SAFE PASSAGE

Astronaut Care for Exploration Missions

John R. Ball and Charles H. Evans, Jr., Editors

Committee on Creating a Vision for Space Medicine During Travel Beyond Earth Orbit

Board on Health Sciences Policy

INSTITUTE OF MEDICINE

NATIONAL ACADEMY PRESS
Washington, DC



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Safe Passage: Astronaut Care for Exploration Missions SAFE PASSAGE Astronaut Care for Exploration Missions John R. Ball and Charles H. Evans, Jr., Editors Committee on Creating a Vision for Space Medicine During Travel Beyond Earth Orbit Board on Health Sciences Policy INSTITUTE OF MEDICINE NATIONAL ACADEMY PRESS Washington, DC

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Safe Passage: Astronaut Care for Exploration Missions NATIONAL ACADEMY PRESS 2101 Constitution Avenue, N.W. Washington, DC 20418 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. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance. Support for this project was provided by the National Aeronautics and Space Administration. The views presented in this report are those of the Institute of Medicine Committee on Creating a Vision for Space Medicine During Travel Beyond Earth Orbit and are not necessarily those of the funding agency. Library of Congress Cataloging-in-Publication Data Institute of Medicine (U.S.). Committee on Creating a Vision for Space Medicine during Travel Beyond Earth Orbit. Safe passage: astronaut care for exploration missions/John R.Ball and Charles H.Evans, Jr., editors; Committee on Creating a Vision for Space Medicine during Travel Beyond Earth Orbit, Board on Health Sciences Policy, Institute of Medicine. p.; cm. Includes bibliographical references. ISBN 0-309-07585-8 (pbk.) 1. Astronauts—Health and hygiene. 2. Space medicine. [DNLM: 1. Aerospace Medicine—standards. 2. Health Services Needs and Demand. 3. Astronauts. 4. Radiation Effects. 5. Space Flight. 6. Weightlessness—adverse effects. WD 751 I59s 2001] I. Ball, John, 1944- II. Evans, Charles H. (Charles Hawes), 1940- III. Title. RC1135 .I576 2001 616.9’80214–dc21 2001005443 Additional copies of this report are available for sale from the National Academy Press, 2101 Constitution Avenue, N.W., Box 285, Washington, DC 20055. Call (800) 624–6242 or (202) 334–3313 (in the Washington metropolitan area), or visit the NAP’s home page at www.nap.edu. The full text of this report is available at www.nap.edu/readingroom. For more information about the Institute of Medicine, visit the IOM home page at www.iom.edu. Copyright© 2001 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.

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Safe Passage: Astronaut Care for Exploration Missions “Knowing is not enough; we must apply. Willing is not enough; we must do.” —Goethe INSTITUTE OF MEDICINE Shaping the Future for Health

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Safe Passage: Astronaut Care for Exploration Missions THE NATIONAL ACADEMIES National Academy of Sciences National Academy of Engineering Institute of Medicine National Research Council The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Bruce M.Alberts is president of the National Academy of Sciences. The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Wm.A.Wulf is president of the National Academy of Engineering. The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Kenneth I.Shine is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Bruce M.Alberts and Dr. Wm.A.Wulf are chairman and vice chairman, respectively, of the National Research Council.

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Safe Passage: Astronaut Care for Exploration Missions COMMITTEE ON CREATING A VISION FOR SPACE MEDICINE DURING TRAVEL BEYOND EARTH ORBIT JOHN R.BALL (Chair), Executive Vice President Emeritus, American College of Physicians, Havre de Grace, MD JOSEPH V.BRADY, Director, Behavioral Biology Research Center, The Johns Hopkins University, Baltimore, MD BRUCE M.COULL, Head, Department of Neurology, University of Arizona College of Medicine, Tucson, AZ N.LYNN GERBER, Chief, Department of Rehabilitation Medicine, National Institutes of Health, Bethesda, MD BERNARD A.HARRIS, President, The Harris Foundation, Houston, TX CHRISTOPH R.KAUFMANN, Colonel MC (USA), Division of Surgery for Trauma, Uniformed Services University of the Health Sciences, Bethesda, MD JAY M.McDONALD, Professor and Chair, Department of Pathology, University of Alabama at Birmingham, Birmingham, AL RONALD D.MILLER, Professor and Chair of Anesthesia and Perioperative Care, University of California at San Francisco, San Francisco, CA ELIZABETH G.NABEL, Scientific Director, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD TOM S.NEUMAN, Professor of Medicine and Surgery and Associate Director, Department of Emergency Medicine, University of California at San Diego, San Diego, CA DOUGLAS H.POWELL, Senior Partner, Powell and Wagner Associates, Cambridge, MA, and Clinical Instructor in Psychology, Harvard Medical School, Boston, MA WALTER M.ROBINSON, Assistant Professor of Pediatrics and Medical Ethics, Harvard Medical School, Boston, MA CAROL SCOTT-CONNER, Professor and Head, Department of Surgery, University of Iowa College of Medicine, Iowa City, IA JUDITH E.TINTINALLI, Professor and Chair, Department of Emergency Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC Committee Liaisons: Institute of Medicine Board on Health Sciences Policy GLORIA E.SARTO, Professor of Obstetrics and Gynecology, National Center of Excellence in Women’s Health, University of Wisconsin, Madison, WI

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Safe Passage: Astronaut Care for Exploration Missions Institute of Medicine Board on Neuroscience and Behavioral Health STEVEN M.MIRIN, Medical Director, American Psychiatric Association, Washington, DC National Research Council Space Studies Board MARY JANE OSBORN, Professor and Head, Department of Microbiology, University of Connecticut, Farmington, CT Institute of Medicine Staff CHARLES H.EVANS, JR., Study Director and Institute Senior Adviser for Biomedical and Clinical Research MELVIN H.WORTH, JR., Scholar-in-Residence JUDITH RENSBERGER, Senior Program Officer VERONICA SCHREIBER, Research Assistant SETH M.KELLY, Project Assistant to August 2000 TANYA M.LEE, Project Assistant from August 2000 GREG T.SHERR, National Research Council Intern (Summer 2000) Institute of Medicine Board on Health Sciences Policy Staff ANDREW POPE, Director CARLOS GABRIEL, Financial Associate ALDEN CHANG, Administrative Assistant Institute of Medicine Auxiliary Staff MICHAEL EDINGTON, Managing Editor to March 2001 PAIGE BALDWIN, Managing Editor from March 2001 SUSAN FOURT, Librarian to December 2000 WILLIAM McCLOUD, Librarian from December 2000 Copy Editor MICHAEL K.HAYES

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Safe Passage: Astronaut Care for Exploration Missions Reviewers The report was reviewed 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 to assist the authors and the Institute of Medicine in making the 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 content of the review comments and the draft manuscript remain confidential to protect the integrity of the deliberative process. The committee wishes to thank the following individuals for their participation in the report review process: JAMES P.BAGIAN, Director, National Center for Patient Safety, Veterans Administration, Arlington, VA SAMUEL BRODER, Executive Vice President, Celera Genomics, Rockville, MD EDNA FIEDLER, Manager, Federal Aviation Administration, Civil Aeromedical Institute, Federal Aviation Administration, Oklahoma City, OK JOHN C.FLETCHER, Professor Emeritus of Biomedical Ethics, University of Virginia School of Medicine, Keswick, VA

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Safe Passage: Astronaut Care for Exploration Missions LAZAR J.GREENFIELD, Frederick A.Coller Distinguished Professor and Chair, Department of Surgery, University of Michigan, Ann Arbor, MI JOHN P.KAMPINE, Professor and Chairman, Department of Anesthesiology, Medical College of Wisconsin, Milwaukee, WI NICK KANAS, Professor, Psychiatry, University of California San Francisco, San Francisco, CA STEPHEN I.KATZ, Director, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health, Bethesda, MD RUSSELL B.RAYMAN, Executive Director, Aerospace Medical Association, Alexandria, VA JAMES L.REINERTSEN, Chief Executive Officer, Care Group, Boston, MA DANNY A.RILEY, Professor, Department of Cell Biology, Neurobiology, and Anatomy, Medical College of Wisconsin, Milwaukee, WI RICHARD H.TRULY, Director, National Renewable Energy Laboratory, U.S. Department of Energy, Golden, CO DEBORAH J.WEAR-FINKLE, Forensic Psychiatrist/Flight Surgeon, United States Navy, Pensacola, FL Although the individuals listed above have provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations nor did they see the final draft of the report before its release. The review of this report was overseen by Robert A.Frosch, Harvard University, and Robert M.Epstein, University of Virginia, Charlottesville, VA. Appointed by the National Research Council and the Institute of Medicine they were responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments are carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution.

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Safe Passage: Astronaut Care for Exploration Missions Foreword Many American astronauts have participated in space shuttle missions which kept them in space for periods of 1–2 weeks. A few American astronauts participated in missions on the Russian space station Mir during which they spent substantially longer periods of time in space, missions measured in months rather than weeks. Some Russian cosmonauts spent substantially longer periods of time in space. For all of these missions, there was the potential to bring an acutely ill participant back to earth in a relatively short period of time. Exploration missions into deep space, such as a journey to Mars, raise a series of new questions about the health of human participants. Some of the physiologic effects of shorter periods in space such as loss of bone calcium are likely to continue indefinitely during longer missions. Some risks such as radiation exposure may be increased as humans proceed further into space. Psychological and mental health issues will grow increasingly important during longer missions in a confined space, often involving individuals of very different social and cultural backgrounds. For prolonged missions, it will not be feasible to return an acutely ill individual to earth in a timely manner. The Institute of Medicine convened a committee of experts to examine the issues surrounding astronaut health and safety for long duration space missions. At the request of the National Aeronautics and Space Administration (NASA), the committee was asked to make recommendations regard-

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Safe Passage: Astronaut Care for Exploration Missions ing the infrastructure for a health system in space, the principles that should guide such a system to provide an appropriate standard of care for astronauts, and to identify the nature of the clinical and health services research required before and during such long-term missions for astronauts. The committee was faced with an extraordinary spectrum of issues related to prolonged travel into deep space. It focused its efforts upon the available data with regard to astronaut health and upon the areas where the evidence base was deficient. It particularly focused on areas that were amenable to investigation and development in preparation for human exploration of deep space. The committee was selected with the intention of including some individuals with significant direct experience with space travel, but it included other experts in health care delivery and clinical research who could bring some fresh perspectives to the subject. We are deeply indebted to this volunteer committee expertly chaired by Dr. John Ball for their dedicated commitment to this project. We believe that the ideas, conclusions, and recommendations contained in this report should be helpful to NASA, as it prepares for further space exploration, as well as being of use to others who are concerned about the care of individuals in isolated locations on earth. Kenneth I.Shine, M.D. President, Institute of Medicine July 2001

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Safe Passage: Astronaut Care for Exploration Missions Preface The National Academies, particularly the Space Studies Board of the National Research Council (NRC), have contributed substantial information on a full range of issues focused on basic aerospace research that has been a principal source of scientific advice to NASA. For example, the Space Studies Board recently provided guidance on a biomedical research strategy (SSB and NRC, 1998a, 2000). The present study by the Committee on Creating a Vision for Space Medicine During Travel Beyond Earth Orbit is the first time that the National Academies has addressed clinical issues through an analysis of the clinical research and health care practice evidence base for space medicine. In presenting its request to the Institute of Medicine (IOM) for the study presented in this report, NASA leadership noted that efforts to develop a more capable medical care delivery system in space have been internal to NASA itself, as documented in Chapter 1 of this report. The request used the language “create a vision” for health care for astronauts traveling on long-duration missions beyond Earth orbit. What was intended by the request was that a perspective beyond that internal to NASA and different from that provided by NRC be applied to the issues. Those issues are reflected in the charge to the committee, which were (1) to assess what is known about the effects of space travel on health (which is the focus of Chapter 2 of this report), what is not known, and what might be done about the latter; (2) to suggest how health care during space travel

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Safe Passage: Astronaut Care for Exploration Missions PTH parathyroid hormone SMAC spacecraft maximum allowable concentrations SMS space motion sickness SPEs solar particle events STS Space Transportation System T3 tri-iodothyronine

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Safe Passage: Astronaut Care for Exploration Missions Contents     EXECUTIVE SUMMARY   1     Task of the Committee,   2     Risk,   3     Health Care,   6     Research,   8     Behavioral Health,   11     Data Collection and Access,   13     Engineering and Biology,   17     Organization,   19 1   ASTRONAUT HEALTH BEYOND EARTH ORBIT   23     Background,   23     Health Risks of Space Travel,   26     Charge to the Committee,   29     The Committee’s Study of Health Care for Astronauts Traveling Beyond Earth Orbit,   30 2   RISKS TO ASTRONAUT HEALTH DURING SPACE TRAVEL   37     Overview,   37     Countermeasure to Solve Physiological Adaptations to Space,   40

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Safe Passage: Astronaut Care for Exploration Missions     Musculoskeletal System,   42     Loss of Bone Mineral Density in Microgravity,   42     Reversibility, Genetic Variability, and Mechanism of Bone Mineral Density Loss,   44     Clinical Research Opportunities in Astronaut Physiology and Health,   46     Effects of Microgravity on Skeletal Muscle,   47     Circulatory and Pulmonary Systems,   48     Orthostatic Hypotension,   48     Other Effects on the Cardiovascular System,   49     Effects of Microgravity on the Pulmonary System,   51     Alimentary System,   51     Nutrition in Space,   51     Space Motion Sickness,   51     Nervous System,   52     Neurovestibular Function,   53     Sleep and Circadian Rhythm,   53     Eye-Hand Coordination and Sustained Gross Motor Activity,   55     Peripheral Nervous System,   55     Reproductive System,   56     Effects of Radiation on Gametes,   56     Human Reproductive Physiology in Space,   57     Sex Differences,   59     Urinary System,   60     Physiological Monitoring,   61     Monitoring During Space Travel: Development of Technology,   61     A Strategy for a Space Medicine Clinical Research Program,   62     A Clinical Research Program for NASA,   69     Conclusion and Recommendation,   71 3   MANAGING RISKS TO ASTRONAUT HEALTH   75     General Principles and Issues,   76     Medical Events in Extreme Environments,   78     Health Risk Assessment,   86     Nutrition,   88     Pharmacodynamics and Pharmacokinetics,   90     Environmental and Occupational Health,   92     Health Care Practice Opportunities,   97     Cardiovascular Care,   97     Dental Care,   98

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Safe Passage: Astronaut Care for Exploration Missions     Endocrine Function,   101     Gastrointestinal Issues,   102     Gynecological Health Issues,   103     Hematology, Immunology, and Microbiology,   105     Mental Health Issues,   106     Neurological Issues,   110     Urinary Disorders,   111     Conclusion and Recommendation,   112 4   EMERGENCY AND CONTINUING CARE   117     Anesthesia and Pain Management,   118     Airway Management in Space,   118     Anesthetics,   119     Regional Anesthesia,   120     Surgery and Trauma,   121     Physiological Response to Injury,   121     Surgical Skills and Training,   123     Surgical Equipment,   124     Technical Aspects of Surgery,   125     Prevention of Infection,   126     Management of Common Surgical Emergencies,   126     Management of Abscesses and Soft-Tissue Infections,   127     Rehabilitation for Astronauts on Long-Duration Missions,   127     Catastrophic Illness, Death, and End-of-Life Considerations,   130     Personnel and Other Health Care Resources,   131     Development of a Space Medicine Catalog and Database,   132     Conclusion and Recommendation,   133 5   BEHAVIORAL HEALTH AND PERFORMANCE   137     Astronaut Performance and General Living Conditions,   138     Background,   138     Current Practice and Knowledge Base,   138     Requirements for Additional Knowledge,   142     Use of Pairs of Transport Vehicles for Small Groups Traveling Beyond Earth Orbit,   149     Support and Recovery Systems,   149     Background,   149     Current Practice and Knowledge Base,   150     Requirements for Additional Knowledge,   152

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Safe Passage: Astronaut Care for Exploration Missions     Screening, Selection, and Training,   158     Background,   158     Current Practice and Knowledge Base,   159     Requirements for Additional Knowledge,   161     Strategic Research Considerations,   165     Conclusion and Recommendation,   167 6   EXPLORING THE ETHICS OF SPACE MEDICINE   173     Ethical Issues in Clinical Care for Astronauts,   174     Institutional Pressure to Underreport Clinical Signs, Symptoms, and Medical Data,   174     Current Practice Regarding the Confidentiality of Individual Astronaut Medical Data,   175     Earth-Based Analogs for Balancing Medical Confidentiality with Public Health,   177     Justification for Using the Occupational Health Model to Balance Privacy and Safety,   178     Ethical Issues in the Astronaut-Flight Surgeon Relationship,   180     Opportunities for Collecting Medical Data Aboard the International Space Station,   181     Expand the Collection of Occupational Health Data,   181     Change the Process for Review of Clinical Research Protocols in Space Medicine,   182     Suggested Changes in the Approach to Review of Proposed Clinical Research or Data Collection for Astronauts,   183     Ethical Issues and the Special Circumstances of International Crews,   186     Conclusion and Recommendation,   187 7   PLANNING AN INFRASTRUCTURE FOR ASTRONAUT HEALTH CARE   189     Mission and Goals,   189     Organizational Components,   191     Leadership,   192     Critical Elements of the Organizational Framework,   193     Alternative Organizational Frameworks,   195     Organizational Structure to Ensure Astronaut Health and Safety,   197     Conclusion and Recommendation,   198     Systems Development,   199

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Safe Passage: Astronaut Care for Exploration Missions     Policy and Legislation,   201     Funding,   202     Internal Relationships,   202     External Relationships,   203     Operational and Clinical Components,   208     Standard of Care,   210     Medical Care,   210     Medical Informatics,   212     Personnel and Training,   214     Evaluation and Performance Improvement,   216     Conclusion and Recommendation,   218     REFERENCES   221     APPENDIXES         A Background and Methodology   247     Letter from Daniel S.Goldin, Administrator, NASA   261     B Committee and Staff Biographies   263     INDEX   275 LIST OF BOXES, FIGURES, AND TABLES EXECUTIVE SUMMARY Box 1   Clinical Research Opportunities for Astronaut Health,   5 Box 2   Health Care Opportunities in Space Medicine,   8 Box 3   Behavioral Health and Performance Research and Development Opportunities,   14 Box 4   The Key Elements in the Committee’s Recommendations,   21 1 ASTRONAUT HEALTH BEYOND EARTH ORBIT Figure 1–1   Trajectory of a human mission to Mars in 2014,   26 Box 1–1   Charge to the Committee,   31 Box 1–2   What Is Space Medicine in Reference to Developing a Vision and Strategy for Astronaut Health?,   34

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Safe Passage: Astronaut Care for Exploration Missions 2 RISKS TO ASTRONAUT HEALTH DURING SPACE TRAVEL Box 2–1   Some Major Human Physiological Changes Resulting from Extended Travel in Earth Orbit,   39 Figure 2–1   Countermeasure (CM) evolution,   41 Table 2–1   Average Bone Mineral Density Loss on Mir,   44 Box 2–2   Altered Sleep Patterns as Example of Multifactorial Problems Arising During Space Travel,   54 Box 2–3   Elements of the Critical Path Roadmap Project,   63 Table 2–2   Critical Path Roadmap Project: Critical Risks,   64 Figure 2–2   Countermeasure (CM) development and evolution,   68 Box 2–4   What Constitutes Clinical Research?,   69 Box 2–5   Clinical Research Opportunities for Astronaut Health,   72 3 MANAGING RISKS TO ASTRONAUT HEALTH Box 3–1   Major Health and Medical Issues During Spaceflight,   77 Table 3–1   In-Flight Medical Events for U.S. Astronauts During the Space Shuttle Program,   81 Table 3–2   Medical Events Among Seven NASA Astronauts on Mir,   82 Table 3–3   Medical Events and Recurrences Among Astronauts of all Nationalities on Mir,   83 Table 3–4   Pharmacopoeia Usage During Mir Missions,   84 Table 3–5   Incidence of Health Disorders and Medical-Surgical Procedures During 136 Submarine Patrols,   84 Table 3–6   Reasons for 332 Medical Evacuations from All Submarines, U.S. Atlantic Fleet, 1993 to 1996,   85 Table 3–7   ANARE Health Register Illnesses in Antarctica from 1988 to 1997,   85 Box 3–2   Potential Methods of Risk Assessment and Screening,   86 Box 3–3   Breast Cancer as an Example of Risk Assessment in Space Medicine,   88 Box 3–4   “Normal” Findings on Physical Examination in Microgravity,   90 Box 3–5   Advances in Preventive Dentistry,   99 Box 3–6   Health Care Opportunities in Space Medicine,   113

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Safe Passage: Astronaut Care for Exploration Missions 4 EMERGENCY AND CONTINUING CARE Box 4–1   Health Care Opportunities in Space Medicine,   134 5 BEHAVIORAL HEATH AND PERFORMANCE Box 5–1   Evidence of Emotional or Social Problems on Short-Duration Missions,   139 Box 5–2   Recovery and Reintegration,   153 Box 5–3   Systematic Multiple Level Observation of Groups,   156 Box 5–4   Potential Uses of Neuroimaging Methods for Astronaut Selection, Training, and Intervention,   163 Box 5–5   Distributed Interactive Simulation,   165 Box 5–6   Behavioral Health and Performance Research and Development Opportunities,   168 6 EXPLORING THE ETHICS OF SPACE MEDICINE Box 6–1   Examples of Earth-Based Limitations on Doctor-Patient Confidentiality to Decrease Risks to Others,   176 Box 6–2   The Common Rule and Informed Consent,   182 Box 6–3   Potential Categories of Clinical Research or Data Collection Protocols for Astronauts,   184 Box 6–4   Examples of Category 2 Clinical Research or Data Collection Protocols for Astronauts,   184 7 PLANNING AN INFRASTRUCTURE FOR ASTRONAUT HEALTH CARE Box 7–1   Infrastructure Elements for Developing a Comprehensive Health Care System for Astronauts,   199

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