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Introduction

Background

The North Atlantic Treaty Organization (NATO) has recently developed guidelines for limits on and controls for exposure of soldiers to ionizing radiation in the course of military operations (NATO, 1996). This NATO guidance addresses radiation doses ranging from those governed by civilian—public and occupational—guidelines to the doses above which acute health effects are expected to develop and would be anticipated during a major nuclear conflict. At the request of the U.S. Army Surgeon General, the Institute of Medicine convened an expert committee to evaluate these guidelines from scientific and ethical perspectives. This is the committee's final report. The interim report (IOM, 1997) focused on the scientific merit of this new NATO guidance by responding to the following charges:

  1. Do the presently proposed NATO guidelines (dose limits, documentation, and control measures) follow generally accepted U.S. national limits and recommended guidelines for radiation protection of occupational and emergency workers?
  2. Are these NATO guidelines reasonable from a scientific viewpoint?
  3. How could the guidelines be improved?
  • The committee's charge in completing this final report was to advise the Army concerning the following:

    1. What general criteria apply in the establishment of exposure guidelines in the gap between civilian occupational exposure levels and performance degrading exposure levels?


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    --> 1 Introduction Background The North Atlantic Treaty Organization (NATO) has recently developed guidelines for limits on and controls for exposure of soldiers to ionizing radiation in the course of military operations (NATO, 1996). This NATO guidance addresses radiation doses ranging from those governed by civilian—public and occupational—guidelines to the doses above which acute health effects are expected to develop and would be anticipated during a major nuclear conflict. At the request of the U.S. Army Surgeon General, the Institute of Medicine convened an expert committee to evaluate these guidelines from scientific and ethical perspectives. This is the committee's final report. The interim report (IOM, 1997) focused on the scientific merit of this new NATO guidance by responding to the following charges: Do the presently proposed NATO guidelines (dose limits, documentation, and control measures) follow generally accepted U.S. national limits and recommended guidelines for radiation protection of occupational and emergency workers? Are these NATO guidelines reasonable from a scientific viewpoint? How could the guidelines be improved? The committee's charge in completing this final report was to advise the Army concerning the following: What general criteria apply in the establishment of exposure guidelines in the gap between civilian occupational exposure levels and performance degrading exposure levels?

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    --> How should risks for acute trauma (e.g., from gunshot, mines, artillery fire, etc.) be weighed against the possible long latency effects of radiation (e.g., tumors developing 30 years after exposure)? These questions should consider: Ethical foundations for establishing and operating standards for radiation exposure. What are the ethical considerations for commanders and medics? What are the responsibilities for prevention, treatment, and follow-up if commander decides to expose? Scientific bases for estimating effects of radiation and conventional risks on the battlefield (in both combat and peacekeeping scenarios). Operational scenarios provided by the Army to focus the deliberations of the committee. Although this final report incorporates the general technical principles discussed in the interim report, it expands on other critical factors, including ethics, risk perception, recordkeeping, training, communication, decisionmaking, and follow-up. During the Cold War, the U. S. Army established radiation dose limits and controls for soldiers based on a scenario of global nuclear war (HQDA, 1994; NATO, 1986). Battlefields were expected to be highly contaminated with radioactive material. In anticipation of such scenarios, radiation dose limits for soldiers were based on criteria that maximized immediate survival and the ability to continue with a combat mission. The upper bounds of the dose limits were set at the threshold at which radiation sickness develops. In the post-Cold War setting, military scenarios involving radiation exposure rarely reflect global nuclear war but more often consider limited nuclear exchanges, terrorist actions with improvised nuclear devices, conventional explosives employed as a means of disseminating radioactive materials, or nuclear power plant accidents. In these scenarios (relative to those during the Cold War), the risk of exposure to radiation would be more limited geographically and the immediate risks to a soldier might be much lower. Except in rare circumstances, the radiation doses received under these scenarios would be well below those that cause serious radiation injuries soon after exposure, yet they could be above the occupational dose limits that are applied to civilian workers and military personnel assigned to routine occupational duties (CFR, 1991). The new NATO guidance addresses protection for soldiers at risk of exposure at levels that could result in doses up to 700 millisievert (mSv). In its interim report, the Committee on Battlefield Radiation Exposure Criteria reviewed this guidance as it is expressed in Allied Command Europe (ACE) Directive 80-63 (NATO, 1996). The U.S. Army, as well as a NATO working group, has continued work on this issue (which the committee addresses in Chapter 4). During the Persian Gulf War, the U.S. Army recognized the potential for the exposure of soldiers to levels of radiation that exceeded occupational levels but

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    --> that were below levels set in Standardized Agreement (STANAG) 2083, Commanders' Guide on Nuclear Radiation Exposure of Groups (NATO, 1986). During Operation Desert Shield and Operation Desert Storm, the U.S. Army Foreign Service and Technology Center warned of the possibility that conventional explosives could be used by threat forces to disseminate radioactive materials (e.g., from reactor waste or radium and radioactive isotopes of cesium and cobalt from radiotherapy sources) on the battlefield. Military commanders have always had to weigh multiple risks in their decisions. In the Cold War setting, the emphasis was on acute (immediately life-threatening) risks related to the survival of military operational personnel. In this new era, commanders face missions, such as those that involve peacekeeping and the provision of humanitarian assistance, in nonbattlefield environments, in which the risk of immediately disabling and life-threatening injuries is lower in comparison with the risk of exposures that are possible in wartime situations. This shift in the nature of military activity has brought with it increased interest in the potential for delayed health effects of battlefield activities (e.g., the potential for the development of a radiation-induced cancer many years after exposure). This is new ethical and doctrinal ground for Army planners, who wish to ensure that the standard of protection proposed in the ACE Directive has a sound scientific and ethical basis before they apply it generally in U.S. Army doctrine. Supreme Headquarters, Allied Powers Europe (SHAPE), recognized a need to plan for potential radiation exposure that might occur among military forces in Europe during the peacekeeping mission in Bosnia. In response, SHAPE staff developed the ACE Directive 80-63, ACE Policy for Defensive Measures against Low Level Radiological Hazards during Military Operations. The U.S. Army participated in the development of NATO radiation protection guidelines for the soldier in the new radiation exposure scenario, with a U.S. Army representative heading the NATO team of experts. The Directive applies to all NATO forces in Europe and is intended to provide guidance to military commanders whose troops may encounter radiation sources. The procedures of the ACE Directive apply to what SHAPE defines as low level* radiation, that is: The doses received from these exposures are higher than those routinely received by health physics [radiation] workers and the general public and are in the range from background radiation to 70 cGy [0.7 Gy]. These hazards [exclusive of nuclear weapon detonation] may occur from inadequate nuclear waste disposal, deterioration of nuclear power facilities and damage to institutions that routinely use radioactive material/sources and terrorism. (NATO, 1996, §1-1.a.) *   See Chapter 5, Recommendations 4 to 6, on the terminology in the ACE Directive.

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    --> The ACE Directive (see Appendix A) provides general policy for the conduct of operations in the presence of radiation. It seeks to avoid unnecessary radiation exposure whenever possible and to minimize doses when exposure is unavoidable. In addition, the policy prescribes planning, coordination, security, dosimetry, recordkeeping, training, equipment, and expertise to deal with radiological hazards. Procedures in the Directive outline actions to be taken by responsible commanders in the event of a situation involving radiation exposure. These include methods for assessment of a radiation hazard, dissemination of hazard information, and personnel protection. Finally, the Directive includes a chart that defines radiation exposure state categories and outlines the actions to be taken when personnel receive (or are at risk of receiving) specified levels of radiation dose. This chart subdivides the dose levels defined in existing guidelines (HQDA, 1994; NATO, 1986) as being of negligible risk to moderate risk. Radiation is not a new hazard for service personnel. Approximately 202,000 military service members participated in U.S. nuclear weapons testing between 1945 and the 1963 signing of the Limited Test Ban Treaty (VA, 1997). No fewer than eight laws have been enacted in the years since 1981 in attempts to provide just consideration of claims for compensation for health problems and disabilities that some atomic test participants attribute to radiation exposure. The National Test Personnel Review program within the Defense Special Weapons Agency was chartered within the U.S. Department of Defense to develop a personnel register and estimate doses for the atomic test participants. Inadequate records for use in estimating the radiation doses received by individuals is one of the most contentious issues surrounding the resolution of these veterans' claims. Accurate primary dosimetry records are unavailable for many of these veterans. The history of the veterans involved in the aboveground nuclear test program demonstrates clearly the need for detailed and advanced planning for radiation protection, assessment of radiation dose, and development of exposure standards before soldiers are put at risk of exposure to radiation. The actions that the U.S. Army has recently taken to control radiation exposures to soldiers at levels that are below the threshold for immediate effects are a significant step in that direction. In this final report, the committee provides information that is intended to assist the Army in developing both an appropriate radiation protection philosophy and appropriate standards applicable to the wide spectrum of radiation exposure situations that soldiers may encounter. Report Layout The committee has chosen to structure this final report so that it encompasses most of the information provided and all the recommendations offered in the interim report (IOM, 1997). Most readers, therefore, will need only this sec-

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    --> ond volume. The additional detail of the interim report remains available, of course, to any reader. Chapters 2, 3, and 4 provide a grounding in radiation protection philosophy and science; currently accepted standards of U.S. and international civilian and emergency practices; and current U.S. Army practices. The committee has enhanced all three chapters since their publication in the first report. Sections on training, recordkeeping, follow-up, and legal considerations have been expanded. Chapter 5 in this report is based on Chapters 5 and 6 of the interim report, which were written to directly relate to a specific (now revised) document of interest to the U.S. Army. For this final report, the committee has reorganized its response to those specific issues so that the information in Chapter 5 can be applied to other current and future policy documents as well. The committee integrates in this chapter descriptions of civilian and military practices (outlined in earlier chapters) with issues raised during the committee's deliberations. New emphasis is placed on risk assessment, communication, training, education, and notification. Chapter 6 provides guidance to commanders charged with making decisions concerning radiation risk. Chapter 7 lays out the scientific issues in planning and conducting follow-up activities. Finally, in Chapter 8, the committee presents its main recommendations. The committee points out that while Army interest in ionizing radiation provided the impetus for this report, the issues that the committee raises in that context are in large part applicable to considerations of any potentially harmful exposure during military operations. This chapter (Chapter 1), having presented the background to the committee's endeavor and the layout of this final report, proceeds with a section on ethics that introduces themes upon which the committee draws throughout this report. These themes have been considered in the scholarly literature and in the immediate context of specific issues (for example, ACHRE, 1995; Beauchamp and Childress, 1994; National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979). Ethics There is a general ethical principle that one should not put individuals at risk of harm. Exceptions to this principle require justification. There are standard, not mutually exclusive, ways of looking at how to ethically justify placing some at risk for the benefit of others: consent and role-related responsibility. The most obvious appeal is consent. In many circumstances it is considered ethically justifiable to place individuals at risk of harm for the benefit of others if they consent to that imposition-that is, if they assume the risk rather than having it imposed on them. However, for consent to justify

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    --> the imposition of risk, the consent itself must be ethically valid. It must be based on an adequate understanding of the nature and implications of the risk, and the person must be free to refuse. Another way of thinking about risk focuses on role responsibility. There are certain roles, like soldiering, that carry with them an obligation to bear risk for the benefit of others. To give a nonmilitary example, inherent in the physician role is the assumption of the risk of contracting an infectious disease in the course of caring for patients. Although a physician may take appropriate preventive precautions, it generally is not an acceptable response for a physician to refuse care. There are both voluntary and involuntary assumptions of roles; it does not necessarily follow that because a role was not voluntarily assumed that it does not carry with it some socially acceptable and morally justifiable risk. For example, whether they enlist or are conscripted, all soldiers assume the role-related risks of military service. Justifications of consent and role responsibility do not exhaust the ethical considerations associated with the imposition of risk. Several other ethical conditions must be satisfied. There must be an analysis that supports, if not demonstrates, that no more risk is being imposed or placed on the individual than is necessary to achieve the goal. This is the optimization principle of radiation protection, implemented by ALARA—as low as reasonably achievable—procedures. In addition, the ethical duty to minimize risk includes taking steps to minimize the likelihood that the risk will materialize into harm. In this context, the duty includes the responsibility for appropriate follow-up of exposed and potentially exposed individuals. Dosimetry, recordkeeping, and medical monitoring all support postexposure efforts to minimize harm. The goal of the enterprise must itself be ethically acceptable. In this context, it is the military mission that must be ethically acceptable, although this judgment cannot be up to the individual military person once an operational situation is underway. Moreover, the military mission must in some meaningful sense be more ethically significant than the violation of or deviation from the general moral principle of not imposing harm on others. There is also the duty to treat with respect the persons being placed at risk. Several considerations fall under this obligation, one of which is disclosure of the risk to the person both before and after the exposure. Failure to disclose the imposition of risk is to treat those exposed as if they were objects rather than persons of moral worth and dignity. Prior disclosure of information enables the person to exercise judgments that aid in protecting the individual against exposure. Postexposure provision of information can alert the person to recognize possible early symptoms and seek medical attention. Another consideration relating to the ethical obligation to respect persons is to respect the privacy of the person who has been put at risk of harm. Privacy enables the individuals to have control over access to information about their exposure and the uses that others might make of this information.

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    --> Another concept related to thinking in moral terms about placing individuals at risk for the benefit of others is remedy. One provides a remedy, which is generally financial compensation but which could be some other action such as hazard pay or access to medical care, for the simple assumption of the risk. Alternatively, the Department of Veterans Affairs limits the provision of a remedy only to circumstances in which the risk materializes into harm. It provides various types of compensation to soldiers who have been at risk and become disabled to some degree. Although the committee addresses only medical harm (physical and psychological) in this report, it recognizes there are other kinds of harm that the government might want to explore. Finally, there is the set of considerations having to do with justice. Who is to be exposed? If the answer to this question includes any groups or individuals who are particularly vulnerable, particularly open to exploitation, or particularly burdened by preexisting harms or risks, then the mission may not be just. Determination of what is just in the distribution of risk often includes the need to make morally problematic trade-offs. Consider, for example, having to decide between a radiation exposure that carries a risk of radiation-related cancer that might become apparent and be diagnosed 20 years later and an imminent risk of injury or death from a non-radiation-related military threat. How should one weigh deaths or injuries that may occur in the present against deaths or illness that may occur in the future? Does it matter morally if, in choosing the nonradiation threat, the harm would befall only a small number of identifiable soldiers, while, if the choice were radiation exposure, it cannot be known at the time who among those exposed will subsequently suffer the harm? Military Context This ethical framework applies generally and is as applicable in a military as in a civilian context. Features of the military context further increase the ethical burdens on commanders and the military in relation to soldiers. Commanders have much more authority over soldiers than civilian employers have over their employees. Members of the military are obligated to follow all lawful orders, even those that put them at risk of death or disability.* Even in the context of ''volunteering" for high-risk duties, the chain of command and the culture of the military do not allow free choice. Moreover, unlike civilians, military personnel *   In combat situations, for example, military personnel may be required to take investigational drugs without informed consent if a determination is made that the drug is necessary to accomplish the military mission and consent is "not feasible." This was done for the first time in the Gulf War (Annas, 1998). In 1998, Congress limited the authority to waive the consent requirement for investigational drugs to the President, and in addition required the President to make specific findings before authorizing a consent waiver and notify specific members of Congress of his decision in writing (USC, 1998).

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    --> cannot sue their employer (the government) for compensation or remedy for injuries due to negligence. Because health care in the military does not involve the range of choice of physician or medical facility exercised by many other groups of individuals, the handling of medical records presents another ethical concern. Although discharged military personnel have a right to compensation for service-related injuries, such compensation is difficult to obtain in the absence of adequate dosimetry records. Medical and related records (including radiation exposure information) are vital to ensuring that ethical consideration of possible radiation injury has been taken into account in addressing the military objective.