Health Standards for Long Duration and Exploration Spaceflight: Ethics Principles, Responsibilities, and Decision Framework (2014)

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Summary Since its inception, the U.S. human spaceflight program has grown from launching a single man into orbit to an ongoing space presence aboard the International Space Station (ISS) with partners from many nations. Human spaceflight inherently involves a high degree of risk dur- ing all phases of any space mission, including terrestrial training and ve- hicle testing, launch, inflight during the mission, and landing. Health risks during long duration and exploration spaceflights include short- term health consequences (e.g., nausea or fatigue from acute radiation exposure during a solar storm, injury, blurred vision), as well as long- term health consequences that arise or continue months or years after a flight (e.g., radiation-induced cancers, loss of bone mass). Long duration and exploration spaceflights (including extended stays on the ISS or ex- ploration missions to an asteroid or Mars) will likely expose crews to levels of known risks beyond those allowed by current health standards, as well as to a wide range of risks that are poorly characterized, uncer- tain, and perhaps unforeseeable. The National Aeronautics and Space Administration (NASA) asked the Institute of Medicine (IOM) to develop an ethics framework and to identify principles to guide decision making about health standards for long duration and exploration class missions “when existing health standards cannot be fully met” or adequate standards cannot be devel- oped based on existing evidence (see Box S-1). The committee was not asked to review NASA’s risk management processes. 1 

2 LONG DURATION AND EXPLORATION SPACEFLIGHT BOX S-1 Statement of Task The National Aeronautics and Space Administration (NASA) is in the process of planning for exploration class missions of long duration and be- yond low Earth orbit (LEO). An ad hoc committee of the Institute of Medi- cine (IOM) will conduct a study to examine policy and ethical issues relevant to crew health standards for these missions. The committee would consider the application of existing health standards and the poten- tial development of a new set of standards for missions beyond LEO. These standards would address potential hazardous exposures and work- ing conditions that are uncertain, unknown, or that go beyond current NASA risk limits. NASA is looking, in particular, for a framework of ethical and policy principles that can help guide decision making associated with implementing health standards for exploration class space missions when existing standards cannot be fully met, or the level of knowledge of a given condition is sufficiently limited that an adequate standard cannot be devel- oped, for the mission. As part of its deliberations, the committee will con- sider and respond to options proposed by NASA, as well as offer options of its own. Given the long-term importance of this task for NASA, the com- mittee’s report will fully detail supporting rationale for all recommendations. Questions to be considered include 1. What factors should be considered in the implementation of current health standards (which are defined in Volumes 1 and 2 of NASA Space Flight Human System Standards) in exploration class missions and the development of exploration class health standards if necessary? a. What ethical considerations are involved in developing and im- plementing health and safety standards for manned space explo- ration when the exposures and risks are uncertain, unknown, and/or when exposures and risks might exceed current standards? b. What standards of informed consent regarding the health risks of the mission are appropriate, and what are the ethical limits of in- formed consent processes in these circumstances? What princi- ples should be applied (when relevant) to communicating the uncertainty regarding health risks? c. What are appropriate modifiers for standards for protecting individ- uals when there is an incomplete understanding and knowledge of the potential risks or hazardous exposures, or when exposures and risks may exceed current standards? d. Should all astronauts and spaceflight crew members be protected to the same risk level or should potential individual differences be considered? Would one standard be sufficient for the entire spaceflight crew or do known or unknown differences in risk need to be addressed to provide a uniform level of protection? 

SUMMARY 3 2. Are there models or examples of other situations with unknown health risks (or risks that could exceed current standards) that could inform NASA policy and, if so, how? To respond to its statement of task, the IOM convened the Commit- tee on Ethics Principles and Guidelines for Health Standards for Long Duration and Exploration Spaceflights. This report provides the commit- tee’s recommendations on ethics principles, responsibilities, and a deci- sion framework to guide decisions about the application of health standards to long duration and exploration spaceflights. The recommen- dations include many components that NASA has considered or is al- ready implementing in its work on health standards for spaceflight. However, the adoption of the recommended ethics principles and respon- sibilities and decision framework not only introduces new processes and responsibilities but also alters the context in which existing components operate. HEALTH STANDARDS FOR HUMAN SPACEFLIGHT The use of health standards to protect individuals engaged in specific types of work or activities is not unique to space exploration. Health standards are used throughout occupational settings to protect workers and guide design, research, and engineering efforts, among other purpos- es. The committee examined various high-risk occupations and activities and identified some common factors (such as types and severity of risk; types and distribution of potential risks and benefits; activity purpose; and the presence of independent oversight) that aided the committee’s deliberations. However, the committee was not able to identify existing ethics frameworks or decision-making models for specific occupations that were directly and wholly applicable to decisions about health stand- ards for long duration and exploration spaceflight. As the federal agency with institutional responsibilities to conduct and evaluate a wide range of spaceflight missions, NASA addresses health risks associated with spaceflight using a number of strategies, in- cluding engineering, design, mission planning, basic and clinical re- search, surveillance and medical monitoring, preventive and treatment countermeasures, and health standards. NASA’s crew health standards consider three categories of preflight, inflight, and postflight health is- sues: fitness-for-duty standards, permissible exposure limits, and permis- 

4 LONG DURATION AND EXPLORATION SPACEFLIGHT sible outcome limits. Additionally, NASA has health standards relevant to human factors, habitability, and environmental health. If a human spaceflight mission cannot meet current health standards, or if inadequate information exists to revise a health standard, the op- tions, as identified and examined by the committee, would be to: (1) lib- eralize the NASA health standards, (2) establish more permissive “long duration and exploration health standards,” or (3) grant an exception to the standard in order to conduct these missions before new protective technologies and strategies are available or additional data are acquired which may allow revision of the standard. The committee found the first two options to be unacceptable when evaluated against the ethics princi- ples and responsibilities described in this report. The committee finds relaxing (or liberalizing) current health stand- ards to allow for specific long duration and exploration missions to be ethically unacceptable. Current NASA policy outlines the administrative processes and levels of approval required to initiate a new health stand- ard or revise a current health standard. NASA’s health standards “are based on the best available scientific and clinical evidence, as well as operational experience.” Moreover, review of health standards occurs every 5 years or can be triggered any time that new research data or clin- ical observations indicate an update may be necessary. Modifying health standards outside of this established process merely to permit long dura- tion and exploration missions would be arbitrary. The second option maintains current health standards for all missions except long duration and exploration spaceflight, which would have a separate set of health standards. This approach presumably would entail setting a more permissive ceiling on allowable risk for long duration and exploration missions under conditions in which existing evidence and knowledge make it nearly impossible to quantify those ceilings. The committee found this approach wanting, lacking a clear and compelling justification for why acceptable risks and levels of uncertainty should be greater for long duration and exploration missions than other human spaceflight missions. Having excluded the options of modifying existing standards or cre- ating a separate set of standards, the committee concludes that the only ethically acceptable option that could allow for increased risk exposures in the context of long duration and exploration spaceflights is granting an exception to existing health standards. The committee believes that ex- ceptions to health standards should be considered on a mission-by- 

SUMMARY 5 mission basis and used in very limited circumstances following the ethics-based framework recommended. When making decisions about whether to allow risk levels that do not meet NASA’s current health standards, it is important that current health standards reflect the most relevant and up-to-date evidence about spaceflight-related risks to human health and safety. Although NASA has formal policies for health standard initiation and revision, the committee believes additional information about decision criteria, process, and ap- plication of ethics principles should be available to the public. Recommendation 1: Expand on the Policies for Initiating and Re- vising Health Standards NASA should ensure that its policies regarding health standards detail the conditions or circumstances (and relevant priorities) that initiate development or revision of health standards and ex- plicitly indicate how these policies are fully consistent with the set of ethics principles outlined in this report. ETHICS PRINCIPLES Over the course of centuries, philosophers have debated the relative merits and shortcomings of the major theories of western moral and po- litical philosophy: utilitarianism, duty-based approaches, virtue-based theories, and others. One successful approach to avoiding the need for a single ethical theory is to focus on mid-level principles rather than the theory to which they belong or from which they are derived. This ap- proach has proven to be particularly successful when used by expert committees or commissions made up of individuals with diverse com- mitments in an effort to find common ground on how best to approach challenging ethical issues in the context of public policy. The committee adopted a principle-based approach in recognition of its accessibility and applicability for its task. Recommendation 2: Apply Ethics Principles to Health Standards Development and Implementation NASA should apply the following ethics principles in the devel- opment and implementation of its health standards for decisions regarding long duration and exploration spaceflights: 

6 LONG DURATION AND EXPLORATION SPACEFLIGHT • Avoid harm—the principle includes the duty to prevent harm, exercise caution, and remove or mitigate harms that occur. Thus, NASA should exhaust all feasible measures to minimize the risks to astronauts from long duration and ex- ploration spaceflights, including addressing uncertainties through approaches to risk prevention and mitigation that in- corporate safety margins and include mechanisms for con- tinuous learning that allow for incremental approaches to risk acceptance. • Beneficence—the principle to provide benefit to others. NASA should consider in its decision making the potential benefits of a specific mission, including its scientific and technological importance, as well as its potential beneficiar- ies including current and future astronauts and members of society at large. • Favorable balance of risk and benefit—the principle to seek both a favorable and acceptable balance between the risk of harm and potential for benefit. In authorizing long du- ration and exploration activities and in approving particular missions, NASA should systematically assess risks and ben- efits and the uncertainties attached to each, drawing on the totality of available scientific evidence, and ensuring that benefits sufficiently outweigh risks. • Respect for autonomy—the principle to ensure that individ- uals have both the right to self-determination and processes in place to exercise that right. NASA should ensure that as- tronauts are able to exercise voluntariness to the extent pos- sible in personal decision making regarding participation in proposed missions, that they have all available information regarding the risks and benefits of the proposed mission, and that they continue to be apprised of any updates to risk and benefit information throughout the mission. • Fairness—the principle requires that equals be treated equally, that burdens and benefits be distributed fairly, and that fair processes be created and followed. NASA’s deci- sion making surrounding missions should explicitly address fairness, including the distribution of the risks and benefits of the mission, crew selection, and protections for astronauts after missions. 

SUMMARY 7 • Fidelity—the principle recognizes that individual sacrifices made for the benefit of society may give rise to societal duties in return. Given the risks that astronauts accept in participating in hazardous missions, NASA should respect the mutuality of obligations and ensure health care and protection for astro- nauts not only during the mission but after return, including provision of lifetime health care for astronauts. ETHICS-BASED RESPONSIBILITIES Acting on ethics principles creates specific responsibilities that apply to individuals and organizations engaged in particular activities. NASA, as an employer, a federal agency responsible for innovation and explora- tion, a research sponsor, and an international partner, has moral obliga- tions to formally recognize and act on responsibilities that logically flow from the ethics principles outlined in Recommendation 2. Specifically, the ethics principles need to be incorporated into decisions about whether risks in excess of those allowed under current health standards are ac- ceptable and, if so, what conditions must be satisfied to engage in ethi- cally acceptable long duration and exploration class missions. These decisions are further influenced by the limitations imposed by costs, time lines, and technological feasibility. Recommendation 3: Implement Ethics Responsibilities NASA should adopt policies or processes that formally recognize the following ethics responsibilities related to health standards for long duration and exploration spaceflights: • Fully inform astronauts about the risks of long duration and exploration spaceflights and make certain that the informed decision-making process is adequate and appropriate. • Adhere to a continuous learning strategy (including health surveillance and data collection) to ensure that health standards evolve and improve over time and are informed by data gained before, during, and after long duration and exploration spaceflights, as well as from other relevant sources. 

8 LONG DURATION AND EXPLORATION SPACEFLIGHT • Solicit independent advice about any decision to allow any specific mission that fails to meet NASA health standards or any decision to modify health standards. • Communicate with all relevant stakeholders (such as as- tronauts and the public at large) the rationale for, and possible impacts (including harm type, severity, and probability estimates) related to any decision about health standards in a procedurally transparent, fair and timely manner, providing adequate opportunity for pub- lic engagement. • Provide equality of opportunity for participation in long duration and exploration spaceflights to the fullest extent possible. For example, fairness in crew selection means that NASA should accept some group differences in pop- ulation risk in order to create equality of opportunity to participate in missions, and accommodate individual var- iance from population-based risk estimates to the extent that individual differences do not jeopardize mission operations. • Provide preventive long-term health screening and surveil- lance of astronauts and lifetime health care to protect their health, support ongoing evaluation of health stand- ards, improve mission safety, and reduce risks for cur- rent and future astronauts. • Develop and apply policies that appropriately and suffi- ciently protect the privacy and confidentiality of astronaut health data. AN ETHICS-BASED DECISION FRAMEWORK In assessments of long duration and exploration spaceflights that are unlikely to meet current health standards, NASA can facilitate its planning by structuring decision making in a three-step process (see Box S-2). The first and broadest decision (Level 1) is whether, and under what condi- tions, any missions that are unlikely to meet current health standards are ethically acceptable. If NASA decides that missions that fail to meet ex- isting health standards are not acceptable, then such missions must be deferred until new knowledge about risk or uncertainties or risk mitiga- tion strategies are available. 

SUMMARY 9 If NASA decides that exceptions to existing health standards are eth- ically acceptable, NASA must then decide what process and criteria should be applied to determine whether a specific mission should be granted an exception. Based on the ethics principles identified, criteria for reviewing exception requests could include requirements that the proposed mission • be expected to have exceptionally great social value; • have great time urgency; • have expected benefits that would be widely shared; • be justified over alternate approaches to meeting the mission’s objectives; • establish that existing health and safety standards cannot be met; • be committed to minimizing harm and continuous learning; • have a rigorous consent process to ensure that astronauts are fully informed about risks and unknowns, meet standards of informed decision making, and are making a voluntary decision; and • provide health care and health monitoring for astronauts before, during, and after flight and for the astronaut’s lifetime. An ethically acceptable process to grant exceptions would also be evidence-based, transparent, and solicit independent advice. The commit- tee emphasizes that exceptions should only be granted in rare circum- stances and should increase the responsibilities for NASA and society. The second decision level (Level 2) is whether a specific, contem- plated mission that is unlikely to meet current health standards is ethical- ly acceptable. This requires evaluating whether the mission fulfills the conditions articulated in Level 1. Whereas Level 1 could be a one-time decision by NASA that affects all long duration and exploration mis- sions,1 Level 2 decisions would be made on a mission-by-mission basis. Once a specific mission is deemed ethically acceptable, the third lev- el (Level 3) of decision making involves identification of the crew for the mission given the mission’s requisite skills and expertise, the astronauts’ health susceptibilities and personal risk factors (if known), and an indi- vidual astronaut’s informed decision to participate. Level 3 includes de- cisions by both NASA and individual astronauts. 1 It is important to note that this decision may be revisited by NASA but should adhere to the same ethics-based decision framework to justify any alterations. 

10 LONG DURATION AND EXPLORATION SPACEFLIGHT Recommendation 4: Adopt an Ethics-Based Decision Framework NASA should apply the relevant ethics principles and fulfill the concomitant responsibilities through a three-level, ethics-based decision framework that examines • Level 1: Decisions about allowing risk to astronaut health and safety in excess of that permitted by health standards, • Level 2: Decisions about undertaking specific missions, and • Level 3: Decisions concerning individual astronaut par- ticipation and crew composition. BOX S-2 Decision Framework Level 1: Decisions About Missions That Fail to Meet Health Standards Decision points: • Should NASA conduct space missions that will (a) fail to meet health standards, (b) involve significant risks where there are no applicable standards, and/or (c) involve such great uncertainty that NASA cannot exclude the possibility of a or b? • If so, what criteria should be used to determine whether excep- tions for specific missions should be allowed? Ethics principles and applications: Avoid harm, beneficence, acceptable risk-benefit balance, fidelity, transparency of decision making, commitment to continuous learning, procedural fairness of decision making Examples of ethics responsibilities: • Ensure that all feasible means will be taken to reduce astronaut risks to the lowest achievable levels • Examine all approaches to minimizing risk including alternate ap- proaches to meeting the mission’s objectives • Assess and communicate the benefits • Determine and communicate the time urgency to conduct the mission • Thoroughly monitor and conduct research on health impacts dur- ing and after spaceflight to inform current and future missions • Commit to the future health of current and future astronauts by ensuring access to health care, longitudinal follow-up, and pre- ventive screenings 

SUMMARY 11 Level 2: Decisions About Specific Missions Decision point: Given authorization for missions that will likely fail to meet existing health standards, is a specific long duration and/or explora- tion mission ethically acceptable? Ethics principles and applications: Avoid harm, acceptable risk-benefit balance, transparency of decision making, commitment to continuous learning, procedural fairness of decision making Examples of ethics responsibilities: • Adherence to criteria that are established and transparent • Share risk escalation decisions and strategies • Continue independent input to standards development and re- finement • Implement a robust program of occupational health monitoring and data collection during and after the mission • Demonstrate that standards cannot be met despite having taken all feasible measures to reduce exposures to the lowest achieva- ble level Level 3: Decisions About Crew Selection and Individual Astronaut Participation Decision point: What factors should be considered as NASA and individual astronauts make informed decisions about crew selection and indi- vidual astronaut participation for a given mission? Ethics principles and applications: Informed decision making by astro- nauts, fairness, avoid harm, risk minimization (including risk to other crew members), commitment to continuous learning while protecting privacy and confidentiality Examples of ethics responsibilities: • Thorough sharing of risk data with astronauts • Transparent and fair processes and policies on decision making • Astronaut responsibilities to participate in data collection and health monitoring during and after spaceflights to inform current and future crews • Selecting crew members in a manner that ensures fairness among groups and considers risk susceptibilities in general and for individuals in a way that allows inclusion, individual decision making within a range of risk that is prudent for the welfare of all astronauts during the mission 

12 LONG DURATION AND EXPLORATION SPACEFLIGHT CONCLUDING REMARKS From its inception, human spaceflight has pushed the boundaries of acceptable health and safety risks for astronauts. NASA, its international partners, and commercial space ventures will continue to face complex ethical decisions about risk acceptability as technologies improve and longer and more distant spaceflights become feasible. The ethics frame- work outlined in this report builds on the work of NASA and others and identifies a set of recommendations for ethically assessing and respond- ing to the challenges associated with health standards for long duration and exploration spaceflight. Establishing and maintaining a firmly grounded ethics framework for this inherently risky activity is essential to guide NASA’s decisions today and to create a strong foundation for decisions about future challenges and opportunities.