PERSPECTIVE Open camera or QR reader and scan code to access this article and other resources online. Downloaded by 174.78.3.137 from www.liebertpub.com at 05/12/24. For personal use only. Preparing Civilians to Travel, Live, and Work in Space: A Human Research Agenda Michael Marge1,2 1 CSF/MITRE Workshop Summary Report, Commercial Spaceflight Federation, Washington, DC, USA. 2 Research Professor, SUNY Upstate Medical University, Millersville, Maryland, USA. ABSTRACT The prospect of thousands—perhaps even millions—of civilians traveling, living, and working in space in the coming decades requires a collaborative human research program (HRP) to ensure their health and safety. After a substantial review of the literature on the health of civilians in space, it was found that little is known about the impact of the space environment on health and safety of civilians, many with underlying health conditions and disabilities. To address this gap, the author and the Commercial Spaceflight Federation (CSF) decided to conduct a workshop on developing an HRP to study the impact of the space environment on the health and safety of average civilians in the commercialization of space. With the cooperation of experts in health research in space, a Workshop Planning Committee was created. The committee included experts from CSF, the space industry, government, and academia to develop the first ever HRP for civilians in the commercialization of space. The CSF/MITRE workshop was conducted on May 11–12, 2021, with *100 participants. Recommendations were made to conduct specific research projects to understand and prevent/mitigate any adverse impact of the space environment on average civilians in suborbital space and in space travel and habitation in low Earth orbit and beyond. The summary report of the workshop’s recommendations was written, vetted, and completed for public dissemination in November 2021. The summary concludes with recommendations for implementation of the HRP for civilians in commercial space. 240 NEW SPACE ª MARY ANN LIEBERT, INC. VOL. 10 NO. 3 2022 Keywords: human research, civilians in space travel, commercialization of space, protecting civilian health THE ROLE OF CIVILIANS IN THE COMMERCIALIZATION OF SPACE W ith increased space exploration activity and as the science and technology of space have grown almost exponentially, numerous new recommendations about the advantages of the commercialization of space have been proposed. The literature now abounds with reports of scientific meetings and opinion articles about the commercialization of space.1–5 As one reviews the potential commercial and research activities in the coming decades, the role of the civilian in space travel and habitation becomes tantamount but with great concern about protecting their health, safety, and comfort. It has been predicted that the civilian will be involved in space-related medical research, manufacturing, development, and management of housing for orbital and lunar tourists and workers, transportation systems, mining, communication systems, space-based solar power as clean energy for Earth, and space-centric educational programs.6,7 NASA has already contracted U.S.-based companies—Blue Origin, Nanoracks, and Northrop Grumman—to design space stations that would combine scientific and commercial activities.8,9 Blue Origin and partner Sierra Space will build the Orbital Reef, a space station that will be used for research, commercial, and governmental purposes. The Nanoracks Company also plans to construct a commercial space station (Starlab) for biology, plant, physical science, and materials research. Plans for the space station by Northrup Grumman will be used for commercial purposes with modular construction so that its base may be expanded as required. DOI: 10.1089/space.2022.0006 Downloaded by 174.78.3.137 from www.liebertpub.com at 05/12/24. For personal use only. PREPARING CIVILIANS TO TRAVEL, LIVE, AND WORK IN SPACE The health needs of civilians in the commercialization of space have not been adequately addressed. This has implications for a new and challenging role for space medicine and human space research. Space medicine’s focus on the health and function of career astronauts will expand to the health of civilians involved in spaceflight, many with underlying health problems and disabilities.10 To successfully operate the planned range of potential commercial enterprises in space, the health and fitness of the workforce need to be considered. We are assuming that this workforce will include people of diverse races, cultures, and backgrounds. Dr. Mark Shelhamer observed ‘‘Anytime you send a person into space, it’s an experiment. To explain why, let’s compare aviation and spaceflight. In 2019, pre-COVID, airlines carried 4.5 billion passengers on 39 million flights. Commercial aviation is a very, very mature field, both technologically and biomedically. Things do still go wrong, but they’re extremely rare because the experience base is huge. Comparatively, fewer than 600 people have ever flown into space. Spaceflight is not a mature field at all, so any data you can get is extremely valuable.’’11 Collection of physiological, behavioral, molecular, and phenotype data will help us generate proper assessment, screening, and countermeasures for civilians. In support of this initiative, Dr. Michael Schmidt stated, ‘‘The vascular health of the average space tourist/worker is likely to be more akin to the average person on Earth (as opposed to [the] average astronaut). The vascular system is one of those vulnerable systems that we should pay close attention to.’’12 In addition, the research to protect and mitigate adverse effects of traveling and working in space needs to examine the activity in which the civilian will be engaged. WORKSHOP ON CREATING A HUMAN RESEARCH PROGRAM FOR CIVILIANS IN THE COMMERCIALIZATION OF SPACE In September 2020, the need to address the potential biomedical risks that civilians will face in this decade and beyond as space is commercialized was discussed with National Space Council (NSpC) staff. This led to an NSpC request for a workshop proposal to explore the issue. The aim of the workshop was to bring together leading experts in space medicine and space research to assist in establishing a practical, prudent, and sustainable framework for a human research program (HRP) for civilians in space. The proposal was favorably considered by the NSpC and directed to the Commercial Spaceflight Federation (CSF) for implementation. The workshop was conducted on May 11–12, 2021, with the participation of *100 colleagues representing the key leaders in space medicine and space research. This special report is a summary of the workshop and the recommendation to create and implement an HRP for civilians in spaceflight. For civilians who will engage in business and industry in space, the workshop participants recommended that we review what is known about the biomedical risks to these civilians in suborbital, low Earth orbit (LEO), and deep space travel to identify the gaps in knowledge and develop a meaningful human research agenda. The authors conducted such a review of the literature and conferred with astronauts, space researchers, and space medicine specialists. Because of the notable differences between the health and fitness of NASA’s astronauts and civilians who will become involved in space commercialization, much of the data about the physiological and psychological responses of career astronauts were not found useful. It was noted that although some hazards to human health, safety, and comfort have been identified— microgravity, radiation, acceleration, and distance from Earth anxiety—physiological risks and uncertainties for civilians remain with no standardized medical criteria for selection. Based on the limited data, it was decided that a robust HRP for spaceflight participants be initiated. STUDIES TO IDENTIFY BIOMEDICAL RISKS TO CIVILIANS WHO WILL PARTICIPATE IN THE COMMERCIALIZATION OF SPACE Space medical experts know that orbital and cislunar and long duration space travel have significant adverse effects on the human body. These effects include physiological changes at the tissue and molecular levels. Although NASA’s twin study represented only an N of 2, it has provided us with an insight into the omics of spaceflight and points to the possibility of unanticipated changes in human health.13 Antuñano et al. discuss the challenges of suborbital and orbital commercial human spaceflights, the recommended medical standards and management of medical risks, and the informed consent process applicable to the launch, flight, and landing. They state, ‘‘Space flights are associated with a number of physiological and psychological changes that may cause and/or aggravate certain medical conditions during flight, and could adversely impact an individual’s health and safety.’’14 They continue that the spaceflight environment is far more hazardous than the operational risks encountered during commercial aviation flights. ‘‘Such increased risk factors include: acceleration, barometric pressure, microgravity, ionizing radiation, nonionizing radiation, noise, vibration, temperature and humidity, breathable air and ventilation, as well as behavioral issues.’’ ª MARY ANN LIEBERT, INC. VOL. 10 NO. 3 2022 NEW SPACE 241 Downloaded by 174.78.3.137 from www.liebertpub.com at 05/12/24. For personal use only. MARGE They suggest that the space medical specialist identify and mitigate significant pre-existing diseases, illnesses, injuries, infections, treatments (pharmacological, surgical, prosthetic, or other), or other physiological or pathological or psychiatric conditions among commercial space vehicle occupants (flight crews and passengers).14 They conclude with the recommendation that commercial spaceflight participants, crew, and passengers, will have to be carefully evaluated before allowing them to participate in suborbital and orbital spaceflights. Similar recommendations were made by Schroeder et al.15 The Association of Spaceflight Professionals’ Life Sciences Working Group reviewed U.S. medical guidelines for commercial spaceflight participants. The review examines available data and publications, and makes recommendations going forward with respect to pre- and in-flight mitigation of medical risk, covering medical screening and evaluation, in-flight medical capabilities, training recommendations, and opportunities for refining the guidelines as more data become available. Using relevant search terms to identify publications of interest, these researchers conducted a search of Google and Pub Med to obtain their data. AREAS OF UNCERTAINTY The review of the current state of knowledge about civilian health in space resulted in identifying the essential research topics to meet the goal of protecting the health and safety of civilians in space. These include: . The need for research on the impact of space travel on a representative large population of civilians, including women, people of color, people with a variety of chronic health conditions, and those with disabilities. To date, almost all data refer to fit professional astronauts and several studies of civilians subjected to the stresses of centrifuge tests simulating the acceleration profiles (+Gx and +Gz) that are expected to occur on suborbital spaceflights.16–18 Table 1. Human Research Project Recommendations for Civilians in Suborbital Spaceflight Needs for Human Research Description of Human Research Projects Assess functional capability of civilians Develop a functional abilities test for individuals with disabilities that is reliable and proven valid to determine functional to sustain impact of spaceflight ability to handle space travel. Identify effective interventions to prevent a. Develop interventions to prevent and/or treat space motion sickness (SMP). or mitigate the impact of spaceflight b. Identify interventions to prevent the psychological effects of spaceflight: fear, anxiety, and stress. c. Examine the postflight and long-term impact of suborbital flight on the health status of individuals with disabilities, such as the potential for developing additional health complications (secondary conditions). d. Study the impact of suborbital space travel on civilians with pre-existing health conditions, not considered disabling, to include medically stabilized diabetes, stabilized mild–moderate heart conditions, asthma, stabilized kidney and liver disease, treated migraine headaches, obesity, controlled high blood pressure, controlled seizures, and medically stabilized mental health conditions (psychoneuroses). e. Assess the impact of spaceflight on civilians with implanted devices and who take life-sustaining medications. Study additional priority health concerns a) Examine g-transitions to determine effects on physiology and performance. G-transitions are a combination of acceleration forces and microgravity. In addition, address the questions of ‘‘What acceleration forces can civilians endure without adverse outcomes’’ and ‘‘How to contend with acceleration forces upon launches, during flight, and landing?’’ b) Measure cardiovascular disease (CV) responses, including vestibular-autonomic (sympathetic) stimulation inducing cardiac dysrhythmias during suborbital spaceflight. In addition, study the impact of spaceflight on blood pressure, pulse, regularity of heart beat, and heightened risk for thrombosis. c) Conduct a research project pursued either separately or in concert with item (b) above to study the mechanisms underlying increased risk for CV changes, such as fluid shifts, during spaceflight, and duration of experience in microgravity. Fluid shifts are expected to be relatively inconsequential on suborbital flights, but may be more pronounced in flyers with certain medical conditions (heart failure and cardiac insufficiency) and should be studied. d) Study the impact of nominal and off-nominal launch/landing loads: potential for intervertebral disk damage; explore preventive interventions. e) Explore the effectiveness of new microgravity medical sensors, tools, and procedures (novel biometric sensors, ultrasound for jugular venous stasis, microgravity wound management, etc.) to assess physiological responses during spaceflight. 242 NEW SPACE 2022 ª MARY ANN LIEBERT, INC. PREPARING CIVILIANS TO TRAVEL, LIVE, AND WORK IN SPACE Currently, there is no research evidence in support of a type of training for suborbital or orbital flight for civilians that will prepare them effectively for the experience, especially to ensure an appropriate response in case of an emergency. Stepanek et al. state, ‘‘Participants in longerduration missions, especially persons with pre-existing health conditions who are critically reliant on a healthy immune system, may also be subject to the known effects of the spaceflight environment (thought to be mediated by radiation and stress responses) on immune function. Alterations in T-cell function, the skin microbiome, and bacterial virulence, as well as asymptomatic viral reactivation, have been described.’’10 . The need to understand how factors in the space environment impact the health and capacity of civilians to fly successfully with differences in age, gender, race Downloaded by 174.78.3.137 from www.liebertpub.com at 05/12/24. For personal use only. . and ethnicity, physical and mental health status, underlying health conditions, immunity, and resilience. . The need to identify effective measures to prevent adverse outcomes of spaceflight and habitation in civilians, regardless of distinguishing differences in the physiology and mental characteristics of the individual, and to identify effective measures to treat adverse outcomes if they occur during and after spaceflight and habitation. . The need to create a publicly accessible database that contains information from peer-reviewed scientifically based studies about adverse outcomes of space travel and habitation, effective measures to prevent and mitigate these outcomes, and promising new areas of research. Schmidt et al. state the following: ‘‘The cohort of professional astronauts has been uniquely fit and exceptionally well Table 2. Human Research Recommendations for Civilians for Orbital and Beyond Low Earth Spaceflight and Habitation Need for Human Research Description of Human Research Project Study the significant hazard of microgravity This proposes a multiyear study of the impact of microgravity on the physiology and psychology of civilians, using on civilians in orbital and beyond space analog environments and simulation tests. Physiological factors include major bodily systems: CV, digestive, endocrine, eyes and ears sensory, immune and hematology, lymphatic, musculoskeletal, nervous, reproductive, respiratory, skin, and urinary systems. This will require extensive testing of each civilian, including comprehensive molecular profiling of all civilians so that personalized countermeasures may be developed to address the heightened risks each individual may face. It is essential to obtain preflight baselines, measures during analog experiences or flights, and postexperience or postflight measures. This may include various durations of visits to ISS for a cohort of civilians. Study strategies to protect civilians in orbital This includes the impact of radiation on the 12 bodily systems. It will require extensive testing of civilians before, during, flight and beyond from the dangerous effects and after the analog experience and/or spaceflight. It may also include various durations of visits to ISS for a cohort of of space-encountered radiation, including solar civilians. and galactic cosmic radiation Address the impact of isolation and confinement Examine the impact of ‘‘Distance from Earth’’ and feelings of isolation and confinement on the psychology and function on civilians in orbital and beyond space of individuals with disabilities, using analog environments and simulation tests. This may be a collaborative research effort in conjunction with ways to reduce anxiety and stress for civilians discussed under the suborbital space flight recommendations. Develop a preflight training program for civilians Develop an effective preflight training program that best prepares civilians for spaceflight. The preparation is to (1) that addresses the safety and comfort of the reduce SMS, (2) reduce anxiety and stress, (3) function successfully in case of emergencies, and (4) become a team space traveler member of the spaceflight passengers and crew. Study issues related to special accommodations Identify which special accommodations, if any, are required for individuals with disabilities so that spaceflight is for individuals with disabilities in spaceflight and habitation accessible, safe, and comfortable. This project will entail spacecraft design, vehicle operations, emergency procedures, and other technical factors that may be modified so that the needs of the civilians are addressed. Determine the effects of acceleration forces, a. Measure the impact of these factors on civilians in analog environments and experiences. The experience could vibration, noise, and G transition factors on civilians during launch and landing include travel to ISS by a representative group of civilians who are carefully monitored and measured before, during, and after the spaceflight to ISS. b. Measure the impact of these factors on individuals with disabilities in analog environments and experiences. This project could be collaborative with other projects already stated that involve travel to ISS. ISS, International Space Station. ª MARY ANN LIEBERT, INC. VOL. 10 NO. 3 2022 NEW SPACE 243 MARGE Downloaded by 174.78.3.137 from www.liebertpub.com at 05/12/24. For personal use only. trained. The advent of commercial spaceflight will see a wider range of individuals enter space, who lie on a variegated continuum of physical fitness, metabolic fitness, disease complexity, drug therapeutics, and genetics. Yet, there are currently little data on individuals of lesser fitness entering space.’’19 Schmidt and his coresearchers acknowledge that spaceflight medicine ‘‘has grown in sophistication,’’ but we are still confronted with serious knowledge gaps. Research efforts to address the biomedical hazards faced by civilians who will be involved in space travel and habitation are disparate, uncoordinated, limited, and not part of a national plan of action to meet research goals according to a timetable. HRP FOR CIVILIANS IN THE COMMERCIALIZATION OF SPACE The human research projects of highest priority were identified based on review of the relevant literature and the recommendations of the workshop participants. The identified human research priorities are presented in 2 sections: Suborbital Space, and Orbital and Beyond Low Earth Orbit Spaceflight and Habitation found in Tables 1 and 2. In addition, a publicly accessible database should be created to include the results of the research projects and the biomedical testing that will be applied before, during and after spaceflight and habitation. All data will be anonymized to protect the privacy of civilians who participated in the human research studies. .commercialspaceflight.org/wp-content/uploads/2021/11/2021Summary-Report-of-the-CSF-MITRE-Workshop-and-HRP-forcivilians.pdf) ACKNOWLEDGMENTS The author expresses his sincere appreciation for the contributions of the following who served as scientific advisors in the editing of the CSF/MITRE Workshop Summary Report upon which this article is based: Melchor Antunano, MD, Federal Aviation Administration; Kenneth Davidian, PhD, Federal Aviation Administration; Tommy Sanford, Commercial Spaceflight Federation; Erika Wagner, PhD, Blue Origin; Sirisha Bandla, Virgin Galactic; Jaime Mateus, PhD, SpaceX; Christian Maender, Axiom Space; Christopher Scheibler, MD, DoD; Victor Schneider, MD, NASA; Leith States, MD, OASH/ HHS; Valerie Gowran PhD, MITRE; Mark Shelhamer, PhD, Johns Hopkins University School of Medicine; Michael Schmidt, PhD, Sovaris Space. AUTHOR DISCLOSURE STATEMENT No competing financial interests exist. FUNDING INFORMATION No funding was received for this article. REFERENCES 1. SUMMARY The proposed HRP for civilians focuses on studies to make space travel and habitation accessible to all, including individuals with underlying health conditions and disabilities. We also identify opportunities to leverage this large diverse population of flyers to conduct hypothesis-driven research in the general flying public or specialized research subjects. In addition, we recommend nonhypothesis-based research to advance discovery. The results of these biomedical studies should be anonymized and included in a publicly accessible database. Although spaceflight accessibility is a topic of primary relevance to the space industry, opportunistic research within this population represents a mixture of aeromedicine, public health, and technology maturation. Next step is the implementation of the HRP for civilians in space travel and habitation with the cooperation and support of all stakeholders dedicated to protecting the health and safety of civilians in the commercialization of space. Copies of the CSF/MITRE Workshop Summary Report may be accessed on the CSF website at this link: (www 244 NEW SPACE 2022 2. 3. 4. 5. 6. 7. 8. 9. Weinzierl M, Sarang M. The Commercial Space Age Is Here; Private space travel is just the beginning. Harvard Business Review Digital Articles. 2021. https:// hbr.org/2021/02/the-commercial-space-age-is-here (Last accessed on January 12, 2022). Why Big Business is Making a Giant Leap into Space. Knowledge at Wharton, Wharton/University of Pennsylvania. 2019. https://knowledge.wharton.upenn. edu/article/commercial-space-economy/ (Last accessed on February 15, 2022). NASA and the Rise of Commercial Space: A Symposium to Examine the Meaning(s) and Context(s) of Commercial Space, March 17–25, 2021. https:// www.nasa.gov/centers/marshall/history/nasa-and-the-rise-of-commercial-space .html (Last accessed on January 25, 2022). Kostek P. Space 2021–the commercialization of space. Innovation News Network. 2021. https://www.innovationnewsnetwork.com/commercialisationof-space/9995/ (Last accessed on February 2, 2022). Smith M. Science in the News/Harvard University; Commercial Space and You. 2018. https://sitn.hms.harvard.edu/flash/2018/commercialized-space-andyou/ (Last accessed on February 2, 2022). Satsearch. 8 Types of Products That Could One Day Be Made In Space. 2019. https://blog.satsearch.co/2019-04-25-8-types-of-product-that-could-one-daybe-made-in-space (Last accessed on February 3, 2022). Space Policy Online. Commercial Space Activities, Space Economy. 2021. https:// spacepolicyonline.com/topics/commercial-space-activities/ (Last accessed on January 15, 2022). Skibba R. Here’s how 3 space companies aim to replace the ISS. Wired. 2021. https://www.wired.com/story/heres-how-3-space-companies-aim-to-replacethe-iss/ (Last accessed on January 4, 2022). Abent E. NASA reveals 3 contenders to replace the International Space Station. Slash Gear. 2021. https://www.slashgear.com/nasa-reveals-the- 3-contendersto-replace-the-international-space-station-03701144/ (Last accessed on January 4, 2022). ª MARY ANN LIEBERT, INC. Downloaded by 174.78.3.137 from www.liebertpub.com at 05/12/24. For personal use only. PREPARING CIVILIANS TO TRAVEL, LIVE, AND WORK IN SPACE 10. Stepanek J, Blue RS, Parazynski S. Space medicine in the era of civilian spaceflight. N Engl J Med. 2019;380(11):1053–1060. 11. Shelhamer MJ. And spaceflight for all. Hub interview, JHU. 2021. https:// hub.jhu.edu/2021/09/13/spacex-consumer-spaceflight/ (Last accessed on February 4, 2022). 12. Personal communication from Dr. Michael Schmidt, Sovaris Space, September 27, 2020. 13. Garrett-Balkeman F, Darshi M, Green SJ, et al. The NASA twin study: A multidimensional analysis of a year-long human spaceflight. Science. 2019; 364(6434):eaau8650. 14. Antuñano MT, Blue RS, Jennings R, Vanderploeg JA. The commercial spaceflight industry: medical challenges and risk mitigation. In: Handbook of Bioastronautics. Springer International Publishing, 2021. 15. Schroeder GS, Clark JC, Gallagher M, et al. Medical guidelines for suborbital commercial human spaceflight: A review. Acta Astronaut. 2021;187:529– 536. 16. Blue RS, Pattarini JM, Reyes DP, et al. Tolerance of centrifuge-simulated suborbital spaceflight by medical condition. Aviat Space Environ Med. 2014;85: 721–729. 17. Blue RS, Bonato F, Seaton K, et al. The effects of training on anxiety and task performance in simulated suborbital spaceflight. Aerosp Med Hum Perform. 2017;88:641–645. 18. Blue RS, Riccitello JM, Tizard J, et al. Commercial spaceflight participant G-force tolerance during centrifuge-simulated suborbital flight. Aviat Space Environ Med. 2012;83:929–934. 19. Schmidt MA, Schmidt CA, Hubbard RA, et al. Why personalized medicine is the frontier of medicine and performance for humans in space. New Space. 2019; 8(2):1–14. Address correspondence to: Michael Marge SUNY Upstate Medical University c/o 449 Old Orchard Circle Millersville, MD 21108 USA E-mail: michael.marge@comcast.net ª MARY ANN LIEBERT, INC. VOL. 10 NO. 3 2022 NEW SPACE 245