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NASA NTRSDate not supplied

HRP Data Management Plan

The purpose of Human Research Program Data Management Plan (DMP) is to define the processes and activities required for the overall management of the research data collected and managed by HRP throughout their life cycle. New updates to the Data Management Plan in 2023 include 1. CAPABILITIES AND SERVICES Data Repositories. Principal Investigators (PIs) funded by HRP may be asked to submit data to one of several NASA data repositories. HRP archives data in the NASA Life Sciences Portal (NLSP) that it considers to be unique and high value. This includes data from human subjects in space flight (ISS and commercial flights) and ground analogs to spaceflight; spaceflight tech demos involving humans; human omics data including the microbiome; parabolic flight studies; and the NASA Space Radiation Laboratory (NSRL). The Open Science Data Repository (OSDR) includes The Ames Life Sciences Data Archive (ALSDA), used to archive non-human biological data (e.g., animal) generated by the Human Research program, and GeneLab, available to HRP PIs to archive non-human omics data. Catalog for search and retrieval. A catalog of non-human HRP life science experiments, with all associated descriptions (mission, payload, hardware, and personnel related information), and biospecimens is provided on the NLSP public web site for search and retrieval. 2. IRB ROLE IN RETURN OF INDIVIDUAL RESEARCH RESULTS The NASA IRB manages the process for incidental findings and for returning results to subjects for studies for which NASA IRB is the IRB of record. Omics data, especially genomics data, may generate information significant to the health of or risk to a research subject. These data potentially hold the keys to understand lifetime risks of chronic diseases, such as cancer, as well as risks associated with exposures common in space flight. 3. UPDATE OF TERMS – IDENTIFIABLE AND ATTRIBUTABLE DATA HRP now follows Federal and NASA policy by using “identifiable” instead of “attributable” for Personally Identifiable Information (PII). 4. POLICY ABOUT INTERNAL NON-RESEARCH USE OF DATA The HRP Chief Scientist grants access to data from HRP-funded research for non-research internal use that includes program management, customer facilitation, strategic planning, and risk research planning. Typical HRP personnel granted access to HRP research data for internal use include the Element Scientist, Subject Matter Experts (SME), and Data/bioinformatics Scientists. If data accessed for Internal Use is provided to an intramural or extramural scientist for hypothesis driven research, all Federal and NASA regulations (e.g., IRB review) regarding human subject research apply.

Data Management Plan↗
NASA NTRS2014

How HRP Research Results Contribute to Human Space Exploration Risk Mitigation

In addition to the scientific value of publications derived from research, results from Human Research Program (HRP) research also support HRP’s goals of mitigating crew health and performance risks in space flight. Research results are used to build the evidence base characterizing crew health and performance risks, to support risk research plan development, to inform crew health and performance standards, and to provide technologies to programs for meeting those standards and optimizing crew health and performance in space. This talk will describe examples of how research results support these efforts. For example, HRP research results are used to revise or even create new standards for human space flight, which have been established to protect crew health and performance during flight, and prevent negative long-term health consequences due to space flight. These standards are based on the best available clinical and scientific evidence, as well as operational experience from previous space flight missions, and are reviewed as new evidence emerges. Research results are also used to update the HRP evidence base, which is comprised of a set of reports that provide a current record of the state of knowledge from research and operations for each of the defined human health and performance risks for future NASA exploration missions. A discussion of the role of evidence within the HRP architecture will also be presented. The scope of HRP research results extends well beyond publications, as they are used in several capacities to support HRP deliverables and, ultimately, the advancement of human space exploration beyond low-Earth orbit.

Lumpkins, S. B.↗
NASA NTRS2014

How HRP Research Results Contribute to Human Space Exploration Risk Mitigation

In addition to the scientific value of publications derived from research, results from Human Research Program (HRP) research also support HRP's goals of mitigating crew health and performance risks in space flight. Research results are used to build the evidence base characterizing crew health and performance risks, to support risk research plan development, to inform crew health and performance standards, and to provide technologies to programs for meeting those standards and optimizing crew health and performance in space. This talk will describe examples of how research results support these efforts. For example, HRP research results are used to revise or even create new standards for human space flight, which have been established to protect crew health and performance during flight, and prevent negative long-term health consequences due to space flight. These standards are based on the best available clinical and scientific evidence, as well as operational experience from previous space flight missions, and are reviewed as new evidence emerges. Research results are also used to update the HRP evidence base, which is comprised of a set of reports that provide a current record of the state of knowledge from research and operations for each of the defined human health and performance risks for future NASA exploration missions. A discussion of the role of evidence within the HRP architecture will also be presented. The scope of HRP research results extends well beyond publications, as they are used in several capacities to support HRP deliverables and, ultimately, the advancement of human space exploration beyond low-Earth orbit.

Lumpkins, Sarah↗
NASA NTRS2014

Concepts to Support HRP Integration Using Publications and Modeling

Initial efforts are underway to enhance the Human Research Program (HRP)'s identification and support of potential cross-disciplinary scientific collaborations. To increase the emphasis on integration in HRP's science portfolio management, concepts are being explored through the development of a set of tools. These tools are intended to enable modeling, analysis, and visualization of the state of the human system in the spaceflight environment; HRP's current understanding of that state with an indication of uncertainties; and how that state changes due to HRP programmatic progress and design reference mission definitions. In this talk, we will discuss proof-of-concept work performed using a subset of publications captured in the HRP publications database. The publications were tagged in the database with words representing factors influencing health and performance in spaceflight, as well as with words representing the risks HRP research is reducing. Analysis was performed on the publication tag data to identify relationships between factors and between risks. Network representations were then created as one type of visualization of these relationships. This enables future analyses of the structure of the networks based on results from network theory. Such analyses can provide insights into HRP's current human system knowledge state as informed by the publication data. The network structure analyses can also elucidate potential improvements by identifying network connections to establish or strengthen for maximized information flow. The relationships identified in the publication data were subsequently used as inputs to a model captured in the Systems Modeling Language (SysML), which functions as a repository for relationship information to be gleaned from multiple sources. Example network visualization outputs from a simple SysML model were then also created to compare to the visualizations based on the publication data only. We will also discuss ideas for building upon this proof-of-concept work to further support an integrated approach to human spaceflight risk reduction.

Mindock, J.↗
NASA NTRS2014

HRP's Healthcare Spin-Offs Through Computational Modeling and Simulation Practice Methodologies

Spaceflight missions expose astronauts to novel operational and environmental conditions that pose health risks that are currently not well understood, and perhaps unanticipated. Furthermore, given the limited number of humans that have flown in long duration missions and beyond low Earth-orbit, the amount of research and clinical data necessary to predict and mitigate these health and performance risks are limited. Consequently, NASA's Human Research Program (HRP) conducts research and develops advanced methods and tools to predict, assess, and mitigate potential hazards to the health of astronauts. In this light, NASA has explored the possibility of leveraging computational modeling since the 1970s as a means to elucidate the physiologic risks of spaceflight and develop countermeasures. Since that time, substantial progress has been realized in this arena through a number of HRP funded activates such as the Digital Astronaut Project (DAP) and the Integrated Medical Model (IMM). Much of this success can be attributed to HRP's endeavor to establish rigorous verification, validation, and credibility (VV&C) processes that ensure computational models and simulations (M&S) are sufficiently credible to address issues within their intended scope. This presentation summarizes HRP's activities in credibility of modeling and simulation, in particular through its outreach to the community of modeling and simulation practitioners. METHODS: The HRP requires all M&S that can have moderate to high impact on crew health or mission success must be vetted in accordance to NASA Standard for Models and Simulations, NASA-STD-7009 (7009) [5]. As this standard mostly focuses on engineering systems, the IMM and DAP have invested substantial efforts to adapt the processes established in this standard for their application to biological M&S, which is more prevalent in human health and performance (HHP) and space biomedical research and operations [6,7]. These methods have also generated substantial interest by the broader medical community though institutions like the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) to develop similar standards and guidelines applicable to the larger medical operations and research community. DISCUSSION: Similar to NASA, many leading government agencies, health institutions and medical product developers around the world are recognizing the potential of computational M&S to support clinical research and decision making. In this light, substantial investments are being made in computational medicine and notable discoveries are being realized [8]. However, there is a lack of broadly applicable practice guidance for the development and implementation of M&S in clinical care and research in a manner that instills confidence among medical practitioners and biological researchers [9,10]. In this presentation, we will give an overview on how HRP is working with the NIH's Interagency Modeling and Analysis Group (IMAG), the FDA and the American Society of Mechanical Engineers (ASME) to leverage NASA's biomedical VV&C processes to establish a new regulatory standard for Verification and Validation in Computational Modeling of Medical Devices, and Guidelines for Credible Practice of Computational Modeling and Simulation in Healthcare.

Mulugeta, Lealem↗
NASA NTRSDate not supplied

Managing HRP’S External Deliverables: The Process and the Customers

The Human Research Program’s (HRP) external deliverables (EDs) are the final outcomes of the research that the HRP Elements develop and execute. Four categories of HRP EDs exist: standards, requirements, countermeasures, and tools/technology. The NASA Human Health and Performance directorate’s primary stakeholders, i.e., the customers for the EDs, include the Office of the Chief Health and Medical Officer (OCHMO) (Standards Team, Chief Health and Performance Officers and Chief Medical Officers, Human System Risk Board), and the agency’s System Capability Leadership Teams. The EDs may address the need of a specific customer, a specific design reference mission, or a vehicle lifecycle milestone. HRP’s Maturation and Integration Office External Programs facilitates the process of delivering the EDs to the targeted customers according to the customer’s expectations. This presentation describes this coordinated process and provides an overview of the nature of different types of EDs and how they impact the customers’ products. Successful transfer of the EDs to the customers will help mitigate the health and performance risks that crewmembers will face during NASA’s future exploration missions.

HRP research external deliverables↗
NASA NTRS2017

HRP Chief Scientist's Office: Conducting Research to Enable Deep Space Exploration

The HRP Chief Scientist's Office sets the scientific agenda for the Human Research Program. As NASA plans for deep space exploration, HRP is conducting research to ensure the health of astronauts, and optimize human performance during extended duration missions. To accomplish this research, HRP solicits for proposals within the U.S., collaborates with agencies both domestically and abroad, and makes optimal use of ISS resources in support of human research. This session will expand on these topics and provide an opportunity for questions and discussion with the HRP Chief Scientist. Presentations in this session will include: NRA solicitations - process improvements and focus for future solicitations, Multilateral Human Research Panel for Exploration - future directions (MHRPE 2.0), Extramural liaisons - National Science Foundation (NSF) and Department of Defense (DOD), Standardized Measures for spaceflight, Ground-based Analogs - international collaborations, and International data sharing.

Charles, J. B.↗
NASA NTRSDate not supplied

NASA HRP Food and Nutrition Risk Strategy

The Human Health Countermeasures (HHC) Element of NASA’s Human Research Program (HRP), along with other organizations within NASA, conduct research and capability developments to buy down the risk of performance decrement and crew illness due to inadequate food and nutrition. Food and nutrition are critical for health and performance both in low Earth orbit and on exploration missions. On the International Space Station (ISS), crewmembers share a defined set of pantry foods, and have limited preference and shelf-life foods (e.g. fruits and vegetables) from resupply missions. Exploration design reference missions (DRMs) will likely be more constrained than missions to ISS, where those crewmembers would be subject to a more restricted food system due to resource limitations. HRP food and nutrition research consists of studies to close the following research gaps: determination of the nutritional requirements to maintain health and performance for the defined DRMs, determining the nutrient content, safety, and acceptability of the spaceflight food system specific to DRM and vehicle constraints, development of countermeasures either within or in addition to the food system to mitigate decrements to health and performance by DRM, and the validation and integration of food system countermeasures in analogs and in flight. The current spaceflight food system is shelf-stable, consisting of freeze-dried foods, thermostabilized foods, natural form foods, and powdered beverages. Crops represent a food system countermeasure that has the potential to supplement the pre-packaged food system. As an applied research program, HRP goals for crop research are centered around three main themes: nutrition, safety, and acceptability. As crops advance through Crop Readiness Level evaluations, HHC partners with the sponsoring organization to ensure that HRP goals are met for crops to be consumed in spaceflight.

food↗
NASA NTRSDate not supplied

Outcomes of a NASA Human Research Program’s (HRP) Space Radiation Element-sponsored Mini-Technical Interchange Meeting/workshop on Cardiovascular Disease Risk from Space Radiation

The NASA HRP’s Space Radiation Element funds research to characterize and mitigate adverse health outcomes from space radiation including cardiovascular risks to astronauts to enable deep space exploration and sustained human presence in space. Non-cancer effects such as damage to the cardiovascular system have been observed at clinically relevant high doses of ionizing radiation. However, an association between lower doses and risk of cardiovascular disease (CVD) remains somewhat controversial, especially in relation to the existence of low dose thresholds, radiation quality, and dose-rate effects, as well as gaps in characterizing the mechanisms and major pathways of disease. To facilitate, accelerate, and incubate new ideas to characterize and mitigate this risk, the Element is planning to organize a series of miniature technical interchange meetings (Tiny-TIMs) to provide a venue for HRP-funded investigators and thought leaders to present ongoing work and engage in open discussion on presented results, limitations of current approaches, incorporating better experimental strategies, model systems, etc. The initial Tiny-TIM held during the NASA HRP Investigators’ Workshop earlier this year – Upping the ante on characterizing and mitigating cardiovascular disease risk from space radiation exposure – aimed to stimulate discussion on the current state of scientific knowledge of CVD risk from space-like radiation exposure. The Tiny-TIM consisted of two 90-minute sessions; the first session concentrated on current knowledge of CVD risk from space radiation and the second session focused on innovative ideas, newer approaches, and techniques to accelerate research. The second session was followed by an open spirited discussion amongst peers on the current issues impeding the characterization of CVD risk from space radiation. The Element facilitated the discussion using a set of pressing open questions/gaps in knowledge that need to be addressed by the scientific community. The outcomes of the Tiny-TIM will be presented along with a plan of proposed future workshops and other initiatives of the Space Radiation Element.

Janapriya Saha↗
NASA NTRSDate not supplied

Managing HRP's External Deliverables: The Process and the Customers

The Human Research Program’s (HRP) external deliverables (EDs) are the final outcomes of the research that the HRP Elements develop and execute. The NASA Human Health and Performance directorate’s primary stakeholders, i.e., the customers for the EDs, include the Office of the Chief Health and Medical Officer (OCHMO) (Standards Team, Chief Health and Performance Officers and Chief Medical Officers, Human System Risk Board), and the agency’s System Capability Leadership Teams. The EDs may address the need of a specific customer, a specific design reference mission, or a vehicle lifecycle milestone. HRP’s Maturation and Integration Office External Programs facilitates the process of delivering the EDs to the targeted customers according to the customer’s expectations. This presentation describes this coordinated process and provides an overview of the nature of different types of EDs and how they impact the customers’ products. Successful transfer of the EDs to the customers will help mitigate the health and performance risks that crewmembers will face during NASA’s future exploration missions.

research↗
NASA NTRS2009

Human Research Program (HRP) Exploration Medical Capability (ExMC) Standing Review Panel (SRP)

The SRP believes strongly that regularly performed in-flight crew assessments are needed in order to identify a change in health status before a medical condition becomes clinically apparent. It is this early recognition in change that constitutes the foundation of the "occupational health model" expounded in the HRP Requirements Document as a key component of the HRP risk mitigation strategy that will enable its objective of "prevention and mitigation of human health and performance risks". A regular crew status examination of physiological and clinical performance is needed. This can be accomplished through instrumented monitoring of routine embedded tasks. The SRP recommends addition of a new gap to address this action under Category 3.0 Mitigate the Risk. This new gap is closely associated with Task 4.19 which addresses the lack of adequate biomedical monitoring capabilities for performing periodic clinical status evaluations and contingency medical monitoring. A corollary to these gaps is the critical emphasis on preventive medicine, not only during pre- and post-flight phases of a mission as is the current practice, but continued into the in-flight phases of exploration class missions.

Cintron, Nitza↗
NASA NTRS2014

NASA HRP Immunology Discipline - Use of Terrestrial Analogs

Due to the cost and operational constraints, as well as technical implementation limitations, it is desirous to perform relevant space physiology investigations first in terrestrial 'space analogs'. This is particularly true for initial investigations, which may then provide appropriate focus for subsequent flight investigations, or for mechanistic investigations that simply cannot be performed during spaceflight. Appropriate analog choice is extremely important. There are a wide variety of terrestrial space analogs, each relevant to a particular physiological discipline (or disciplines) and each with a particular fidelity (or lack thereof) to spaceflight, and each with unique operational constraints. The HRP Immunology Discipline is tasked with managing the HRP Risk concerning clinical risk for Astronaut crews related to spaceflight-associated immune dysregulation. Such dysregulation has been documented to occur during spaceflight, and found to persist for the duration of a 6-month ISS mission. Studies continue to characterize the onorbit phenomenon, but it generally consists of diminished immunocyte function, dysregulated cytokine profiles, and persistent herpesvirus reactivation. Causes are thought to synergistically include microgravity, psychological or physiological stress, radiation, and/or circadian misalignment. An appropriate terrestrial analog for immune dysregulation would replicate as many of these influences as possible. Such analogs may include clinostat or bioreactor cell culture (microgravity), hindlimb suspension (stress, fluid shifts, hypokinesis), or human deployment to remote or extreme environments (isolation, stress, circadian). Also, the laboratory setting may be used as an analog, or to augment analogs, such as sleep deprivation/misalignment or human centrifugation to replicate gravitational stress. As an appropriate example of a NASA Disciplines use of Terrestrial space analogs, this talk will discuss spaceflight associated immune dysregulation, terrestrial immune analogs, and recent analog investigations.

Crucian, Brian↗
NASA NTRS2009

NASA Human Research Program (HRP). International Space Station Medical Project (ISSMP)

This viewgraph presentation describes the various flight investigations performed on the International Space Station as part of the NASA Human Research Program (HRP). The evaluations include: 1) Stability; 2) Periodic Fitness Evaluation with Oxygen Uptake Measurement; 3) Nutrition; 4) CCISS; 5) Sleep; 6) Braslet; 7) Integrated Immune; 8) Epstein Barr; 9) Biophosphonates; 10) Integrated cardiovascular; and 11) VO2 max.

Sams, Clarence F.↗
NASA NTRS2015

Identification and Evaluation of Integration and Cross Cutting Issues Across HRP Risks

The HRP Integrated Research Plan contains the research plans for the 32 risks requiring research to characterize and mitigate. These risks to human health and performance in spaceflight are identified by evidence and each one focuses on a single aspect of human physiology or performance. They are further categorized by aspects of the spaceflight environment, such as altered gravity or space radiation, that that play a major role in their likelihood and consequence. From its inception the "integrate" in the Research Plan has denoted the integrated nature of risks to human health and performance, the connectedness of physiological systems within the human body regardless of the spaceflight environment, and the integrated response of the human body to the spaceflight environment. Common characteristics of the spaceflight environment include altered gravity, atmospheres and light/dark cycles, space radiation, isolation, noise, and periods of high or low workload. Long term exposure to this unique environment produces a suite of physiological effects such as stress; vision, neurocognitive and anthropometric changes; circadian misalignment; fluid shifts, deconditioning; immune dysregulation; and altered nutritional requirements. Matrix diagraming was used to systematically identify, analyze and rate the many-to-many relationships between environmental characteristics and the suite of physiological effects. It was also to identify patterns in the relationships of common physiological effects to each other. Analyses of patterns or relationships in these diagrams help to identify issues that cut across multiple risks. Cross cutting issues benefit from a multidisciplinary approach that synthesizes concepts or data from two or more disciplines to identify and characterize risk factors or develop countermeasures relevant to multiple risks. They also help to illuminate possible problem areas that may arise when a countermeasure impacts risks other than those which it was developed to mitigate, or identify groupings of physiological changes that are likely to occur that may impact the overall risk posture.

Steinberg, S. L.↗
NASA NTRS2017

HRP Overview - Increments 51/52 and 53/54

NASA's Human Research Program (HRP) on ISS. Conducting research for safe, productive human space travel and for astronauts to remain healthy during and after extended space travel.

Torney, Susan↗
NASA NTRSDate not supplied

GeneLab: Current and Future Omics Data Integration Between Space Biology and HRP

For the past five years, the Biological and Physical Sciences Division has pioneered Open Science in Space Biology by funding the NASA GeneLab project. Along with the Ames Life Sciences Data Archive, GeneLab has quickly become the world leader in archiving and scientifically curating spaceflight and spaceflight relevant multi-omics data. Specifically, the GeneLab Data System has become a full enterprise solution providing advanced mining capabilities, several application programming interfaces for data federation and machine learning approaches, and delivering to the world an analytical and visualization platform which has enabled collaboration within the scientific community. Over the past three years, large meta-analysis and modeling studies have been published by the GeneLab Analysis Working Groups (AWGs), which are comprised of ~200 volunteer scientists. One natural extension of GeneLab data reuse has recently turned towards linking animal data with human data, which is the next necessary step to further validate animal models for inferring biological risks to humans conducting LEO, lunar or Martian missions. As such, data from the Human Research Program are an essential component of GeneLab and ALSDA. At the moment, simulated space radiation experiments conducted at Brookhaven National Laboratory make the most of HRP GeneLab data, and the scientific community has been eager to also link their animal spaceflight results to actual Astronaut data and human analog data. We will discuss further the current status of knowledge and future approaches to accelerate our basics understanding of the impact of space stressors on humans using latest omics technology.

omics↗
NASA NTRS2024

Evolution of Spaceflight Renal Stone Risks and Update to the NASA Human Research Program (HRP) Renal Stone Evidence Report and Integrated Concept of Operations

BACKGROUND: The NASA HRP Evidence Report on the Risk of Renal Stone Formation is being updated based on new information obtained from 9 years of data from NASA’s astronaut renal stone surveillance program. In addition, the Concept of Operations for missions beyond Low Earth Orbit (LEO) was created to supplement the Evidence Report, and the NASA clinical practice guideline(CPG)for renal stone surveillance was updated. OVERVIEW: A literature review was performed to evaluate the state of literature regarding renal stone prevention, mitigation, and management both in terrestrial and spaceflight environments. Current renal stone treatment guidelines for the ISS, which were created by the Inflight Clinical Medicine Working Group and approved by the Multilateral Medical Operations Panel (MMOP)were reviewed, as well as recent ultrasound technology demonstrations onboard the ISS. This information was used in conjunction with emerging evidence from the surveillance program to update the Evidence Report and in-flight Concept of Operations. DISCUSSION: There are known and emerging renal stone prevention strategies including astronaut selection, the use of medications and resistive exercise, early diagnosis with regular urine studies and ultrasound imaging. In-flight treatment options include pharmaceuticals, use of lithotripsy and propulsive ultrasound, placement of percutaneous drains and other modalities. This information is useful to gauge future risks and update our strategies for prevention and management of renal stones in astronauts to reduce the risk of in-flight renal stone colic that could cause morbidity and mission impact.

E Stratton↗