HEALTH STANDARDS FOR
LONG DURATION AND
EXPLORATION SPACEFLIGHT

Ethics Principles, Responsibilities,
and Decision Framework

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

Board on Health Sciences Policy

Jeffrey Kahn, Catharyn T. Liverman,
and Margaret A. McCoy, Editors

INSTITUTE OF MEDICINE
          OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS

Washington, D.C.

www.nap.edu



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HEALTH ST TANDA ARDS F FOR LO DU ND ONG URATION AN EXPLO ORATIO SP ON PACEFL LIGHT Ethics Princip ples, Resp ponsibiliti ies, and Dec cision Framework Committee on Ethics Prin C n nciples and G Guidelines f Health for Standards for Long Durat S r tion and Expploration Spaaceflights Board on He B ealth Science Policy es Jef ffrey Kahn, Catharyn T. Liverman, C and Margare A. McCoy Editors a et y,

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THE NATIONAL ACADEMIES PRESS • 500 Fifth Street, NW • Washington, DC 20001 NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. This project was supported by Contract NNH13CK14D between the National Academy of Sciences and the National Aeronautics and Space Administration. The views presented in this publication are those of the editors and attributing authors and do not necessarily reflect the view of the organizations or agencies that provided support for this project. International Standard Book Number-13: 978-0-309-29657-1 International Standard Book Number-10: 0-309-29657-9 Additional copies of this report available for sale from the National Academies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624-6242 or (202) 334-3313; http://www.nap.edu. For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu. Copyright 2014 by the National Academy of Sciences. All rights reserved. Printed in the United States of America The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The serpent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin. Cover credit: All photos courtesy of the National Aeronautics and Space Administration Suggested citation: IOM (Institute of Medicine). 2014. Health standards for long duration and exploration spaceflight: Ethics principles, responsibilities, and decision framework. Washington, DC: The National Academies Press.

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The National Acade emy of Scienc is a privat nonprofit, self-perpetuati ces te, ing society of distinguish scholars en y hed ngaged in scien ntific and engin neering researc ch, dedicat to the furth ted herance of scie ence and technnology and to their use for t the general welfare. Upo the authority of the charte granted to it by the Congre l on y er ess in 1863, the Academ has a man my ndate that req quires it to ad dvise the fedeeral governnment on scie entific and tecchnical matter Dr. Ralph J. Cicerone is rs. h preside of the Natio Academy of Sciences. ent onal The National Acade emy of Engin neering was e established in 1964, under t the charter of the Natio onal Academy of Sciences, as a parallel organization of outstan nding engineers It is autonomo in its admin s. ous nistration and i the selection of in n its mem mbers, sharing with the Nation Academy o Sciences the responsibility f w nal of for advisin the federal government. The National Academy of E ng T Engineering al lso sponsor engineering programs aim at meetin national ne rs g med ng eeds, encouragges educati and researc and recogn ion ch, nizes the super rior achieveme ents of engineeers. Dr. C. D. Mote, Jr., is president of th National Aca D he ademy of Engin neering. The Institute of Med dicine was estaablished in 197 by the Natio 70 onal Academy of Science to secure th services of eminent memb es he bers of approp priate professio ons in the examination of policy matter pertaining to the health of the public. T e rs o f The Institut acts under th responsibilit given to the National Acad te he ty demy of Scienc ces by its congressional charter to be an adviser to the federal gover c c n e rnment and, up pon its own initiative, to identify issues of medical car research, an education. D n i re, nd Dr. Harvey V. Fineberg is president of the Institute of Medicine. y t f The Na ational Resea arch Council was organized by the Natio w d onal Academy of Science in 1916 to associate the broad commun of science and technolo es b nity e ogy with th Academy’s purposes of fu he urthering know wledge and adv vising the fede eral governnment. Function ning in accordance with gene policies determined by t eral the Academ the Counc has become the principal operating age my, cil e l ency of both tthe National Academy of Sciences an the Nationa Academy of Engineering in o nd al f providiing services to the govern t nment, the pu ublic, and the scientific a e and engineeering communi ities. The Coun is administ ncil tered jointly by both Academ y mies and the Institute of Medicine. Dr. Ralph J. Cicero and Dr. C. D. Mote, Jr., a e M R one are chair an vice chair, respectively, of the National Research Coun nd r ncil. w www.national l-academies.o org

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COMMITTEE ON ETHICS PRINCIPLES AND GUIDELINES FOR HEALTH STANDARDS FOR LONG DURATION AND EXPLORATION SPACEFLIGHTS JEFFREY KAHN (Chair), Johns Hopkins University, Berman Institute of Bioethics, Baltimore, MD NANCY CONRAD, The Conrad Foundation, Washington, DC PETER F. DEMITRY, 4-D Enterprises, LLC, Haymarket, VA BONNIE J. DUNBAR, University of Houston, TX BARBARA J. EVANS, University of Houston Law Center, TX BERNARD A. HARRIS, JR., Vesalius Ventures, Houston, TX DAVID G. HOEL, Medical University of South Carolina JONATHAN KIMMELMAN, McGill University, Montreal, Canada ANNA C. MASTROIANNI, University of Washington School of Law, Seattle 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 (Analytic Services, Inc.), Falls Church, VA R. LEONARD VANCE, Virginia Commonwealth University, Richmond GREGORY R. WAGNER, National Institute for Occupational Safety and Health, Washington, DC IOM Staff CATHARYN T. LIVERMAN, Co-Study Director MARGARET A. MCCOY, Co-Study Director SARAH DOMNITZ, Associate Program Officer (since December 2013) CLAIRE F. GIAMMARIA, Research Associate JUDITH L. ESTEP, Program Associate ASHNA KIBRIA, Research Associate (since December 2013) R. BRIAN WOODBURY, Senior Program Assistant (since December 2013) ANDREW M. POPE, Director, Board on Health Sciences Policy v

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Consultants TRISH LEADER, Technical Writer VICTORIA WEISFELD, Technical Writer vi

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Reviewers This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the National Research Council’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following individuals for their review of this report: John R. Ball, American College of Physicians Thomas F. Budinger, University of California, Berkeley Naomi L. Gerber, George Mason University Sven Ove Hansson, Royal Institute of Technology Mae C. Jemison, BioSentient Corporation Gloria Leon, University of Minnesota Melissa A. McDiarmid, University of Maryland School of Medicine Walter Schimmerling, East Carolina University David H. Wegman, University of Massachusetts at Lowell Laurie Zoloth, Northwestern University Although the reviewers listed above have provided many constructive comments and suggestions, they did not see the final draft of the report before its release. The review of this report was overseen by James F. Childress, University of Virginia, and Steve Fienberg, Harvard Univer- sity. Appointed by the Institute of Medicine, they were responsible for vii

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viii REVIEWERS making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review com- ments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution.

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Preface The prospect of long duration and exploration human spaceflight poses many significant challenges, not the least of which are the ethical issues raised by exposing astronauts to environments with uncertain and even unknown risks to their health, and excessive levels of known health risks. As a federally funded institution, National Aeronautics and Space Administration (NASA) recognizes that undertaking missions with such great risk and high levels of uncertainty raises challenges for decision making related to the health and safety of astronauts. In response to these concerns, the Institute of Medicine (IOM) convened a group with inter- disciplinary expertise and a range of backgrounds to analyze the ethical issues faced when existing health standards will be exceeded or when health risks are uncertain or unknown. This report represents the collective conclusions and recommenda- tions of a diverse group of experts, each of whom brought their expertise and perspectives. The charge to the committee was clear. However it did not lend itself to the typical approach of collection of data, but instead largely relied on conceptual considerations and analysis. The resulting recommendations take the form of a collection of ethics principles and a framework for their application when faced with decisions about exceed- ing existing health standards or when standards do not exist. In recom- mending this collection of principles, the committee sought to identify and articulate the relevant moral rules that must be followed in the con- text of health standards for long duration and exploration spaceflight. The committee’s considerations were informed by information from NASA, input from a range of stakeholders, and presentations from invit- ed experts at public workshops. These principles and decision-making framework are not a checklist or recipe, but rather are intended to pro- ix

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x PREFACE vide the parameters that must be satisfied for ethically acceptable health standards in these contexts. We hope they perform that function as NASA plans for future space exploration. This report benefitted immensely from the dedicated, diligent, and skilled work of the IOM staff, including Meg McCoy, Cathy Liverman, Claire Giammaria, and Judy Estep; the committee gratefully acknowl- edges their tireless efforts. Lastly, I want to thank my colleagues on the committee for their hard work and unflagging patience as we considered, and often reconsidered the ethical issues and challenges relevant to health standards for long duration and exploration spaceflight. It was a privilege to work with such a dedicated and insightful group. Jeffrey Kahn, Chair Committee on Ethics Principles and Guidelines for Health Standards for Long Duration and Exploration Spaceflights

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Acknowledgments The Institute of Medicine (IOM) Committee on Ethics Principles and Guidelines for Health Standards for Long Duration and Exploration Spaceflights would like to express its sincere gratitude to everyone who made this report possible. This report was informed by the contributions of many individuals who provided expertise, personal insights and perspectives, and data. First, the committee would like to thank National Aeronautics and Space Administration (NASA) for its support of the study. The committee especially appreciates the leadership of Richard Williams, Chief Health and Medical Officer, NASA, who was instrumental in the development of this study and in leading the responses to a number of committee requests for information throughout the study. The committee appreciates input and assistance from many other current and former NASA staff members, including John Allen, Francis Cucinotta, Jeff Davis, Homayoon Dezfuli, Donna Good, Michael Griffin, David Liskowsky, Vincent Michaud, Victor Schneider, Marc Shepanek, Ed Simones, and Paul Wolpe. The insights gained from the NASA Astronaut Office, particularly from Michael Barratt, Robert Behnken, Shannon Walker, and Peggy Whitson, provided important context for the committee’s work. The thorough and considered input provided to all of the committee’s queries was much appreciated. The committee held two public workshops in May and July 2013 and gained valuable insights from the substantive presentations provided by the speakers (see Appendix A) and participants. The committee greatly benefited from the work of the IOM study staff team: Cathy Liverman and Meg McCoy co-directed the study; Claire Giammaria provided research support; and Judy Estep skillfully xi

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xii ACKNOWLEDGMENTS managed all logistical and administrative aspects of the study. Our thanks to Andrew Pope for his leadership. Additionally, Sarah Domnitz, Ashna Kibria, and Brian Woodbury were instrumental in finalizing the report. The committee is also grateful to Trish Leader and Vicki Weisfeld of NEW Associates, LLC, for their assistance in editing the report and to Laura Penny for copyediting the report. Finally, the committee would like to express its thanks to the IOM and the National Research Council staff members who worked behind the scenes to ensure a seamless study process and successful production and dissemination of this report: Anton Bandy, Clyde Behney, Daniel Bethea, Laura DeStefano, Chelsea Frakes, Molly Galvin, Janice Mehler, Donna Randall, Lora Taylor, Erika Vijh, and Jennifer Walsh.

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Contents SUMMARY 1 1 INTRODUCTION 13 2 NASA RISK MANAGEMENT AND HEALTH STANDARDS 25 3 HEALTH RISKS 45 4 RISK ACCEPTANCE AND RESPONSIBILITIES IN HUMAN SPACEFLIGHT AND TERRESTRIAL ACTIVITIES 75 5 RECOMMENDATIONS FOR ETHICS PRINCIPLES 103 6 RECOMMENDATIONS FOR ETHICS RESPONSIBILITIES AND DECISION FRAMEWORK 133 APPENDIXES A Meeting Agendas 155 B Committee Biographical Sketches 163 xiii

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