Health Standards for Long Dura3on and Explora3on Spaceight:

Ethics Principles, Responsibili3es, and Decision Framework

FISO Telecon 04.15.2015Jeffrey Kahn, Chair IOM Committee on the

Ethics Principles and Guidelines for Health Standards for Long Duration and Exploration Spaceflights

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IOM Committee JEFFREY KAHN (Chair), Johns Hopkins University NANCY CONRAD, The Conrad Founda:on PETER F. DEMITRY, 4-D Enterprises, LLC BONNIE J. DUNBAR, University of Houston, Texas BARBARA J. EVANS, University of Houston Law Center BERNARD A. HARRIS, Vesalius Ventures DAVID G. HOEL, Medical University of South Carolina JONATHAN KIMMELMAN, McGill University ANNA C. MASTROIANNI, University of Washington School of Law LAWRENCE PALINKAS, University of Southern California CAROL E.H. SCOTT-CONNER, University of Iowa Hospitals & Clinics MICHAEL A. SILVERSTEIN, University of Washington School of Public Health RONALD E. TURNER, ANSER (Analy:c Services) R. LEONARD VANCE, Virginia Commonwealth University GREGORY R. WAGNER, Na:onal Ins:tute for Occupa:onal Safety and Health

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Statement of Task Highlights

The IOM commiTee was asked to examine ethical and policy principles relevant to long dura:on and explora:on spaceights that are unlikely to meet NASAs exis:ng health standards. The commiTee considered the applica:on of exis:ng health standards and the poten:al development of new health standards. Ques:ons considered included:

What factors should be considered in the implementa:on of current health standards in explora:on class missions and the development of explora:on class health standards if necessary?

Are there models or examples of other situa:ons with unknown health risks (or risks that could exceed current standards) that could inform NASA policy and, if so, how?

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Relevant Factors from Decision Making for Other High-Risk Occupations The commiTee found no exis3ng ethics frameworks or decision-making models for terrestrial occupa3ons that were directly and wholly applicable to decisions about health standards spaceight.

The commiTee iden3ed some common factors that underlie decisions about risk across a wide range of oversight:

Types and severity of risk The presence of actual harm Types and distribu:on of poten:al risks and benets Purpose of the ac:vity The nature of the rela:onship between individuals approving ac:vity and those subject to risk from it

The presence of independent oversight The feasibility of mi:ga:on of risk

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Options If a human spaceight mission cannot meet NASAs current health standards, or if inadequate informa3on exists to revise a health standard, the op3ons as iden3ed and examined by the commiTee, would include:

Liberalizing exis:ng health standards, Establishing more permissive health standards for long dura:on and explora:on class missions, or

Gran:ng an excep:on to exis:ng health standards to allow missions before new mi:ga:on technologies and strategies are available to meet health standards or before health standards can be revised based on new data.

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Recommendation 1 Expand on the Policies for Ini4a4ng and Revising Health Standards NASA should ensure that its policies regarding health standards detail the condi3ons or circumstances (and relevant priori3es) that ini3ate development or revision of health standards and explicitly indicate how these policies are fully consistent with the set of ethics principles outlined in the commiTees report.

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Recommendation 2 Apply Ethics Principles to Health Standards Development and Implementa4on NASA should apply the following ethics principles in the development and implementa3on of its health standards for decisions regarding long dura3on and explora3on spaceights:

Avoid harm Benecence Favorable balance of risk and benet Respect for autonomy Fairness Fidelity

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Recommendation 2 Ethics Principles Avoid harm the principle includes the duty to prevent harm, exercise cau:on,

and remove or mi:gate harms that occur. Thus, NASA should exhaust all feasible measures to minimize the risks to astronauts from long dura:on and explora:on spaceights including addressing uncertain:es through approaches to risk preven:on and mi:ga:on that incorporate safety margins and include mechanisms for con:nuous learning that allow for incremental approaches to risk acceptance.

Benecence the principle to provide benet to others. NASA should consider in its decision making the poten:al benets of a specic mission including its scien:c and technological importance, as well as its poten:al beneciaries including current and future astronauts and members of society at large.

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Recommendation 2 Ethics Principles Favorable balance of risk and benet the principle to seek both a favorable

and acceptable balance between the risk of harm and poten:al for benet. In authorizing long dura:on and explora:on ac:vi:es and in approving par:cular missions, NASA should systema:cally assess risks and benets and the uncertain:es aTached to each, drawing on the totality of available scien:c evidence, and ensuring that benets suciently outweigh risks.

Respect for autonomy the principle to ensure that individuals have both the right to self-determina:on and processes in place to exercise that right. NASA should ensure that astronauts are able to exercise voluntariness to the extent possible in personal decision making regarding par:cipa:on in proposed missions, that they have all available informa:on regarding the risks and benets of the proposed mission, and that they con:nue to be apprised of any updates to risk and benet informa:on throughout the mission.

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Recommendation 2 Ethics Principles Fairness the principle requires that equals be treated equally, that burdens

and benets be distributed fairly, and that fair processes be created and followed. NASAs decision making surrounding missions should explicitly address fairness, including the distribu:on of the risks and benets of the mission, crew selec:on, and protec:ons for astronauts aaer missions.

Fidelity the principle recognizes that individual sacrices made for the benet of society may give rise to societal du:es in return. Given the risks that astronauts accept in par:cipa:ng in hazardous missions, NASA should respect the mutuality of obliga:ons and ensure health care and protec:on for astronauts not only during the mission but aaer return, including provision of life:me health care for astronauts.

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Recommendation 3 Implement Ethics Responsibili4es NASA should adopt policies or processes that formally recognize the following ethics responsibili3es related to health standards for long dura3on and explora3on spaceights.

Fully inform astronauts about the risks of long dura3on and explora3on spaceights and make certain that the informed decision-making process is adequate and appropriate.

Adhere to a con4nuous learning strategy (including health surveillance and data collec3on) to ensure that health standards evolve and improve over 3me and are informed by data gained before, during, and a]er long dura3on and explora3on spaceights, as well as from other relevant sources.

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Recommendation 3 (contd) Implement Ethics Responsibili4es

Solicit independent advice about any decision to allow any specic 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 ra3onale for, and possible impacts (including type of harm, its severity, and probability es3mates) related to any decision about health standards in a procedurally transparent, fair and 4mely manner, providing adequate opportunity for public engagement.

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Recommendation 3 (contd) Implement Ethics Responsibili4es

Provide equality of opportunity for par3cipa3on in long dura3on and explora3on spaceights to the fullest extent possible. For example, fairness in crew selec3on means that NASA should accept some group dierences in popula3on risk in order to create equality of opportunity to par3cipate in missions, and accommodate individual variance from popula3on-based risk es3mates to the extent that individual dierences do not jeopardize mission opera3ons.

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Recommendation 3 (contd) Implement Ethics Responsibili4es

Provide preven4ve long-term health screening and surveillance of astronauts and life4me health care to protect their health, support ongoing evalua3on of health standards, improve mission safety, and reduce risks for current and future astronauts.

Develop and apply policies that appropriately and suciently protect the privacy and conden4ality of astronaut health data.

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Recommendation 4

Adopt an Ethics-Based Decision Framework NASA should apply the relevant ethics principles and fulll the concomitant responsibili3es 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 permiTed by health standards,

Level 2: Decisions about undertaking specic missions, and Level 3: Decisions concerning individual astronaut par3cipa3on and crew composi3on.

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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

signicant 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 excepDons for specic missions are allowable?

Ethics principles and applica4ons: Avoid harm, benecence, acceptable risk/benet balance,

delity, transparency of decision making, commitment to con:nuous learning, procedural fairness of decision making

Examples of ethics responsibili4es: Ensure all feasible means are taken to reduce astronaut risks to the lowest achievable levels Examine all approaches to minimizing risk, including alternate approaches to mee:ng the

missions objec:ves Assess and communicate the benets Determine and communicate the :me urgency to conduct the mission Thoroughly monitor and conduct research on health impacts during and aaer spaceight 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 preven:ve screenings

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Process and Criteria for Granting Exceptions

The selec3on of the process and criteria to grant excep3ons to exis3ng health standards should be evidence-based and should reect policies that encourage independent advice and transparency of process. Based on the ethics principles iden3ed, criteria for reviewing excep3on requests could include requirements that the proposed mission: be expected to have excep:onally great social value, have great :me urgency, have expected benets that would be widely shared, be jus:ed over alternate approaches to mee:ng the missions objec:ves, establish that exis:ng health and safety standards cannot be met, be commiTed to minimizing harm and con:nuous learning, have a rigorous process to assure that astronauts are fully informed about risks and unknowns, their decisions meet standards of informed decision making, and that they are making a voluntary decision, and provide health care and health monitoring for astronauts before, during, and aaer ight and for the astronauts life:me.

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Level 2: Decisions about Specific Missions Decision points: Given authorizaDon for missions that will likely fail to meet exisDng health standards, is a specic long duraDon and/or exploraDon mission ethically acceptable? Ethics principles and applica4ons: Avoid harm, acceptable risk/benet balance, transparency of decision making, commitment to con:nuous learning, procedural fairness of decision making Examples of ethics responsibili4es: Adherence to criteria that are established and transparent Share risk escala:on decisions and strategies Con:nue independent input to standards development and renement Implement a robust program of occupa:onal health monitoring and data collec:on during and aaer the mission Demonstrate that standards cannot be met despite having taken all feasible measures to reduce risks to the lowest achievable level

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Level 3: Decisions About Crew Selection and Individual Astronaut Participation Decision points: What factors should be considered as NASA and individual astronauts make informed decisions about crew selecDon and individual astronaut parDcipaDon for a given mission? Ethics principles and applica4ons: Informed decision making by astronauts, fairness, avoid harm, risk minimiza:on (including risk to other crew members), commitment to con:nuous learning while protec:ng privacy and conden:ality Examples of ethics responsibili4es: Thorough sharing of risk data with astronauts Transparent and fair processes and policies on decision making Astronaut responsibili:es to par:cipate in data collec:on and health monitoring during and aaer spaceights to inform current and future crews Selec:ng crew members in a manner that ensures fairness among groups and considers risk suscep:bili:es 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

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Wrap-up

Public release: April 2, 2014 NASA implementa3on ongoing Free PDFs of the report

available at : www.iom.edu/LongDura3onSpaceight