Executive Summary

ABSTRACT

Space travel is inherently risky. Space beyond Earth orbit is an extreme and isolated unique environment. Currently, not enough is known of the risks of prolonged travel in deep space to enable humans to venture there for prolonged periods safely. To support safe human exploration of space, the National Aeronautics and Space Administration (NASA) should pursue a two-component strategy: (1) it should pursue a comprehensive health care system for astronauts to capture all relevant epidemiological data, and (2) it should pursue a long-term, focused health care research strategy to capture all necessary data on health risks and their amelioration. An occupational health model should apply to the first pursuit, and a modification of the interpretation of the Common Rule (45 C.F.R., Part 46, Subpart A) for human research participants should apply to the second one. One special focus of research should be the complex behavioral interactions of humans in extreme, isolated microenvironments such as inside spacecraft. To accomplish this strategy, there should be an organizational component within NASA that has authority over and accountability for all aspects of astronaut health.

Space travel is inherently risky, and space travel on long-duration missions (those of a year or longer) beyond Earth orbit (beyond the orbital



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Safe Passage: Astronaut Care for Exploration Missions Executive Summary ABSTRACT Space travel is inherently risky. Space beyond Earth orbit is an extreme and isolated unique environment. Currently, not enough is known of the risks of prolonged travel in deep space to enable humans to venture there for prolonged periods safely. To support safe human exploration of space, the National Aeronautics and Space Administration (NASA) should pursue a two-component strategy: (1) it should pursue a comprehensive health care system for astronauts to capture all relevant epidemiological data, and (2) it should pursue a long-term, focused health care research strategy to capture all necessary data on health risks and their amelioration. An occupational health model should apply to the first pursuit, and a modification of the interpretation of the Common Rule (45 C.F.R., Part 46, Subpart A) for human research participants should apply to the second one. One special focus of research should be the complex behavioral interactions of humans in extreme, isolated microenvironments such as inside spacecraft. To accomplish this strategy, there should be an organizational component within NASA that has authority over and accountability for all aspects of astronaut health. Space travel is inherently risky, and space travel on long-duration missions (those of a year or longer) beyond Earth orbit (beyond the orbital

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Safe Passage: Astronaut Care for Exploration Missions band of launched satellites and the International Space Station [ISS]) entails special risks to humans. Deep space is a unique environment. It is unique for several reasons: (1) it likely has unknown risks, (2) there are no validated effective responses to most of the known risks that humans will encounter there, and (3) it isolates humans, in that humans in deep space will not have the capability for either real-time communication with Earth or a timely return. The acquisition of a fundamental understanding of these risks and the development of solutions to the problems that they present are the subjects of this report. TASK OF THE COMMITTEE The general charge to the Committee on Creating a Vision for Space Medicine During Travel Beyond Earth Orbit was to develop a vision for space medicine for long-duration space travel. With the important exception of the ISS, such travel is many years in the future. During the interim, innumerable changes will occur, many of which are unpredictable. As new knowledge is developed, humans will learn much that is directly applicable to the task of enabling safe space travel. Institutional arrangements will shift, and as priorities change, new management principles will be applied; often, these will be affected by political realities. In this report, the committee focuses on the development of principles that should guide future approaches to the issues. In planning for long-duration space travel beyond Earth orbit, the National Aeronautics and Space Administration (NASA) is undergoing a transition from the relatively known (e.g., the space shuttle has flown more than 100 missions) to the unknown. In addition, a second transition is occurring: from an emphasis on the machinery of spaceflight to an increased emphasis on the biology of spaceflight. For both NASA and the engineering community this is a conceptual shift that has important practical implications as biology adds to chemistry, mathematics, and physics as guiding sciences in engineering in general and in NASA’s mission. The challenges afforded by these twin transitions offer NASA a strategic opportunity to reexamine its processes and structure and to build on its successes. In addition to the general charge to the committee, NASA gave the committee several specific tasks. Chapter 1 introduces the health problems that may confront humans in deep space. Chapter 2 addresses what is known about the risks to health during space travel and where clinical research opportunities exist. Chapters 3 and 4 review what is known about health care during space travel and where opportunities may exist for the develop-

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Safe Passage: Astronaut Care for Exploration Missions ment of effective approaches to health care during travel in deep space. Chapters 5 and 6 highlight two specific areas that the committee believes are critical: (1) behavioral, cultural, and social issues (Chapter 5) and (2) an approach to the collection of the clinical data necessary to ensure the safety of space travel beyond Earth orbit (Chapter 6). Chapter 7 suggests ways in which an effective health care system for astronauts might be organized. Two themes run throughout the report: (1) that not enough is yet known about the risks to human health during long-duration missions beyond Earth orbit or about what can effectively mitigate those risks to enable humans to travel and work safely in the environment of deep space and (2) that everything reasonable should be done to gain the necessary information before humans are sent on missions of space exploration. RISK Throughout its history, NASA has dealt successfully with transition: the transition from atmospheric flight, to supersonic flight, to suborbital flight, to orbital flight (which culminated with the space shuttle), and to orbital missions, both with Mir and, more recently, with the ISS. Long-duration missions beyond Earth orbit represent another transition and another opportunity. Such missions are not merely quantitatively different; they are also qualitatively different. The three most important health issues that have been identified for long-duration missions are radiation, loss of bone mineral density, and behavioral adaptation. First, although exposure to radiation is of concern during missions in low Earth orbit, its potential effects become more acutely worrisome during extravehicular activity and are chronically worrisome for those living on the ISS. Longer-duration missions increase the risk at least arithmetically because of the length of the mission and the changing character of radiation in the environment. This is a formidable challenge for engineering, basic biomedical, and clinical research, as discussed in the section Environmental and Occupational Health in Chapter 3. Second, loss of bone mineral density, which apparently occurs at an average rate of 1 percent per month in microgravity, is relatively manageable on the short-duration missions of the space shuttle, but it becomes problematic on the ISS, as described in Chapter 2. If this loss is not mitigated, interplanetary missions will be impossible. Finally, human interactions aboard a spacecraft, isolated in time and space from Earth, may well be one of the more serious challenges to exploratory missions by humans (Chapter 5).

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Safe Passage: Astronaut Care for Exploration Missions Risk is of high priority to NASA, and determination of what risks to humans exist and what countermeasures should be taken are addressed through NASA’s Critical Path Roadmap project (“countermeasure” is NASA’s designation for preventive and therapeutic interventions before or during space missions). Nevertheless, risk should be addressed at other levels. At the level of the individual astronaut, for example, how may an astronaut come to a personal decision in a truly informed way to accept the risk of a maiden voyage to Mars? To make an informed personal decision, astronauts should be involved in the process that identifies risks and their amelioration, not only from the standpoint of immediate countermeasures over which they might have control while in flight but also from the standpoint of those risks for which they have no personal or immediate control. At the level of society, on the other hand, risks should be addressed explicitly. The successes of the space program may have fostered the impression that space travel has few associated risks. Making potential problems and overall risks clear and openly disclosing them will allow NASA to gain continuing public understanding, trust, and support for exploration-class space missions. NASA can tailor the amount of detail disclosed in relation to the anticipated severity and prevalence of the risks to astronaut health and safety and the level of support that NASA is seeking. At the extreme, the public must be prepared for the possibility that all countermeasures may tragically fail, that a crew may not return from a prolonged mission, or that individuals may not be able to function physically or mentally upon their return. There is a profound professional and ethical responsibility to evaluate honestly the risk to human life that accompanies long-duration space travel. This risk should be evaluated through clinical research (Box 1) in the context of the benefit to humans, but it should be stated at the level of the individual in terms that can be plainly understood. Conclusion 1 Space travel is inherently hazardous. The risks to human health of long-duration missions beyond Earth orbit, if not solved, represent the greatest challenge to human exploration of deep space. The development of solutions is complicated by lack of a full understanding of the nature of the risks and their fundamental causes. The unique environment of deep space presents challenges that are both qualitatively and quantitatively different from those encountered in Earth orbit. Risks are compounded by the impossibility of a timely

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Safe Passage: Astronaut Care for Exploration Missions BOX 1 Clinical Research Opportunities for Astronaut Health Musculoskeletal System Establishing the course of changes in bone mineral density and markers of bone mineral density turnover in serum and urine before, during, and after space travel. Developing a capacity for real-time measurement of bone mineral density and enhanced three-dimensional technology to assess the risk of fracture during space travel. Identifying human phenotypes and genotypes resistant to space travel-induced bone mineral density loss. Tailoring therapeutic interventions (i.e., countermeasures such as diet, exercise, and medications) as a high priority and then validating the promising countermeasures in studies with astronauts during exposure to microgravity. Cardiovascular Considering artificial gravity and pharmacological interventions as solutions to orthostatic hypotension. Gastrointestinal Investigating the relationship between space motion sickness and absent bowel sounds including pharmacological and adaptive countermeasures. Nervous System Building a coordinated clinical research program that addresses the issues of neurological safety and care for astronauts during long-duration space travel. Performing pharmacological trials with dose-response and pharmacokinetic measures to assess the efficacies and toxicities of medications commonly used to treat sleep disturbances during space travel. Considering clinical trials on the use of growth hormone or other countermeasures and developing devices to control spacecraft ambient light and the core temperature at appropriate levels during space travel to reduce sleep disturbances. Reproductive Health Determining whether radiation exposure during space travel causes genetic damage or altered fertility in men and women and, for women, premature ovarian failure. Determining female and male reproductive hormone levels during space travel. Determining the effect of microgravity on menstrual efflux and retrograde menstruation. Physiological Monitoring Collecting clinical data for both men and women when anatomically possible and physiologically sensible for all individuals in the space program and, on a regular basis, subjecting the data to analysis for sex-related differences. Giving priority to high-resolution, high-precision, yet minimally invasive or noninvasive methods for the monitoring of physiological parameters and for imaging of the human body during space travel.

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Safe Passage: Astronaut Care for Exploration Missions return to Earth and of easy resupply and by the greatly altered communications with Earth. The successes of short-duration space missions may have led to misunderstanding of the true risks of space travel by the public. Public understanding is necessary both for support of long-duration missions and in the event of a catastrophe. Recommendation 1 NASA should give increased priority to understanding, mitigating, and communicating to the public the health risks of long-duration missions beyond Earth orbit. The process of understanding and mitigating health risks should be open and shared with both the national and the international general biomedical and health care research communities. The benefits and risks—including the possibility of a catastrophic illness or death—of exploratory missions should be communicated clearly, both to astronauts and to the public. HEALTH CARE To understand, prevent, and mitigate risks, knowledge of the risks is necessary. Because of the relatively few opportunities to acquire and analyze data from studies conducted in microgravity environments, every possible opportunity to do so must be exploited. Opportunities for the collection of two types of data exist: clinical data on the astronauts and the results of astronaut health care research (Box 2). Clinical data, including personal health data, have been collected over the 40 years that humans have flown in space, but data collection has not been done in a systematic way, nor have the data been fully analyzed. A comprehensive health care system for astronauts—both active and retired— should ensure that all data relevant to space travel are collected. Combined with a strategic health care research plan that would enable the analysis of those data, such a system would foster data-driven decisions about health risks, prevention, and mitigation. “Comprehensive” means that all health care for astronauts is coordinated through an astronaut health care system and covers all periods while the astronaut is active, including the selection, premission, intramission, postmission, and intermission phases. “Comprehensive” also means that there is retrospective as well as prospective collection and analysis of clinical

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Safe Passage: Astronaut Care for Exploration Missions data. The astronaut health care system should include not only a health care component but also health care research and training components. The standard of clinical care for a health care system for astronauts should be equivalent to the best clinical care available on Earth for those problems that occur before and after a mission. The goals of the health care system should be to maximize the astronaut’s ability to function as a productive member of the crew while in deep space and to maintain or to restore normal function in the premission and the postmission phases. Conclusion 2 Crew health has not received the attention that it must receive to ensure the safety of astronauts on long-duration missions beyond Earth orbit, nor has NASA sufficiently integrated astronaut health care into mission operations. Currently, there is no comprehensive and inclusive strategy to provide optimum health care for astronauts in support of long-duration missions beyond Earth orbit, nor is there sufficient coordination of health care needs with the engineering aspects of such missions. An effective health care system is founded on data that are accumulated, analyzed, and used to continuously improve health care for astronauts on future space missions. Inherent in an appropriate health care system is a mechanism that can be used to gather and analyze data relevant to key variables. NASA could have collected and analyzed many more medical data had a comprehensive health care system focused on astronauts been in place and been given the priority and resources that it Although the equipment and expertise that will be needed to provide health care during future long-duration missions beyond Earth orbit cannot be reliably predicted, a health care system that is data driven and linked to a research strategy will position NASA to better monitor pertinent developments and meet future challenges. Recommendation 2 NASA should develop a comprehensive health care system for astronauts for the purpose of collecting and analyzing data while providing the full continuum of health care to ensure astronaut health. A NASA-sponsored health care system for astronauts should

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Safe Passage: Astronaut Care for Exploration Missions BOX 2 Health Care Opportunities in Space Medicine Expanding, validating, and standardizing a modified physical examination, the microgravity examination technique, and including a technique for pelvic examination for use in microgravity. Developing an easily identifiable database for medications on the spacecraft, including dosage, indications, adverse effects, and anticipated changes in the pharmacokinetic profile in microgravity. Developing an easily accessible hazardous materials manual for space travel to aid in the surveillance, detection, decontamination, and treatment of chemical exposures. Monitoring and quantifying particulates on a continuing basis. Examining the capability of microbial identification, control, and treatment during space travel. Developing methods for noise cancellation or reduction. Standardizing ergonomic practices on the basis of the human body’s response to the microgravity environment. Developing methods to measure human solar and cosmic radiation exposures and the means to prevent or mitigate their effects. Providing a thorough cardiovascular evaluation similar to the premission evaluation at the cessation of space travel to provide useful data as part of the continuum of astronaut care and to aid in establishing an evidence base for cardiovascular disorders during space travel. Developing a program for instruction in basic dental prophylaxis; the treatment of common dental emergencies such as gingivitis, tooth fracture, dental trauma, caries, and dental abscesses; and tooth extractions. care for current astronauts, astronauts who are in training, and former astronauts, as well as, where appropriate, their families; cover all premission, intramission, and postmission aspects of space travel; incorporate innovative technologies and practices—including clinical practice guidelines—into prevention, diagnosis, treatment, and rehabilitation, including provision for medical care during catastrophic events and their sequelae; be uniform across the international space community and cooperatively developed with the international space community; and receive external oversight and guidance from prominent experts in clinical medicine. RESEARCH The goal of NASA-sponsored health care research is, first, to learn how

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Safe Passage: Astronaut Care for Exploration Missions Studying the bioavailability and pharmacological function of exogenous hormone therapy during space travel and, as new medical therapies for gynecological surgical conditions evolve, testing these therapies for use during space travel. Performing clinical studies on anemia, immunity, wound infection, and wound healing as part of every space mission. Developing methods for the identification and management of mood disorders and suicidal or homicidal ideation and developing protocols for the management of violent behavior, including crisis intervention, pharmacological restraint, and physical restraint. Establishing a coordinated clinical research program that addresses the issues of neurological safety and care for the astronauts during long-duration missions beyond Earth orbit. Developing a resource-based medical triage system that contains guidelines for the management of individual and multiple casualties during space travel. Developing an anesthetic approach associated with rapid and comfortable recovery using anesthetic drugs with short durations of action or for which there are antagonists. Creating guidelines for withdrawal of care in space and for dealing with the death of a crewmember from physiological and behavioral points of view. Developing a mechanism for skill maintenance and retraining in psychomotor skills during long-duration space missions. Recording routine surveillance of health status measures, incidents of illnesses and injuries, and their treatments in a database with standardized rates of occurrence so that data between studies and missions can be compared. Developing and maintaining a centralized catalogue of all written materials related to space and analog-environment biomedical research and experience according to current medical informatics standards. to send and keep humans safely in space and have them return to Earth in good health. In Chapter 7 of this report, the committee recommends a comprehensive health care system that will enable the collection of all relevant clinical information. Such clinical information—the results of natural experiments that reveal common physiological responses to the microgravity environment—may be thought of as epidemiological data. The results of targeted and planned experimentation provide a second element of the health care research plan, broadly construed. Chapter 2 reviews what is known from both epidemiological and targeted research and suggests opportunities for further research. The principle underlying a health care research strategy is that it have a steadfast, prospective, and methodologically sound approach to the collection of data. Although some work on assessing the efficacies of countermeasures has been done, none has been shown to be effective in reducing the most significant effects of microgravity (bone mineral density loss, muscle

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Safe Passage: Astronaut Care for Exploration Missions loss, and neurovestibular maladaptation). Although artificial and analog environments on Earth have been useful in predicting certain effects of microgravity and isolation on humans, there is no substitute for the microgravity environment for clinical research. The ISS represents the single most important test bed for that research. Both the intramural and extramural research programs of NASA, especially the research conducted through the National Space Biomedical Research Institute, are mechanisms for addressing two principal issues: the relative paucity of relevant clinical data and the heretofore relatively closed clinical research environment that has characterized NASA. NASA should have a process that opens its research awards and requests for proposals to the widest audience, and NASA should foster substantial investigator-initiated research. A far more basic understanding of fundamental processes is needed, however; and investigator-initiated research in broad areas is an appropriate strategy for the development of such an understanding. Whatever the organizational approach, the outcome should be an infrastructure that will (1) test hypotheses about the risks to humans during long-duration travel beyond low Earth orbit, (2) test the efficacies of treatments or countermeasures in reducing or eliminating the defined risks, and (3) evaluate the long-term sequelae of space travel on humans. Conclusion 3 NASA has devoted insufficient resources to developing and assessing the fundamental clinical information necessary for the safety of humans on long-duration missions beyond Earth orbit. Although humans have flown in space for nearly four decades, a paucity of useful clinical data have been collected and analyzed. The reasons for this include inadequate funding; competing mission priorities; and insufficient attention to research, analysis including insufficient investigator access to data and biological samples, and the scientific method. Although NASA’s current approach to addressing health issues through the use of engineering design and countermeasures has been successful for short-duration missions, deep space is a unique environment that requires a different approach. A major problem of space medicine research is the small number of astronaut research participants, which requires special design and analysis of the data from clinical trials with small numbers of participants. This necessitates a strategy focused on maximization of opportunities for learning.

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Safe Passage: Astronaut Care for Exploration Missions Recommendation 3 NASA should develop a strategic health care research plan designed to increase the knowledge base about the risks to humans and their physiological and psychological adaptations to long-duration space travel; the pathophysiology of changes associated with environmental forces and disease processes in space; prediction, development, and validation of preventive, diagnostic, therapeutic, and rehabilitative measures for pathophysiological changes including those that are associated with aging; and the care of astronauts during space missions. The strategic research plan should be systematic, prospective, comprehensive, periodically reviewed and revised, and transparent to the astronauts, the research community, and the public. It should focus on providing an understanding of basic pathophysiological mechanisms by a systems approach; using the International Space Station as the primary test bed for fundamental and human-based biological and behavioral research; using more extensively analog environments that already exist and that have yet to be developed; using the research strengths of the federal government, universities, and industry, including pharmaceutical, bioengineering, medical device, and biotechnology firms; and developing the health care system for astronauts as a research database. BEHAVIORAL HEALTH The prototype for a long-duration mission beyond Earth orbit is an interplanetary mission, with Mars as the likely destination. Such a voyage of discovery and return will take nearly 3 years. The crew is likely to be multicultural, international, and of both sexes. They will spend all their time together in a very confined space. The habitability of the spacecraft will be compromised by the need to carry all necessary equipment and nourishment (even if it is replenishable), at least for the voyage to Mars (if supplies have already been stockpiled there), if not for the entire 3 years. Realtime communication with Earth will be impossible, as at the farthest distance from Earth, radio messages and messages transmitted by even more advanced means will take 20 minutes to reach their destination. Finally, the success of the mission and the lives of the astronauts may depend on every

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Safe Passage: Astronaut Care for Exploration Missions member of the crew functioning appropriately, both physically and emotionally. Maintaining a healthy behavioral condition, that is, behavioral health, in such an extreme, isolated microenvironment is, in the committee’s view, critical to the success of the mission and to the return to Earth of normally functioning human beings. Understanding the behavior of individuals in such environments and understanding the interactions of members of a team in prolonged isolation are necessary prerequisites to preventing disruptive behaviors and to dealing with them adequately should they occur. Crew selection and training are also key in the process, but much remains unknown (Box 3). NASA has taken steps in two areas of importance: it has learned from the experiences of others on missions in analog environments such as operations on research stations in Antarctica, prolonged submarine missions, and deep diving operations; and it has learned about the nature of teams and the interaction of their members. The distinction between missions in low Earth orbit and long-duration missions beyond Earth orbit is that in the latter there is no means of timely return, and all problems, including disruptive behaviors and negative crew interactions, must be dealt with within the spacecraft by the crew. Historically, crew selection has been an opaque process, in terms both of the individuals selected and of the composition of the crew. Both crew selection and crew composition will assume far greater importance, as the compatibility of individuals has the potential of preventing, to a degree, significant disruptive behaviors. Crew training in positive interactions and conflict resolution, as well as in dealing with adverse behavioral events, will be necessary. Conclusion 4 Behavioral health and performance effectiveness present major challenges to the success of missions that involve quantum increases in the time and the distance traveled beyond Earth orbit. The available evidence-based spaceflight data are insufficient to make an objective evaluation or projection regarding the behavioral health issues that are likely to arise. The analysis of the complex individual and group habitability interactions that critically influence behavioral health and performance

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Safe Passage: Astronaut Care for Exploration Missions effectiveness in the course of long-duration missions remains to be planned and undertaken. There is a need for more information about support delivery systems at the interface between ground-based and space-dwelling groups. In the absence of a valid and reliable analysis of the existing database, it is not possible to determine whether the current procedures will be adequate for the screening and selection of candidates for long-duration missions. Although the data from natural analog environments, including simulation studies, may be helpful, there remains a need to accumulate knowledge based on observations from systematic research in both natural and simulated extreme terrestrial environments and venues like the International Space Station. Recommendation 4 NASA should give priority to increasing the knowledge base of the effects of living conditions and behavioral interactions on the health and performance of individuals and groups involved in long-duration missions beyond Earth orbit. Attention should focus on understanding group interactions in extreme, confined, and isolated microenvironments; understanding the roles of sex, ethnicity, culture, and other human factors on performance; understanding potentially disruptive behaviors; developing means of behavior monitoring and interventions; developing evidence-based criteria for reliable means of crew selection and training and for the management of harmonious and productive crew interactions; and training of both space-dwelling and ground-based support groups specifically selected for involvement in operations beyond Earth orbit. DATA COLLECTION AND ACCESS Because of the high degree of risk of long-duration space missions and the relatively few data available, the need for the collection and analysis of all relevant data is a message that appears throughout this report. Currently, NASA distinguishes between astronaut health-related data, which are medical data and which are considered private, and supplemental data (mission-based data and responses to space travel) and integrated test regimen data

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Safe Passage: Astronaut Care for Exploration Missions BOX 3 Behavioral Health and Performance Research and Development Opportunities Astronaut Performance, General Living Conditions, and Group Interactions Enhancing the evidence base on the organization of general living conditions and performance requirements for small groups of humans in isolated and confined microsocieties over extended time intervals and developing an evidence-based approach to the management of harmonious and productive, small, multinational groups whose members will have to function effectively in isolated, confined, and hazardous environments. Coordinating the development of design engineering and habitability requirements on the one hand and evidence-based behavioral health imperatives on the other. Identifying and analyzing those features of small social systems that foster the effectiveness of groups functioning semiautonomously over extended periods of time. Analyzing potentially disruptive group influences that adversely affect harmonious and productive performance interactions under the isolated, confined, and hazardous conditions that characterize long-duration space missions beyond Earth orbit. Support and Recovery Systems Developing a technology that will provide an adequate means for assessment of the behavioral health effects of long-duration space missions and that will establish and maintain safe and productive human performance in isolated, confined, and hazardous environments and developing an evidence-based approach to the establishment and maintenance of a system for the delivery of behavioral health support and to the analysis of those internal and external factors that influence the effectiveness of the system. Evaluating and enhancing communication with family, friends, and other ground personnel and onboard recreational activities as means of providing behavioral health support for long-duration missions. Evaluating the validity and reliability of performance-monitoring procedures including the Crew Status and Support Tracker, the Windows Space Flight Cognitive Assessment Tool, and the Space Behavioral Assessment Tool and the extent to which methodologies for intromission performance monitoring are enhanced by online downlink capabilities in studies conducted during long-duration missions. Developing and refining procedures for effective intervention under conditions of potentially disruptive personal interactions both among astronauts and between astronauts and Earth-bound support components and for evaluation of the nature and extent of changes in group interaction patterns.

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Safe Passage: Astronaut Care for Exploration Missions Evaluating the effects of ground-based support system design factors including backup components and personnel changes on group integration and stability as they affect personal coaching and technical support functions. Developing and assessing countermeasure interventions that meet the challenges presented by emergencies and technical assistance requirements under conditions with complexities related to cultural and language differences as well as under conditions that involve crews of mixed sexes. Screening, Selection, and Training Systematically analyzing and evaluating the extensive existing database on the methods and procedures for screening and selection of astronauts used over the past several decades. Evaluating personality measures in the development of valid and reliable procedures for the screening and selection of astronauts and determining the extent to which intelligence and aptitude measures may predict performance more accurately than the more commonly applied personality measures. Developing and evaluating screening and selection procedures that validly and reliably discriminate effective group interaction skills and competences. Developing and refining training technologies including automated training for the preparation of multinational space-dwelling microsocieties as well as their Earth-bound support groups including those related to the interactions of individuals and small groups in the context of distributed ground-based and space-dwelling performance sites. Data Collection, Analysis, and Monitoring Incorporating and enhancing relevant behavioral health factors as an effective contribution to a more comprehensive plan for the collection and management of astronaut health care data. Developing and testing valid and reliable individualized monitoring and assessment procedures to enhance intrapersonal self-management. Refining communication-monitoring techniques and countermeasure interventions for interactions within and between ground-based and space-dwelling groups. Developing and refining technological approaches to the assessment of individual and group behavioral integrity as well as the efficacies of countermeasure evaluations during long-duration space missions. Establishing a systematic approach to the collection and analysis of postmission (recovery), debriefing, and longitudinal follow-up astronaut health data, including data on behavioral health and performance components. Planning and undertaking a systematic collation and relational analysis of the existing archives of astronaut evaluation data to develop an evidence-based approach to valid and reliable means of screening and selection of candidates for long-duration missions beyond Earth orbit.

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Safe Passage: Astronaut Care for Exploration Missions (research data from studies with astronauts as participants), which are available for analysis, although they are nonattributable. The reality is that the astronaut is, in most cases, the only individual from whom clinical information relevant to space travel can be collected. Therefore, reliance on the voluntary participation of astronauts in clinical research to the same extent as reliance on volunteer participants on the ground may not be appropriate. This is especially true when the information gained is potentially critical to the lives and well-beings of both the individual astronaut and the astronaut corps. The crux of the issue is this: is the astronaut the same as any other volunteer participant of human experimentation, or is he or she de facto an experimental participant? More importantly, is there a middle ground, one that ensures the collection of all relevant data while protecting the individual from the inappropriate release of private information? Conclusion 5 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 5 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.

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Safe Passage: Astronaut Care for Exploration Missions 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. ENGINEERING AND BIOLOGY The preceding section and Chapter 6 of this report outline a conceptual shift in terms of the collection and analysis of astronaut health data using an occupational health model. A second shift is the movement of engineering and biology toward each other. The approaches to problem solving that NASA historically applied to engineering design and machinery may not be appropriate when they are applied to human anatomy and physiology. In engineering terms, NASA identifies risk and then develops countermeasures. The development of a specific countermeasure may be addressed by a task order to a contractor. In biological terms, however, the degree of risk varies because of biodiversity. What this implies practically is that the task order approach, likely appropriate as a solution to a technological problem, may be insufficient as a solution to a biological problem; a broader approach, one that develops a deeper understanding of the nature and causes of risk and the diversity of the responses, may be necessary. This broader approach is reflected in the committee’s recommendation for a strategic health care research plan for astronauts. NASA originated because of an engineering need, and its most remarkable successes have been technological. Indeed, the committee heard in its discussions with astronauts that even the most biologically oriented of astronauts, the physician-astronauts, frequently identify themselves first as astronauts and then as physicians. A conceptual shift from engineering to biology, however, must take into account the fact that people are not machines. Such a shift must also take into account the fact that the habitat and environment that may be appropriate for machines on long-duration missions or

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Safe Passage: Astronaut Care for Exploration Missions even for humans on short-duration missions may be inappropriate or even detrimental to the productivity and well-being of humans on long-duration missions into deep space. Conclusion 6 Exploratory missions with humans involve a high degree of humanmachine interaction. The human factor will become more important as the durations of missions into deep space with humans increase and as the spacecraft crew functions more autonomously, adapts to unexpected situations, and makes real-time decisions. NASA, because of its mission and history, has tended to be an insular organization dominated by traditional engineering, because of the engineering problems associated with early space endeavors, the historical approach to solving problems has been that of engineering. Long-duration space travel will require a different approach, one requiring wider participation of those with expertise in divergent, emerging, and evolving fields. NASA has only recently begun to recognize this insufficiency and to reach out to communities, both domestic and international, to gain expertise on how to remedy it. Engineering and biology are increasingly integrated at NASA, and this integration will be of benefit to the flexibility and control of long-duration missions into deep space. NASA’s structure does not, however, easily support the rapidly advancing integration of engineering and biology that is occurring throughout the engineering world outside NASA. NASA does not have a single entity that has authority over all aspects of astronaut health, health care, habitability, and safety that could facilitate the integration of astronaut health and health care with engineering. The human being must be integrated into the space mission in the same way in which all other aspects of the mission are integrated. A comprehensive organizational and functional strategy is needed to coordinate engineering and human needs. Recommendation 6 NASA should accelerate integration of its engineering and health sciences cultures. Human habitability should become a priority in the engineering aspects of the space mission, including the design of spacecraft. Investigators in engineering and biology should continue to ex-

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Safe Passage: Astronaut Care for Exploration Missions plore together and embrace emerging technologies that incorporate appropriate advances in biotechnology, nanotechnology, spaceworthy medical devices, “smart” systems, medical informatics, information technology, and other areas to provide a safe and healthy environment for the space crew. More partnerships in this area of integration of engineering and health sciences should be made with industry, academic institutions, and agencies of the federal government. ORGANIZATION Throughout this report the committee expresses concern over the lack of existing data and the lack of analyses of data on which decisions about the health and safety of astronauts on long-duration missions beyond Earth orbit can be based. For that reason, the committee recommends two basic mechanisms for retrieval of the necessary information: (1) a health care system for astronauts that will allow the collection and analysis of epidemiological data and (2) a strategic health care research plan that will promote the development of a fuller understanding of the risks of space travel to human health. The committee further recommends that NASA consider a different model—that of occupational health—for use in its approach to data collection. Implementation of these conceptual and practical recommendations will require a different structure within NASA. An approach to planning the organizational and administrative structures needed to ensure astronaut health is presented in Chapter 7. Conclusion 7 The challenges to humans who venture beyond Earth orbit are complex because of both the unique environment that deep space represents and the unsolved engineering and human health problems related to long-duration missions in deep space. The committee believes that the organizational structure of NASA may not be appropriate to successfully meet the challenge of ensuring the health and safety of humans on long-duration missions beyond Earth orbit. Astronaut health and performance will be central to the success of long-duration space missions, but the responsibility for astronaut health and performance is buried deep within NASA. Within NASA the focus on health care research and astronaut health care is not sufficient, nor does NASA sufficiently coordinate and

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Safe Passage: Astronaut Care for Exploration Missions integrate the research activities needed to support successful long-duration missions beyond Earth orbit. Recommendation 7 NASA should establish an organizational component headed by an official who has authority over and accountability for all aspects of astronaut health, including appropriate policy-making, operational and budgetary authority. The organizational component should be located at an appropriate place and level in the NASA organizational structure so that it can exercise the necessary authority and responsibility. The official who heads the organizational component should be assisted by officials who are separately responsible for astronaut clinical care and health care research. The proposed organizational component should have authority over basic, translational, and clinical biomedical and behavioral health research; foster coordination between NASA and the external research community; and be overseen by an external advisory group, modeled on advisory groups of the National Institutes of Health and other federal external advisory groups, to provide program review, strategic planning, and leverage to assist NASA in meeting its goals for astronaut health.

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Safe Passage: Astronaut Care for Exploration Missions BOX 4 The Key Elements in the Committee’s Recommendations Managing and Communicating Risks to Astronaut Health Recommendation 1. NASA should give increased priority to understanding, mitigating, and communicating to the public the health risks of long-duration missions beyond Earth orbit. Comprehensive Astronaut Health Care System Recommendation 2. NASA should develop a comprehensive health care system for astronauts for the purpose of collecting and analyzing data while providing the full continuum of health care to ensure astronaut health. Strategic Health Care Research Plan Recommendation 3. NASA should develop a strategic health care research plan designed to increase the knowledge base about the risks to astronaut health. Understanding Behavioral, Social and Cultural Issues and Challenges Recommendation 4. NASA should give priority to increasing the knowledge base of the effects of living conditions and behavioral interactions on the health and performance of astronauts on long-duration space missions. Astronaut Health and Safety Data Collection and Access Recommendation 5. 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. Integration of Engineering and Health Sciences Recommendation 6. NASA should accelerate integration of its engineering and health sciences cultures. Authority and Accountability for Astronaut Health Recommendation 7. NASA should establish an organizational component headed by an official who has authority over and accountability for all aspects of astronaut health, including appropriate policy-making, operational, and budgetary authority.