Fundamentals of Space Medicine — Chapter 8 Photo NASA Investigators' Guide Space Life Sciences Investigators' Guide Gilles Clément, Ph.D CNRS "Cerveau et Cognition" Laboratory Toulouse, France Kluwer Academic Publishers • Copyright © 2003 • All rights reserved 1 Investigators' Guide Outline 2 • Resources – Opportunities for space life sciences experiments – Constraints of space missions • How to "fly" an experiment – Experiment proposal – Experiment design – Experiment integration – Documentation – Crew science training – In-flight operations Spacelab Integration. Photo ESA Investigators' Guide Steps of Life Science Research Experiment Proposal Peer Review Testable Hypothesis ? Acceptance of Proposal Questions Concerns Problems Observations Development of Protocol/Hardware Knowledge and Solution Flight Experimentation Supporting Ground-Based Studies 3 Investigators' Guide Access to Microgravity Microgravity Duration Clinostat Simulated Unlimited Bed rest Simulated 3-12 months Centrifuge >1g 2 months (animals) Drop tower < 10-4 seconds Parabolic flight 10-1-10-2 20 seconds Sounding rocket 10-5 6-15 minutes Unmanned capsule 10-5-10-6 15 days Space Shuttle 10-4 10 days SpaceHab 10-4 < 16 days ISS 10-4 Unlimited 4 Investigators' Guide Research Opportunities 5 • International Space Station • Spacehab Science Missions • Shuttle Small Payload Flight Experiments • Biosatellites (Photon) • Ground-Based Investigations : Photon capsule after landing. Photo CNES – Parabolic flight – Centrifuge – Laboratory (e.g., clinostat) – Simulations (e.g., bed rest) Movie: 05_KC135 – Ground-based development studies NASA KC-135 during parabolic flight.Photo Document Clinostat. CNESNASA Investigators' Guide Ground-Based Investigations 6 • Performed in the investigator’s laboratory or in space agencies’ identified research facilities • Objectives clearly related with space research, e.g., effects of changing gravity levels, lesion experiments, development of new data analysis methods, space data modelisation, etc. • Space agencies’ special research facilities include : – Zero-G aircrafts – Centrifuges – Slow Rotating Room – Clinics for bed-rest studies – Neutral buoyancy facilities – Isolated/confined environments: closed chambers, spacecraft mockups, polar bases, etc. Parabolic flight experiment Photo NASA Investigators' Guide Space Shuttle Middeck & SpaceHab 7 Documents NASA Movie: 07_stsISStour Storage lockers in the middeck of the Space Shuttle Shuttle and ISS tour Investigators' Guide “Small Payload” Experiments • Proposals focus on scientific or technical research programs (e.g., space biology, space radiation, health, countermeasures, etc.) defined by NASA • Studies are being flown in the middeck area of the Space Shuttle or on ground before and just after landing • Considerable resources limitations : – 1 or 2 lockers (56 liters, 25 kg each) – Maximum power 130 W, both 28 and 115 VAC, not available during ascent and re-entry – Latest access is 14 hours before launch • Use existing flight hardware, or NASA Life Sciences Laboratory Equipment (LSLE) such as Plant Growth Unit, Biological Canisters, Animal Enclosure Modules, Physiological Monitoring Systems, etc. 8 Document NASA Investigators' Guide International Space Station (ISS) 9 Investigators' Guide ISS Experiment Cycles 10 Documents NASA Movie: 10_docking Investigators' Guide ISS Experiment Implementation 11 Document NASA Time Investigators' Guide Experiments on board ISS 12 • Ethical approval • Crew consent • Multinational crew as subjects and operators • Crew training • Small number of subjects and observations • Limited access to real time data • Integrated experiments: multiple Principal Investigators (PIs) must share the same equipment • Mainly unexpected results ISS Columbus module. Document ESA Investigators' Guide Crew Time • For a life science mission, crew time is the most precious resource • On Shuttle or Spacehab missions, the crew typically consists of 7 crewmembers: – The Commander and Pilot are responsible for spacecraft operations and are available as subjects and / or operators on a limited basis – Two Missions Specialists are trained for EVAs and are available after the EVA has been completed – Three Missions Specialists are dedicated to payload operations/activities as operators, and as subjects on a voluntary basis • One ISS increment (expedition) includes 3 crewmembers for a duration of 3-4 months. All crewmembers participate in life sciences experiments as operators, and as subjects on a voluntary basis 13 Investigators' Guide Space Shuttle Crew Time 14 • Typical on-orbit day (per crewmember) : – 8 hrs for sleep – 6 hrs for pre- and post-sleep activities – 2 hrs for lunch, hygiene, and exercise – 8 hrs for payload activities • Two 1/2 days off required on 14-day missions • First day and last two days of the mission have limited time available for payload activities : – Mission Day 1: approx. 2 hrs/crewmember – Last day minus one: approx. 3 hrs/crewmember – Last day (entry day): approx. 1 hr/crewmember Photo NASA Investigators' Guide MIR (and presumably ISS) Crew Time • On-orbit day averaged over a 3-month stay including one EVA (per crewmember): – 8 hrs for sleep – 4 hrs for pre- and post sleep activities – 5 hrs for lunch, hygiene, and exercise – 1.5 hr for preparing EVA – 1.5 for public relations – 4 hrs for payload activities • Two days off required every week • First two days of the mission (Soyuz) Movie: 15_mirtour have no time available for payload activities • First measurement on board not performed before Mission Day 4 • EVA preparation prevents payload activities for one week 15 Investigators' Guide Postflight Data Collection 16 • Space Shuttle Entry Day – Crew to be awake 8-14 hrs before landing (3 hrs for postsleep activity, 4 hrs for de-orbit prep., 1 hr from de-orbit to landing). Maximum wake time: 18 hrs – Wheel-stop to clinic: 1-2 hr – Medical exam: 0.5 hr – Visit+meal+shower: 1 hr – If DC exceeds 4 hrs, must have 1-hr break • Soyuz Entry Day – Crew spends up to 10 hrs in Soyuz Crew transfer vehicle. Photo NASA – Medical exam on landing site: 1.5 hr – Transfer to clinic (including meal+visit+rest): 6 hrs – First measurements at R+20 hrs; duration not to exceed two hrs, with crew in supine or sitting position Investigators' Guide Example: STS-111 R+0 Schedule Movie: 17_landing2 17 Investigators' Guide Additional Constraints • Activities require more time to be performed in 0-g: – Some activities take about 40% longer in space than on the ground (e.g., extensive equipment set-up) – Some activities may require extra operators (e.g., dissections or hazardous operations, rotating chair) – As a result, 4 hrs or crew time in 0-g correspond to only 2.4 hrs on the ground • Non-human species/specimens: – A finite number of animals or specimens is available – The limited number often requires the development of elaborate and detailed sharing plans to maximize their use • Sharing plans are needed for some investigations on human subjects (e.g., volume of blood draw is limited) 18 Investigators' Guide How to Fly an Experiment Spacelab experiment cycle. Document ESA/NASA 19 Investigators' Guide Research Announcements • Edited by NASA and national space agencies • Research Announcements in Space Life Sciences issued about every 18 months • Include space and/or ground-based research • http://peer1.idi.usra.edu/ • NASA/OBPR (Office of Biological and Physical Research) 20 Investigators' Guide Experiment Design • Applied Research – Assessment of operational issues (e.g., countermeasures) – 1 subject per flight, but many flights (N=10) – Hardware and protocol extremely simple • Fundamental Research: – 1-2 flight/increment, with 2-4 subjects – Require control studies for small N data set: • Well-defined dependent variable (i.e., valid, reliable, relevant, practical) • Comparison of astronauts’ preflight data with those of control group on Earth • Repetition of preflight tests for variance analysis • Multiple postflight tests to establish return to baseline – Protocol “integrated” with other experiments 21 Investigators' Guide Flight Experiment Selection 22 3-12 months Select For Definition Feasability Review & Science Merit Proposal Submission Concept Definition •Preliminary science requirements •Feasability analysis •Approach (e.g. hardware, resources, procedures) •Assess maturity of approach •Identify required studies to ensure feasability Requirements Definition •Experiment requirements •Risk reduction studies •Biocompatibility •Procedures development •Cost estimates & schedule Select Flight Candidate 12-24 months Experiment Development •Design, develop, manufacture experiment unique hardware •Mission documentation •Verify experiment interfaces and procedures •Crew training •Logistics for launch 12-24 months Operations and Data Analysis •Pre-, in-, and post-flight data acquisition •Data analysis •Data archiving (after one year) •Publication of results •Post-flight symposia Investigators' Guide Experiment Integration 23 • Weight / Volume — as small and compact as possible • Simple and intuitive to use — training will be limited • Power / Data needs — add immensely to complexity; non-powered or battery-operated if possible • Long shelf-life, "bullet-proof" technology desired • Supports identified standard — meets laboratory data analysis capability (e.g., provides useful information) • Modular — easy to replace and upgrade components • Think zero-g Medical equipment testing during parabolic flight. Photo NASA Investigators' Guide Crew Science Training 24 • Hardware selection and certification: – Identify potential hazards to the crew or to the vehicle – Describe measures taken to eliminate or minimize those risks • Experimental protocol must be approved by committee on human/animal research policy and procedures (Institutional Review Board) • Inform the candidate crewmembers about the rationale of the research and the associated risk (Informed Consent) • Brief the crew operator about the science and suggest appropriate changes in the flight protocol to maximize data return Photo NASA Investigators' Guide Crew Training Overview 25 Investigators' Guide Experiment Document 26 • Experiment objectives • Equipment description • Experiment procedures – Nominal – Malfunctions • Scheduled pre-, in-, and post-flight activities • Crew training manual • Data analysis plan • Data sharing plan Photos NASA Investigators' Guide Example of Experiment Timeline Example of a 12-hour timeline in orbit for the 7 crewmembers of a Shuttle mission. Document NASA 27 Investigators' Guide Example of Payload Crew Activity Plan 28 Investigators' Guide Module Configuration 29 Investigators' Guide Example of Experimental Procedure 30 Investigators' Guide Science Control Center 31 Photos NASA Investigators' Guide Ground-to-Space Communications S-band: Ku-band: 13 - 128 kbps 3Mbps up 6Mbps down 32 Investigators' Guide Additional Reading • Carey W (2001) The International Space Station European Users • • • • • • • Guide. Noordwijk, NL: European Space Agency, UIC-ESA-UM-001 Clément G (2003) Fundamentals of Space Medicine. Dordrecht: Kluwer Academic Publishers ESA (1979) Spacelab Users Manual. Paris, France: European Space Agency, DP/ST(79)3 International Space Life Sciences Working Group (2001) Space Life Sciences and Space Sciences Experiments Information Package. Joels KM, Kennedy GP (1982) The Space Shuttle Operator’s Manual. New York, NY: Ballantine Books Longdon N (1983) Spacelab Data Book. Paris, france: ESA Technical Publications Branch, ESA BR-14 NASA (1986) STS Investigators’ Guide. Huntsville, AL: Marshall Spaceflight Center, PMS-021 NASA (2000) Experiment Document. Format and Instructions for Human Flight Research Experiments. Houston, TX: NASA Johnson Space Center, Biomedical Systems Test and Project Management 33