Payload Operations Integration Working Group (POIWG) January 29, 2013 Human Research Program (HRP) Susan Torney & Gina Miller Human Research Program (HRP) HRP Increment 37/38 Overview Increment Manager Susan Torney/ NASA Increment Lead Gina Miller/ LM Operations Lead Anya Spadaccini/ LM

Payload Operations Integration Working Group (POIWG) January 29, 2013 Human Research Program (HRP) Susan Torney & Gina Miller AGENDA HRP Experiments - HRP Inc 37/38 Complement - New HRP In-flight Experiments - Possible Additions Other In-Flight Activities - Facility Activities - Support to IP Activities Challenges Backup Charts: Investigation Summaries 2

Payload Operations Integration Working Group (POIWG) January 29, 2013 Human Research Program (HRP) Susan Torney & Gina Miller HRP Inc 37/38 Complement ExperimentsPrevious Increments Biochemical ProfileNew Bisphosphonates (Control)18 – 35/36 Cardio OxNew Journals29/30 – 35/36 Microbiome35/36 Ocular Health35/36 Pro K21/22 – 35/36 Reaction Self Test21/22 – 35/36 Repository16 – 35/36 Salivary MarkersNew Spinal Ultrasound33/34 – 35/36 Sprint (Control)27/28 – 33/34 Pre/Post Only Functional Task Test21/22 – 35/36 Hip QCT35/36 Intervertebral Disc Damage33/34 – 35/36 Manual Control33/34 – 35/36 Possible new experiments: Body Measures & Comm Delay Assessment

Payload Operations Integration Working Group (POIWG) January 29, 2013 Human Research Program (HRP) Susan Torney & Gina Miller Participation Matrix for HRP Experiments (In-flight) Experiment35S ESA 35S US 36S US 37S JAXA 37S US Biochemical Profile Bisphosphonates (Control) * * Cardio Ox ** Journals Microbiome Ocular Health Pro K Reaction SelfTest [final subjects] Repository Salivary Markers Spinal Ultrasound [final subjects] Sprint (Control) * * TBD ** Operator Only Note: Possible additions to 36S and 37S: Body Measures and Comm Delay Assessment

Payload Operations Integration Working Group (POIWG) January 29, 2013 Human Research Program (HRP) Susan Torney & Gina Miller Participation Matrix for HRP Experiments (Pre/Post) Experiment35S ESA 35S US 36S US 37S JAXA 37S US Functional Task Test [final subjects] Hip QCT * Intervertebral Disc Damage (IVD) Manual Control * TBD

Payload Operations Integration Working Group (POIWG) January 29, 2013 Human Research Program (HRP) Susan Torney & Gina Miller HRP Inc 37/38 New In-flight Experiments Biochemical Profile Cardio Ox Salivary Markers

Payload Operations Integration Working Group (POIWG) January 29, 2013 Human Research Program (HRP) Susan Torney & Gina Miller PRINCIPAL INVESTIGATOR Robert A. Pietrzyk, M.S., NASA Johnson Space Center, Houston, TX RESEARCH OBJECTIVES The goal is to allow a rapid response to research scientists requesting flight research data investigating effects of microgravity on human physiology and to evaluate the effectiveness of countermeasures ensuring the health and performance of humans during and after spaceflight. Human physiological systems work together and the establishment of this biochemical profile will provide a resource enabling the recognition of interactions through a cross- discipline approach. IN-FLIGHT OPERATIONS FDs 15, 30, 60, 120, and 180/R-14: 24-hour urine collection, blood draw and subsequent processing. Urine samples can be frozen for long-term storage prior to return to Earth for analysis. Blood samples are processed (coagulation and centrifugal spin) and are subsequently frozen for long-term storage. Biochemical Profile

Payload Operations Integration Working Group (POIWG) January 29, 2013 Human Research Program (HRP) Susan Torney & Gina Miller PRINCIPAL INVESTIGATOR Steven H. Platts, Ph.D., NASA Johnson Space Center RESEARCH OBJECTIVES To determine the effects of long-duration spaceflight on measures of inflammatory and oxidative stress. To determine the effects of long-duration spaceflight on measures of arterial structure and function through R+3. To determine how alterations in vascular function and structure correlate with changes in circulating biomarkers of oxidative and inflammatory stress. To monitor oxidative, inflammatory, and vascular status of astronauts for up to five years after the completion of their long-duration space flight mission (surveillance). IN-FLIGHT OPERATIONS Ultrasound scans (carotid/brachial) with ECG recording on flight days (FDs) 15, 60, and R-15 using real-time remote guidance. Each ultrasound session will be preceded or followed by a blood draw and 24-hr void-by-void urine collection. Cardio Ox

Payload Operations Integration Working Group (POIWG) January 29, 2013 Human Research Program (HRP) Susan Torney & Gina Miller PRINCIPAL INVESTIGATOR Richard J. Simpson, Ph.D., University of Houston, Houston, TX RESEARCH OBJECTIVES To longitudinally examine the impact of long-term spaceflight (up to 6 months) on salivary and cellular markers of innate immune function and latent viral reactivation. To determine the impact of acute stressors associated with spaceflight on salivary markers of mucosal and innate immune function. To examine the relationship between changes in salivary and cellular markers of innate immune function and changes in other stressors associated with the spaceflight environment (i.e., circadian desynchronization, sleep loss/disruption, mood state disturbances, stress, infection incidence). IN-FLIGHT OPERATIONS FD 10, FD 90 and R-1: Blood draw, Saliva sampling, 24-hour urine collection, and Health Assessment using Med Ops’ Data Collection Tool (DCT) –FD 90 and R-1 blood samples will return ambient on Soyuz Salivary Markers

Payload Operations Integration Working Group (POIWG) January 29, 2013 Human Research Program (HRP) Susan Torney & Gina Miller HRP is planning a delta Informed Consent Briefing in April –A CEF will be submitted to request the additional crew time  Body Measures  Comm Delay Assessment HRP Inc 37/38 Possible Additions

Payload Operations Integration Working Group (POIWG) January 29, 2013 Human Research Program (HRP) Susan Torney & Gina Miller PRINCIPAL INVESTIGATOR Sudhakar Rajulu, Ph.D., NASA Johnson Space Center, Houston, TX RESEARCH OBJECTIVES To gather and document microgravity effects on body measurements: lengths, breadths, widths, circumferences, and joint angles of subjects exposed to microgravity in an unsuited condition. To determine if/how the Neutral Body Posture (NBP) is influenced by the above factors. It is anticipated that body measurements will change due to microgravity and fluid shifts. The goal of this study is to gather preliminary data to better understand the magnitude and variability of these changes. This data is important for NASA to be able to determine the changes that may occur during long-duration space flight and once obtained, NASA engineers may be able to apply these changes to suit fit, suit sizing, work station design, etc. for current and near future missions. These changes will help NASA to prevent potential crew injury during extended on-orbit missions. IN-FLIGHT OPERATIONS In-flight measurements will be collected using a tape measure for circumferences and still digital cameras on-board ISS to capture photographs. In addition, the tape measure can also be used to measure segment lengths for comparison to data from the photogrammetric method in-flight, if time permits. During in-flight data collection sessions, circumference measurements, photographic imagery, and video imagery will be collected twice during three 140-minute sessions (210 minutes with operator time) on FD15, 80, and R-30 (reserve sessions on FD45, 105, 135). The process includes setup of the cameras, subject preparation (placing body markers on the subject), collecting two photographs of each of three postures, measuring circumferences with a tape measure, and NBP video. Body Measures

Payload Operations Integration Working Group (POIWG) January 29, 2013 Human Research Program (HRP) Susan Torney & Gina Miller PRINCIPAL INVESTIGATOR Lawrence A. Palinkas, Ph.D., University of Southern California, Los Angeles, CA RESEARCH OBJECTIVES The overall aim of the proposed study is to determine whether the communications delays (as an indicator of communication quality) likely to be experienced on a long duration mission to an asteroid or to Mars will result in clinically or operationally significant decrements in crew performance and well-being on the ISS. Specifically, we aim to accomplish the following utilizing the ISS (which are further described below): Aim 1: Determine the feasibility and acceptability of conducting a study of Communication Delays on the ISS. Aim 2: Determine if there is an association between delays in communication (like those expected to be experienced during a Mars mission), individual and crew performance, and well-being. Aim 3: Determine whether this association is affected by task complexity (criticality and novelty), social support, perceived stress, and task autonomy. Comm Delay Assessment

Payload Operations Integration Working Group (POIWG) January 29, 2013 Human Research Program (HRP) Susan Torney & Gina Miller IN-FLIGHT OPERATIONS Mission Operations Directorate (MOD) and International Space Station Testbed for Analog Research (ISTAR) will work together to identify suitable tasks, negotiate with operations to implement the communication delay, and work with schedulers to maintain the requirements necessary to ensure the methodological design of this study. The requirements needed are outlined below. ISSMP will administer the in-flight surveys and schedule the pre- and post-flight baseline data collection for crewmembers; however, MOD and ISTAR reps will be responsible for all activities related to MCC study participants (e.g. recruiting participants, administering surveys, delivering data to PI, etc.). Targeting three USOS crewmembers (prefer 3 crew; however, will accept 2 crew). 16 tasks no more than 60 minutes in length should be designated across the timeline, targeting implementation of tasks early and late All tasks must have a moderate to high communication between crew and Mission Control, with a minimum of four communications between ISS and MCC expected For each task, there must be at least two individuals involved to complete that task (third person if possible), to ensure this is designated as a team-level task. A different task will be completed each day over an approximately 4 day period under each of the following four test conditions: no delay (early and late mission) or delay (early and late mission). Payloads will be account only for the crewtime associated with in-flight surveys (using the DCT) following each task Comm Delay Assessment (cont.)

Payload Operations Integration Working Group (POIWG) January 29, 2013 Human Research Program (HRP) Susan Torney & Gina Miller HRP Inc 37/38 Facility Activities HRF Re-supply inventory GDS/PPFS Gauge Photos RIC v 9.0 Install HRF Build 13 DVD Installs SLAMMD Control Run (body mass measurement)

Payload Operations Integration Working Group (POIWG) January 29, 2013 Human Research Program (HRP) Susan Torney & Gina Miller HRP Inc 37/38 Support to IP Science CSA –BP Reg – Uses HRF Pulmonary Function System (PFS) and Continuous Blood Pressure Monitoring Device (CBPD) –Vascular – Uses HRF centrifuge (RC) ESA –Energy – Uses HRF PFS

Payload Operations Integration Working Group (POIWG) January 29, 2013 Human Research Program (HRP) Susan Torney & Gina Miller HRP Inc 37/38 Challenges Blood Volume Limits –Only so much blood may be collected from a crewmember during a given time span (“30 day rolling blood volume limits”) –HRP carefully manages experiment requirements and crew blood volumes –Timeline changes affect blood volume calculations and could impact science Fluctuating number of EVAs and fluidity of visiting vehicle traffic –The level of EVA operations and/or visiting vehicle traffic affect crew availability and could impact science. –Limited upmass availability could impact HRP resupply Training timeline is tight

Payload Operations Integration Working Group (POIWG) January 29, 2013 Human Research Program (HRP) Susan Torney & Gina Miller HRP Inc 37/38 Challenges (cont.) Fledgling studies –Two new complex studies begin in Inc 35/36  Ocular Health (builds on current Med Ops ocular testing)  Microbiome –New studies in Inc 37/38  Biochemical Profile (similar to Nutrition)  Cardio Ox  Salivary Markers –Possibly new in Inc 37/38  Body Measures  Comm Delay Assessment

Payload Operations Integration Working Group (POIWG) January 29, 2013 Human Research Program (HRP) Susan Torney & Gina Miller Inc 37/38 HRP Contact Information Increment Manager SUSAN TORNEY 281/ Increment Lead GINA MILLER 281/ Operations Lead ANYA SPADACCINI 281/ Increment Planner JOE COEN 281/ Project Scientist SCOTT WOOD 281/ Training Coordinator SONDRA FABIAN 281/ Increment Science Coordinators MATTHEW ROPER (36S crew) 281/ and SHANNA RODGERS (37S crew) 281/

Payload Operations Integration Working Group (POIWG) January 29, 2013 Human Research Program (HRP) Susan Torney & Gina Miller Back Up Slides

Payload Operations Integration Working Group (POIWG) January 29, 2013 Human Research Program (HRP) Susan Torney & Gina Miller 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) January 29, 2013 Human Research Program (HRP) Susan Torney & Gina Miller 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) January 29, 2013 Human Research Program (HRP) Susan Torney & Gina Miller 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) January 29, 2013 Human Research Program (HRP) Susan Torney & Gina Miller 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) January 29, 2013 Human Research Program (HRP) Susan Torney & Gina Miller 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) January 29, 2013 Human Research Program (HRP) Susan Torney & Gina Miller Investigation Summaries Journals: Jack Stuster, Ph.D. Brief Research Summary: This study converts behavioral and human factors information contained in confidential journal entries into quantitative data concerning the importance of the various behavioral issues involved in extended-duration space exploration. In-Flight Data Collection: Periodic journal entries

Payload Operations Integration Working Group (POIWG) January 29, 2013 Human Research Program (HRP) Susan Torney & Gina Miller 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) January 29, 2013 Human Research Program (HRP) Susan Torney & Gina Miller 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) January 29, 2013 Human Research Program (HRP) Susan Torney & Gina Miller 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) January 29, 2013 Human Research Program (HRP) Susan Torney & Gina Miller 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) January 29, 2013 Human Research Program (HRP) Susan Torney & Gina Miller 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) January 29, 2013 Human Research Program (HRP) Susan Torney & Gina Miller 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: involves DXA, QCT, MRI, Muscle Performance and Isokinetic testing. Muscle biopsies are optional. In-flight testing components are being added for Inc 39/40 and subsequent (TBD for Inc 37/38). Investigation Summaries