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NASA NTRSDate not supplied

ExMC Ground-Based Space Radiation Analog Pilot Drug Stability Studay: Final Data Review

Uncertainty regarding space radiation effects on medication degradation and potency remains high, though early data suggest that space radiation may affect the potency and quality of some pharmaceuticals. In the absence of empirical spaceflight measurements to characterize this risk area for long-duration planetary missions, high-fidelity ground-based targeted radiation analogs could provide valuable insights. The NASA Human Research Program's (HRP) Exploration Medical Capability (ExMC) Element conducted a pilot study to characterize the chemical stability of four selected medications exposed to rapid switching, mixed-species simulated galactic cosmic radiation (GCR) beams at the NASA Space Radiation Laboratory (NSRL), at Brookhaven National Laboratory (BNL). The research objective was to compare the effects of simulated GCR beam exposures on drug stability to those previously observed following spaceflight.

Vernie R Daniels↗
NASA NTRSDate not supplied

Application of Agile for Systems Engineering, Project Management and Modeling and Lessons Learned

The Systems Engineering team within the Human Research Program (HRP) Exploration Medical Capability (ExMC) Element has been transforming its development processes to be more efficient, robust,and responsive to change and to its stakeholders. To these ends, the Systems Engineering team trialed the integration of agile development techniques into existing and new processes. Agile development methods are well understood within the software development community. Outside ofsoftware development, however, how non-software project management (PM) and systems engineering (SE) teams implement agile development techniques is less well understood. In its transformation efforts, the ExMC SE team focused on three main areas: Improving the project communications among subsystem teams and stakeholders by adopting a scrum-like process, Changing the status and reporting mechanisms to improve schedule coordination between the subsystem team, SE leadership, and ExMC Element leadership, and Unifying the model-based SE workflow to improve understanding of Concepts of Operations across projects.This presentation highlights several of these transformations and what the SE team learned while undergoing the transformation.

S Lumpkins↗
NASA NTRSDate not supplied

From IMM to IMPACT: Enhanced Functionality for Exploration Missions

The Integrated Medical Model (IMM) is an evidence-based decision support tool used to assess medical risk and optimize medical systems for manned spaceflight missions. The IMM is baselined to the International Space Station (ISS) in terms of the spaceflight environment of low earth orbit and the ISS medical resource capability. IMPACT is the next generation evidence-based decision support tool currently under development by the Human Research Program to assess medical risk and optimize medical systems for future exploration missions to the moon and Mars. IMPACT is being designed to provide a comprehensive integrated suite of decision support tools for mission planners. This presentation will focus on the lessons learned from IMM and the enhanced functionalities of IMPACT.

E L Kerstman↗
NASA NTRSDate not supplied

Implementation of a SysML Model-Based Concept of Operations for Level of Care IV: Long-Duration Lunar Orbital and Surface Operations

One goal of the Human Research Program (HRP) Exploration Medical Capability (ExMC) Element Systems Engineering (SE) team is to define the technical system needed to support crew medical system capabilities for future exploration missions, including orbital and surface operations for long duration lunar missions. This is accomplished through the development of a Medical System Foundation, which communicates medical system requirements, capabilities, conditions, and resources that define a starting point for a medical system that meets the specification for design reference missions and associated Levels of Care (as defined by NASA-STD-3001). The starting point for creating this Medical System Foundation Model is the development of a Concept of Operations (ConOps) that describes the operation of the system from the point of view of the users. It includes a comprehensive and thoroughly vetted list of the users, their specific needs, the goals of the system, key assumptions about the system, and definitions of the system’s operational environments. The use case scenarios included in the ConOps illustrate required medical system capabilities for Level of Care IV and enable the ExMC SE team to develop integrated medical system requirements and identify capabilities required to meet those requirements. For this “Long Duration” Medical System Foundation development effort, ExMC replaced the traditional document-based ConOps with a model-based ConOps using model-based systems engineering. This approach has several advantages, including the facilitation of more efficient understanding of the material through information-dense images with less opportunity for misinterpretation than text alone, the roll-out of changes to the ConOps to stakeholders in real-time as they are approved, and the consolidation of all salient information into one centralized location. This discussion will focus on both how the model represents the ConOps content and how the SE team utilized lessons learned in an agile environment to improve the way this information was created and presented to stakeholders.

M Kaetzer↗
NASA NTRSDate not supplied

Mitigating Headward Fluid Shifts with Venoconstrictive Thigh Cuffs during Spaceflight

Venoconstrictive thigh cuffs (VTC) are a mechanical countermeasure capable of attenuating the spaceflight induced headward fluid shift, and thus may be a viable spaceflight associated neuro-ocular syndrome (SANS) countermeasure. Crewmembers can use VTC to mitigate the headward fluid shift to aid in adapting to spaceflight. However, data are needed to determine if VTC affect ocular structures. PURPOSE The purpose of this study is to determine the efficacy of long duration use of VTC application to mitigate the spaceflight-induced headward fluid shift. We hypothesize that a VTC countermeasure will temporarily reverse the headward fluid shift and attenuate spaceflight-induced changes of internal jugular vein (IJV) cross-sectional area, IJV pressure, stroke volume, cardiac output, intraocular pressure (IOP), and optic nerve head and retinal morphology. METHODS This study will evaluate the effectiveness of VTC countermeasure application on the headward fluid shift, as well as cardiovascular and ocular variables. VTC during spaceflight will be worn for an extended duration (up to 6 hours) with data collected at three time points (30 minutes, 3 hours, and 6 hours) to characterize the temporal profile of key fluid shift outcome measures of the vascular fluid shift, IOP, and ocular structure changes. Ten astronauts will be recruited to participate and will be studied before and during approximately 180-day International Space Station (ISS) spaceflight missions. Baseline data collection will occur approximately 90-days before launch (Figure). Preflight, each leg of the crewmember will be measured to determine the VTC cuff size and a cuff fit check session will occur prior to the preflight baseline ground imaging to verify the appropriate fit measured via a surface contact pressure. Prior to donning the VTC, baseline measures without VTC will be collected seated, supine, and supine followed by data collection with the VTC. The baseline data collection will include ultrasound (IJV area and pressure, stroke volume and cardiac output), brachial blood pressure and heart rate, optical coherence tomography (OCT) imaging (total retinal thickness and choroid thickness), and IOP. An inflight cuff fit check session, same as the preflight fit check, will occur prior to VTC use on ISS. The inflight VTC experiment will be conducted early (FD45) and late (R-45) to determine if mission duration affects VTC fit and the efficacy of fluid redistribution. A system usability scale comfort questionnaire will be included in each VTC session to capture feedback from crewmembers regarding the comfort and usability of the VTC. SCIENTIFIC & MISSION IMPACT Results will narrow knowledge gaps described in the Human Research Roadmap to mitigate the headward fluid shift during spaceflight and help NASA to 1) determine the efficacy of extended use VTC application to mitigate the spaceflight-induced headward fluid shift and 2) further the understanding of the use of VTC on vascular fluid shifts, IOP, and ocular structure during spaceflight. Supported by NASA Human Research Program Directed Research. Figure. Detailed Testing Schedule. Baseline data collection at L-90 will be performed in a randomized order of position.

J V Jasien↗
NASA NTRSDate not supplied

Standard Measures During Spaceflight

The key goal of the Spaceflight Standard Measures project is to ensure that a set of measures, representing the Human Research Program’s key risks and acquired with minimal impact on time and resources, is consistently captured from crewmembers through the end of the International Space Station (ISS) Program. Data collected under the Spaceflight Standard Measures project include assessments of sleep/wake cycles, cognition, immune status and function, general blood and urine chemistry (urine is collected only before flight and after landing), microbiome composition (gastrointestinal tract, saliva, and body surface), cardiovascular structure and function (carotid intima-media thickness, orthostatic responses), sensorimotor function, and team processes. Data is collected once or twice before the flight (180 and 90 days before launch), twice during the 6-month missions (fight day 30 and 30 days before return to Earth) with the exception of actigraphy, which is recorded continuously during the mission, and during two-week periods before and after the mission. In this presentation, we will review the data collected to date on twelve ISS crew members. These data are placed in the NASA Life Sciences Data Archive and are available for occupational surveillance (using non-identifiable data) Institutional Review Board-approved data sharing requests, and retrospective data requests. This data repository enables high-level monitoring of the effectiveness of countermeasures and meaningful interpretation of health and performance outcomes for various mission durations. The knowledge gained from this project informs and supports future hypothesis-driven research that will enable the success of planetary missions.

G R Clement↗
NASA NTRSDate not supplied

Characterization of Jugular Venous Blood Flow During Acute Fluid Shifts

INTRODUCTION Exposure to weightlessness induces a headward fluid shift and redistribution of fluids, resulting in increased internal jugular vein (IJV) cross-sectional area and altered IJV blood flow dynamics including stasis and retrograde flow. These findings may contribute to various risks of spaceflight, including thrombosis or other risks affected by cerebral venous blood flow. To date, our understanding of the cerebral venous outflow dynamics is limited to the left IJV assessed ~45and ~150days into spaceflight. Therefore, it is unknown how quickly the alterations in venous blood flow dynamics change as a result of weightlessness. The purpose of this study is to determine 1) if venous stasis is an immediate effect of weightlessness, and therefore a risk for short-duration missions, and 2) the effect of weightlessness on brachiocephalic venous flow. METHODS In this study, we will determine the effects of acute weightlessness during parabolic flight on right and left IJV cross-sectional area, as well as blood flow dynamics through the IJV and brachiocephalic veins in 12 healthy subjects. Baseline ultrasound images will be obtained on the ground prior to the parabolic flight in the seated and supine postures to determine normal changes in blood flow with posture-induced fluid shifts in a 1genvironment. Subjects will then undergo parabolic flight withrepeated,~20 second exposure to 0g. Each data collection session will include 2D ultrasonography to quantify IJV cross-sectional area and Doppler ultrasonography to characterize venous blood flow patterns in the IJV and brachiocephalic veins. RESULTS Data collection for this study is planned to take place in October, 2021.CONCLUSIONS This study will characterize the immediate venous response in the left and right IJV and brachiocephalic veins upon entry into weightlessness. The results from this parabolic flight study will be compared with previous data from International Space Station crewmembers collectedafter~45 and ~150 days into spaceflight to provide a more complete understanding of the temporal profile of changes in venous blood flow dynamics during weightlessness and whether these findings develop in veins other than the left IJV. Supported by the NASA Human Research Program.

K Marshall-Bowman↗
NASA NTRSDate not supplied

High Value Risk Targets in Human System Risk

The Human System Risk Board (HSRB) has the overall responsibility for tracking the evolution of the top ~30 human system risks that it has identified to be associated with human spaceflight. The Board is also charged with maintaining a consistent, integrated process to mitigate those risks, and developing evidence-based risk posture recommendations. Each Risk Custodian Team (RCT) identifies High Value Risk Mitigation Targets (HVRMT) that have the highest likelihood or greatest impact in reducing their risk. These typically include areas where there are major gaps in knowledge or capability; or other targets that promise to yield returns worthy of investments in time, money and other resources by stakeholders interested in reducing Human System Risk. As part of the review of each risk the Board members consider and discuss the HVRMT statements, which are then approved by the Board Chair. High Value Risk Mitigation Targets can include research activities funded by the Human Research Program, but often involve recommending standards, monitoring, or other operational goals to reduce risk. This presentation will discuss common themes and highlights of the approved HVRTs to inform IWS attendees and the wider research community.

D M Buckland↗
NASA NTRSDate not supplied

Impact of Space Radiation on Plant Seeds: from Arabidopsis thaliana to Crops

One of the major concerns for long-term exploration missions beyond the Earth’s magnetosphere is radiation risk, primarily from solar particle events (SPE) and galactic cosmic rays (GCR). With the goal of manned Mars exploration, the production of fresh food during long-duration space missions provides critical nutritional supplementation and may also benefit astronauts’ behavioral health. However, the effects of space radiation on plants and plant propagules have not been sufficiently investigated and characterized. This is the final report of our project to summarize the findings of the effect of space radiation exposure on plant seeds from morphometrics, nutritional values, to molecular machenisms. In this study, we evaluated the effect of simulated GCR (using dry seeds) or SPE (using hydrated seeds) on seeds of Arabidopsis, Mizuna mustard, ‘Outredgeous’ red romaine lettuce, and ‘Red Robin’ dwarf tomato. Seeds were exposed to various doses of simulated space radiation scenarios, either acutely or at a low dose rate (LDR), using the NASA Space Radiation Laboratory (NSRL) facility at Brookhaven National Lab (BNL). Exposure to simulated GCR or SPE at the levels tested had no significant impact on the germination rate in Arabidopsis and crop seeds; however, GCR reduced the viability of lettuce and tomato seeds. Overall, the morphological changes of the seedlings cultured from irradiated seeds were dose- and ion quality- dependent, with heavier ions causing more severe damage. These changes ranged from cotyledon deformation, shortened root length, smaller seedling size, and other signs of stress, depending on the seed types. Both 40 and 80 cGy (LDR) exposures of GCR or SPE significantly affected tomato early seedling development, delayed tomato fruiting, and reduced the total yield of tomato. Altered nutritional values were also found in edible biomass, especially for the GCR 80 cGy (LDR) groups. Underlying mechanisms were furtherly evaluated using transcriptomic analysis. For both GCR and SPE, 40 cGy showed some effects, but to a much lesser extent compared with 80 cGy, which can be considered as the “maximum permissible exposure” for the seed types we evaluated in this study. The impact of space radiation on seeds potentially affects the ability of plants to adapt to other environmental stresses (e.g. microgravity, water stress, and hardware constraints) as well as susceptibility to plant diseases, which need to be furtherly investigated. This research is funded by NASA’s Human Research Program.

J T Richards↗
NASA NTRSDate not supplied

Selection Factors for Space Crops

NASA is actively researching space crop production to determine its potential to contribute to food system security on long duration missions beyond Low Earth Orbit. Our near-term focus is on nutrient and variety supplementation of prepackaged food with fresh produce that requires little or no processing. The longer-term goal is caloric replacement to become less dependent on Earth, and this will require cultivation of staple crops, processing and cooking equipment, integration with spacecraft air, water, and power systems, and automation. There are numerous technology and knowledge gaps remaining for sustainable space crop production systems, but one high-impact area is in the development of crops specifically customized to meet the needs of controlled environment crop production, astronaut health and well-being, and space-unique environments. Modern crop breeding and genome engineering tools are allowing for rapid development of new genotypes with incredible specificity. Targeted aspects to optimize crops for space have been identified and characterized into five categories: plant growth and development, plant physiology, produce nutrition, produce organoleptic acceptability, and postharvest characteristics. Within each category there are several targets that further the development of crop production systems for spaceflight, such as crop size and harvest index, tolerance to specific environmental stresses, optimizing target nutrients that are low or degrade in the packaged diet, maintenance time requirements, and less indigestible structural material. NASA-funded PIs are already beginning to develop candidate crops, and spaceflight testing and validation of novel space crops is on the horizon. Crops developed for space also have the potential to benefit terrestrial controlled environment agriculture crop production systems. This research was supported by NASA’s Space Biology and Human Research Programs.

Space Crop Production↗
NASA NTRSDate not supplied

Implementation of a SysML Model-Based Concept of Operations for Level of Care IV: Long-Duration Lunar Orbital and Surface Operations

One goal of the Human Research Program (HRP) Exploration Medical Capability (ExMC) Element Systems Engineering (SE) team is to define the technical system needed to support crew medical system capabilities for future exploration missions, including orbital and surface operations for long duration lunar missions. This is accomplished through the development of a Medical System Foundation, which communicates medical system requirements, capabilities, conditions, and resources that define a starting point for a medical system that meets the specification for design reference missions and associated Levels of Care (as defined by NASA-STD-3001). The starting point for creating this Medical System Foundation Model is the development of a Concept of Operations (ConOps) that describes the operation of the system from the point of view of the users. It includes a comprehensive and thoroughly vetted list of the users, their specific needs, the goals of the system, key assumptions about the system, and definitions of the system’s operational environments. The use case scenarios included in the ConOps illustrate required medical system capabilities for Level of Care IV and enable the ExMC SE team to develop integrated medical system requirements and identify capabilities required to meet those requirements. For this “Long Duration” Medical System Foundation development effort, ExMC replaced the traditional document-based ConOps with a model-based ConOps using model-based systems engineering. This approach has several advantages, including the facilitation of more efficient understanding of the material through information-dense images with less opportunity for misinterpretation than text alone, the roll-out of changes to the ConOps to stakeholders in real-time as they are approved, and the consolidation of all salient information into one centralized location. This discussion will focus on both how the model represents the ConOps content and how the SE team utilized lessons learned in an agile environment to improve the way this information was created and presented to stakeholders.

Mary Susan Kaetzer↗
NASA NTRSDate not supplied

HemoCue ISS Tech Demo - Results and Lessons Learned

During long duration space missions, astronauts experience immune system dysregulation [1], and white blood cell (WBC) count can give vital information about the body’s immune response. The ability to measure WBC count is currently an unmet need on the International Space Station (ISS) and for future exploration missions. To address this need, the Human Research Program’s (HRP) Exploration Medical Capability (ExMC) Element, along with the Research Operations and Integration (ROI) Element and the NASA Johnson Space Center Immunology Lab, flew HemoCue®, a commercial-off-the-shelf analyzer with the ability to measure whole blood WBC count with 5-part differential to ISS in December 2020.

Exploration Medical Capability↗
NASA NTRSDate not supplied

Planning for VEG-05 Tomato Crop Production on the International Space Station

Growing fresh, nutritious, palatable produce for crew consumption during spaceflight may provide health-promoting, bioavailable nutrients and enhance the astronaut dietary experience as we move toward longer-duration missions. Tending plants may also serve as a countermeasure for crew psychological stresses associated with spaceflight. However, requirements to support consistent growth of a variety of nutritious crops under spaceflight environmental conditions remain unclear. This study explores the potential to grow crops for consumption on the International Space Station (ISS) using the Veggie vegetable-production system. Mizuna mustard was grown during VEG-04 studies in 2019, and human and plant data from those tests continue to be analyzed. Tomato plants will be grown for the VEG-05 experiment, and preflight definition studies are underway to ascertain the best hardware and operations for growing this fruiting crop. The variety of tomato selected for this study is ‘Red Robin’, a compact cherry tomato. Plants will be grown under two different red: blue lighting treatments using the Veggie units on ISS, and the impact of spectral quality on plant growth and yield, nutrient content, organoleptic acceptability, and microbial composition of the tomatoes will be assessed. Preliminary testing with this crop helped to identify responses to different analog types of growth hardware including both plant pillows and Passive Orbital Nutrient Delivery System (PONDS) units, and current testing is focusing on flight-like versions of this hardware. Challenges with fertilizer salts leaching out into the plant wicks and burning the stems of tomato were observed in earlier tests, so amended fertilizer and wick configurations have been developed. Crew procedures including plant thinning, watering, height adjustment with respect to lighting, and pollination are being validated. VEG-05 will be the first test of tomato fruit production on ISS. Lessons learned during preparation and implementation of the VEG-04 mizuna test for watering, and a separate ISS investigation with peppers (PH-04) in the Advanced Plant Habitat (APH) in terms of fertilizer, plant wicks, and pollination, will be adapted for this experiment. This research was co-funded by the Human Research Program and Space Biology (MTL#1075) in the ILSRA 2015 NRA call. Note: Presentation is a video formatted mp4 with a run time of 3 mins. 24 secs.

Veggie↗
NASA NTRSDate not supplied

Teams in Space: Knowledge Gained, but More to Explore

NASA’s Human Research Program oversees the Team Risk (i.e., Risk of Performance and Behavioral Health Decrements due to Inadequate Cooperation, Coordination, Communication and Psychosocial Adaptation within a Team). Research in this area informs all aspects of an astronaut’s career, from hiring to training to mission support, and works to address new challenges related to lunar and Mars missions. NASA’s astronaut selection process creates an astronaut corps of highly qualified, team-oriented individuals, which allows mission planners much flexibility in composing small crews for specific missions. These crews are further developed and supported through extensive training, including team skills training, and countermeasures available to the crew throughout the mission. However, in the high consequence environment of long-duration missions, team composition is complex and is not a one-time concern to be addressed pre-mission. Team factors such as team cohesion, dyadic relationships, and shared team cognition are likely to change dynamically in response to each interaction and event experienced by the individuals and the team as a whole. Thus, monitoring and optimizing team composition at a more micro level (e.g., per task) is one way to support team functioning and performance. Spaceflight teams research also includes the multi-team system of Mission Control and coordination between space-to-ground, adding another avenue in which risk might be introduced, particularly under exploration missions that experience significant communication delays. Spaceflight teams research has recently experienced a concentrated flurry of analog research over the past decade, shedding light on the many unique challenges and potential solutions to mitigate the team risk in long-duration exploration missions. However, questions still remain about how to, for example, create unobtrusive operational measures and how to advance interdisciplinary teams research and countermeasure development. We present an overview of the challenges facing teams in space, our current knowledge, and the next steps for research and spaceflight operations.

Lauren Blackwell Landon↗
NASA NTRSDate not supplied

Looking into Ocular Risks of Spaceflight through the Mouse Retina

Ocular alterations have been observed at anatomical levels in astronauts on long duration spaceflight missions, such as what would be required for missions to Mars. These alterations cause an array of signs which together constitute the Spaceflight-Associated Neuro-ocular Syndrome (SANS), one of the top risk priorities of the NASA Human Research Program. Not much is known about SANS at the cellular and molecular level, but studies in mice and rats have recently begun to yield observations on how the spaceflight environment might affect the eye’s biology. Preliminary data from shuttle mouse experiments, and more recently experiments on ISS, have shown changes in retinal physiology via histology and gene expression analysis. This study utilizes samples from the CASIS sponsored Rodent Research 8 Experiment (RRRM-1) tissue sharing opportunity, delivered to the ISS by SpaceX CRS-16 on 12/08/2018. Female BALB/cAnNTac mice were on the ISS for 45 days, while ground controls consisted ofa standard vivarium group and spaceflight habitat group. Here we investigate the molecular response of the mouse retina to identify genes and pathways affected by spaceflight conditions using histology and transcriptomic RNAseq data. This Differentially Expressed Gene (DEG) data was used for pathway analysis with Galaxy (Genelab) and Ingenuity Pathway Analysis (IPA). We identified pathways related to neuronal differentiation, cellular transport/movement, and wound healing. Some of the top DEGs have known relation to ophthalmic diseases. Though there were DEGs throughout the comparisons we tested, there was no clear effect of spaceflight. This could be due to sample processing, which required mice to be returned to Earth about a day before they were sacrificed, possibly allowing for readaptation affecting the retinal transcriptome. However, there was a clear effect of age, between the young (10-12 weeks) and old (32 weeks) groups, and between the baseline and end of experiment, about 46 days.

SANS↗
NASA NTRSDate not supplied

Impact of Space Radiation on Plant Seeds: from Arabidopsis thaliana to Crops

One of the major concerns for long-term exploration missions beyond the Earth’s magnetosphere is radiation risk, primarily from solar particle events (SPE) and galactic cosmic rays (GCR). With the goal of manned Mars exploration, the production of fresh food during long-duration space missions provides critical nutritional supplementation and may also benefit astronauts’ behavioral health. However, the effects of space radiation on plants and plant propagules have not been sufficiently investigated and characterized. This is the final report of our project to summarize the findings of the effect of space radiation exposure on plant seeds from morphometrics, nutritiaonal values, to molecular machenisms. In this study, we evaluated the effect of simulated GCR (using dry seeds) or SPE (using hydrated seeds) on seeds of Arabidopsis, Mizuna mustard, ‘Outredgeous’ red romaine lettuce, and ‘Red Robin’ dwarf tomato. Seeds were exposed to various doses of simulated space radiation scenarios, either acutely or at a low dose rate (LDR), using the NASA Space Radiation Laboratory (NSRL) facility at Brookhaven National Lab (BNL). Exposure to simulated GCR or SPE at the levels tested had no significant impact on the germination rate in Arabidopsis and crop seeds; however, GCR reduced the viability of lettuce and tomato seeds. Overall, the morphological changes of the seedlings cultured from irradiated seeds were dose- and ion quality- dependent, with heavier ions causing more severe damage. These changes ranged from cotyledon deformation, shortened root length, smaller seedling size, and other signs of stress, depending on the seed types. Both 40 and 80 cGy (LDR) exposures of GCR or SPE significantly affected tomato early seedling development, delayed tomato fruiting, and reduced the total yield of tomato. Altered nutritional values were also found in edible biomass, especially for the GCR 80 cGy (LDR) groups. Underlying mechanisms were furtherly evaluated using transcriptomic analysis. For both GCR and SPE, 40 cGy showed some effects, but to a much lesser extent compared with 80 cGy, which can be considered as the “maximum permissible exposure” for the seed types we evaluated in this study. The impact of space radiation on seeds potentially affects the ability of plants to adapt to other environmental stresses (e.g. microgravity, water stress, and hardware constraints) as well as susceptibility to plant diseases, which need to be furtherly investigated. This research is funded by NASA’s Human Research Program.

J.T. Richards↗
NASA NTRSDate not supplied

The Evolution of the Impact Evidence Library Methods – What We Learned

During fiscal years 2020-2022 NASA’s Human Research Program, Exploration Medical Capability Element has worked to source this evidence for the model. During the process several lessons learned have been identified and drive recommendations for future efforts. The ICL 1.0: Spaceflight Medical Operational expertise should be consulted regarding the addition of future conditions. A clinician experienced with the nuances of spaceflight is recommended to have a minimum of 20 hours per condition to adequately source the evidence. Condition definitions should be carefully crafted to maintain mutual exclusivity. Common side effects from medications, common and consequential incidental findings in laboratory studies, and consequential side effects of diagnostic and procedural capabilities should be considered for inclusion as unique conditions in future iterations of the ICL 1.0. Incidence: Spaceflight incidence, although based on small population sizes, is the gold standard. Terrestrial incidence should be applied cautiously. Probability of minor vs. severe cases of the condition: Data informing severity probability of the medical condition are nearly always terrestrial. Special attention should be paid to this metric as it drives outcomes in the model and terrestrial data often overestimate severity of expected cases in spaceflight. Condition duration: Three clinical phases currently exist in the model. They represent the time necessary for diagnosis, treatment/convalescence/recurrence, and the remaining duration of the mission after maximal recovery, respectively. Further subdivision of acute and convalescent treatment/recurrence is recommended. Probability of need for evacuation: Surrogates for “Return to Definitive Care” were chosen prior to data collection. In most cases these surrogates were “need for hospitalization” or “need for surgery.” For many conditions these may not be realistic drivers of “Return to Definitive Care” and should be re-examined. Probability of Crew Mortality: Terrestrial mortality data is difficult to apply to astronauts who, invariably, have less comorbidities than terrestrial subjects. It must be applied judiciously. The proportion of mission tasks impaired by the condition: “Task Impairment” was assigned to each condition prior to the condition duration data becoming available. Future efforts should assign Task Impairment as the final step in sourcing the evidence.

A.J. Kreykes↗
NASA NTRSDate not supplied

A PI’s Guide to Analog Research

Congratulation on being awarded a grant to conduct research in a spaceflight analog! NASA funded research in a Human Research Program (HRP) managed analog environment is very different from research in a traditional laboratory. This presentation will provide a guide to help investigators successfully plan studies for integration and implementation in an HRP analog platform. There are many things to consider when planning a study for implementation in an analog facility and campaign or mission. How do you get from grant approval to data analysis? This is where HRP’s Research Operations and Integration (ROI) team comes in. The ROI team works with sponsoring HRP elements and PI teams to capture requirements and help the PI teams through the phases of research complement development, integration and implementation. A complement is comprised of a group of studies requiring a common platform and/or scenario that are able to be integrated on a noninterference basis for implementation. Properly defining and documenting requirements and study needs is crucial in successful integration and implementation. This presentation will outline and provide the information needed for PI teams to understand the integration process and the role of the ROI team in the successful integration and implementation of their study. Topics to be discussed will include but not be limited to science requirement definition and documentation, NASA IRB submissions, subject recruitment, screening and selection, study integration process, efficiency in data collection and data sharing, daily crew schedules, hardware and software shipping, receipt and checkout, biological sample collection, mission support, data management and receipt of data.

B. Caldwell↗