6

Recommendations for Ethics Responsibilities and Decision Framework

An ethics framework to guide decision making is more than just the identification of applicable, individual ethics principles. The translation of ethics principles into ethical policy generally requires specific actions by specific actors across multiple levels, including individual, administrative, and societal. As the National Aeronautics and Space Administration (NASA) considers how to approach ethical questions associated with health standards for long duration and exploration spaceflight, NASA and other policy makers must confront the additional responsibilities that accompany decisions allowing individuals to accept levels of risk to health and safety beyond those generally acknowledged as upper limits. This chapter discusses specific responsibilities that stem from the ethics principles identified in Chapter 5, and endorses a decision framework for health standards for long duration and exploration spaceflight. The recommendations in this chapter contain many components that NASA has considered or is already implementing in its work on health standards for spaceflight. However, the adoption of the recommended responsibilities and decision framework not only introduces new processes and responsibilities but also alters the context in which existing components operate.

ETHICS RESPONSIBILITIES FOR LONG DURATION AND EXPLORATION SPACEFLIGHTS

As an employer, a federal agency responsible for innovation and exploration, a research sponsor, and an international partner, NASA has moral obligations to formally recognize and act on responsibilities that



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6 Recommendations for Ethics Responsibilities and Decision Framework An ethics framework to guide decision making is more than just the identification of applicable, individual ethics principles. The translation of ethics principles into ethical policy generally requires specific actions by specific actors across multiple levels, including individual, adminis- trative, and societal. As the National Aeronautics and Space Administra- tion (NASA) considers how to approach ethical questions associated with health standards for long duration and exploration spaceflight, NASA and other policy makers must confront the additional responsibili- ties that accompany decisions allowing individuals to accept levels of risk to health and safety beyond those generally acknowledged as upper limits. This chapter discusses specific responsibilities that stem from the ethics principles identified in Chapter 5, and endorses a decision frame- work for health standards for long duration and exploration spaceflight. The recommendations in this chapter contain many components that NASA has considered or is already implementing in its work on health standards for spaceflight. However, the adoption of the recommended responsibilities and decision framework not only introduces new pro- cesses and responsibilities but also alters the context in which existing components operate. ETHICS RESPONSIBILITIES FOR LONG DURATION AND EXPLORATION SPACEFLIGHTS As an employer, a federal agency responsible for innovation and ex- ploration, a research sponsor, and an international partner, NASA has moral obligations to formally recognize and act on responsibilities that 133

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134 LONG DURATION AND EXPLORATION SPACEFLIGHT logically flow from the ethics principles outlined in Recommendation 2 if long duration and exploration spaceflights are acceptable. 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.1 The committee’s view is that such responsibilities are consistent not only with the principles identified but also with a range of ethical theo- ries, without any intended or unintended endorsement of a particular eth- ical theory. 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. • 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. 1 Limitations imposed by costs, time lines, and technological feasibility also influence decisions about long duration and exploration spaceflights.

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ETHICS RESPONSIBILITIES AND DECISION FRAMEWORK 135 • 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. The committee recognizes that ethics principles would rarely be con- sidered or applied in isolation when making decisions about health standards for long duration and exploration spaceflights. The following section discusses a few examples of how ethics responsibilities may overlap or can be applied in a coordinated approach. Informed Decision Making The need for well-informed decisions involving risk is recognized in many different legal and ethical contexts, including separate but related informed consent requirements for research involving human participants and for medical treatment decisions (Faden and Beauchamp, 1986; CIOMS, 2002; Mazur, 2003; Tauber, 2005); securities regulations that rely on mandated disclosures by companies as the primary mode of risk protection for investors (Schwartz, 2010); and diverse legal doctrines that treat consents and agreements as ineffective if parties did not understand the acts and consequences to which they were agreeing (e.g., ALI, 1979). Considerable consensus exists about certain requirements that must be satisfied for an individual’s consent to be valid: • Decisional competence of the consenting individual (e.g., an adult of sound mind)

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136 LONG DURATION AND EXPLORATION SPACEFLIGHT • Voluntary decision making (i.e., free of undue influence or pressure) • Sufficient understanding and comprehension of the elements involved (e.g., nature, duration, purpose, and risks) to make an informed decision about the consequences of consent. (Faden and Beauchamp, 1986; Gostin, 1995; Emanuel et al., 2000) The committee adopted the term “informed decision making” to refer to the process through which astronauts make individual decisions to participate in specific long duration and exploration spaceflight. In many respects, astronauts’ participation during such spaceflight parallels other contexts in which the concept of informed consent is applied, especially when space missions involve human research. However, important dis- tinctions exist that make the term “informed consent” inappropriate in the context of this committee’s task. Sophisticated Decision Makers The concept of “informed consent” as applied in medical settings and in research involving human participants presumes significant in- formation asymmetries between knowledgeable clinicians or investiga- tors and the non-expert (and often ill) patients or research participants who must consent to treatment or participation. However, courts have drawn distinctions between different types of decision makers in the con- text of informed decision making. For example, courts distinguish be- tween unsophisticated and sophisticated investors when applying the protections of U.S. securities regulations (Fletcher, 1988). Even in this circumstance, courts afford some protection to the sophisticated investor, particularly with respect to ensuring accurate disclosure of risk infor- mation: “Sophisticated investors, like all others, are entitled to the truth.”2 Similarly, concerns about lack of sophistication and inability to un- derstand and apply information are usually more limited in the context of astronauts’ decisions about spaceflight risks. Astronauts are members of a professional community and culture committed to discovery and explo- ration, and their role is, in part, that of a co-venturer who shares (rather than passively incurs) risk in pursuit of goals that are personal as well as organizational. As part of the astronaut corps training, NASA provides 2 Stier v. Smith, 473 F.2d. 1205, 1207 (5th Cir. 1973).

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ETHICS RESPONSIBILITIES AND DECISION FRAMEWORK 137 astronauts with detailed risk information during all phases of their train- ing and work, including regular updates and involvement of the astro- nauts in all phases of the analysis and dissemination of risk data (Behnken, 2013). These efforts proactively afford astronauts an oppor- tunity to consider the risks somewhat dispassionately, and over extended time periods, before accepting a crew position for any given spaceflight. Decisions to participate in long duration and exploration spaceflights must be consistent with valid informed decision making for individuals engaged in activities with elevated levels of risk. Not all risks can be morally adjudicated by leaving the decisions entirely to high-functioning, autonomous, and sufficiently voluntary participants. Astronauts are oc- cupationally, psychologically, and culturally predisposed to accept the risks associated with spaceflight. NASA already recognizes the need for additional layers of approval in situations involving elevated levels of risk. In addition to an astronaut’s decision to participate in a specific mission, the “responsible program, project, or operations manager needs to formally accept” residual risks to human safety, in addition to formal concurrence from the responsible technical authorities (NASA, 2012, p. 35). Concerns about possible influences on individual astronaut’s deci- sions to agree or refuse participation in activities with certain types or levels of risk persist. After years of training, astronauts may feel pres- sured to accept residual risk3 or risks inherent to human research during the mission because selection for spaceflight is rare. NASA procedural requirements state that an astronaut’s decision not to participate in re- search during a spaceflight “may result in removal of that individual from that mission” (NASA, 2008, p. 20). Although the procedural re- quirements state that such withdrawal should not influence an astronaut’s future career opportunities, the withdrawal may be considered in deci- sions about the astronaut’s inclusion in other missions with similar re- search protocols (NASA, 2008). Irreducible Uncertainty of Available Risk Information Another decisional challenge lies in “confronting the unknown and making difficult choices in the face of limited information” (Farber, 2011, p. 901). The reality of long duration and exploration human space- flight is that there is an irreducible level of uncertainty about the risks 3 Residual risk “is the remaining risk that exists after all mitigation actions have been implemented or exhausted in accordance with the risk management process” (NASA, 2013, p. 2).

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138 LONG DURATION AND EXPLORATION SPACEFLIGHT involved. Even after disclosure of the best available information about risks to the decision maker, a truthful and complete disclosure must acknowledge that material risks may exist that remain unforeseen and unknown, and many risks that are anticipated are impossible to quantify with any precision. Informed decision making does not require that all risk factors be known or quantifiable, but efforts to communicate the un- certainties to astronauts are a fundamental part of acting on ethics princi- ples in the context of long duration and exploration spaceflight. Continuous Learning As noted throughout this report, long duration and exploration space- flights include some highly uncertain and unknown risks, particularly those associated with the types and probabilities of harm. Implementing the relevant ethics principles requires the collection and analysis of in- formation before, during, and after the mission to reduce uncertainty and improve understanding of known health and safety risks. Continuous learning in health care has the potential to improve the care of individual patients, as well as other future patients, by rapidly translating data collected from patients’ encounters into generalizable knowledge that can be incorporated into future clinical practice (IOM, 2007). The “learning health system” model is based upon the implemen- tation of effective and efficient policies to promote continuous learning. The Institute of Medicine (IOM) has defined a learning health system as a health care system “in which knowledge generation is so embedded into the core of the practice of medicine that it is a natural outgrowth and product of the healthcare delivery process and leads to continual im- provement in care” (IOM, 2007, p. 6). This model has had profound implications for clinical and research ethics involving humans because ethics and policy in this area have tradi- tionally recognized a sharp distinction between the clinical care of pa- tients and research that involves human participants (Kass et al., 2013). Efforts are now under way to modernize ethical frameworks in response to this blurring of roles (Faden et al., 2013). Continuous learning has clear application for long duration and ex- ploration missions, including the collection of information for both moni- toring and research on individual health impacts and for setting or refining health standards. As NASA’s own processes for continuous risk management indicate, each space mission provides opportunities for learning about health risks, thus enabling refinement of monitoring, es-

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ETHICS RESPONSIBILITIES AND DECISION FRAMEWORK 139 timations, and management. In addition to these efforts, NASA has op- portunities to strengthen its policies about collection and analysis of data relevant to health risks and uncertainties. In a recent report, the IOM not- ed a huge gap in knowledge of how medications are used during space- flight because “there is no mandatory systematic collection of data” (IOM, 2014, p. 15). The IOM has suggested the use of an occupational health and safety model to enhance data collection at NASA (IOM, 2001, 2014). As part of a policy for managing health risks and uncertainty, NASA should build on its health monitoring processes and protocols before, during, and after missions (including its longitudinal study of astronauts’ health) with the goal of learning more about the short- and long-term health effects of spaceflight on astronauts and the impact of prevention and treatment strategies. Often, uncertainties can be dimin- ished with relatively modest exposures to risk, and policies enabling con- tinuous learning could contribute to substantial advancements in understanding of, and responses to, risks and uncertainties related to current and future spaceflights involving humans. Of course, data collection often implicates important privacy and confidentiality interests that must be appropriately protected and respect- ed. A 2007 IOM report on the learning health care system advocated “advancement … of the use of clinical data as a central common resource for advancing knowledge and evidence for effective care—including di- rectly addressing current challenges related to the treatment of data as a proprietary good and interpretations of the Health Insurance Portability and Accountability Act (HIPAA) and other patient privacy issues that currently present barriers” (IOM, 2007, p. 6). Concerns about confidenti- ality may affect an astronaut’s willingness to supply medical data for purposes beyond current treatment. However, such cooperation will like- ly serve astronauts’ interests when shared medical information is used to refine treatment or protocols during the course of a mission or to revise health standards for future missions. The use of a “trusted broker” as an intermediary to ensure patient confidentiality while facilitating access to data is one possible means of ensuring privacy while collecting useful data (Boyd et al., 2009). More nuanced balancing of the goals of privacy protections and continuous learning will be required when the infor- mation about individuals sought is: (1) sensitive (i.e., with potential neg- ative impact for future participation in missions, misuse by others, or even embarrassment); and (2) likely to be used in ways that will benefit astronauts on future missions rather than the individuals from whom the information is sought.

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140 LONG DURATION AND EXPLORATION SPACEFLIGHT Independent Advice In the United States, independent advisors or decision makers are commonly involved in regulatory activities or policy determinations that involve high-risk activities. Many institutions charged with engaging in risky activities are also responsible for related risk management assess- ments. For instance, U.S. academic institutions, which earn revenue and prestige by hosting clinical trials, also are required to perform their own ethical assessments of human studies. NASA is similarly structured. Ac- cording to the National Aeronautics and Space Act, NASA’s responsibil- ities include, among others, the expansion of human knowledge of space through experience and research, as well as improvement of the efficien- cy and safety of space vehicles.4 To put it simply, NASA is obligated to engage in space travel while managing health and safety risks, techno- logical limitations, costs, and time lines associated with overarching pro- grams and specific missions. Such a governance structure has the potential to lead to significant conflicts of interest within the governing agency or institution. In many other high-risk fields, independent review processes are used to insulate decisions about safety and risk from other competing institutional imperatives, such as production pressures. For example, in research involving humans, institutional review boards review, approve, and may modify research protocols independently of, but in coordination with, research-related entities to ensure compliance with federal research rules and regulations and the ethics principles intended to protect research participants (HHS, 1993). In some cases, elevated risks to research participants may require oversight by Data Safety Monitoring Boards, which review and evaluate study data to maintain participant safety, study conduct and progress, and efficacy (NIDCR, 2014). Independent advisors should inform NASA’s decisions about wheth- er to participate in long duration and exploration spaceflights that are unlikely to meet existing health standards to protect astronauts’ health and safety. NASA’s process to establish health standards involves both internal and external medical experts (see Chapter 2). Before determining whether specific circumstances allow for spaceflights that fail to meet health standards, NASA should continue to seek independent advice from individuals with relevant medical, social, ethical, and engineering expertise (including former astronauts). Further, such independent analy- 4 National Aeronautics and Space Act of 1958, P.L. 85-568 (July 29, 1958).

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ETHICS RESPONSIBILITIES AND DECISION FRAMEWORK 141 sis should include people with varying but credible views on mission benefits, risks, and safety countermeasure feasibility to ensure a thorough and exhaustive analysis before NASA reaches any final decisions. Transparency Successful long duration and exploration missions require sufficient levels of transparency regarding policy and procedure development and implementation to promote accountability, provide a mechanism and incentive for amending decisions, and build trust among stakeholders. Although transparency can also carry liabilities, such as inhibition of open and frank deliberations, the committee views transparency as a responsibility to share information and engage external stakeholders, in- cluding the public, as critical voices to shape the vision and sustain the moral foundation of public institutions. The committee endorses NASA’s recent efforts to enhance its decision-making culture through processes that are available to all stake- holders, which is an important step toward building and maintaining the ongoing trust in NASA as an agency and in its directives. As a public agency whose actions are of great interest and potential consequence to the broad public, NASA will be more likely to satisfy its ethics responsi- bilities if opportunities are provided for public comment and input about decisions related to health standards for long duration and exploration spaceflight. The Federal Register is an effective means by which to engage the public, and NASA should consider using this vehicle not only to main- tain transparency of process but also to seek useful suggestions, advice, and reactions from the public about health standards for long duration and exploration spaceflights. Many agencies use the Federal Register to post notices of proposed and final rulemaking and to provide the public with an opportunity to review and comment on government regulations or policies. For example, proposed new or modified OSHA regulations are subject to public review and comment as a statutory requirement. Under the National Aeronautics and Space Act, in performance of its functions to “plan, direct, and conduct aeronautical and space activities,” NASA is authorized to make rules and regulations governing the manner of its operations.5 Pursuant to the Administrative Procedure Act, which exempts matters relating to agency management or personnel from Fed- 5 51 U.S.C. 203(a)(1).

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142 LONG DURATION AND EXPLORATION SPACEFLIGHT eral Register publication requirements,6 NASA is not required to publish its health standards in the Federal Register for formal rulemaking.7 In most cases, it would be possible for NASA to use the Federal Register in a way that would not needlessly delay or interfere with sound and timely decisions. The committee believes that using mechanisms such as the Fed- eral Register to enhance transparency about decisions regarding health standards for long duration and exploration spaceflights would increase un- derstanding about motivation, goals, and objectivity and promote stakehold- er trust and willingness to support the commitment of resources required for long duration and exploration missions. AN ETHICS-BASED DECISION FRAMEWORK If a human spaceflight mission cannot meet current health standards, or if inadequate information exists to revise a health standard, the options, as identified and examined by the committee, would be to: (1) liberalize the NASA health standards, (2) establish more permissive “long duration and exploration health standards,” or (3) grant an excep- tion to the standard in order to conduct these missions before new protec- tive 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 principles 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” (NASA, 2007, p. 8). Moreover, review of health standards occurs every 5 years or can be triggered any time that new research data or clinical observations indicate an update may be necessary. Modifying health standards outside of this established process merely to permit long duration 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 6 5 U.S.C. 553(a)(2). 7 Personal communication, Richard Williams, NASA, March 6, 2014.

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ETHICS RESPONSIBILITIES AND DECISION FRAMEWORK 143 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- mission basis and used under very limited circumstances following the ethics-based decision framework recommended. To determine whether exceptions to health standards are ever acceptable for space missions and, if so, whether individual missions adhere to the ethics principles and responsibilities articulated in this report, NASA should adopt the follow- ing ethics-based decision framework based on three separate levels of decision making. In addition to concerns about astronaut health and safe- ty, considerations about cost, technical feasibility, and timeliness will also influence these decisions, as they affect both potential risks and ben- efits of specific missions. 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.

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144 LONG DURATION AND EXPLORATION SPACEFLIGHT The first and broadest decision (Level 1) is whether, and under what conditions, any missions that are unlikely to meet current health stand- ards are ethically acceptable. If such missions are ethically acceptable, NASA must articulate specific conditions that must be fulfilled to ap- prove an exception to health standards. If NASA decides that missions that fail to meet existing health standards are not acceptable, then such missions must be deferred until new knowledge about risk or uncertain- ties or risk mitigation strategies are available. The second level of decision making concerns whether a specific mission is ethically acceptable. This analysis requires evaluating whether the mission meets the conditions enumerated under Level 1. Whereas Level 1 could be a one-time decision by NASA that affects all long dura- tion and exploration missions that are unlikely to meet existing health standards,8 Level 2 decisions would be made on a mission-by-mission basis. If a specific mission is deemed ethically acceptable, the third level of decision making involves decisions by both NASA and individual astro- nauts. Level 3 decisions include, among other considerations, identifica- tion of mission crews given the requisite skills and expertise, the astronauts’ health susceptibilities and personal risk factors (if known), and an individual astronaut’s informed decision to participate. The fol- lowing section describes how the recommended ethics-based decision framework could be applied. Level 1: Decisions About the Limits of Health Standards Level 1 decisions involve two basic questions (see Box 6-1). First, as a general rule, 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? Second, if so, what crite- ria should be used to determine whether exceptions for specific missions should be allowed? Ethically, a thorough risk-benefit analysis is essential to determine whether health standards should ever be granted. The risks and uncer- tainties inherent to long duration and exploration spaceflights need to be balanced against the societal value or necessity of such missions, duties 8 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.

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ETHICS RESPONSIBILITIES AND DECISION FRAMEWORK 145 BOX 6-1 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 exceptions 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 during and after spaceflight to inform current and future missions • Commit to the future health of current and future astronauts by ensur- ing access to health care, longitudinal follow-up, and preventive screenings to astronauts as expressed through fidelity, and a commitment to contin- uous learning and procedural fairness. When considering whether risks in excess of those allowed under existing health standards are ethically ac- ceptable for long duration and exploration spaceflight, NASA should consider factors such as whether alternate approaches to obtaining de- sired information (e.g., unmanned spaceflights) are possible, whether delays in human spaceflights would likely lead to missions of similar benefits at significantly lower risk in the future, whether all feasible measures have been taken to minimize risks through engineering or other controls, and whether such missions are sufficiently urgent to justify risks to astronauts’ health and safety above existing limits. Two of the ethics responsibilities that result from sanctioning high- risk activities include continuous learning and engagement in health- related activities that protect astronaut health, support ongoing evaluation

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146 LONG DURATION AND EXPLORATION SPACEFLIGHT of health standards, improve mission safety, and reduce risks for current and future astronauts. Employers that knowingly expose employees to risks have an ethical responsibility to provide protection to the extent possible and to address the harms that occur when protection fails or turns out to be inadequate. Robust research and health-monitoring or surveillance programs that fully inform all who are involved, including astronauts and their families, are required. Furthermore, the committee maintains that the nation, through NASA, has the ethical duties to protect and sustain astronauts’ health based on the ethics principles of fairness and fidelity. In the same way that the nation maintains its fidelity to its military veterans, providing lifetime health care to astronauts respects the commitment that astronauts have made and the risks they have taken on society’s behalf. If NASA decides that exceptions to existing health standards are eth- ically acceptable, in general, the second part of a Level 1 analysis re- quires NASA to decide what process and criteria should be applied to determine whether a specific mission should be granted an exception. An ethically acceptable process to grant exceptions would require a strict set of evidence-based criteria to evaluate whether a mission should qualify for an exception. The same criteria would apply to any mission that would fail to meet existing health standards. Based on the ethics princi- ples 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 ful- ly informed about risks and unknowns, meet standards of in- formed 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. It is important to finalize the process and criteria prior to considera- tion of any specific mission to better ensure objective evaluation and se-

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ETHICS RESPONSIBILITIES AND DECISION FRAMEWORK 147 lection of proposed criteria and to allow sufficient time for NASA to en- gage in an independent review of the selected process and criteria, there- by ensuring both objective and broad input about engagement in high- risk activities and associated risk management decisions. The committee emphasizes that, even if determined to be ethically acceptable, excep- tions to existing health standards should only be granted in rare circum- stances and should increase the responsibilities of NASA and society. The selection of the process and criteria to grant exceptions to exist- ing health standards should be evidence-based and should reflect policies that encourage independent advice and transparency of process to as- suage and respond to stakeholder concerns about decisions that may ex- pose U.S. astronauts to greater health and safety risks. The Federal Register would provide a central location for NASA to either solicit pub- lic input or publish the rationale and final decisions about whether to grant exceptions to existing health standards and, if so, about the process and criteria used to weigh exceptions for a specific long duration and exploration mission. Whether provided through the Federal Register or NASA’s website, these notices or solicitations for public comment should define key terms (e.g., what constitutes an “exceptional” mission and what constitutes a “sufficient” understanding of relevant facts for purposes of informed decision making), identify common characteristics of the class of spaceflights at issue, designate specific ethics principles upon which analyses are based, explain how potential conflicts between principles were resolved, clarify the factors considered when weighing anticipated benefits and risks of harm, and describe any limitations to the decision’s applicability. Level 2: Decisions Regarding Specific Missions If NASA concludes that any space missions that fail to meet health standards are ethically acceptable, Level 2 decisions focus on the health risks of specific, contemplated missions (see Box 6-2). If a mission fulfills the criteria established under Level 1, the scope of the health- standards exception (e.g., upper limits of excess exposure) would be determined on a mission-by-mission basis. Decisions regarding a specific mission’s goals and destination (e.g., the International Space Station for 12 months, the Moon, near-Earth asteroid, Mars) involve a complex evaluation of whether a mission meets the criteria articulated in the first tier of decision making. In particular, an independent ethical review of the specific mission should examine all

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148 LONG DURATION AND EXPLORATION SPACEFLIGHT processes to ensure that the relevant ethics responsibilities are imple- mented before, during, and after flight and that the public has access to decisions and actions related to those responsibilities. Given the long lead time of most mission planning, the ethical review process should in- clude periodic reassessments, as warranted, during the period from provisional approval to launch. Poor decisions often result from excessive commitment to a prior decision without the benefit of subsequently available infor- mation, contrary to the ethics responsibility of continuous learning. The ongoing ethics review would consider the risk-benefit balance, detail the feasibility of alternative mission designs, demonstrate that ex- isting health standards still cannot be met despite technological advances and having taken all possible measures to reduce exposures to the lowest achievable level, and explore how this specific mission could impact the institutional integrity of NASA as a leader in safe and productive space exploration. The review would examine the plans for continuous learning throughout the flight and postflight, including how knowledge gained would be used to improve crew members’ health, as well as to inform health standards for future crews. Additionally, the review would ensure that protocols for health status monitoring, treatment, and health care were in place postflight for astronauts. BOX 6-2 Decision Framework—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 exploration 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 refinement • 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 achievable level

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ETHICS RESPONSIBILITIES AND DECISION FRAMEWORK 149 Because NASA’s health standards reflect “the best available scien- tific and clinical evidence” (NASA, 2007, p. 8), decisions about whether a specific mission is ethically acceptable should use existing health standards to characterize, to the extent possible, the levels of risk to as- tronaut health and safety beyond generally accepted levels of risk associ- ated with specific long duration and exploration spaceflights. As such, NASA should continue to review emerging evidence to ensure appropri- ate revision of existing health standards and development of new health standards. NASA should also continue to identify gaps in knowledge and launch research efforts to generate information where needed. Level 3: Decisions on Crew Selection and Individual Astronaut Participation Level 3 includes decisions by NASA officials and individual astro- nauts related to crew selection and participation (see Box 6-3). NASA should continue its efforts to fully inform potential crew members about the nature and extent of spaceflight risks, the state of research knowledge, and the risk management plans. Ensuring that astronauts have the full range of information available on which to base their partic- ipation decisions (including information about unknown and uncertain risk) continues to be an essential component of NASA’s risk manage- ment process. If an individual astronaut is invited to participate in space missions that expose that individual to risks in excess of those allowed by existing health standards, NASA must fully disclose the types, magni- tudes, and possible consequences of known and uncertain risk beyond established limits, as well as the increased likelihood of unknown risks to health and safety. As discussed in Chapters 4 and 5, informed decision-making pro- cesses relevant to long duration or exploration spaceflight participation may differ from traditional informed consent (e.g., clinical trials for drug development).9 For example, information asymmetries between astro- nauts and NASA decision makers may not be as pronounced as between patient and doctor or research participants and clinical researcher. More- over, astronauts’ incentives to participate typically do not include the possibility of direct, physical benefit, and the consequences of not partic- ipating are either actually or perceived to be career limiting. Despite 9 Note that traditional informed consent, in accordance with federal regulations, will continue to be needed for participation in research protocols.

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150 LONG DURATION AND EXPLORATION SPACEFLIGHT these differences, efforts to insulate astronauts from actual or perceived undue pressure to participate in long duration and exploration space- flights are essential. In addition to individual astronauts’ decisions about whether to par- ticipate in long duration and exploration spaceflights, Level 3 also re- quires NASA to make decisions about the balance between individual risk susceptibilities affecting health and the need for a diverse mission crew. The rare opportunities for spaceflight heighten the need to ap- proach each mission as a source of potential data that may contribute to understanding of general health impacts of long duration and exploration spaceflight, and the risks for specific subpopulations. In the same manner that terrestrial medicine is rapidly recognizing individual variation in response to illness and medication, specific susceptibilities of individual astronauts should influence preventive measures, countermeasures, and tailoring of treatments. As more information emerges about genomic and other markers of susceptibility to injury or disease, it could be possible BOX 6-3 Decision Framework—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 individual 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 indi- viduals 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

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ETHICS RESPONSIBILITIES AND DECISION FRAMEWORK 151 that every astronaut candidate would be found to have one or more marker of increased sensitivity. Depending on the long-term vision for human space travel, it will likely be important to understand the impact of spaceflight and the space environment on individuals with varied sen- sitivities and susceptibilities. Regardless of the balance struck between the ethics principles “avoid harm” and “fairness,” NASA must follow polices and guidelines that ensure continuous learning while protecting astronauts’ privacy and confidentiality. 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. REFERENCES ALI (American Law Institute). 1979. Restatement of the law second, torts. Vol. 4. Philadelphia, PA: ALI. Behnken, R., M. Barratt, S. Walker, and P. Whitson. 2013. Presentation to the Institute of Medicine, Ethics Principles and Guidelines for Health Standards for Long Duration and Exploration Spaceflights: Astronaut Office. PowerPoint presented at the second meeting of the IOM Committee on Ethics Principles and Guidelines for Health Standards for Long Duration and Exploration Spaceflights. Washington, DC, July 25. http://www.iom.edu/~/ media/Files/Activity%20Files/Research/HealthStandardsSpaceflight/2013- JUL-25/Panel%202%20Astronaut%20Corp%20Final%20IOM_presentation final2.pdf (accessed November 8, 2013).

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