2
Programmatic Issues

NASA faces numerous challenges in carrying out the aspirations of the United States to advance its space exploration mission. Over its 50-year history, NASA progress in space exploration has depended on the ability to address a wide range of biomedical, engineering, physical science, and other challenges. The partnership of NASA with the research community reflects the original mandate from Congress in 1958 to promote science and technology, which requires an active and vibrant research program. This level of programmatic vision and dedication to scientific excellence is no less important today as NASA prepares to tackle the considerable hurdles that must be surmounted before the goal of long-duration human exploration missions in space can be realized. As has always been the case, achievement of these goals will depend on a steady stream of results from high-quality research. However, more than ever before, it will be necessary for NASA to embrace life and physical sciences research as part of its core exploration mission, and to develop an energized community of life and physical scientists and engineers with a strong focus on both exploration-enabling research and scientific discovery (i.e., fundamental research enabled by space exploration). Importantly, life and physical sciences research needs to be viewed as essential to the NASA exploration mission and to be given correspondingly appropriate recognition in the organization.

The scientific community engaged in space exploration research has dwindled as a result of marked reductions in budget funding levels, from approximately $500 million shared equally between life and physical sciences in 2002 to the current level of about $180 million, and the concomitant reduction in the ISS research portfolio, from 966 investigations in 2002 to 285 in 2008.1 Considerable effort will be required to overcome current obstacles and restore the life and physical sciences research program to a committed, comprehensive, and highly visible organizational resource that effectively promotes research to meet the national space exploration agenda. This goal can be best achieved with a portfolio that supports both intra- and extramural programs (i.e., similar to the NIH support of intra- and extramural research), including a program of ground-based research. To advance an appropriate program of basic and translational research, the most scientifically meritorious and programmatically relevant research should be identified and promoted. It is a generally accepted principle that a rigorous and transparent peer review process is an important means of identifying meritorious scientific research. In addition, agency-specific programmatic needs will have to be taken into account in maintaining a high-quality research portfolio. A successful and transparent review system would be based on scientific merit, as judged by peer review, and programmatic relevance, as determined by internal review, and would result in the assembly of a research portfolio that continuously generates new ideas and translates them to new missions.

The development of integrated multidisciplinary team science, both within and across the life and physical science communities, will likely become important to the delivery of science to close knowledge gaps, reduce costs and risks, and enable new missions. Overall, an organizational focus on the research mission, an appropriate research solicitation and review process, a strong outreach to the larger research community, and a strategy to develop a new generation of scientists and engineers that will enhance the future workforce represent important mechanisms to meet NASA goals. These issues are discussed in more detail in the following sections.

1

David L. Tomko, “History of Life and Physical Sciences Research Programs at NASA,” presentation to the Committee for the Decadal Survey on Biological and Physical Sciences in Space, Washington, D.C., May 6, 2008.



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2 Programmatic Issues NASA faces numerous challenges in carrying out the aspirations of the United States to advance its space exploration mission. Over its 50-year history, NASA progress in space exploration has depended on the ability to address a wide range of biomedical, engineering, physical science, and other challenges. The partnership of NASA with the research community reflects the original mandate from Congress in 1958 to promote science and technology, which requires an active and vibrant research program. This level of programmatic vision and dedication to scientific excellence is no less important today as NASA prepares to tackle the considerable hurdles that must be surmounted before the goal of long-duration human exploration missions in space can be realized. As has always been the case, achievement of these goals will depend on a steady stream of results from high-quality research. However, more than ever before, it will be necessary for NASA to embrace life and physical sciences research as part of its core exploration mission, and to develop an energized community of life and physical scientists and engineers with a strong focus on both exploration-enabling research and scientific discovery (i.e., fundamental research enabled by space exploration). Importantly, life and physical sciences research needs to be viewed as essential to the NASA exploration mission and to be given correspondingly appropriate recognition in the organization. The scientific community engaged in space exploration research has dwindled as a result of marked reductions in budget funding levels, from approximately $500 million shared equally between life and physical sciences in 2002 to the current level of about $180 million, and the concomitant reduction in the ISS research portfolio, from 966 investigations in 2002 to 285 in 2008.1 Considerable effort will be required to overcome current obstacles and restore the life and physical sciences research program to a committed, comprehensive, and highly visible organizational resource that effectively promotes research to meet the national space exploration agenda. This goal can be best achieved with a portfolio that supports both intra- and extramural programs (i.e., similar to the NIH support of intra- and extramural research), including a program of ground-based research. To advance an appropriate program of basic and translational research, the most scientifically meritorious and programmatically relevant research should be identified and promoted. It is a generally accepted principle that a rigorous and transparent peer review process is an important means of identifying meritorious scientific research. In addition, agency-specific programmatic needs will have to be taken into account in maintaining a high-quality research portfolio. A successful and transparent review system would be based on scientific merit, as judged by peer review, and programmatic relevance, as determined by internal review, and would result in the assembly of a research portfolio that continuously generates new ideas and translates them to new missions. The development of integrated multidisciplinary team science, both within and across the life and physical science communities, will likely become important to the delivery of science to close knowledge gaps, reduce costs and risks, and enable new missions. Overall, an organizational focus on the research mission, an appropriate research solicitation and review process, a strong outreach to the larger research community, and a strategy to develop a new generation of scientists and engineers that will enhance the future workforce represent important mechanisms to meet NASA goals. These issues are discussed in more detail in the following sections. 1 David L. Tomko, “History of Life and Physical Sciences Research Programs at NASA,” presentation to the Committee for the Decadal Survey on Biological and Physical Sciences in Space, Washington, D.C., May 6, 2008. 8

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PROGRAMMATIC ISSUES FOR STRENGTHENING THE RESEARCH ENTERPRISE Elevating the Priority of Life and Physical Sciences Research in Space Exploration When NASA was established by Congress in 1958, its critical roles as both the driver and the beneficiary of future U.S. scientific and technological advances were widely recognized. It is noteworthy that the enabling of scientific inquiry by space exploration was a critical issue during the inception of the agency and, half a century later, the promotion of scientific and technological advancement endures as a key imperative for NASA. Scientific advances go to the core of the NASA mission because they enable future space exploration. As the nation and NASA prepare for the next decade of space exploration, numerous challenges must be met to ensure successful outcomes. Among these are the developments needed to buy down risks and costs, an effort that will depend on a deeper understanding of the performance of people, materials, microbes and plant life, and physical systems in the environments of space. To meet these challenges, which span the life and physical sciences, it is essential to develop a long-term, strategic research plan firmly anchored in a broad research community. For such a plan to become a reality, research must be central to NASA’s exploration mission and be embraced throughout the agency as an essential tool to achieve future space exploration goals. Feedback received by the committee from numerous interviews, town hall meetings, and white paper submissions associated with this decadal survey indicated that a very large proportion of the research community does not see such an environment currently within the exploration programs at NASA, at least with regard to the life and physical sciences. NASA has faced a number of challenges in fulfilling the original objectives identified by Congress. It has been a challenge from the outset to organize and manage the life and physical sciences research program within the overall NASA administrative infrastructure. Some of the organizational challenges have included the ability to select and prioritize the most meritorious research projects, the provision of adequate and sustained support for such research projects, the ability to draw on a community of scientists with the necessary skills and experience to conduct these studies, and the ability and will to create a new generation of scientists and engineers focused on research questions relevant for space exploration missions. To meet these challenges, it is of paramount importance that the life and physical sciences research portfolio supported by NASA, both extramurally and intramurally, receive appropriate attention and that the organizational structure be optimally designed to meet NASA’s needs. The utility of a coherent research plan that provides appropriate resources and is consistently applied to enable exploration cannot be overemphasized. This is especially the case given the frequent and lengthy postponements that NASA’s exploration-related goals have experienced over the past several decades. The NASA exploration research enterprise will be improved only if it is emphasized throughout the organizational structure of NASA. Because the agency prioritized goals for building flight infrastructure for the Constellation Project at the expense of maintaining a vigorous life and physical sciences research program, this important research program has been relegated to a very-low-priority status with many areas virtually eliminated. Since retirement of the Spacelab (in 1997) and the completion of the International Neurolab project (mission conducted in 1998)⎯in which many sophisticated experiments took place in the context of dedicated research missions implemented by a highly trained and intellectually engaged crew⎯the priority for research has been reduced to levels that compromise not only the research endeavor but also the likelihood of success in future exploration missions. The view of research as optional, rather than essential, is reflected in the attitudes of flight and ground personnel toward crew participation in research projects and appears to be driven by NASA’s overall expectations and its reward system for flight missions. Currently, astronauts can opt out of their participation in approved and manifested research projects, in terms of both serving as a subject in and acting as a surrogate investigator for a research project. Mission managers, who often have no research background and are not given incentives to place a priority on research, have the authority to control crew availability and make decisions about crew scheduling that can compromise research studies and outcomes, even when acceptable alternatives to these competing activities are available. 9

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To address these systemic problems and improve the results of NASA’s life and physical sciences research program over the next decade, the following issues are viewed by the committee as important: • Recognition that a change of attitude and commitment toward the need for life and physical sciences research is essential. To ensure that life and physical sciences research is recognized as central to NASA’s space exploration mission, research itself needs to be viewed as a priority. However, an emphasis on research is often not evident in day-to-day decisions. It is essential that every employee, from management through crew, subscribe to the view that a key objective of the organization is to support and conduct life and physical sciences research as an essential translational step in the execution of space exploration missions. • Acknowledgment of life and physical sciences research as an integral component of spaceflight operations. For research to become a central component of exploration programs, it is necessary to develop a culture in which participation in research, both as a subject of investigation and as a surrogate investigator, is viewed as a fundamental element of the astronaut mission. Many crew members already display this attitude, and they frequently go to extraordinary lengths to participate in research studies in partnership with the extramural research community. However, the level of autonomy astronauts have in choosing whether or not to participate in research is surprising, given the need to capitalize on the very scarce opportunities for human research in space. In addition, many types of experiments require individuals with specialized scientific or technical expertise to make knowledgeable observations, measurements, and judgments. It is important to optimize very scarce opportunities to gain a better understanding of the effects of the space environment on human health, safety, and performance because such information will define the future limits of space exploration. One possible solution is to include scientific and technical expertise, and willingness to participate in research, as part of the criteria for crew selection in the planning of specific mission assignments, and perhaps even as part of the astronaut selection process. It is also important that the high priority of research be reinforced during the training provided to ground support personnel (e.g., flight directors, mission controllers, training managers, and instructors). This approach would require careful thought as to its precise implementation because it must also take into account concerns about such issues as coercion and privacy rights. However, it seems reasonable and ethical that, if research participation is defined as part of a mission’s task, then the consequence of choosing not to participate would be understood as leading to assignment of a different type of job. This approach would remain aligned with the Federal Policy for the Protection of Human Subjects.2 Because the NASA exploration mission is of national importance, research opportunities to advance this agenda become part of strategic decisions. This philosophy is consistent with that embodied in the National Aeronautics and Space Act of 19583 and in the reports Safe Passage4 and A Strategy for Research in Space Biology and Medicine in the New Century.5 Establishing a Stable and Sufficient Funding Base A renewed funding base for fundamental and applied life and physical sciences research is essential for attracting the scientific community that is needed to meet prioritized research objectives. Scientists must have a reasonable level of confidence in the sustainability of research funding if they are to be expected to focus their laboratories, staff, and students on research relevant to space exploration. Given the time frame required for completion of the types and scales of experiments necessary for space exploration, grant funding mechanisms would have to cover multiple years, with contingencies for delays 2 See http://www.hhs.gov/ohrp/policy/common.html. 3 National Aeronautics and Space Act of 1958. 4 Institute of Medicine, Safe Passage: Astronaut Care for Exploration Missions, National Academy Press, Washington, D.C., 2001. 5 National Research Council, A Strategy for Research in Space Biology and Medicine in the New Century, National Academy Press, Washington, D.C., 1998. 10

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in flight experiments. A stable research funding level is essential for reinvigorating the scientific community that will not only carry out the research to enable future space exploration, but also advance scientific discoveries that are enabled by space exploration and educate future generations of space scientists. As discussed above, a healthy space exploration research program would support both intramural and extramural research, including a highly developed ground-based research program to inform and complement space-based research. An intramural program is essential to ensure that there are timely and ongoing research efforts focused on barriers that currently limit space exploration. An extramural program increases the intellectual wealth and breadth of innovative crosscutting ideas to stimulate advances in both space exploration capabilities and fundamental scientific discoveries. A robust and sustained extramural research program also ensures that there will be a stable community of scientists prepared to lead future space exploration research. Life and physical sciences research for space exploration can potentially be supported by many federal agencies, but, to date, efforts to align and coordinate research programs between such agencies have been relatively limited. This may be due, in part, to the different missions of the respective agencies. However, there is a growing need to achieve synergies in multiagency efforts (as discussed below). An increased coordination among agencies would be expected to harness and leverage existing resources. Possible mechanisms for encouraging interagency collaborations include: • Dedicated interagency funds for technology development or research in the space environment that serves a dual use, both for NASA and for another agency, • Interagency strategic resource planning, • Use of a similar review process, • Continued use of interagency workshops and symposia, • Interagency dual-use technology pilot grant programs, and • Interagency, interdisciplinary training programs involving mentors. The success of interagency initiatives will depend on support for such initiatives across the agencies, creation of a spirit of collaboration, and development of new partnerships leading to novel research teams. A comprehensive interagency team effort will serve as a creative scientific resource for implementation of a comprehensive space exploration research program. Improving the Process for Solicitation and Review of High-Quality Research Scientists who plan to compete for major research grants typically conduct preliminary studies years in advance of submitting a grant application. Thus, familiarity with the research solicitation process is critical for researchers to sustain activities in their laboratories that enable them to prepare proposals for high-quality research. A regular frequency of solicitations, ideally with multiple solicitations per year, would serve to maintain a community of investigators focused on life and physical science research areas relevant to the agency, thereby creating a research network. This approach is used successfully by major granting agencies, including the NIH and NSF. It is an important goal for any funding agency to ensure that supported research projects are aligned with agency needs. To meet NASA’s future space exploration goals, complex scientific and engineering problems need to be tackled. Many of these problems will require team-based solutions bridging multiple scientific domains. Accordingly, research solicitations will need to target both individual principal-investigator-driven and team-driven research. Further, solicitations would need to include both broad research announcements in order to encourage highly innovative research grant applications, and targeted research announcements to ensure that high-priority mission-oriented goals are met. This multifaceted solicitation approach would be expected to attract cutting-edge life and physical sciences research that both enables and is enabled by space exploration. 11

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Beyond the mission of any single funding agency, a coordinated interagency collaboration is likely to significantly enhance the opportunities for progress in research areas critical to space exploration. However, success from such an interaction will depend on the degree to which the collaboration is embraced by all stakeholders and seen as important to the mission of the specific agency. It is important to direct special attention to flight hardware development for a particular experiment, where such costs may not be embraced by the funding agencies. It is promising that there are model collaborations from existing interdisciplinary programs in place, such as the NIH Clinical and Translational Science Award (CTSA) program, Ecology of Infectious Diseases (NSF and NIH), National Plant Genome Initiative (NSF, NIH, USDA, DOE, USAID, OSTP, and OMB), and the UK Engineering and Physical Sciences Research Program. An advantage of interdisciplinary programs is a shared contribution of several agencies to the amount of funding needed for ambitious and expensive projects that likely will be necessary to enable space missions. It would be valuable to strengthen and sustain the historical collaborations of NASA with agencies such as the NIH, as well as to expand them to other agencies such as the DOE and DOD. These collaborations can build on such efforts as the Memorandum of Understanding between the National Institutes of Health and the National Aeronautics and Space Administration for Cooperation in Space-Related Health Research, which went into effect in September 2007.6 This memorandum of understanding established a framework of cooperation between the NIH and NASA to encourage (1) communication and interaction between the NIH and NASA research communities to facilitate space-related research and to integrate results from that research into an improved understanding of human physiology and human health; (2) the exchange of ideas, information, and data arising from their respective research efforts; (3) the development of biomedical research approaches and clinical technologies for use on Earth and in space; and (4) research in Earth- and space- based facilities that could improve human health on Earth and in space. The research community that deals with life and physical sciences in space has remained quite robust internationally, even as NASA has reduced its support in this area. Investigations in Japan, Europe, and Russia have continued, with new results being published continuously. To regain a place as a member of the global scientific team in life and physical sciences in space, there is a need for the United States to increase international scientific activities, through interactions with such organizations as, but not limited to, the International Space Station Life Sciences Working Group (ISSLSWG). Such cooperation worked well in the decades before 2000 and will undoubtedly reduce costs to NASA. New partnerships, such as with India, Australia, and China, are possible. Strong interactions with groups such as ISSLSWG and the offering of joint research announcements with international partner agencies will aid discovery and internationalize space life sciences, offering opportunities for collaboration in ground-based studies prior to flight experiments. The United States has enjoyed a leadership position in space exploration due to its long and successful history of space missions. However, during the coming decade, it is likely that significant efforts in this area will be initiated by other nations. Because there are unresolved problems in ensuring safe and successful long-duration missions that affect all nations attempting human spaceflight, a convergence of efforts would likely be of universal benefit. Similar steps as discussed above regarding interagency collaboration within the United States seem logical to explore in support of international scientific projects designed to resolve issues relevant to technological challenges and astronaut health and welfare. The process of peer review is firmly established as a mechanism for identifying the most meritorious research in any scientific area. The concept is universally embraced by the global research community and viewed as a guarantor for a transparent, fair, and equitable process that results in significant scientific progress. For both life science and physical scientists, the peer review process utilized by many federal agencies is well known, and the research community as a whole has significant experience in navigating such processes. In addition, many researchers serve on peer review panels in a volunteer capacity and see these efforts as a vitally important societal responsibility and a demonstration 6 See http://nihrecord.od.nih.gov/newsletters/2007/10_19_2007/story1.htm. 12

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of the inclusion of the broad scientific community in meeting the goals of the sponsoring agency. In this context, the legitimacy of the peer review process is highly dependent on the adoption of panel or study- section recommendations by the respective funding agencies, and lack of adherence to recommendations raises the risk of alienating the research community. It is the committee’s belief that NASA has a well- designed peer review system for the evaluation of extramural research applications. However, it is also the strong opinion of the committee that the standards for the “non-advocate review” of intramural research could be elevated by ensuring that the review process, including the actions taken by NASA as a result of review recommendations, is more transparent with a clear rationale for prioritizing both intra- and extramural investigations. Past NRC reports have noted that spaceflight opportunities should unconditionally give maximal access to peer-reviewed experiments that have a strong basis in ground tests and spaceflight performance verifications.7 Given the severe limitations of actual spaceflight access, it is important that spaceflights do not carry science that has not been deemed of high merit by peer review and prioritized by NASA or formal NASA science partnerships. As part of this effort, it is also important that NASA coordinate agency assets, commercial payload developers, and flight systems developers in a manner that serves the best science and reduces the end-to-end time for flight experiments. Rejuvenating a Strong Pipeline of Intellectual Capital Through Training and Mentoring Programs Realizing the growing challenge of the need to rapidly translate basic findings to applications, the biomedical research enterprise in the United States has reorganized to expand the emphasis on education and training programs for target audiences, ranging from practitioners to researchers to students, as one way to expedite the translation of discoveries to practice. One successful vehicle for these efforts, for example, is the recently launched, NIH-funded Clinical and Translational Science Award (CTSA). An ancillary goal of these programs is to increase the number and quality of collaborations among practitioners, scientists, patients, and administrators. The NIH model of expanded research education offers clues as to how NASA could design unique educational programs that improve translation of the research in the life and physical sciences by including some or all of the following elements: • A curriculum-based program for flight surgeons and physician-astronauts to expand their research knowledge and skill set. Such programs are comparable to the NIH team-based K30 awards (clinical research curriculum awards). • Mentored research training of junior faculty in biomedical sciences, similar to the NIH K (career development) awards. An essential element of these programs is their demand that a majority of a trainee’s time be protected for instruction and research. When such expectations are not feasible or practical, CTSAs often provide continuing and professional education in specific areas of research. • Career enhancement awards for junior faculty in nonmedical life sciences, physical sciences, and engineering. In the physical sciences and engineering, and in many nonmedically related disciplines in the life sciences, junior faculty are expected to develop independent research portfolios upon their academic appointment. Thus, to attract new talent, it is essential to create funding mechanisms targeted specifically to junior faculty. These typically provide significant multiyear support and also confer prestige. Examples from which NASA could draw to develop such an award program include the NSF CAREER Award, the Office of Naval Research Young Investigator Program, the Air Force Office of Scientific Research Young Investigator Program, the Army Research Office Young Investigator Program, the DARPA Young Faculty Award, and the DOE Early Career Research Program. 7 See, for example, National Research Council, A Strategy for Research in Space Biology and Medicine in the New Century, National Academy Press, Washington, D.C., 1998. 13

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Similar programs, if tailored to the concerns of extended-duration spaceflight, could also provide meaningful opportunities for management personnel, engineers, physicians, and astronauts to expand their understanding of the research payloads for which they are responsible. Moreover, such programs could include combinations of virtual and traditional modes of instruction. Further, a strong pipeline of intellectual capital can be developed by modeling a training and mentoring program after other successful programs in the life and physical sciences. A critical number of investigators is required to sustain a healthy and productive scientific community. Building a program in the life and physical sciences would benefit from ensuring that an adequate number of investigators, including flight and ground-based investigators, are participating in research that will enable future space exploration. Linking Science to Mission Capabilities Through Multidisciplinary Translational Programs Complex systems problems of the type that crewed missions will increasingly encounter will need to be solved with integrated teams that are likely to include scientists from a number of disciplines as well as engineers, mission analysts, and technology developers. The interplay between and among the life and physical sciences, along with a strong focus on cost-effectiveness, will require multidisciplinary approaches. Multidisciplinary translational programs can better link the science to the gaps in mission capabilities through comprehensive data collection and data-sharing mechanisms that facilitate access by the scientific community. Centralized Information Networks Centralized information networks based on NASA-sponsored research that are accessible to intramural and extramural investigators would be a very valuable research tool. Modern analytical techniques offer a tremendous opportunity to understand the effects of spaceflight on life and physical science systems. Such techniques generate vast amounts of data that can be mined and analyzed for information by multiple researchers. An example is the National Human Genome Research Institute’s Encyclopedia of DNA Elements (ENCODE) project.8 The creation of a formalized program to promote the sharing and analysis of such data would greatly enhance the science derived from flight opportunities. Elements of such a program would include guidelines on data sharing and community access, with a focus on rapid release of data sets while respecting the rights of the principal investigators. A program of analysis grants dedicated to the spaceflight-derived data sets, which should include operational medical data, would provide value-added interpretation while ensuring that all data are maximally mined for information. Larger-scale multiple investigator experiments with related science objectives, methods, and common data products would result in the production of large data sets and would emphasize analysis over implementation. This type of data set, which is similar to those used by the space and Earth sciences, would likely be a tremendous resource for student research. Research Team Approach As noted in Chapter 1 of this interim report, a life and physical sciences research program to address the complex problems posed by space exploration will need to include both horizontal integration across multiple disciplines and vertical translation of fundamental discoveries to practical application. As an example, the loss of bone and muscle will remain a barrier to prolonged spaceflight until effective countermeasures are developed. Although exposure to microgravity per se triggers bone and muscle loss because of the reduction in mechanical loading forces, losses are likely exacerbated by additional factors in the space environment (e.g., altered nutrition, hormonal disruptions, psychological stress). Thus, the 8 See http://www.genome.gov/ENCODE/. 14

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development of effective countermeasure strategies will require input from experts across multiple disciplines (e.g., basic bone and muscle biologists, cardiovascular physiologists, endocrinologists, exercise physiologists, nutritionists, biomechanists, behavioralists). Further, physical scientists and engineers will need to work side by side with life scientists to ensure that countermeasures can be implemented in the space environment. Beyond meeting the need to provide scientific underpinnings to fulfill future space exploration goals, the space research community represents an ideal foundation around which life and physical scientists and engineers can coalesce to address common goals. Because scientific advances can occur as a result of serendipity, it is important to have life scientists, physical scientists, and engineers working side by side to take full advantage of both planned and serendipitous discoveries. Examples of the benefits of multidisciplinary interactions include the development of protective gear, and issues related to temperature control during extravehicular activity have engaged both the life and the physical sciences communities. However, at this time, a broad-based, multidisciplinary, integrative approach to conducting space exploration research has not been formally implemented. Clearly, given the scarce opportunities to carry out scientific studies under extraterrestrial conditions, careful planning is needed to optimize efficiencies. Although a considerable amount of planning has occurred to ensure efficient and optimal use of such research opportunities within the respective life or physical sciences communities, a concurrent and simultaneous implementation of life and physical sciences experiments would provide opportunities to obtain further synergies from research: a long-term strategic plan to maximize team research opportunities and initiatives could be expected to lead to more efficient solutions to the complex problems associated with space exploration. Implementing such initiatives would require forming integrative teams with representation from across the life and physical sciences, as well as from across funding agencies, to assist in this crucial planning process. Improved Access to Samples and Data from Astronauts The medical and scientific communities interested in human health, safety, and performance during long-duration spaceflight have been consistent in their requests for greater access to biological samples and other data collected from astronauts before, during, and after space missions. The rights of astronauts to privacy have, at times, appeared to conflict with the need for access to valuable data to benefit future space travelers. The 2001 Institute of Medicine report Safe Passage: Astronaut Care for Exploration Missions9 included suggestions for resolving this conflict. Among the recommendations were that NASA should (1) establish a comprehensive health information system for astronauts, for the purpose of collecting and analyzing data, and (2) develop a strategic research plan designed to increase the knowledge base about the risks to astronaut health. Some of these goals have been met, but much remains to be done to provide more widespread scientific access to such data. There are potentially three different types of research that are important for advancing knowledge of the biological effects of the space environment, each with unique strategies for collecting biomedical data. The first is hypothesis-driven experiments designed for space which generate data to address specific biological questions. The second type of research capitalizes on routinely captured operational data that could be used to address biomedical research questions. For example, NASA already has extensive operational data (e.g., to enable the precision of navigation maneuvers performed by crew) that could be linked to data on crew characteristics and made available for data mining. Such a database would enable scientists to address such questions as whether astronauts who perform with more or less precision in space are characterized by potential mediators of performance (e.g., sleep disruption, motion sickness). The third type of research is on the persistent effects of spaceflight on health. This research requires the creation of a long-term astronaut health information registry to enable learning what, if any, health problems are encountered by flight crews long after their mission. For example, there is relatively little 9 Institute of Medicine, Safe Passage: Astronaut Care for Exploration Missions, National Academy Press, Washington, D.C., 2001. 15

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knowledge of post-mission long-term changes in the bone health of astronauts who have flown on long- duration space missions. Current policies on the availability of and access to such follow-up data are perceived as limiting progress toward the development of effective countermeasures. A potential strategy that would benefit all three of these research approaches would be the creation of a robust astronaut health study database. The database could be populated retrospectively with currently archived data from the many space research studies that have been conducted, archived data from flight medicine, and available long-term follow-up health data such as the data obtained in the Longitudinal Study of Astronaut Health (LSAH),10 with plans to expand the database prospectively. Such a database could be generated through a formal research announcement to attract independent investigators who have established similar population databases (e.g., the Nurses’ Health Study database). Coupling the database with a genetic bank and repository of astronaut samples would ensure the availability of the maximal amount of data to address future investigations. Because of the limited number of humans who undergo exposure to the space environment, maintaining an extensive and well-organized database and managing it as a resource to be shared with the scientific community have long been viewed as essential steps for scientific discovery. Ground-based Research Space research programs are unlikely to advance rapidly unless supported by a highly developed ground-based research program. Ground-based research is an important way to refine technologies for conducting life and physical sciences experiments to a point that precious time in low gravity can be optimized for obtaining important research results. Ground research also provides key information to inform the design and complement the results of space research, thereby maximizing the scientific yield. Experiments conducted in space are complex and expensive. To optimize space-based research opportunities and results, it is important that an enhanced commitment is made to ensure ground-based analogs of spaceflight and complementary ground-based studies for the purposes of life and physical sciences research. The return to society from most space experiments in the fundamental physical sciences depends critically on advancing the state of the art in measurement science, and such advances have to be made and confirmed within a ground-based program, and often as selection criterion for major flight commitments. An example of an important ground-based analog is head-down-tilt bed rest to simulate the effects of microgravity. This intervention paradigm has been used to evaluate the efficacy of countermeasures aimed at preserving physiologic function during spaceflight.11 Interventions that have been found to be effective under these controlled conditions of reduced loading (i.e., bed rest) are now being evaluated on the ISS to determine their effectiveness in an environment that includes not only reduced loading (i.e., microgravity) but also multiple other stressors (e.g., psychological, behavioral, nutritional). Translational Research and Team Science To meet the demands for new scientific knowledge to guide future space missions, there is a strong need to improve the research productivity pipeline. This might best be addressed by a systematic analysis of where inefficiencies might be occurring in the translational process. In the physical sciences, the gap between the results of basic research studies and successful commercial or government 10 The LSAH was reviewed in a 2004 IOM study (Institute of Medicine, Review of NASA’s Longitudinal Study of Astronaut Health, The National Academies Press, Washington, D.C., 2004). 11 T.A. Trappe, N.A. Burd, E.S. Louis, G.A. Lee, and S.W Trappe, Influence of concurrent exercise or nutrition countermeasures on thigh and calf muscle size and function during 60 days of bed rest in women, Acta Physiologica 191:147-159, 2007. 16

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applications has been referred to for many years as “the valley of death.”12 Clinical and translational scientists in recent years have also begun to define particularly problematic gaps that commonly prove to be the “valley of death” for new drugs, devices, or interventions. Overcoming or at least minimizing these gaps has been a hallmark of the CTSA program launched by NIH. The kinds of interventions currently being undertaken to improve the process of clinical and translational research in the CTSAs should be generalizable to some aspects of NASA’s research enterprise. One important aspect of the above-mentioned CTSA process is the deployment of informatics capabilities addressing all aspects of the research process so that captured information about all transactions, whether research, contractual, bureaucratic, laboratory, facility, or other types, is monitored to examine inefficiencies that may be delaying, or in some cases sidelining, a rapid and orderly discovery process. As discussed above, this process also provides important tools for increasing communications among scientists and, in the space research area, between NASA and the extramural community of investigators. Hallmarks of this approach include (1) focusing on investigator needs, (2) collecting and analyzing metrics to assist in the evaluation of the success of projects, (3) providing for auditing to ensure that evaluation metrics are available to support program review and future prioritization, (4) leveraging existing resources whenever possible to avoid duplication of effort, and (5) building a well-connected community of investigators. Developing Commercial Sector Interactions to Advance Science, Technology, and Economic Growth It is important to ensure that NASA’s interactions with the commercial sector are as conducive as possible to the advancement of science, technology, and economic growth. As an example, contract specifications for commercial flight providers may hinder research unless they are formulated with specific requirements to accommodate science needs. Because up-mass and down-mass to the ISS may be delivered by commercial contractors in the future, it is important that the contract specifications for vehicles include adequate capacity for transporting biological and/or inorganic samples. Conditioned down-mass is of particular importance because there are limited facilities on the ISS for storage of samples. Unless suitable down-mass transportation is made available, only the results of the relatively simple analyses that can be conducted on the ISS will be available. Broad, multidisciplinary teams will be necessary to coordinate and integrate activities across the commercial sector, the space medicine community, and the space operations community. Issues related to the control of intellectual property, technology transfer, conflicts of interest, and data integrity will also have to be addressed. Commercial suborbital spaceflight is on the horizon and has the potential to provide a platform for the reduced-gravity study of rapidly occurring processes such as combustion phenomena. Several companies are now developing the hardware and procedures for suborbital flights.13 The flights will be available to the public, initially at high cost but becoming more affordable as operations continue. While flight trajectories and, therefore, dynamics differ among the companies and remain to some extent proprietary, it is reasonable to expect flights to reach peak altitudes in the range of 100 km with flight times of about 15 minutes. Hyper-gravity launch and landing phases will surround a free-fall or near- weightless (milli-g) phase of 4 to 5 minutes duration. One aspect that needs to be addressed is how to make flight opportunities available to the research community. A typical NIH or NSF grant, for example, will not support more than one or two such flights, which obviates much of their appeal. One approach is for funding agencies (NASA, NIH, NSF) to pool resources and purchase a set of flights to be dedicated to life and physical sciences, or to research in general. 12 National Research Council, Accelerating Technology Transition: Bridging the Valley of Death for Materials and Processes in Defense Systems, The National Academies Press, Washington, D.C., 2004. 13 K. Sanderson, Science lines up for seat to space, Nature 463:716-717, 2010. 17

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Vehicles under development by commercial suborbital companies, such as Virgin Galactic, Armadillo Aerospace, Blue Origin, Masten Space Systems, and XCOR Aerospace, will likely provide scientists, university researchers, and students with a new way to access the space environment.14 The scientific community has reacted enthusiastically to the promise of these vehicles, with more than 200 scientists from around the country participating in a series of workshops with suborbital vehicle developers, a distinguished group of scientists coming together to form the Suborbital Applications Researchers Group, and a conference on next-generation suborbital research. NASA also recognized the potential of commercial suborbital spacecraft and formed the NASA Commercial Re-usable Suborbital Research (CRuSR) Program at NASA Ames Research Center.15 It is important that these types of educational networking opportunities be fostered to help catalyze research interactions among commercial developers, the scientific community, and NASA. ADMINISTRATIVE OVERSIGHT OF LIFE AND PHYSICAL SCIENCES RESEARCH Currently, life and physical science endeavors focused on understanding phenomena in low- gravity environments have no clear institutional home at NASA. As determined by the decadal survey committee from its examination of the highly varied history of these programs, and as commented on in the Augustine Committee Final Report,16 administratively embedding crucial forward-looking elements such as this in larger or operationally focused organizations virtually guarantees that its resources will be swallowed up by other needs. The discussion in this chapter has focused on the essential needs for a successful renewed research endeavor in life and physical sciences—the development of a credible agenda, the selection of the research most likely to provide value to an optimum range of future missions designs, the crucial inclusion of a translational science component to continuously build bridges between basic science and the development of new mission options, and the necessity of encouraging and then accommodating team science approaches to what are inherently fully multidisciplinary challenges. This chapter has also addressed the importance of funding stability. In the context of a programmatic home for an integrated research agenda, it notes that program leadership and execution are likely to be productive only if aggregated under a single management structure and housed in a NASA directorate or key organization that understands both the value of science and its potential application in future exploration missions. All of these factors emphasize the need for the following elements: • Leadership with both true scientific gravitas and a sufficiently high level in the overall organizational structure at NASA to have a “voice at the table” when the agency engages in difficult discussions about prioritizing resources and engaging in new activities, • Unique authority over a dedicated and enduring funding stream, and • Organizational positioning that allows the conduct of a unique basic research program as well as interactions and influence within the mission-planning elements that develop new exploration options. 14 Alan Stern, Southwest Research Institute, “Research and Education and Next-Gen Suborbital Flight,” presentation to the Committee for the Decadal Survey on Biological and Physical Sciences in Space, October 2009. 15 See http://suborbitalex.arc.nasa.gov/ for more details on the NASA CRuSR Program. 16 Review of U.S. Human Spaceflight Plans Committee, Seeking a Human Spaceflight Program Worthy of a Great Nation, Final Report, 2009, available at http://www.nasa.gov/pdf/396093main_HSF_Cmte_FinalReport.pdf, p. 113. 18