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Meeting Agendas

COMMITTEE ON ETHICS PRINCIPLES AND GUIDELINES FOR HEALTH STANDARDS FOR LONG DURATION AND EXPLORATION SPACEFLIGHTS

National Academy of Sciences Building, Room 125
2101 Constitution Avenue, NW
Washington, DC 20001

OPEN SESSION – May 30, 2013

10:45 – 11:15 a.m. Welcome and Introductions

Carol Scott-Conner, Chair, IOM Standing Committee on Aerospace Medicine and the Medicine of Extreme Environments

Jeffrey Kahn, Chair, IOM Committee on Ethics Principles and Guidelines for Health Standards for Long Duration and Exploration Spaceflights

 
11:15 a.m. – 12:00 p.m. Charge to the New Committee

Richard Williams, Chief Health and Medical Officer, NASA

Jeffrey Davis, Director, Human Health and Performance Directorate, Johnson Space Center, NASA

 


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A Meeting Agendas COMMITTEE ON ETHICS PRINCIPLES AND GUIDELINES FOR HEALTH STANDARDS FOR LONG DURATION AND EXPLORATION SPACEFLIGHTS National Academy of Sciences Building, Room 125 2101 Constitution Avenue, NW Washington, DC 20001 OPEN SESSION – May 30, 2013 10:45 – 11:15 a.m. Welcome and Introductions Carol Scott-Conner, Chair, IOM Standing Committee on Aerospace Medicine and the Medicine of Extreme Environments Jeffrey Kahn, Chair, IOM Committee on Ethics Principles and Guidelines for Health Standards for Long Duration and Exploration Spaceflights 11:15 a.m. – 12:00 p.m. Charge to the New Committee Richard Williams, Chief Health and Medical Officer, NASA Jeffrey Davis, Director, Human Health and Performance Directorate, Johnson Space Center, NASA 155

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156 LONG DURATION AND EXPLORATION SPACEFLIGHT 12:00 – 1:00 p.m. Committee Discussion with NASA Staff Lunch 1:00 – 1:30 p.m. NASA and the Importance of Risk Charles Bolden, Administrator, NASA 1:30 – 3:15 p.m. Risk Acceptance and Health Standards 1:30 – 1:50 p.m. NASA Risk Acceptance – George Gafka, Chief, Safety Officer, International Space Station Program, NASA 1:50 – 2:10 p.m. NASA Health Standards – David Liskowsky, Director, Medical Policy and Ethics, NASA 2:10 – 2:30 p.m. Ethics of Standard Setting – Paul R. Wolpe, Bioethicist, NASA 2:30 – 3:15 p.m. Discussion 3:15 – 3:30 p.m. Break 3:30 – 5:00 p.m. Specific Health Issues 3:30 – 4:15 p.m. Radiation – Francis A. Cucinotta, Chief Scientist, NASA Space Radiation 4:15 – 5:00 p.m. Ocular and Intracranial Pressure – Dave Francisco, Program Integration Manager, Human Health and Performance, NASA Terrance Taddeo, Chief, Space and Clinical Operations Division, NASA 5:00 – 5:30 p.m. Revisit the Statement of Task and Questions for NASA Staff 5:30 p.m. Adjourn

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APPENDIX A 157 COMMITTEE ON ETHICS PRINCIPLES AND GUIDELINES FOR HEALTH STANDARDS FOR LONG DURATION AND EXPLORATION SPACEFLIGHTS National Academy of Sciences Building, Room 120 2101 Constitution Avenue, NW Washington, DC 20001 OPEN SESSION – July 25, 2013 8:00 – 8:05 a.m. Welcome Jeffrey Kahn, Committee Chair 8:05 – 8:30 a.m. Decision Making in the Context of Uncertainty Harvey V. Fineberg, Institute of Medicine 8:30 – 9:25 a.m. Panel 1: Risk Acceptance and Risk Management at NASA Facilitator: Carol Scott-Conner, Committee Member 8:30 – 8:35 a.m. Panel Introductions 8:35 – 8:50 a.m. Evolution of Risk Management at NASA– Homayoon Dezfuli, NASA 8:50 – 9:05 a.m. External Regulatory Framework for NASA Health Standards–David Liskowsky, NASA 9:05 – 9:25 a.m. Discussion with the Committee Panel Questions: • How has risk management evolved at NASA over the years? • What is the external regulatory framework under which NASA develops health standards?

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158 LONG DURATION AND EXPLORATION SPACEFLIGHT • How do OSHA, NRC, and other standards and regulations impact NASA standards and decision making? • Are risk considerations different for long duration and exploration missions? Does the risk management approach change? 9:25 – 10:35 a.m. Panel 2: Perspective from the Astronaut Corps Facilitator: Bonnie Dunbar, Committee Member 9:25 – 9:30 a.m. Panel Introductions 9:30 – 10:10 a.m. Perspectives on Risk Management and Risk Acceptance Peggy Whitson, NASA (via video conference) Mike Barratt, NASA Shannon Walker, NASA Robert Behnken, NASA 10:10 – 10:35 a.m. Discussion with the Committee Panel Questions: • Are risk considerations different for long duration and exploration missions? Does the risk management approach change? • In light of the unknowns and uncertainties, how much risk can be taken? Who makes those decisions? What data and considerations go into those decisions? • What input do astronauts have into decisions regarding risk and health standards? What are the processes for that input? 10:35 – 10:50 a.m. Break

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APPENDIX A 159 10:50 – 12:20 p.m. Panel 3: Ethics Framework for Considering Health Standards for Long Duration and Exploration Spaceflights Facilitator: Jonathan Kimmelman, Committee Member 10:50 – 10:55 a.m. Panel Introductions 10:55 – 11:25 a.m. Perspectives on an Ethics Framework– Laurie Zoloth, Northwestern University, and Paul Root Wolpe, Emory University/NASA (via video conference) 11:25 – 11:40 a.m. Ethics, Risk, and Individual Differences– Alta Charo, University of Wisconsin–Madison (via video conference) 11:40 – 11:55 a.m. Informed Consent in High-Uncertainty Contexts– David Wendler, National Institutes of Health 11:55 – 12:20 p.m. Discussion with the Committee Panel Questions: • What ethical principles and considerations should guide establishment and application of health standards concerning uncertain health effects of long duration and exploration spaceflight? What ethical framework can guide development and interpretation of such standards? • How does the nature of activities (e.g., exploration, directed mission, routine tasks) alter ethical evaluation of risk exposure in spaceflight? How should spaceflight agencies weigh the risks and benefits? Are there absolute limits on acceptable risk?

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160 LONG DURATION AND EXPLORATION SPACEFLIGHT • How can health standards be established in light of large uncertainties? Should current health standards be broadened for exploration missions? If so, what are the ethical considerations regarding how much risk can be taken? • What are the ethical considerations about the role of individual susceptibilities setting and applying health standards (e.g., age, gender, genetics)? • What issues regarding informed consent should the committee consider? 12:20 – 1:15 p.m. Working Lunch 1:15 – 2:30 p.m. Panel 4: Decision Making and Uncertain Risk: Learning from Other Occupations Facilitator: Larry Palinkas, Committee Member 1:15 – 1:20 p.m. Panel Introductions 1:20 – 1:35 p.m. Professional Sports and High Degrees of Physical Risk–Sean Sansiveri, NFL Players Union (via video conference) 1:35 – 1:50 p.m. Diving in Extreme Environments: The Scientific Diving Experience–Michael A. Lang, American Academy of Underwater Sciences (via video conference) 1:50 – 2:05 p.m. Psychological and Physical Health Risks at the Circumpoles–Peter Suedfeld, University of British Columbia (via video conference) 2:05 – 2:30 p.m. Discussion with the Committee Panel Questions: • What is the purpose/benefit of activities in your field? • In general, what are the major known and uncertain risks in your field?

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APPENDIX A 161 • How/why do benefits outweigh these risks, justifying societal and individual acceptance of identified risks? • Are limits placed on individual acceptance of risk in your field? In other words, what criteria or health standards govern whether individuals are allowed to expose themselves to known or uncertain risks? Briefly describe the major standards/limitations. Do these standards/limitations change in the context of uncertain risk? • How are individuals informed about risks and benefits, and what are the processes for informed consent/decision making? • How have the risks changed in your field based on new evidence, the ability to detect risk, or improved protections (e.g., technological or engineering)? Give an example of how health standards/criteria have changed in light of new evidence about risk. • What lessons can NASA draw from your experiences? 2:30 – 2:45 p.m. Break 2:45 – 4:10 p.m. Panel 5: Issues in Health Standard Implementation and Enforcement Facilitator: Michael Silverstein, Committee Member 2:45 – 3:10 p.m. Perspective on OSHA Standards–John Mendeloff, University of Pittsburgh 3:10 – 3:25 p.m. FAA Medical Standards–Fred Tilton, Federal Aviation Administration 3:25 – 3:45 p.m. Ethics, Risk, and the Problems with Trimming Radiation-Dose Data–Kristin Shrader-Frechette,

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162 LONG DURATION AND EXPLORATION SPACEFLIGHT University of Notre Dame 3:45 – 4:10 p.m. Discussion with the Committee Panel Questions: • What laws and regulations govern health standard implementation and enforcement in your agency? What are these standards? • How are risks and benefits weighed in selection of health standards? In other words, what tips the balance between acceptable and unacceptable risk? • Are standards universally applied or tailored to individuals, and what are the associated ethical issues? • Can existing health standards be modified or waived? If so, under what circumstances can risk exposures exceed set standards and what is the rationale for allowing this? • Are there examples of how health standard selection or enforcement criteria have evolved in response to new evidence or shifts in culture? • What lessons can NASA draw from your experiences? 4:10 – 4:45 p.m. Public Testimony – Registered Speakers Moderator: Jeff Kahn, Committee Member (3 minutes per speaker) 4:45 p.m. Public Session Adjourn