The Mir with Earth below, as photographed from the space shuttle Discovery during space shuttle mission STS-91 on June 12, 1998, during the space shuttle-Mir final fly around before bringing the last group of space shuttle-Mir astronauts back to Earth. NASA image.



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Safe Passage: Astronaut Care for Exploration Missions The Mir with Earth below, as photographed from the space shuttle Discovery during space shuttle mission STS-91 on June 12, 1998, during the space shuttle-Mir final fly around before bringing the last group of space shuttle-Mir astronauts back to Earth. NASA image.

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Safe Passage: Astronaut Care for Exploration Missions 6 Exploring the Ethics of Space Medicine No data attributable to an individual will be publicly released without written permission of the subject. This concept encompasses non-disclosure of an individual’s name and also requires sufficient pooling of data to preclude determining an individual’s identity by combining or cross-referencing data. Institutional Review Board, Johnson Space Center, 1996 Current ethical standards for clinical research and practice with astronauts were developed in an era of short space missions when repeat missions were the norm and a return to Earth within days was possible. In future missions beyond Earth orbit, however, a diverse group of astronauts will travel to unexplored destinations for prolonged periods of time. Contact with Earth will be delayed, and a rapid return will be impossible. Long-duration missions beyond Earth orbit, space colony habitation, or interplanetary travel will create special circumstances for which ethical standards developed for terrestrial medical care and research may be inadequate for astronauts. These ethical standards may require reevaluation.

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Safe Passage: Astronaut Care for Exploration Missions ETHICAL ISSUES IN CLINICAL CARE FOR ASTRONAUTS This chapter analyzes ethical challenges in clinical care and research in space medicine as it is currently practiced and suggests a new ethical framework by which space medicine can address these challenges. In particular, the chapter addresses the issues of confidentiality of astronaut medical information, the underlying conflicts in the astronaut-flight surgeon relationship, the difficulties of research with human participants, and the special difficulties that may arise in a long-duration space mission with an international crew. Institutional Pressure to Underreport Clinical Signs, Symptoms, and Medical Data Astronauts are subject to a unique set of pressures to keep medical information private. They fear that abnormal preflight medical test results, disclosure of an illness during a space mission, or even evidence of common responses to space travel such as prolonged space motion sickness may be used to disqualify the astronaut from subsequent missions. During its conversations with physician-astronauts in Woods Hole, Massachusetts (see Appendix A), the committee learned that astronauts feel that “the best you can do is come out even” after a meeting with the flight surgeon. The astronauts report that any medical information disclosed to the flight surgeons may jeopardize an astronaut’s chance to return to space, particularly if the medical data or the results of those conversations become known outside the examination or interview room. Because astronauts find the mission selection process opaque (Flynn and Holland, 2000), an undesired mission assignment or a disqualification may be falsely attributed to the disclosure of medical information. The fear of mission disqualification increases their reluctance to report medical information. Rendering the process more transparent by elucidating the procedures and rationales used for astronaut selection for a mission would eliminate medical disqualification as the potential catchall reason for failure to be selected for a mission and increase the likelihood of full reporting of medical information necessary to establish an evidence base for space medicine. The culture of the astronaut corps, which values stoicism and a “can-do” attitude, further reinforces the individual’s reluctance to report medical information. Within this culture illness is often associated with poor job performance or even mental or physical weakness (Flynn and Holland, 2000). Although spaceflight is arduous and requires rising above physical

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Safe Passage: Astronaut Care for Exploration Missions challenges, an atmosphere that equates signs and symptoms (which may be a normal or a common physiological response to an unusual environment) with poor job performance hampers reporting of clinical information about the experience of space travel and thus may limit the attempt to design rationally based countermeasures. Similarly, any tendency to equate medical symptoms with physical or psychological weakness should be eliminated during the National Aeronautics and Space Administration’s (NASA’s) transition to long-duration space missions. Underreporting of medical information will limit attempts to establish norms for physiological and psychological adaptations to long-duration space travel and habitation and to design preventive and therapeutic strategies for potentially mission-threatening medical illnesses during long-duration space missions. Current Practice Regarding the Confidentiality of Individual Astronaut Medical Data Current knowledge about the physiological and psychological effects of long-duration space travel is surprisingly modest (SSB and NRC, 1998a). Humans have been in space for more than four decades, yet the amount of available data about human responses to prolonged exposure to microgravity remains limited. One of the stated reasons for the limited amount of data that have been analyzed has been a desire to protect the privacy of individual astronauts (Flynn and Holland, 2000). Astronauts, flight surgeons, and NASA staff told the committee that they interpret the Privacy Act of 1974 (5 U.S.C. § 552a [1974]) to strictly forbid disclosure of any astronaut medical data in any form to anyone outside the flight surgeon-astronaut pair. Whether this is a correct interpretation of the act is unclear, as there are certainly exceptions in medical confidentiality for Earth-based doctor-patient communications (Box 6–1). Limited doctor-patient confidentiality also exists in dual-agency settings in which the clinician has a duty both to the organization and to the individual. Examples of dual-agency settings include the military, prisons, schools, and other government agencies (Federal Aviation Administration, Central Intelligence Agency, U.S. Department of Transportation, etc.). In any dual-agency setting there is only limited confidentiality to the members of that organization, the members are very aware of these limits, and they sign a Privacy Act statement in their medical records and again in several specific settings (for a psychiatric evaluation, for instance) that document

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Safe Passage: Astronaut Care for Exploration Missions BOX 6–1 Examples of Earth-Based Limitations on Doctor-Patient Confidentiality to Decrease Risks to Others Control of communicable diseases, as seen in state laws for mandated reporting of resistant tuberculosis, measles, syphilis, and other infectious diseases. Danger or threatened harm to others expressed by patients to physicians (e.g., “Tarasoff” restrictions or child and elder abuse reporting statutes). Occupational health issues that threaten a safe workplace, especially in novel and particularly dangerous workplaces. Restrictions on aviation personnel including military aviators when any symptom or condition might negatively affect safety of flight. their awareness of the limitations. An example of a portion of the signed Privacy Act statement used in medical records since the mid-1970s in the military is as follows (from U.S. Department of Defense form 2005 of February 1, 1976): Routine Uses: The primary use of this information is to provide, plan, and coordinate health care. As prior to enactment of the Privacy Act, other possible uses are to: Aid in preventive health and communicable disease control programs and report medical conditions required by law to federal, state, and local agencies; compile statistical data; conduct research; teach; determine suitability of persons for service or assignments; adjudicate claims and determine benefits; other lawful purposes, including law enforcement and litigation; conduct authorized investigations; evaluate care rendered; determine professional certification and hospital accreditation; provide physical qualifications of patients to agencies of federal, state, or local government upon request in the pursuit of their official duties. At NASA, medical information that is not part of a defined research protocol has been regarded as confidential, to be known only to the astronaut’s flight surgeon and the astronaut. This strict stance on privacy also applies to data collected for the Longitudinal Study of Astronaut Health and to all medical information about current astronauts and astronauts in training (Pool, 2000). Because only a few astronauts participate in any given mission, the concern persists that medical data, even if they are presented anonymously, could be linked to individuals. The possibility that an astronaut could be identified is seen as an inescapable barrier to the collection and interpretation of astronaut health data.

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Safe Passage: Astronaut Care for Exploration Missions Finding: Because of concerns about astronaut privacy, data and biological specimens that might ensure the health and safety of the astronaut corps for long-duration missions have not been analyzed. If these data and other data to be accumulated in the future are to be used to facilitate medical planning for the unique sets of pressures and extreme environments that astronauts will experience on long-duration space missions, the ethical concerns about astronaut privacy must be appropriately modified. An unfortunate side effect of the overemphasis on individual astronaut privacy may be that future astronauts will be required to undergo observation and experimental investigations that would have been unnecessary if data from past space missions were available and had been analyzed. Repeating research or data collection, particularly if there is a risk to the participants in doing so, adds to the burdens placed on astronauts and is unjustified on grounds of individual privacy. Furthermore, whenever possible all of the data relevant to long-duration travel should be assembled and examined before the design of new protocols for such travel. Earth-Based Analogs for Balancing Medical Confidentiality with Public Health There is a long history of balancing individual rights against the health of the public in the monitoring and control of communicable diseases. Disclosure of limited aspects of individual medical data to public health authorities is required for some diseases such as measles and syphilis; in the case of drug-resistant tuberculosis, disclosure of individual medical data can lead to substantial limitations of privacy. These disclosures are based on the following rationale. If a physician is treating a patient for an illness that could affect in a substantive way either the general population or the local population to which the patient will return, the physician is justified in balancing the public health risks against the private needs of the patient. If the public health risk is particularly pressing, the boundaries of confidentiality may be loosened in a manner proportionate to the public health risk. In another example, a physician may observe that several patients who are all working in a nearby factory each exhibit similar signs and symptoms. The physician may suspect that the work environment is causing or contributing to the health problems. If so, the physician has a duty to investigate the workplace for the source of the illness, even if doing so may require limited disclosure of information about the workers. Again, the severity of the risk

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Safe Passage: Astronaut Care for Exploration Missions to other workers is the standard by which to judge the loosening of patient confidentiality. Taking these occupational examples further, imagine that the health and safety system for the first nuclear power plant is in the design phase. Because the hazards of working in such an environment could be neither fully understood nor fully anticipated, it would be justifiable to require workers in the plant to wear radiation sensors, to provide routine biological samples to check for radiation exposure effects, and to agree to report signs and symptoms that could be related to radiation exposure to the designers of the health and safety system. Such data would not be released to the general public and should not be released to the employer under the majority of instances, but the data would be essential to those who are in charge of designing the safest possible workplace. Failure of the health officer to know all such data (so that shielding practices could be improved) on the grounds that the data are private could place other workers in danger. The degree of monitoring and the breadth of data gathering should be proportional to the newness of the work environment; more monitoring, and thus less privacy, would be more appropriate in the first 5 plants than in the 20th plant. Individual astronauts traveling beyond Earth orbit for the first time are quite similar to those workers in early nuclear power plants; there are known and unknown risks to long-duration space missions, and there is a need to create a safe workplace for astronauts on current and future missions. Justification for Using the Occupational Health Model to Balance Privacy and Safety Several unique aspects of space travel beyond Earth orbit serve to constrain the presumption in favor of medical confidentiality. First, the opportunity to observe the effects of space travel on humans is remarkably rare and thus is a scarce resource that should be used or allocated in the most efficient manner possible. In this instance, the rarity of the opportunity to make clinical observations should be balanced against the likely benefits and harms of a strict policy of confidentiality. Second, astronauts will live and work in particular space environments for longer and longer periods of time. The longer the environment is inhabited, the more it will come to resemble a workplace rather than a temporary spacecraft. Issues of occupational health and safety will arise with increasing frequency. In the occupational health context, the confidentiality of the individual’s medical information can be judged to be less important when balanced

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Safe Passage: Astronaut Care for Exploration Missions against the safety of the workplace for all “workers” (i.e., astronauts). Commonly in occupational and environmental medicine practice “there is a natural tension between the clinical health issues relating to the individual patient and broader public health issues, which transcend the traditional doctor-patient relationship” (Cullen and Rosenstock, 1994, p. 1). Several principles of occupational and environmental health practice will apply to any space medicine occupational health model. Modern systems for the surveillance of disease and injury have three components (Baker, 1988): data collection, data analysis, and capacity for response. In any occupational setting, the broad purposes of occupational health surveillance are the same (Markowitz, 1992). They are to determine the incidence and prevalence of occupational diseases and injuries, identify individual cases of occupational disease and injury, find and evaluate other persons in the same workplaces who may be at risk, and discover new associations between occupational agents and disease. Third, the opportunity to travel in space is highly desired by those in the astronaut corps. Although long-duration space missions will involve substantial hazards, there are likely to be many who will gladly accept the risk in exchange for the unique opportunity to leave the bounds of Earth’s orbit. One may rightly view astronauts as they evidently view themselves: a highly privileged group with a rare and valuable opportunity. Such an opportunity brings with it the responsibility to give up some privacy to ensure the safety of fellow astronauts and those astronauts who will follow. If protection of medical confidentiality for individual astronauts hinders the understanding of the risks of long-duration space travel and thus prevents the development of a reasonable medical care program for long-duration space travel, the emphasis on strict confidentiality has been misplaced. In summary, although the medical privacy needs of astronauts are in some ways similar to those of individuals on Earth, there are models of medical care, most particularly that of occupational health, that permit the ethi-

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Safe Passage: Astronaut Care for Exploration Missions cal collection of individual data if the intention is to design a safer workplace. The work environment of long-duration space missions will be both hazardous and novel. The development of preventive and curative responses to unpredictable hazards will require a refocusing of the usual boundaries of medical confidentiality. Given the small number of astronauts and the small number of space missions, good-faith attempts to protect confidentiality may be more difficult in space than on Earth. Finding: The possibility of identifying an individual astronaut as the source of particular information is not sufficient rationale to continue the current practice of failing to collect and analyze information that could make space travel safer (or even possible) for current astronauts and for those who will journey forth on missions in the future. NASA’s Clinical Care Capability Development Project (NASA, 1998b; Fisher, 2000) may be an appropriate framework for an astronaut occupational health model to provide optimal health and safety protection of individual astronauts. The analogy of occupational health carries with it the precedent for certain compromises of individual privacy that will be required for long-duration space missions. A long-duration space mission is, among other things, a traveling space laboratory where experiments, including self-experimentation, are performed. Astronauts in such a traveling laboratory play many roles: a single individual may be both a scientist and a subject, an explorer and a worker, a doctor and a patient. These complicated and multiple roles require rethinking the usual boundaries of medical confidentiality. ETHICAL ISSUES IN THE ASTRONAUT-FLIGHT SURGEON RELATIONSHIP Astronauts and flight surgeons often have divergent opinions regarding the boundaries and norms of the doctor-patient relationship in the context of space missions. This is not surprising, given the fact that on the ground the norms of the doctor-patient relationship are deeply influenced by the context of medical care. There are different ethical demands upon both patients and physicians in specialized settings such as an insurance company office, a military battlefield, or a psychiatrist’s office. Each of these settings creates variations in the physician’s responsibility to the patient and the patient’s obligations to the physician. In the context of space missions, the flight surgeon plays multiple roles, from coach, to clinician, to clinical-

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Safe Passage: Astronaut Care for Exploration Missions researcher, to fellow astronaut. The aspects and boundaries of this relationship need to be explored further, not only for their influence on the creation of a safer space travel environment but also for the unstated assumptions that define the roles of astronauts as patients, physician-astronauts in flight, and flight surgeons on the ground (Rayman, 1997, 1998). OPPORTUNITIES FOR COLLECTING MEDICAL DATA ABOARD THE INTERNATIONAL SPACE STATION The International Space Station (ISS) will be the main environment for extended astronaut habitation in space during the coming decade or two. How might data about the health experiences of astronauts aboard the ISS be collected to overcome the difficulties in medical data collection and analyses? Expand the Collection of Occupational Health Data One important step is to make collection of individual medical data an expected part of participation in all space missions. Monitoring of physiological and psychological data would be expected in return for the opportunity to engage in a unique and desirable activity, namely, the chance to travel in space aboard the ISS. This sort of routine collection of medical data would be part of good preventive health care on any long-duration mission on the ISS or in future missions beyond Earth orbit. Planned analysis of various physical and psychological factors, as well as routine testing to measure the ongoing medical and psychological stresses of space travel, would be required. Reasonable attempts would be made to protect the privacy of any individual astronaut. In many cases, however, the need to design a safer workplace on the ISS and beyond Earth orbit in the future would take precedence over the individual’s medical privacy. A complete listing of the astronaut medical information that would be routinely collected cannot be specified beforehand by this committee. Information that has nothing to do with the ability to travel in space should not be routinely collected, but the committee believes that it would be up to NASA to come up with a policy for routine data collection. It is essential that this policy be created with extensive input from the astronauts. The central assumption of any mandated medical data collection should be that the safety of the astronaut crew takes precedence over individual astronaut confidentiality, although the details of the data to be collected will necessar-

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Safe Passage: Astronaut Care for Exploration Missions ily change as more becomes known about the hazards of long-duration space travel. Change the Process for Review of Clinical Research Protocols in Space Medicine The committee believes that a modified approach to the ethical review of clinical research protocols in space medicine will be required in the era of long-duration missions beyond Earth orbit. Any procedure for review of clinical research performed with astronauts should take into account the unique organizational, cultural, and ethical aspects of the space program. The process for ethical review of research protocols needs to recognize that astronauts are in a unique situation with regard to participation in clinical research. Their situation is quite unlike that of either the healthy or the sick participants in clinical research in typical settings on Earth (Levine, 1986). In particular, the research review process must recognize the unique pressure on astronauts to overcome any obstacle to participating in space travel. The usual methods of informed consent (Box 6–2) fail to recognize the intense competition among astronauts to be assigned to a particular mission and the implicit coercive effects of such competition. Although it is NASA policy that refusal to participate in a research protocol should not influence the crew selection process, as stated in Appendix BOX 6–2 The Common Rule and Informed Consent The federal policy for the protection of human research participants, referred to as the “Common Rule” (45 C.F.R., Part 46, Subpart A), establishes the ethical framework for all federally funded research with human participants, requiring that research institutions form institutional review boards and delegate to them the authority to review, stipulate changes in, approve or disapprove, and oversee protection of human participants for all research conducted at that institution. A prominent feature of the Common Rule is the requirement for informed consent. Informed consent is agreement (consent) by the potential participant to participate in a research activity. This agreement is based on an explanation by the principal investigator (the individual who will be conducting the proposed research activity with human participants) in enough detail and in appropriate language to ensure that the potential participant fully understands what he or she is consenting to and that the consent is based on complete knowledge of the nature and risk of the procedure.

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Safe Passage: Astronaut Care for Exploration Missions V of the handbook of the Johnson Space Center Institutional Review Board (1996), there is evidence that the competition for crew positions renders this policy almost meaningless in practice. Astronauts are reluctant to reveal medical incidents or complaints and to report symptoms during space missions for fear that any physiological variation, however small, may jeopardize their chances of future space travel. If this is the case, astronauts could be expected to sign clinical research consent forms out of the same reluctance, regardless of the official policy. In addition, the methods of crew selection are not so independent of research consent, as the policy suggests. Procedures outlined in Appendix V of the current handbook of the Johnson Space Center Institutional Review Board (1996) acknowledge that a crewmember may be removed from a flight (space mission) for refusing to participate in a specific research protocol “if such action is in the best interest of the flight and the Government” (p. V-2). In addition, such refusal “may prejudice the crew member’s assignment to missions of a similar nature in the future” (p. V-2). It is difficult to see how an astronaut could not interpret this to mean that refusal to consent will have substantial negative consequences for her or his career as an astronaut. Finally, there is clear precedent for modifying policies protecting human research participants to respond to unique or highly unusual circumstances. Perhaps the best-known example is the 1996 exception in the Food and Drug Administration’s final rule on informed consent requirements for studies of emergency medical procedures. The exception establishes narrow limits permitting research to go forward without informed consent because, in the emergency or critical care setting, obtaining informed consent often is not feasible. At the same time, the exemption recognizes that patients who have sudden catastrophic illnesses or injuries and who may be unconscious are a special class of vulnerable patients for whom additional safeguards are required. These new safeguards include consultation with the community where the research will be performed, as well as public disclosure of the study design, the risks involved, and the results (Biros et al., 1995, 1998; Menasche and Levine, 1995; Nightingale, 1996). Suggested Changes in the Approach to Review of Proposed Clinical Research or Data Collection for Astronauts One approach to the review of proposed clinical research or data collection for astronauts is to divide astronaut clinical research or data collection protocols into two categories (Box 6–3). The first category would include

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Safe Passage: Astronaut Care for Exploration Missions BOX 6–3 Potential Categories of Clinical Research or Data Collection Protocols for Astronauts Category 1 Low-risk, noninvasive, and non-time-intensive clinical research and data collection protocols designed to enhance the safety and performance of the crewmembers and the habitability of the spacecraft. Category 2 Protocols that examine procedures, methods, devices, and so forth that are not likely to be needed during long-duration space travel but that are of value for the testing of early phases of experimental countermeasures or hypotheses about clinical care on Earth. low-risk and noninvasive research and data collection protocols that are not time intensive. They are designed solely to enhance the safety and livability of all future space travel missions and for the collection of longitudinal health data for astronauts. In such cases, participation in the protocols should be required of all astronauts. The second category would include protocols that examine procedures, methods, devices, and so forth that are not likely to be needed during long-duration space travel but that are of value for the testing of early phases of experimental countermeasures or hypotheses about clinical care for the general population on Earth (Box 6–4). In this type of protocol, astronauts should have wide latitude in declining or agreeing to participate in research, and no mission selection pressure should be brought to bear to encourage participation. Astronauts would be considered “healthy volunteers” for such BOX 6–4 Examples of Category 2 Clinical Research or Data Collection Protocols for Astronauts Protocols without a direct effect on space travel. Protocols that examine treatments intended for commercial use on Earth. Those that are high risk or that are invasive or time intensive, even if they are intended to address issues related to prolonged space travel.

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Safe Passage: Astronaut Care for Exploration Missions research, and strict precautions should be required to make sure the consent process is free of coercion. Informed consent should be most rigorous for studies that are significantly invasive, that are high risk for the individual astronaut, and that offer little potential benefit to the individual astronaut or invade the astronaut’s privacy. Classification of astronaut clinical research and data collection protocols into these two categories will require assessment of the physical and psychological risks of the procedures in the context of long-duration space travel. The clinical research review process should not rely on randomization or the use of particular methods to discriminate between protocols that require consent and those that may be mandated. Instead, the level of risk to the individual astronaut should be balanced against the importance of the results to the creation of safe, long-duration space travel (Truog et al., 1999). In addition, the review process should take into account the physical and in some cases the personal invasiveness of the planned data collection, as well as the other demands on astronaut time, to limit the degree of risk that astronauts must accept. It is only particular types of protocols—low-risk protocols designed specifically to create a safer space travel environment— to which the pressures related to crew selection can legitimately be applied. If such a two-category system of astronaut clinical research and data collection protocols is adopted, a new clinical research review process for space medicine will have to be developed with greatly increased and active participation from the astronaut corps. The burden of proof for requiring participation in a category 1 protocol should rest with the clinical investigator and the Life Sciences Directorate of NASA, not with the individual astronaut who will participate. The following conditions must be met before participation can be justifiably mandated: Astronauts must have a clear sense that space medicine clinical research results will be relevant to the development of a safer space travel environment. Astronauts must believe that the space medicine clinical research results will in fact be incorporated into the design of a safer space travel environment. Astronauts must be assured that the clinical research protocol will involve the minimal amount of risk possible to attain the desired information. Astronauts must be convinced that space medicine clinical research protocols have been designed to have statistical validity and that procedures

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Safe Passage: Astronaut Care for Exploration Missions or rules based on the results of the research will be implemented within the unique restrictions of long-duration space travel. Clinical research results will be openly shared with the astronauts themselves. Stringent standards must be applied to any clinical research protocol in which astronauts participate, and the review process must be transparent, accountable, and trustworthy from the astronauts’ perspective. Application of a dual-agency occupational health model with a clear understanding of the limitations on doctor-patient confidentiality (see Box 6–1 and the paragraph preceding that box) will support a category system of astronaut clinical research with the presence of full and honest informed consent. ETHICAL ISSUES AND THE SPECIAL CIRCUMSTANCES OF INTERNATIONAL CREWS The international nature of the ISS presents additional concerns regarding the ethical boundaries of privacy and research. Although there are ongoing attempts to establish international research regulations (e.g., the guidelines of the Council for International Organizations of Medical Sciences [CIOMS, 1993]), little precedent exists for international agreement about clinical and research ethics during long-duration missions in space. The current different approaches of the Russian and U.S. medical programs toward astronaut-patients both on the ground and in space (Williams, 2000) demonstrate that the potential for conflict is strong. One must assume that there will be different approaches to prevention, treatment, and participation in research among nations and that the coordination and organization of data collection will continue to be a difficult task (Levine, 1991). The committee strongly supports the initiation and continuation of discussions among national space agencies and ISS partners including key stakeholders—that is, astronauts and their families, policy makers, and ethicists— of the ethical principles for clinical care and participation in space medicine clinical research. It would be unacceptable to assume that all members of an international crew will share the same views about research participation or the release of medical information. Nor would it be acceptable to limit the collection of data from particular ISS crewmembers simply because of a failure to discuss the ethical boundaries of data collection before that crewmember’s launch into space.

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Safe Passage: Astronaut Care for Exploration Missions CONCLUSION AND RECOMMENDATION Conclusion The ultimate reason for the collection and analysis of astronaut healthrelated data is to ensure the health and safety of the astronauts. Emphasis on the confidentiality of astronaut clinical data has resulted in lost opportunities to understand human physiological adaptations to space, and concern for the protection of privacy and over the implications regarding disclosure and use of clinical data may have led to the underreporting of relevant information. Reevaluation of the application of the Privacy Act and statutory privacy provisions may be necessary to enable appropriate access to necessary data while protecting the privacy of the individual astronaut. The unique environment of deep space, combined with the social and institutional contexts of health care research with astronauts, requires that astronauts be considered a unique population of research participants. A limited international consensus exists on the appropriate principles and procedures for the collection and analysis of astronaut medical data. The potential for conflict among the national space agencies and International Space Station partners is high. Recommendation NASA should develop and use an occupational health model for the collection and analysis of astronaut health data, giving priority to the creation and maintenance of a safe work environment. NASA should develop new rules for human research participant protection that address mission selection, the limited opportunities for research on human health in microgravity, and the unique risks and benefits of travel beyond Earth orbit. A new interpretation or middle ground in the application of the Common Rule (45 C.F.R., Part 46, Subpart A) to research with astronauts is needed to ensure the development of a safe working environment for long-duration space travel. NASA should continue to pursue consensus among national space agencies and International Space Station partners on principles and procedures for the collection and analysis of astronaut medical data.