities in which information is gathered following events whose effects are not well understood? Language and authority: Does it matter whether the word experiment is used, and by whom? Is the force of the term different if used by a scientist than a general? Professional role: Conversely, does the involvement of certain kinds of professionals create a presumption that a certain activity is an experiment? Does it matter if the activities themselves are then conducted by persons other than physicians or scientists? 1 2. Another set of questions has to do with the ethics of risk exposure and its regulatory implications. Creation of risk for specifically identified individuals: Is there a morally relevant distinction between deliberately placing people at risk in order to study the results (Case 1) and merely observing the results for human beings who are in risky situations (Case 2)? For example, is there a moral difference between before-and-after urine sampling of soldiers facing exposure at the Nevada test site and simultaneous sampling of soldiers stationed elsewhere in the world to establish baseline levels relating to fallout? (And is there a moral obligation to inform the latter of suspected risk, and at what level of suspicion or gravity of risk?) Risk creation and oversight obligations: Should Cases 1 and 2 above generate differences in regulation? Should different kinds of oversight be required in each Case? Or should no oversight be required in Case 2? (That is, none beyond usual democratic processes.) 3. Other questions have to do with the appropriate understanding of military exercises, the duties of military personnel and the limits of military authority. Weapons testing and human beings: Are all studies of human beings associated with weapons tests exempt from being understood as either experiments or research involving human subjects? Are some? If the latter, how is the distinction drawn? Military authority and its limits: How far does military authority extend concerning exposure to risk regarding weapons testing and human health effects? Are any such exposures considered "beyond the call of duty"? If so, how are these distinguished from other risks associated with military service? Further, how do special considerations of military tradition and necessity affect the understanding of what counts as appropriate experiments, both then and now? 4. If studies of effects on human subjects in nuclear weapons testing are considered experiments, and if involvement in those studies as a subject is considered beyond the call of duty, then another set of questions engages ethical standards, both historic and contemporary. Historic standards: Did prevailing ethics policies and rules establish specific requirements concerning subject participation? (E.g., disclosure of risk, consent, etc.) If so, were those requirements implemented? Could military personnel (whether volunteers or conscripts) or laboratory workers give truly uncoerced consent? What were their moral or legal rights in this regard? Contemporary standards: Would current ethics policies and rules (e.g., the Common Rule) apply to participation in nuclear weapons testing? Can military personnel (whether volunteers or conscripts) give truly uncoerced consent? What are their moral or legal rights in this regard? 2 5. The roles and responsibilities of medical professionals raise several questions. Conflict of interest: Were medical professionals concerned with planning studies of human beings exposed to nuclear weapons test in an awkward position with regard to their traditional moral duties to patients? Separation of functions: To the extent that there was such a conflict, could it have been avoided by empowering separate medical science groups to promote and to regulate the experiments? Historical significance of their participation: To the extent that human experiments were conducted, how would the history of nuclear testing have been different if medical professionals had not participated in experiments related to nuclear weapons? 6. A final set of questions has to do with activities that had national as well as medical purposes, activities conducted to some degree under conditions of secrecy, and the implications for future policy in a free society. Extent to which experiments were generally known: Again, if there were experiments involving human subjects in connection with nuclear weapons testing, who knew that they were being conducted? Top officials, generals, Congress, the public? Knowledge of role of medical professionals: How well-known was the role of medical professionals in, for example, planning experiments, promoting data gathering, approving decisions made by others, or assuring no undue risk to subjects? Would the role of medical professionals have been different if their participation had been more publicly known or widely understood? If so, what are the implications for future cases where, for whatever reason, secrecy may be appropriate? 3 a:\abomb.eth (jm) 9/1/94