-
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
-
2
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
-
3
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?
-
4
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
-
5
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.
-
6
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.
-
7
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
-
8
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.
-
9
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.
-
10
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.
-
11
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.
-
12
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.
-
13
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.
-
14
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.
-
15
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.
-
16
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
-
17
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.
-
18
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
-
19
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
-
20
Wrap-up
Public release: April 2, 2014 NASA implementa3on ongoing Free
PDFs of the report
available at : www.iom.edu/LongDura3onSpaceight