Payload Operations Integration Working Group (POIWG) July 26, 2012 Human Research Program (HRP) Malinda Moller Payload Operations Integration Working Group (POIWG) July 26, 2012 Human Research Program (HRP) HRP Increment 35/36 Overview Increment Manager Nichole Schwanbeck/ NASA Increment Lead Malinda Moller/ LM Operations Lead James Thaxton/ LM

Payload Operations Integration Working Group (POIWG) July 26, 2012 Human Research Program (HRP) Malinda Moller AGENDA HRP Inc 35/36 Complement Investigation Summaries New HRP In-flight Experiments New Facility Implementation Support to IP Activities Risks / Issues Open Work 2

Payload Operations Integration Working Group (POIWG) July 26, 2012 Human Research Program (HRP) Malinda Moller 3 HRP Inc 35/36 Complement *Inc 35/36 is only Increment targeted for this experiment **33S crew are final subjects for experiments # Included in delta Informed Consent Briefings In-flight and Pre/Post  Bisphosphonates (Control)  Comm Delay*  (New)  Integrated Cardiovascular (ICV)**  Microbiome  (New)  Nutrition**  Ocular Health  (New)  Pro K  Reaction Self Test  Repository  Spinal Ultrasound Pre/Post Only  Functional Task Test  Hip QCT   Intravertebral Disk Damage (IVD)  Manual Control  Sprint (Control)

Payload Operations Integration Working Group (POIWG) July 26, 2012 Human Research Program (HRP) Malinda Moller 33S CSA FE33S NASA FE34S NASA FE 35S ESA FE35S NASA FE Bisphosphonates (Control Subjects)  Comm DelayTBD ICV  Opr Journals  MicrobiomeTBD Nutrition  Ocular HealthTBD Pro K  Reaction Self Test  Repository  Spinal Ultrasound  Participation Matrix for HRP Experiments (In-flight)

Payload Operations Integration Working Group (POIWG) July 26, 2012 Human Research Program (HRP) Malinda Moller HRP Inc 35/36 New In-flight Experiments Comm Delay Microbiome Ocular Health

Payload Operations Integration Working Group (POIWG) July 26, 2012 Human Research Program (HRP) Malinda Moller Comm Delay: Larry Palinkas Brief Research Summary: The overall aim of the proposed study is to determine whether the communications delays likely to be experienced on future exploration missions will result in clinically or operationally significant negative impacts in crew behavior and performance, and where in that changing communication delay is the critical point that behavioral and task performance is most affected. In-Flight Data Collection: Performance Questionnaires after each “control” and “comm delay” task. Investigation Summaries

Payload Operations Integration Working Group (POIWG) July 26, 2012 Human Research Program (HRP) Malinda Moller New In-flight Operations: Comm Delay Imposes a 50 second voice communication delay (each way) during already scheduled ISS systems tasks. Two to three crewmembers participate in each task. Questionnaires are filled out by each crewmember, Flight Director, and CAPCOM following each task. This study is implemented in conjunction with ISTAR and MOD.  ISTAR / MOD will select the tasks and implement the comm delay.  HRP will schedule the in-flight crew questionnaires after each task.  ISTAR / MOD will coordinate the MCC questionnaires.  Questionnaires will be implemented using the CHeCS Data Collection Tool. No procedures; implemented via execution note. PI will request video and voice of activity if available No training is required. 2 hr 40 min in-flight crew time (not counting task time) This study is only being pitched to I35/36 crew and requires at least 2 of 3 crew members to participate Early in IncrementLate in Increment 4 control tasks (no Comm Delay) 4 tasks with Comm Delay

Payload Operations Integration Working Group (POIWG) July 26, 2012 Human Research Program (HRP) Malinda Moller Investigation Summaries Microbiome: Hernan Lorenzi, M.D. Brief Research Summary: The Microbiome experiment investigates changes to astronauts’ immune systems and microbiomes (the collection of microbes that live in and on the human body). These changes can be detected by taking periodic samples from different parts of the body and the surrounding International Space Station (ISS) environment. As part of this study, the likelihood and consequences of alterations in the microbiome due to extreme environments, and the related human health risk, will be assessed. In-Flight Data Collection: Blood, Saliva, Perspiration, Potable water collections; Microbiome (body swab), ISS Surface, and optional Gastrointestinal sampling.

Payload Operations Integration Working Group (POIWG) July 26, 2012 Human Research Program (HRP) Malinda Moller New In-flight Operations: Microbiome Uses both existing and new sample collection hardware. Requires substantial cold stowage space One integrated training session performed for sample collections (minimum required due to Training constraints) Crew time: 815 minutes with GI sampling; 680 minutes without. ActivityDates Microbiome Swabs (forehead, forearms, nasal, and oral cavity), Saliva Collection, and optional Gastrointestinal Sampling FD 7, FD 90, R-14 Blood Collection (R-2 is ambient)FD 7, R-2 ISS Surface Sampling and Post-exercise Perspiration Collection FD7, R-14 Potable Water Collection (ambient)R-14, Soyuz return

Payload Operations Integration Working Group (POIWG) July 26, 2012 Human Research Program (HRP) Malinda Moller Investigation Summaries Ocular Health: Christian Otto, M.D. Brief Research Summary: The International Space Station (ISS) Ocular Health Protocol aims to systematically gather physiological data to characterize the Risk of Microgravity-Induced Visual Impairment/Intracranial Pressure on crewmembers assigned to a 6 month ISS increment. The data collected will mirror Medical Requirements Integration Documents (MRID) requirements and testing performed during annual medical exams with an increase in the frequency of in-flight and post flight testing to more accurately assess changes that occur in the visual, vascular, and central nervous systems upon exposure to microgravity and the resulting fluid shifts. Monitoring in-flight changes, in addition to post flight recovery, is the main focus of this protocol. In-Flight Data Collection: Fundoscopy, Tonometry, Visual Testing, Ocular Ultrasound, BP and Vascular Compliance (cardiac ultrasound, BP, EKG)

Payload Operations Integration Working Group (POIWG) July 26, 2012 Human Research Program (HRP) Malinda Moller New In-flight Operations: Ocular Health This study has six instances of testing for each crewmember. Each instance consists of two days of testing at FD10, 30, 60, 90, 120, and R-30 (windows of +/- 7 days for all). This study will be implemented in conjunction with Medical Operations The Bolded activities for FD30 & R-30 activities satisfy MRID requirements Data from MedOps-required sessions will be shared, decreasing required crew time HRP training limited to Vascular Compliance training and Subject Overview Crew time: Utilization Crew time hours Day ADay B Fundoscopy Tonometry Blood Pressure Visual Acuity Amsler Grid Ocular Ultrasound Vascular compliance (Cardiac Ultrasound, EKG and Blood Pressure)

Payload Operations Integration Working Group (POIWG) July 26, 2012 Human Research Program (HRP) Malinda Moller In-flight Timeline Bolded activities will be Utilization crew time Italicized activities are items already performed as Med Ops MRID activities

Payload Operations Integration Working Group (POIWG) July 26, 2012 Human Research Program (HRP) Malinda Moller Ocular Health Forward Work Formal MOA in work between Med Ops and HRP/ISSMP which will further define implementation plan Utilization Operations products related to Ocular Health: procedures, training products, OIP Data management Scheduling responsibilities New fundoscope being flown prior to Increment 35 New Visual Acuity software being implemented to support Ocular Health Expect Ocular Health Operations Assessment mid to late August.

Payload Operations Integration Working Group (POIWG) July 26, 2012 Human Research Program (HRP) Malinda Moller HRP Inc 35/36 Facility Activities Build 13 DVD install/RIC 9.0 Install HRF Supply Kit Logistics Activities GDS/PFS Gauge Photos 8PU Drawer Installation and Configuration (HRF1)

Payload Operations Integration Working Group (POIWG) July 26, 2012 Human Research Program (HRP) Malinda Moller HRP Support to IP Science Biological Rhythms 48 hr (JAXA) – Uses Actiwatch Reader and Cable BP Reg (CSA) – Uses HRF Continuous Blood Pressure Device (CBPD) & PFS Energy (ESA) – Uses HRF PFS Sarcolab (ESA)- Uses MARES and HRF PEMS 2 & Ultrasound 2 Vascular (CSA) * – Uses HRF Centrifuge (RC) Vessel Imaging (ESA) * - Uses HRF Ultrasound 2; performed in conjunction with ICV Scans * 33S crew are final subjects for studies

Payload Operations Integration Working Group (POIWG) July 26, 2012 Human Research Program (HRP) Malinda Moller Inc. 35/36 Assumptions & Risks Depending on the number of participants in the new studies, this could be an extremely busy and complex increment for both crew and ground support personnel. –New studies add operational complexity –Ocular Health study requires extensive crew time & precise coordination with Med Ops –Microbiome study requires substantial cold stowage space. Availability of SpaceX downmass is essential. Assumes all HRP equipment is operational.

Payload Operations Integration Working Group (POIWG) July 26, 2012 Human Research Program (HRP) Malinda Moller Inc. 35/36 Open Work Operations products Manifesting experiment unique hardware for Microbiome Agreements with other groups for Ocular Health and Comm Delay

Payload Operations Integration Working Group (POIWG) July 26, 2012 Human Research Program (HRP) Malinda Moller I35/36 Contact Information Increment Manager Nichole Schwanbeck Increment Lead Malinda Moller Increment Operations Lead James Thaxton Increment Scientist Scott J. Wood HRP Training Coordinator Joyce Schultz Robert Strahan Integrated Science Coordinator Monica Desai (34S) Terri Bauer (35S)

Payload Operations Integration Working Group (POIWG) July 26, 2012 Human Research Program (HRP) Malinda Moller Back Up Slides

Payload Operations Integration Working Group (POIWG) July 26, 2012 Human Research Program (HRP) Malinda Moller Acronyms, Abbreviations, Definitions ASCRSAstronaut Strength, Conditioning, and Rehabilitation Specialist CDRCommander CMDCommand C/OCheck out CSACanadian Space Agency DVDDigital Video Disc ESAEuropean Space Agency FTTFunctional Task Test GDSGas Delivery System HRFHuman Research Facility HRPHuman Research Program IPInternational Partner ISSInternational Space Station ISSMPISS Medical Project (implementation leg of HRP) LMLockheed Martin NASANational Aeronautical Space Agency PFSPulmonary Function System PIGPressurized Inhalation Gases RCRefrigerated Centrifuge RICRack Interface Controller SLAMMDSpace Linear Acceleration Mass Measurement Device SSCShared Station Computer SWSoftware T61ptype of Portable Computer TBDTo Be Determined UMSUrine Monitor System URCUser Requirements Collection WHCWaste Hygiene Compartment

Payload Operations Integration Working Group (POIWG) July 26, 2012 Human Research Program (HRP) Malinda Moller Intervertebral Disc Damage: Alan Hargens, Ph.D. Brief Research Summary: The goal of this study is to use state-of- the-art imaging technologies to comprehensibly characterize and quantify space-flight induced changes in disc morphology, biochemistry, metabolism, and kinematics. Subjects will be imaged before and after prolonged spaceflight. These data will be correlated with low back pain that spontaneously arises in space so as to establish pain and disc damage mechanisms that will serve as a basis for future countermeasure development. Data Collection: Pre-/Post-flight testing only; involves MRI testing. Pre-/Post- Investigation Summaries

Payload Operations Integration Working Group (POIWG) July 26, 2012 Human Research Program (HRP) Malinda Moller Pre-/Post- Investigation Summaries Functional Task Test: Stuart M.C. Lee & Barry A. Spiering Brief Research Summary: The primary objective of the Functional Task Test (FTT) project is to develop and evaluate an integrated set of functional and physiological tests, and then use those tests to determine how post flight changes in sensorimotor, cardiovascular, and muscle physiology impact functional performance (e.g. standing, ladder climbing, and hatch opening). Data Collection: Pre-/Post-flight testing only; series of timed muscle performance tests

Payload Operations Integration Working Group (POIWG) July 26, 2012 Human Research Program (HRP) Malinda Moller Sprint (Control): Lori Ploutz-Snyder, Ph.D. Brief Research Summary: The Sprint experiment evaluates the efficacy of exercise countermeasures; this includes detailed measurements of cardiovascular and muscle function and bone health and evaluates the effectiveness of a new exercise prescription integrating both resistance and aerobic training exercise. Control subjects will not follow the Sprint exercise protocol in-flight. They will follow the standard ISS exercise protocol and share exercise data with the Principal Investigator. Data Collection: Pre-/Post-flight testing only; involves DXA, QCT, MRI, Muscle Performance and Isokinetic testing. Muscle biopsies are optional and will occur in Inc 35/36. Pre-/Post- Investigation Summaries

Payload Operations Integration Working Group (POIWG) July 26, 2012 Human Research Program (HRP) Malinda Moller Hip QCT: Jean Sibonga, Ph.D. & Thomas Lang, Ph.D. Brief Research Summary: The primary objective of Hip QCT is to monitor changes in hip sub-regions in response to in-flight countermeasures (CM). This QCT study will also demonstrate how countermeasures that involve mechanical loading of the hip (e.g., exercise) could be distinguished from CMs that involve biochemical suppression of bone resorption (e.g., bisphosphonates) because these two categories of CMs affect different bone compartments of the hip (anti-resorptives on trabecular bone, exercise on cortical bone). Finally, QCT will enable hip strength estimations by Finite Element [FE] Modeling – which detects more changes in hip strength due to space than with DXA modality. Data Collection: Pre-/Post-flight testing only; involves QCT assessment. Pre-/Post- Investigation Summaries

Payload Operations Integration Working Group (POIWG) July 26, 2012 Human Research Program (HRP) Malinda Moller Manual Control: Stephen Moore, Ph.D. Brief Research Summary: Lack of gravity causes sensorimotor deficits post-landing. This experiment's comprehensive cognitive/sensorimotor test battery will determine the relative contribution of specific mechanisms (including sleepiness and fatigue) underlying decrements in post-flight operator proficiency. These results will be critical in determining whether sensorimotor countermeasures are required for piloted landings and early surface operations, and what functional areas countermeasures should target. Data Collection: Pre-/Post-flight testing only; involves physiological and performance measures. Pre-/Post- Investigation Summaries

Payload Operations Integration Working Group (POIWG) July 26, 2012 Human Research Program (HRP) Malinda Moller Investigation Summaries Spinal Ultrasound : Scott A. Dulchavsky, Ph.D. Brief Research Summary: Sonographic Astronaut Vertebral Examination (Spinal Ultrasound) aims to use ground and space- based studies to fully characterize spinal changes during and after spaceflight. Ground based pre- and post-flight MRI and high fidelity ultrasound, combined with in-flight ultrasound will be used to characterize and assign a mission health risk to microgravity- associated spinal alterations for back pain and potential injury. This research will determine the accuracy of MRI and musculoskeletal ultrasound in characterizing the anatomy/composition of the vertebral unit and develop training methodologies. In-Flight Data Collection: Cervical and Lumbar Ultrasounds

Payload Operations Integration Working Group (POIWG) July 26, 2012 Human Research Program (HRP) Malinda Moller Investigation Summaries ProK: Scott M. Smith, PhD. Brief Research Summary: The Dietary Intake Can Predict and Protect Against Changes in Bone Metabolism during Spaceflight and Recovery investigation is NASAs first evaluation of a dietary countermeasure to lessen bone loss of astronauts. Pro K proposes that a flight diet with a decreased ratio of animal protein to potassium will lead to decreased loss of bone mineral. In-Flight Data Collection: Controlled/monitored diet with urine and blood samples.

Payload Operations Integration Working Group (POIWG) July 26, 2012 Human Research Program (HRP) Malinda Moller Investigation Summaries Reaction Self Test: David F. Dinges, Ph.D. Brief Research Summary: The Psychomotor Vigilance Self Test on the International Space Station is a portable 5-minute reaction time task that will allow the crewmembers to monitor the daily effects of fatigue on performance while on board the International Space Station. In-Flight Data Collection: Testing using reaction feedback software, scheduled on specific days and sleep shifted schedules, and around EVAs.

Payload Operations Integration Working Group (POIWG) July 26, 2012 Human Research Program (HRP) Malinda Moller Bisphosphonates (Control): Adrian Leblanc, Ph.D. & Toshio Matsumoto, Ph.D. Brief Research Summary: Bisphosphonates as a Countermeasure to Space Flight Induced Bone Loss. The purpose of the Bisphosphonates study is to determine whether an antiresorptive agent, in conjunction with the routine in-flight exercise program, protects International Space Station (ISS) crewmembers from the regional decreases in bone mineral density documented on previous ISS missions. Control subjects will not ingest the bisphosphonate pill in order to provide a comparison. In-Flight Data Collection: 24-h Urine collection, Diet/Exercise Logs Investigation Summaries

Payload Operations Integration Working Group (POIWG) July 26, 2012 Human Research Program (HRP) Malinda Moller Investigation Summaries Integrated Cardiovascular: Benjamin D. Levine, M.D. & Michael W. Bungo, M.D. Brief Research Summary: Cardiac Atrophy and Diastolic Dysfunction During and After Long Duration Spaceflight: Functional Consequences for Orthostatic Intolerance, Exercise Capability and Risk for Cardiac Arrhythmias (Integrated Cardiovascular) will quantify the extent, time course and clinical significance of cardiac atrophy (decrease in the size of the heart muscle) associated with long-duration space flight. This experiment will also identify the mechanisms of this atrophy and the functional consequences for crewmembers who will spend extended periods of time in space. In-Flight Data Collection: Hardware used: NASA Ultrasound 2, NASA Actiwatch, NASA Holter Monitor2, ESA Cardiopres. 48 Hr Ambulatory Monitoring within 1 week of Ultrasound scan.

Payload Operations Integration Working Group (POIWG) July 26, 2012 Human Research Program (HRP) Malinda Moller Investigation Summaries Nutrition: Scott M. Smith, Ph.D. Brief Research Summary: Nutritional Status Assessment is a comprehensive in-flight study being done to understand changes in human physiology during long-duration space flight. This study includes measures of bone metabolism, oxidative damage, and chemistry and hormonal changes, as well as assessments of the nutritional status of the astronauts participating in the study. In-Flight Data Collection: Blood & 24-Hr urine samples, Food Frequency Questionnaire.