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

Chapter: 6 Recommendations for Ethics Responsibilities and Decision Framework

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Suggested Citation:"6 Recommendations for Ethics Responsibilities and Decision Framework." Institute of Medicine. 2014. Health Standards for Long Duration and Exploration Spaceflight: Ethics Principles, Responsibilities, and Decision Framework. Washington, DC: The National Academies Press. doi: 10.17226/18576.
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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, 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

Suggested Citation:"6 Recommendations for Ethics Responsibilities and Decision Framework." Institute of Medicine. 2014. Health Standards for Long Duration and Exploration Spaceflight: Ethics Principles, Responsibilities, and Decision Framework. Washington, DC: The National Academies Press. doi: 10.17226/18576.
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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 acceptable, and, if so, what conditions must be satisfied to engage in ethically 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 theories, without any intended or unintended endorsement of a particular ethical 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 astronauts 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 public engagement.

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1Limitations imposed by costs, time lines, and technological feasibility also influence decisions about long duration and exploration spaceflights.

Suggested Citation:"6 Recommendations for Ethics Responsibilities and Decision Framework." Institute of Medicine. 2014. Health Standards for Long Duration and Exploration Spaceflight: Ethics Principles, Responsibilities, and Decision Framework. Washington, DC: The National Academies Press. doi: 10.17226/18576.
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  • 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 population risk in order to create equality of opportunity to participate in missions, and accommodate individual variance from population-based risk estimates to the extent that individual differences do not jeopardize mission operations.
  • Provide preventive long-term health screening and surveillance of astronauts and lifetime health care to protect their health, support ongoing evaluation of health standards, improve mission safety, and reduce risks for current and future astronauts.
  • Develop and apply policies that appropriately and sufficiently protect the privacy and confidentiality of astronaut health data.

The committee recognizes that ethics principles would rarely be considered 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)
Suggested Citation:"6 Recommendations for Ethics Responsibilities and Decision Framework." Institute of Medicine. 2014. Health Standards for Long Duration and Exploration Spaceflight: Ethics Principles, Responsibilities, and Decision Framework. Washington, DC: The National Academies Press. doi: 10.17226/18576.
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  • 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 distinctions 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 information asymmetries between knowledgeable clinicians or investigators 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 context of informed decision making. For example, courts distinguish between 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 information: “Sophisticated investors, like all others, are entitled to the truth.”2

Similarly, concerns about lack of sophistication and inability to understand 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 exploration, 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

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2Stier v. Smith, 473 F.2d. 1205, 1207 (5th Cir. 1973).

Suggested Citation:"6 Recommendations for Ethics Responsibilities and Decision Framework." Institute of Medicine. 2014. Health Standards for Long Duration and Exploration Spaceflight: Ethics Principles, Responsibilities, and Decision Framework. Washington, DC: The National Academies Press. doi: 10.17226/18576.
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astronauts with detailed risk information during all phases of their training and work, including regular updates and involvement of the astronauts in all phases of the analysis and dissemination of risk data (Behnken, 2013). These efforts proactively afford astronauts an opportunity 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 occupationally, 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 decisions to agree or refuse participation in activities with certain types or levels of risk persist. After years of training, astronauts may feel pressured 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 research during a spaceflight “may result in removal of that individual from that mission” (NASA, 2008, p. 20). Although the procedural requirements state that such withdrawal should not influence an astronaut’s future career opportunities, the withdrawal may be considered in decisions about the astronaut’s inclusion in other missions with similar research 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 spaceflight is that there is an irreducible level of uncertainty about the risks

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3Residual 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).

Suggested Citation:"6 Recommendations for Ethics Responsibilities and Decision Framework." Institute of Medicine. 2014. Health Standards for Long Duration and Exploration Spaceflight: Ethics Principles, Responsibilities, and Decision Framework. Washington, DC: The National Academies Press. doi: 10.17226/18576.
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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 uncertainties to astronauts are a fundamental part of acting on ethics principles in the context of long duration and exploration spaceflight.

Continuous Learning

As noted throughout this report, long duration and exploration spaceflights 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 information 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 implementation 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 improvement 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 traditionally recognized a sharp distinction between the clinical care of patients 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 exploration missions, including the collection of information for both monitoring 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-

Suggested Citation:"6 Recommendations for Ethics Responsibilities and Decision Framework." Institute of Medicine. 2014. Health Standards for Long Duration and Exploration Spaceflight: Ethics Principles, Responsibilities, and Decision Framework. Washington, DC: The National Academies Press. doi: 10.17226/18576.
×

timations, and management. In addition to these efforts, NASA has opportunities to strengthen its policies about collection and analysis of data relevant to health risks and uncertainties. In a recent report, the IOM noted a huge gap in knowledge of how medications are used during spaceflight 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 diminished with relatively modest exposures to risk, and policies enabling continuous 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 respected. 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 directly 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 confidentiality may affect an astronaut’s willingness to supply medical data for purposes beyond current treatment. However, such cooperation will likely 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 information about individuals sought is: (1) sensitive (i.e., with potential negative 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.

Suggested Citation:"6 Recommendations for Ethics Responsibilities and Decision Framework." Institute of Medicine. 2014. Health Standards for Long Duration and Exploration Spaceflight: Ethics Principles, Responsibilities, and Decision Framework. Washington, DC: The National Academies Press. doi: 10.17226/18576.
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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 assessments. 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. According to the National Aeronautics and Space Act, NASA’s responsibilities include, among others, the expansion of human knowledge of space through experience and research, as well as improvement of the efficiency and safety of space vehicles.4 To put it simply, NASA is obligated to engage in space travel while managing health and safety risks, technological limitations, costs, and time lines associated with overarching programs 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 whether 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-

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4National Aeronautics and Space Act of 1958, P.L. 85-568 (July 29, 1958).

Suggested Citation:"6 Recommendations for Ethics Responsibilities and Decision Framework." Institute of Medicine. 2014. Health Standards for Long Duration and Exploration Spaceflight: Ethics Principles, Responsibilities, and Decision Framework. Washington, DC: The National Academies Press. doi: 10.17226/18576.
×

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, including 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 stakeholders, 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 responsibilities 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 maintain 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-

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551 U.S.C. 203(a)(1).

Suggested Citation:"6 Recommendations for Ethics Responsibilities and Decision Framework." Institute of Medicine. 2014. Health Standards for Long Duration and Exploration Spaceflight: Ethics Principles, Responsibilities, and Decision Framework. Washington, DC: The National Academies Press. doi: 10.17226/18576.
×

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 Federal Register to enhance transparency about decisions regarding health standards for long duration and exploration spaceflights would increase understanding about motivation, goals, and objectivity and promote stakeholder 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 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 principles and responsibilities described in this report.

The committee finds relaxing (or liberalizing) current health standards 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 standard 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

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65 U.S.C. 553(a)(2).

7Personal communication, Richard Williams, NASA, March 6, 2014.

Suggested Citation:"6 Recommendations for Ethics Responsibilities and Decision Framework." Institute of Medicine. 2014. Health Standards for Long Duration and Exploration Spaceflight: Ethics Principles, Responsibilities, and Decision Framework. Washington, DC: The National Academies Press. doi: 10.17226/18576.
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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 creating 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 exceptions 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 following ethics-based decision framework based on three separate levels of decision making. In addition to concerns about astronaut health and safety, considerations about cost, technical feasibility, and timeliness will also influence these decisions, as they affect both potential risks and benefits 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 participation and crew composition.
Suggested Citation:"6 Recommendations for Ethics Responsibilities and Decision Framework." Institute of Medicine. 2014. Health Standards for Long Duration and Exploration Spaceflight: Ethics Principles, Responsibilities, and Decision Framework. Washington, DC: The National Academies Press. doi: 10.17226/18576.
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The first and broadest decision (Level 1) is whether, and under what conditions, any missions that are unlikely to meet current health standards are ethically acceptable. If such missions are ethically acceptable, NASA must articulate specific conditions that must be fulfilled to approve 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 uncertainties 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 duration 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 astronauts. Level 3 decisions include, among other considerations, identification 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 following 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 criteria 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 uncertainties inherent to long duration and exploration spaceflights need to be balanced against the societal value or necessity of such missions, duties

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8It 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.

Suggested Citation:"6 Recommendations for Ethics Responsibilities and Decision Framework." Institute of Medicine. 2014. Health Standards for Long Duration and Exploration Spaceflight: Ethics Principles, Responsibilities, and Decision Framework. Washington, DC: The National Academies Press. doi: 10.17226/18576.
×

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 approaches 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 ensuring access to health care, longitudinal follow-up, and preventive screenings

to astronauts as expressed through fidelity, and a commitment to continuous learning and procedural fairness. When considering whether risks in excess of those allowed under existing health standards are ethically acceptable for long duration and exploration spaceflight, NASA should consider factors such as whether alternate approaches to obtaining desired 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

Suggested Citation:"6 Recommendations for Ethics Responsibilities and Decision Framework." Institute of Medicine. 2014. Health Standards for Long Duration and Exploration Spaceflight: Ethics Principles, Responsibilities, and Decision Framework. Washington, DC: The National Academies Press. doi: 10.17226/18576.
×

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 ethically acceptable, in general, the second part of a Level 1 analysis requires 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 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.

It is important to finalize the process and criteria prior to consideration of any specific mission to better ensure objective evaluation and se-

Suggested Citation:"6 Recommendations for Ethics Responsibilities and Decision Framework." Institute of Medicine. 2014. Health Standards for Long Duration and Exploration Spaceflight: Ethics Principles, Responsibilities, and Decision Framework. Washington, DC: The National Academies Press. doi: 10.17226/18576.
×

lection of proposed criteria and to allow sufficient time for NASA to engage in an independent review of the selected process and criteria, thereby 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, exceptions to existing health standards should only be granted in rare circumstances and should increase the responsibilities of NASA and society.

The selection of the process and criteria to grant exceptions to existing health standards should be evidence-based and should reflect policies that encourage independent advice and transparency of process to assuage and respond to stakeholder concerns about decisions that may expose U.S. astronauts to greater health and safety risks. The Federal Register would provide a central location for NASA to either solicit public 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

Suggested Citation:"6 Recommendations for Ethics Responsibilities and Decision Framework." Institute of Medicine. 2014. Health Standards for Long Duration and Exploration Spaceflight: Ethics Principles, Responsibilities, and Decision Framework. Washington, DC: The National Academies Press. doi: 10.17226/18576.
×

processes to ensure that the relevant ethics responsibilities are implemented 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 include 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 information, 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 existing 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
Suggested Citation:"6 Recommendations for Ethics Responsibilities and Decision Framework." Institute of Medicine. 2014. Health Standards for Long Duration and Exploration Spaceflight: Ethics Principles, Responsibilities, and Decision Framework. Washington, DC: The National Academies Press. doi: 10.17226/18576.
×

Because NASA’s health standards reflect “the best available scientific 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 astronaut health and safety beyond generally accepted levels of risk associated with specific long duration and exploration spaceflights. As such, NASA should continue to review emerging evidence to ensure appropriate 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 astronauts 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 participation decisions (including information about unknown and uncertain risk) continues to be an essential component of NASA’s risk management 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, magnitudes, 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 processes 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 astronauts and NASA decision makers may not be as pronounced as between patient and doctor or research participants and clinical researcher. Moreover, astronauts’ incentives to participate typically do not include the possibility of direct, physical benefit, and the consequences of not participating are either actually or perceived to be career limiting. Despite

______________________

9Note that traditional informed consent, in accordance with federal regulations, will continue to be needed for participation in research protocols.

Suggested Citation:"6 Recommendations for Ethics Responsibilities and Decision Framework." Institute of Medicine. 2014. Health Standards for Long Duration and Exploration Spaceflight: Ethics Principles, Responsibilities, and Decision Framework. Washington, DC: The National Academies Press. doi: 10.17226/18576.
×

these differences, efforts to insulate astronauts from actual or perceived undue pressure to participate in long duration and exploration spaceflights are essential.

In addition to individual astronauts’ decisions about whether to participate in long duration and exploration spaceflights, Level 3 also requires 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 approach 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 astronauts, 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
Suggested Citation:"6 Recommendations for Ethics Responsibilities and Decision Framework." Institute of Medicine. 2014. Health Standards for Long Duration and Exploration Spaceflight: Ethics Principles, Responsibilities, and Decision Framework. Washington, DC: The National Academies Press. doi: 10.17226/18576.
×

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 sensitivities 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 framework outlined in this report builds on the work of NASA and others and identifies a set of recommendations for ethically assessing and responding 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.

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Suggested Citation:"6 Recommendations for Ethics Responsibilities and Decision Framework." Institute of Medicine. 2014. Health Standards for Long Duration and Exploration Spaceflight: Ethics Principles, Responsibilities, and Decision Framework. Washington, DC: The National Academies Press. doi: 10.17226/18576.
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Suggested Citation:"6 Recommendations for Ethics Responsibilities and Decision Framework." Institute of Medicine. 2014. Health Standards for Long Duration and Exploration Spaceflight: Ethics Principles, Responsibilities, and Decision Framework. Washington, DC: The National Academies Press. doi: 10.17226/18576.
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Suggested Citation:"6 Recommendations for Ethics Responsibilities and Decision Framework." Institute of Medicine. 2014. Health Standards for Long Duration and Exploration Spaceflight: Ethics Principles, Responsibilities, and Decision Framework. Washington, DC: The National Academies Press. doi: 10.17226/18576.
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Suggested Citation:"6 Recommendations for Ethics Responsibilities and Decision Framework." Institute of Medicine. 2014. Health Standards for Long Duration and Exploration Spaceflight: Ethics Principles, Responsibilities, and Decision Framework. Washington, DC: The National Academies Press. doi: 10.17226/18576.
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Suggested Citation:"6 Recommendations for Ethics Responsibilities and Decision Framework." Institute of Medicine. 2014. Health Standards for Long Duration and Exploration Spaceflight: Ethics Principles, Responsibilities, and Decision Framework. Washington, DC: The National Academies Press. doi: 10.17226/18576.
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Suggested Citation:"6 Recommendations for Ethics Responsibilities and Decision Framework." Institute of Medicine. 2014. Health Standards for Long Duration and Exploration Spaceflight: Ethics Principles, Responsibilities, and Decision Framework. Washington, DC: The National Academies Press. doi: 10.17226/18576.
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Suggested Citation:"6 Recommendations for Ethics Responsibilities and Decision Framework." Institute of Medicine. 2014. Health Standards for Long Duration and Exploration Spaceflight: Ethics Principles, Responsibilities, and Decision Framework. Washington, DC: The National Academies Press. doi: 10.17226/18576.
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Suggested Citation:"6 Recommendations for Ethics Responsibilities and Decision Framework." Institute of Medicine. 2014. Health Standards for Long Duration and Exploration Spaceflight: Ethics Principles, Responsibilities, and Decision Framework. Washington, DC: The National Academies Press. doi: 10.17226/18576.
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Suggested Citation:"6 Recommendations for Ethics Responsibilities and Decision Framework." Institute of Medicine. 2014. Health Standards for Long Duration and Exploration Spaceflight: Ethics Principles, Responsibilities, and Decision Framework. Washington, DC: The National Academies Press. doi: 10.17226/18576.
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Since its inception, the U.S. human spaceflight program has grown from launching a single man into orbit to an ongoing space presence involving numerous crewmembers. As the U.S. space program evolves, propelled in part by increasing international and commercial collaborations, long duration or exploration spaceflights - such as extended stays on the International Space Station or missions to Mars - become more realistic. These types of missions will likely expose crews to levels of known risk that are beyond those allowed by current health standards, as well as to a range of risks that are poorly characterized, uncertain, and perhaps unforeseeable. As the National Aeronautics and Space Administration (NASA) and Congress discuss the next generation of NASA's missions and the U.S. role in international space efforts, it is important to understand the ethical factors that drive decision making about health standards and mission design for NASA activities.

NASA asked the Institute of Medicine to outline the ethics principles and practices that should guide the agency's decision making for future long duration or exploration missions that fail to meet existing health standards. Health Standards for Long Duration and Exploration Spaceflight identifies an ethics framework, which builds on the work of NASA and others, and presents a set of recommendations for ethically assessing and responding to the challenges associated with health standards for long duration and exploration spaceflight.As technologies improve and longer and more distant spaceflight becomes feasible, NASA and its international and commercial partners will continue to face complex decisions about risk acceptability. This report provides a roadmap for ethically assessing and responding to the challenges associated with NASA's health standards for long duration and exploration missions. 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.

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