Human Research Program Carl Walz

1. Human Research ProgramCarl Walz September 17, 2007

2. Human Research Program Overview • Goals • Reduce spaceflight risks to humans and focus on the highest risks to crew health and performance during exploration missions • Enable development of human spaceflight medical and human factors standards • Develop and validate technologies that serve to reduce medical risks associated with human spaceflight

3. Program Content • Space Radiation • Human health effects, limiting factors for vehicle environments and crew selection; computational shielding modeling; measurement technologies • Exploration Medical Capability • Medical care and crew health maintenance technologies; medical data management; risk assessment • Human Health Countermeasures • Integrated physiological, pharmacological and nutritional countermeasures; Extra-Vehicular Activity (EVA) physiology research supporting lunar EVAs • Behavioral Health & Performance • Behavioral health selection, assessment, and training capabilities; intervention and communication techniques to support exploration missions • Space Human Factors & Habitability • Anthropometry, display/control, usability, cognition, habitability, lighting, ergonomics; advanced food development; lunar dust characterization and toxicological testing • ISS Medical Project • ISS research integration and operations, including Human Research Facility Racks 1 & 2 • Program Science Management/NSBRI • Integration for HRP and National Space Biomedical Research Institute (NSBRI) funding

4. National Aeronautics and Space Administration HRP Participants HQ • Advocacy • Int’l Agreements Glenn • Human Health Countermeasures • Exploration Medical Capability Ames • Space Human Factors & Habitability • Exploration Medical Capability • Behavioral Health & Performance • ISS Medical Project • Space Radiation Langley • Space Radiation Johnson • ISS Medical Project • Space Radiation • Human Health Countermeasures • Exploration Medical Capability • Behavioral Health & Performance • Space Human Factors & Habitability Kennedy • ISS Medical Project 4

5. Research Center Lead Roles • ARC • ExMC Technologies incl. non-contact biomedical sensors • In-flight Laboratory Analysis capability • Support to Lunar Dust Toxicity research • Space Human Factors • Radiation Measurement Technologies • Support to ISSMP • GRC • Digital Astronaut • Support to Integrated Medical Modeling • Flight experiment for Medical Grade Water • Exercise hardware advanced concepts • LaRC • Radiation Shielding and analysis tools • Lead of LAT/MAT architecture study radiation tasks

6. Human Research Program Requirements Document Human Research Program Baseline May 2007 National Aeronautics and Space Administration Lyndon B. Johnson Space Center Houston, T Texas 77058 HRP Requirements and Content Alignment HRP: Enable Maturation of Standards Focused on Standards and Risk Mitigation (Risks to Mission and Risks to Long Term Astronaut Health) HRP: Mitigate Human Health and Performance Risks Evidence Requirements assigned to Program Elements Integrated Research Plan HRP Programmatic Review (Discipline Teams & Flight Surgeons/Astronauts) Exploration Missions Back Element Research Plans

7. HRP Exploration Risks33 Exploration risks are allocated to the HRP projects (Program Requirements Document) SHFH Risks Risk of Error Due to Inadequate Information Risk Associated with Poor Task Design Risk of Adverse Health Affects from Lunar Dust Exposure Risk Factor of Inadequate Food System Risk Factor of Inefficient Food System Risk of Reduced Safety and Efficiency Due to Poor Human Factors Design HHC Risks Risk of Accelerated Osteoporosis Risk of Orthostatic Intolerance During Re-Exposure to Gravity Risk of Inaccurate Assessment of Cardiovascular Performance Risk Factor of Inadequate Nutrition Risk of Compromised EVA Performance and Crew Health Due to Inadequate EVA Suit Systems Risk of Urinary Tract Infection Risk of Impaired Vision Due to Refractive Visual Changes During Long Duration Spaceflight Risk of Impaired Performance Due to Reduced Muscle Mass, Strength and Endurance Risk of Operational Impact of Prolonged Daily Required Exercise Risk of Bone Fracture Risk of Invertebral Disc Damage Risk of Renal Stone Formation Risk of Cardiac Rhythm Problems Risk of Reduced Physical Performance Capabilities Due to Reduced Aerobic Capacity Risk of Adverse Health Effects Due to Exposure to Hypoxic Environments Risk of Adverse Health Effects Due to Prolonged Exposure to Elevated Carbon Dioxide Levels Risk of Crew Adverse Health Event Due to Altered Immune Response Risk of Impaired Ability to Maintain Control of Vehicles and Other Complex Systems Risk of Therapeutic Failure Due to Ineffectiveness of Medicine BHP Risks Risk of Behavioral and Psychiatric Conditions Risk of Performance Errors Due to Sleep Loss, Circadian Desynchronization, Fatigue and Work Overload Risk of Performance Errors Due to Poor Team Cohesion and Performance, Inadequate Selection/Team Composition, Inadequate Training, and Poor Psychosocial Adaptation Space Radiation Risks Risk of Radiation Carcinogenesis Risk of Acute Radiation Syndromes Due to Solar Particle Events Risk of Acute or Late Central Nervous System Effects from Radiation Exposure Risk of Degenerative Tissue or other Health Effects from Radiation Exposure ExMC Risks Risk of Inability to Adequately Treat and Ill or Injured Crew Member

8. HRP Schedule of Major Deliverables/Milestones FY-09 FY-10 FY-11 FY-12 FY-13 HRP Program Program Implementation Review Program Implementation Review Independent Program Reviews Joint NASA/NSBRI NRA Release Radiation Multidiscipline Radiation Multidiscipline Radiation Multidiscipline Radiation Multidiscipline Radiation Multidiscipline Behavioral Health and Performance Element Behavioral Health; Sleep; and Team Cohesion Standards Update to Support Lunar Mission Ops Evidence Base for Sleep Loss Vs. Adaptation To Inform Standards Fatigue And Workload Guidelines To Support Mission Ops Design Vacuum Injection System (injection Of meds during EVA emergency) Exploration Medical Capability Element TRL-6 Biomedical Sensor System to Support EVA Suit-2 PDR Behavioral Health and Performance Module for Integrated Medical Model (Critical Input to FY-11 Delivery of IMM) Lightweight Trauma Module (Supports ISS and Cx Med Ops) Musculoskeletal Module for Integrated Medical Model (Critical Input to FY-11 Delivery of IMM) Requirements From Integrated Medical Model, a Probablistic Risk Assessment To Support Med Kit Design and Mission Ops Definition Medical Grade Water Technology Demonstration on ISS Complete Improved Max Absorbency Garment for EVA Human Health And Countermeasures Element Functional Task Test Designed and Initiated Test Supports Numerous Disciplines (Neuro, Cardiovascular Muscle, etc.) to develop standards And design guidelines for Cx Exercise Countermeasures Project Update Muscle Standard to Support Mission Ops Development EVA Physiology & Systems Project EVA Suit-1 Design Recommendations to Support PDR Countermeasure Recommendations To Prevent Suit Trauma

9. HRP Schedule of Major Deliverables/Milestones FY-09 FY-10 FY-11 FY-12 FY-13 Human Health And Countermeasures Element Invertebral Disc Damage Study to Update Standard Nutrition Standard Update to Support Mission Ops Design Bone Standard Update to Inform Mission Ops Design Aerobic Capacity Standard Update To Support Mission Ops Design Integrated Cardiovascular Standard Update To Support Mission Ops Design Non-Exercise Physiology Countermeasures Project Orthostatic Intolerance Cardiovascular Standard Update To support Mission Ops Design Immune System Standard Update To Support Mission Ops Design Midodrine Countermeasure Recommendation for Orthostatic Intolerance Update Radiation Standard & LSAM Design Reqt’s Radiation Element Update Shielding Engineering Design Tool To Support Lander Design Update Crew Risk Assessment Model to Support Mission Ops Design Baseline Crew Risk Assessment Model To Support Mission Ops Concept Development Monitoring Technologies Inserted to Cx Design to support Mission Ops Space Human Factors & Habitability Element Advanced Environmental Lunar Dust Toxicity Standard To Support Lander Design and Mission Ops Concept Development DoD Collaborative Food Technology Study Complete- Food System Recommendation For Lunar System Design Advanced Food Technology Human Integration Design Handbook Update To support lander design Space Human Factors Engineering Self Test Tool for Critical Tasks To facilitate crew Self-evaluation of Readiness to Perform critical tasks Acoustic Models to support Guidelines for noise Environment design Automation Evaluation Methods Available to Support Orion Design Display & Control Guidelines For EVA Ops Environment

10. Human Research on ISS - Critical • ISS is critically necessary to mitigate 17 of the 32 human health risks relevant to exploration • Human Research Program has research content on every Shuttle flight out through the end of the program • Document human adaptations to long duration exposure to microgravity and determine if those adaptations result in clinically relevant risks. • Develop/Refine countermeasures to mitigate risks • Validate medical support technologies

11. HRP Priorities for ISS Understanding Physiological Changes with Potential Clinical Impact • Bone loss • Immune system changes • Cardiovascular changes • Nutritional status changes Exercise Countermeasure Effects • Understanding what works Validating Non-Exercise Countermeasures • Renal stone formation • G-transition effects Nutrition and Pharmaceutical Stability • Radiation effects Behavior and Performance • Team dynamics • Sleep and fatigue problems

12. HRP Program Elements

13. Program Science Management/NSBRI Content • Program Integration Office • Process support, risk management reporting, requirements development, configuration mgt, Metrics (Program, Research); Lessons learned database website maintenance, etc. • Integrated Research Plan • NSBRI – Ensure NSBRI project alignment with HRP goals and objectives • Science Management Office • Strategic planning of research activities for HRP, including Integrated Research Plan • Process support, support crew health risk assessment • HRP Investigator’s Workshop • Grants management • Research Proposal Review • Program Reserves

14. The NSBRI • The National Space Biomedical Research Institute (NSBRI) is an important partner in defining, selecting and conducting research associated with exploration risks • Non-profit organization with a unique partnership between the academic biomedical community and NASA • Established in 1997 through a NASA Cooperative Agreement following a competitive selection • Product-driven team approach (11 research, 1 education and outreach)

15. ISS Medical Project Objectives: • Maximize the opportunity provided by the ISS for human health and performance evaluations during long duration missions • Use the ISS to understand the effects of long duration spaceflight on the human body to inform Crew Health and Performance Standards and protocols and manage risks • Manifest, integrate, operate and maintain research hardware • Support cooperative ISS research activities with International Partners Content: • Research integration, including training, procedures development, interface with ISS program • Sized to support approximately 20 on-going investigations • Sustaining engineering of on-orbit and ground facilities • Baseline Data Collection, including facilities in Russia • New hardware development • Telescience Support Center • Real-time operations support Clay Anderson preparing to centrifuge Nutrition blood samples during Increment 15

16. Space Radiation Objectives: • Ensure that NASA can safely live and work in the space radiation environment • Develop scientific basis to accurately project and mitigate health risks from the space radiation environment Products: • Recommendations to Permissible Exposure Limits for exploration missions • Radiobiological data, projection models, and computational tools to assess and project crew risk of cancer, central nervous system and degenerative tissue risks, and acute radiation syndrome from space radiation • Computational tools and models to assess vehicle design for radiation protection • Radiation monitoring technologies, leveraged with ISS and Cx • Uncertainty reductions to enable radiation protection design and crew constraints for lunar and Mars missions • Assessment of effectiveness and development of physical or biological countermeasures NSRL Beam Line (Exposure Room) CEV Shield Analysis

17. Space Radiation – Content • Scientific basis (and communication thereof) for Permissible Exposure Limits (PEL) and requirements development/updates • Provide recommendations on crew exposure limits and design requirements for lunar and Mars missions • Provide discipline expertise to participate in Agency mission and architecture analyses, concept evaluation, and trade studies • Recommendations on Crew Health and Performance Standards and PEL at 95% level • Mission operations • Astronaut risk assessment model • Cancer, acute (updated model planned in FY10 and FY14) • Central nervous system and degenerative risk (after NSCOR research matures in FY14) • Operational shielding assessment procedures • Facilities • Brookhaven National Laboratory Electron Beam Ionization Source (EBIS) for NASA Space Radiation Laboratory (NSRL) • Engineering design tools for vehicle shielding optimization to evaluate mitigation and operational approaches • Support to development of Measurement Technologies • CEV real time dose measurement

18. Human Health Countermeasures Objective: • Conduct ground and flight research to close research gaps: • Take a Project Approach to closing gaps • Provide the biomedical expertise for the development & assessment of Crew Health and Performance Standards and vehicle & spacesuit requirements dictated by human physiological needs Products: • Information to develop Crew Health and Medical Standards • EVA human-suit requirements and pre-breathe protocols • Integrated physiological countermeasures • Validated exercise system requirements

19. Human Health Countermeasures - Content • Exercise Countermeasures Project (ECP) • Identify improved 0-g exercise prescriptions, Develop requirements for exercise devices, prescriptions, and monitoring needs for Exploration • EVA Physiology, Systems and Performance Project • Research to increase human performance during EVA with the aim of developing a more safe and efficient EVA system. Minimize risk of Decompression Sickness. • Flight Analogs Project • Provide bed rest analog by which HRP elements and projects evaluate and validate standard measures, countermeasures, hardware and risk reduction prescriptions prior to spaceflight • Non-Exercise Physiological Countermeasures (NxPCM) • Conducts studies to close gaps associated with human health risks. Includes physiological disciplines: Bone, Cardiovascular,Immunology, Nutrition, Pharmacotherapeutics, Sensorimotor • Digital Astronaut Project • Develop physiological models to assist in medical support during Mars missions

20. HRP Work in Support of EVA Systems • Risks to Human Health • Decompression sickness • Injury to joints and appendages • Increased energy expenditure and dehydration • Risks to Human Performance • Diminished work efficiency, fatigue • Biomechanical efficiency • Activities • Teaming with EVA Systems to evaluate • Metabolic rate and thermal control • Biomechanical efficiency • Hydration and caloric needs • Injuries and their cause • Decompression sickness risks and prebreathe protocols • Biomedical sensor technology • Benefits • Information that contributes to • Reduce injuries • Improve work efficiency • Protocols that minimize risk of DCS • Reliable technology for non-invasive biomedical sensors • Information to allow optimal EVA suit weight, mass, pressure, CG, and kinematics from the human standpoint

21. Exploration Medical Capability Objectives: • Sponsor research and technology leading to the development of clinical care capability, medical equipment technology and medical informatics • Identify and test next generation medical care and crew health maintenance technologies (monitoring technologies, diagnostic capabilities, treatment tools and techniques) • Develop, implement, and maintain data management systems to ensure human health and performance data is captured, maintained and useable Products: • Data and knowledge to support development of Health and Medical standards • Tools to support exploration operations, (i.e. Integrated Medical Model) • Medical technologies to meet Level of Care standards that require fewer resources, cost less and are more reliable Content • Medical Technology Development • Data Archive and Management Ultrasound diagnostics on ISS Medical Data Systems

22. Space Human Factors & Habitability Objectives • Mitigate risks associated with human-systems interface designs and operational processes. • Enable safe, nutritious, and acceptable foods to promote crew health and performance. • Mitigate risks associated with human exposure to environmental factors. Products • Development and validation of human-systems integration standards and guidelines (Human Integration Design Handbook) • Technology development in human factors areas, i.e.; training, procedures, human interface systems designs, analytical tools • Habitability concept design and evaluations • Human performance analysis and assessment • A food system that addresses nutritional, psychological, safety and acceptability and minimizes mass, volume, waste, power, and trace gas emissions • Lunar dust research and Space Flight Human System Standard development Space Human Factors and Food Eugene A. Cernan, Apollo 17 Lunar Dust exposure

23. Space Human Factors & Habitability - Content • Space Human Factors Engineering • Research into 3 key exploration risks: cognitive, physical and system level mismatch between system design and human capability during spaceflight • Space Flight Human System Standard and Human Integration Design Handbook development and maintenance • Advanced Food • Food shelf life testing • Mass reduction techniques • Leveraging with DOD to enable advanced packaging technologies • Advanced Environmental Health • Lunar Airborne Dust Toxicity Advisory Group activities • Microbial risk assessments and mitigation research

24. Behavioral Health & Performance Objectives: - Perform ground and flight research to prevent behavioral health issues from impacting the missions Content • Sleep Loss, Circadian Desynchronization, Fatigue and Work Overload • Team Performance, Adaptation, Cohesion, Composition, Training • Optimizing adaptation of the individual and the crew to the space environment • Provide services and support to the crew and family members during the mission, the development of select in criteria for the astronaut and the mission • Behavioral Medicine Problems • Capabilities to detect, prevent, minimize, or treat: • Providing input for crew composition and selection processes and criteria Studies to determine factors contributing to team cohesion Sleep on Shuttle

25. HRP Challenges • Cold stowage and transportation implications to performing necessary research on ISS • Space Radiation gaps represent a large challenge • Pursue partnerships aggressively

26. Within GuidelineDetails by Program Element Back-up

27. Space Flight Human System StandardNASA-STD-3001 • Volume 1: Crew Health • Human health and performance standards • Fitness-for-Duty, Permissible Outcome and Permissible Exposure Limits • Levels of Medical Care • Volume 2: Habitability and Environmental Health • Air and water quality standards • Habitability and human factors

28. Major Decision Point Informing Missions Ops Major Milestone/ Event/Accomplishment HRP PRD Requirement: 4.1.1; 5.2 Informing Health Stds Updating Health Stds FY’08 FY’09 FY’10 FY’11 FY’12 FY’13 FY’14 FY’15 FY’16 FY’17 FY’18 FY’19 FY’20 FY’21 FY’22 FY’23 FY’24 FY’25 End of US Commitment Shuttle Retired 6 Crew Capability SRR SRR PDR-init cap PDR-suit2 PDR PDR PDR-suit1 PDR CDR-suit2 CDR CDR-init cap CDR CDR CDRsuit1 CDR PDR NO Lunar Bed Rest N=12 CM Element: HHC ISS & Shuttle Human Lunar Return Program Level Lunar Architecture Baseline Initial Ops (Orion) Orion Constellation EVA Suit SRR-suit2 Lander Mission Operations Occupational Health Measures Space Medicine Risk of Cardiac Rhythm Problems Gaps: (CV1) Unknown in-flight alterations in cardiac structure and function. Flight Validation Studies Ground-based CM Studies Select best CM YES YES Microgravity CM needed? NO Are microgravity CM adequate? Pre flght planning Integrated Cardiovascular SMO (RFP) ISS Study N=12 NxPCM Lunar CM Studies NO Lunar Data Needed Lunar Study N=12 ECP Data necessary for study Gaps: (N7) What are K+, Mg+, and P+ changes in relation To CV issues and Bone Loss? DRAFT Ground-based CM Studies Flight Validation Studies Select best CM YES NO CM needed for CV? Nutrition SMO* (Directed Study) NxPCM ISS Study N=12 CM needed for Bone? YES Ground-based CM Studies Flight Validation Studies Select best CM * Nutrition SMO listed multiple times to answer several gaps

29. Projected experiment readiness Projected flight opportunity At Risk Reserve R ISS Fly-Off Plan Projection ** Pre/post only

30. Consortium Members Baylor College of Medicine Brookhaven National Laboratory Harvard Medical School The Johns Hopkins University Massachusetts Institute of Technology Morehouse School of Medicine Mount Sinai School of Medicine Rice University Texas A&M University University of Arkansas for Medical Sciences University of Pennsylvania Health System University of Washington Research and education program involves investigators at more than 70 institutions across the United States in 22 states The NSBRI Program