1. Investigators' Guide 1 Space Life Sciences Investigators' Guide Gilles Clément, Ph.D CNRS "Cerveau et Cognition" Laboratory Toulouse, France Photo NASA Kluwer Academic Publishers Copyright © 2003 All rights reserved Fundamentals of Space Medicine — Chapter 8

2. Investigators' Guide 2 Outline 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

3. Investigators' Guide 3 Steps of Life Science Research Testable Hypothesis Experiment Proposal Peer Review Acceptance of Proposal Development of Protocol/Hardware Supporting Ground-Based Studies Flight Experimentation Knowledge and Solution Observations Questions Concerns Problems ?

4. Investigators' Guide 4 Access to Microgravity MicrogravityDuration ClinostatSimulatedUnlimited Bed restSimulated3-12 months Centrifuge> 1 g2 months (animals) Drop tower< 10 -4 seconds Parabolic flight10 -1 -10 -2 20 seconds Sounding rocket10 -5 6-15 minutes Unmanned capsule10 -5 -10 -6 15 days Space Shuttle10 -4 10 days SpaceHab10 -4 < 16 days ISS10 -4 Unlimited

5. Investigators' Guide 5 Research Opportunities International Space Station Spacehab Science Missions Shuttle Small Payload Flight Experiments Biosatellites (Photon) Ground-Based Investigations : –Parabolic flight –Centrifuge –Laboratory (e.g., clinostat) –Simulations (e.g., bed rest) –Ground-based development studies Photon capsule after landing. Photo CNES Clinostat. Photo CNES NASA KC-135 during parabolic flight. Document NASA Movie: 05_KC135

6. Investigators' Guide 6 Ground-Based Investigations 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

7. Investigators' Guide 7 Space Shuttle Middeck & SpaceHab Storage lockers in the middeck of the Space Shuttle Documents NASA Shuttle and ISS tour Movie: 07_stsISStour

8. Investigators' Guide 8 “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.

9. Investigators' Guide 9 International Space Station (ISS) Document NASA

10. Investigators' Guide 10 ISS Experiment Cycles Documents NASA Movie: 10_docking

11. Investigators' Guide 11 ISS Experiment Implementation Time Document NASA

12. Investigators' Guide 12 Experiments on board ISS 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

13. Investigators' Guide 13 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

14. Investigators' Guide 14 Space Shuttle Crew Time 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

15. Investigators' Guide 15 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) 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 Movie: 15_mirtour

16. Investigators' Guide 16 Postflight Data Collection Space Shuttle Entry Day –Crew to be awake 8-14 hrs before landing (3 hrs for post- sleep 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 –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 Crew transfer vehicle. Photo NASA

17. Investigators' Guide 17 Example: STS-111 R+0 Schedule Movie: 17_landing2

18. Investigators' Guide 18 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)

19. Investigators' Guide 19 How to Fly an Experiment Spacelab experiment cycle. Document ESA/NASA

20. Investigators' Guide 20 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)

21. Investigators' Guide 21 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

22. Investigators' Guide 22 Flight Experiment Selection Requirements Definition Experiment requirements Risk reduction studies Biocompatibility Procedures development Cost estimates & schedule Concept Definition Preliminary science requirements Feasability analysis Approach (e.g. hardware, resources, procedures) Assess maturity of approach Identify required studies to ensure feasability Select Flight Candidate Experiment Development Design, develop, manufacture experiment unique hardware Mission documentation Verify experiment interfaces and procedures Crew training Logistics for launch Operations and Data Analysis Pre-, in-, and post-flight data acquisition Data analysis Data archiving (after one year) Publication of results Post-flight symposia Select For Definition Feasability Review & Science Merit Proposal Submission 3-12 months 12-24 months

23. Investigators' Guide 23 Experiment Integration 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

24. Investigators' Guide 24 Crew Science Training 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

25. Investigators' Guide 25 Crew Training Overview

26. Investigators' Guide 26 Experiment Document 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

27. Investigators' Guide 27 Example of Experiment Timeline Example of a 12-hour timeline in orbit for the 7 crewmembers of a Shuttle mission. Document NASA

28. Investigators' Guide 28 Example of Payload Crew Activity Plan

29. Investigators' Guide 29 Module Configuration

30. Investigators' Guide 30 Example of Experimental Procedure

31. Investigators' Guide 31 Science Control Center Photos NASA

32. Investigators' Guide 32 Ground-to-Space Communications S-band:13 - 128 kbps Ku-band:3Mbps up 6Mbps down

33. Investigators' Guide 33 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