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NASA NTRS1999

Continuous Risk Management at NASA

NPG 7120.5A, "NASA Program and Project Management Processes and Requirements" enacted in April, 1998, requires that "The program or project manager shall apply risk management principles..." The Software Assurance Technology Center (SATC) at NASA GSFC has been tasked with the responsibility for developing and teaching a systems level course for risk management that provides information on how to comply with this edict. The course was developed in conjunction with the Software Engineering Institute at Carnegie Mellon University, then tailored to the NASA systems community. This presentation will briefly discuss the six functions for risk management: (1) Identify the risks in a specific format; (2) Analyze the risk probability, impact/severity, and timeframe; (3) Plan the approach; (4) Track the risk through data compilation and analysis; (5) Control and monitor the risk; (6) Communicate and document the process and decisions. This risk management structure of functions has been taught to projects at all NASA Centers and is being successfully implemented on many projects. This presentation will give project managers the information they need to understand if risk management is to be effectively implemented on their projects at a cost they can afford.

Hammer, Theodore F.↗
NASA NTRS2003

Multiple Changes to Reusable Solid Rocket Motors, Identifying Hidden Risks

The Space Shuttle Reusable Solid Rocket Motor (RSRM) baseline is subject to various changes. Changes are necessary due to safety and quality improvements, environmental considerations, vendor changes, obsolescence issues, etc. The RSRM program has a goal to test changes on full-scale static test motors prior to flight due to the unique RSRM operating environment. Each static test motor incorporates several significant changes and numerous minor changes. Flight motors often implement multiple changes simultaneously. While each change is individually verified and assessed, the potential for changes to interact constitutes additional hidden risk. Mitigating this risk depends upon identification of potential interactions. Therefore, the ATK Thiokol Propulsion System Safety organization initiated the use of a risk interaction matrix to identify potential interactions that compound risk. Identifying risk interactions supports flight and test motor decisions. Uncovering hidden risks of a full-scale static test motor gives a broader perspective of the changes being tested. This broader perspective compels the program to focus on solutions for implementing RSRM changes with minimal/mitigated risk. This paper discusses use of a change risk interaction matrix to identify test challenges and uncover hidden risks to the RSRM program.

Greenhalgh, Phillip O.↗
NASA NTRS2003

An Extensible Information Grid for Risk Management

This paper describes recent work on developing an extensible information grid for risk management at NASA - a RISK INFORMATION GRID. This grid is being developed by integrating information grid technology with risk management processes for a variety of risk related applications. To date, RISK GRID applications are being developed for three main NASA processes: risk management - a closed-loop iterative process for explicit risk management, program/project management - a proactive process that includes risk management, and mishap management - a feedback loop for learning from historical risks that escaped other processes. This is enabled through an architecture involving an extensible database, structuring information with XML, schemaless mapping of XML, and secure server-mediated communication using standard protocols.

Maluf, David A.↗
NASA NTRS2004

Radiation Risk Assessment of the Individual Astronaut: A Complement to Radiation Interests at the NIH

Predicting human risks following exposure to space radiation is uncertain in part because of unpredictable distribution of high-LET and low-dose-derived damage amongst cells in tissues, unknown synergistic effects of microgravity upon gene- and protein-expression, and inadequately modeled processing of radiation-induced damage within cells to produce rare and late-appearing malignant cancers. Furthermore, estimation of risks of radiogenic outcome within small numbers of astronauts is not possible using classic epidemiologic study. It therefore seems useful to develop strategies of risk-assessment based upon large datasets acquired from correlated biological models useful for resolving radiogenic risk-assessment for irradiated individuals. In this regard, it is suggested that sensitive cellular biodosimeters that simultaneously report 1) the quantity of absorbed dose after exposure to ionizing radiation, 2) the quality of radiation delivering that dose, and 3) the biomolecular risk of malignant transformation be developed in order to resolve these NASA-specific challenges. Multiparametric cellular biodosimeters could be developed using analyses of gene-expression and protein-expression whereby large datasets of cellular response to radiation-induced damage are analyzed for markers predictive for acute response as well as cancer-risk. A new paradigm is accordingly addressed wherein genomic and proteomic datasets are registered and interrogated in order to provide statistically significant dose-dependent risk estimation in individual astronauts. This evaluation of the individual for assessment of radiogenic outcomes connects to NIH program in that such a paradigm also supports assignment of a given patient to a specific therapy, the diagnosis of response of that patient to therapy, and the prediction of risks accumulated by that patient during therapy - such as risks incurred by scatter and neutrons produced during high-energy Intensity-Modulated Radiation Therapy. Value of assessment of radiogenic outcome for individuals exposed to radiation is suggested to be common to both NASA and NIH.

Richmond, Robert C.↗
NASA NTRS2005

Bridging the Divide between Safety and Risk Management for your Project or Program

This presentation will bridge the divide between these separate but overlapping disciplines and help explain how to use Risk Management as an effective management decision support tool that includes safety. Risk Management is an over arching communication tool used by management to prioritize and effectively mitigate potential problems before they concur. Risk Management encompasses every kind of potential problem that can occur on a program or project. Some of these are safety issues such as hazards that have a specific likelihood and consequence that need to be controlled and included to show an integrated picture of accepted) mitigated, and residual risk. Integrating safety and other assurance disciplines is paramount to accurately representing a program s or projects risk posture. Risk is made up of several components such as technical) cost, schedule, or supportability. Safety should also be a consideration for every risk. The safety component can also have an impact on the technical, cost, and schedule aspect of a given risk. The current formats used for communication of safety and risk issues are not consistent or integrated. The presentation will explore the history of these disciplines, current work to integrate them, and suggestions for integration for the future.

Lutomski, Mike↗
NASA NTRS2008

Root Source Analysis/ValuStream[Trade Mark] - A Methodology for Identifying and Managing Risks

Root Source Analysis (RoSA) is a systems engineering methodology that has been developed at NASA over the past five years. It is designed to reduce costs, schedule, and technical risks by systematically examining critical assumptions and the state of the knowledge needed to bring to fruition the products that satisfy mission-driven requirements, as defined for each element of the Work (or Product) Breakdown Structure (WBS or PBS). This methodology is sometimes referred to as the ValuStream method, as inherent in the process is the linking and prioritizing of uncertainties arising from knowledge shortfalls directly to the customer's mission driven requirements. RoSA and ValuStream are synonymous terms. RoSA is not simply an alternate or improved method for identifying risks. It represents a paradigm shift. The emphasis is placed on identifying very specific knowledge shortfalls and assumptions that are the root sources of the risk (the why), rather than on assessing the WBS product(s) themselves (the what). In so doing RoSA looks forward to anticipate, identify, and prioritize knowledge shortfalls and assumptions that are likely to create significant uncertainties/ risks (as compared to Root Cause Analysis, which is most often used to look back to discover what was not known, or was assumed, that caused the failure). Experience indicates that RoSA, with its primary focus on assumptions and the state of the underlying knowledge needed to define, design, build, verify, and operate the products, can identify critical risks that historically have been missed by the usual approaches (i.e., design review process and classical risk identification methods). Further, the methodology answers four critical questions for decision makers and risk managers: 1. What s been included? 2. What's been left out? 3. How has it been validated? 4. Has the real source of the uncertainty/ risk been identified, i.e., is the perceived problem the real problem? Users of the RoSA methodology have characterized it as a true bottoms up risk assessment.

Brown, Richard Lee↗
NASA NTRS2009

Determining the Relative Criticality of Diverse Exploration Risks in NASA's Human Research Program

The mission of NASA s Human Research Program (HRP) is to understand and reduce the risk to crew health and performance in exploration missions. The HRP addresses 27 specific risks, primarily in the context of Continuous Risk Management. Each risk is evaluated in terms of two missions (a six month stay on the Moon and a thirty month round trip to Mars) and three types of consequences (in-mission crew health, post-mission crew health, and in-mission performance). The lack of a common metric between the three consequence scales, such as financial costs or quality adjusted life years lost, makes it difficult to compare the relative criticality of the risks. We are, therefore, exploring the use of a ternary scale of criticality based on the common metric of influencing an operational decision. The three levels correspond to the level of concern the risk generates for a "go/no-go" decision to launch a mission: 1) no-go; 2) go with significant reservations; 3) go. The criticality of each of the 27 risks is scored for the three types of consequence in both types of mission. The scores are combined to produce an overall criticality rating for each risk. The overall criticality rating can then be used to guide the prioritization of resources to affect the greatest amount of risk reduction.

Kundrot, Craig E.↗
NASA NTRS2010

Space Radiation Heart Disease Risk Estimates for Lunar and Mars Missions

The NASA Space Radiation Program performs research on the risks of late effects from space radiation for cancer, neurological disorders, cataracts, and heart disease. For mortality risks, an aggregate over all risks should be considered as well as projection of the life loss per radiation induced death. We report on a triple detriment life-table approach to combine cancer and heart disease risks. Epidemiology results show extensive heterogeneity between populations for distinct components of the overall heart disease risks including hypertension, ischaemic heart disease, stroke, and cerebrovascular diseases. We report on an update to our previous heart disease estimates for Heart disease (ICD9 390-429) and Stroke (ICD9 430-438), and other sub-groups using recent meta-analysis results for various exposed radiation cohorts to low LET radiation. Results for multiplicative and additive risk transfer models are considered using baseline rates for US males and female. Uncertainty analysis indicated heart mortality risks as low as zero, assuming a threshold dose for deterministic effects, and projections approaching one-third of the overall cancer risk. Medan life-loss per death estimates were significantly less than that of solid cancer and leukemias. Critical research questions to improve risks estimates for heart disease are distinctions in mechanisms at high doses (>2 Gy) and low to moderate doses (<2 Gy), and data and basic understanding of radiation doserate and quality effects, and individual sensitivity.

Cucinotta, Francis A.↗
NASA NTRS2009

Human Research Program Human Health Countermeasures Element Cardiovascular Risks Standing Review Panel (SRP)

The Cardiovascular Risk Standing Review Panel (SRP) evaluated several cardiovascular risks associated with space flight along with the ongoing and emerging plans to study these issues and potentially propose and/or develop countermeasures. The areas of focus included: 1) The risk of cardiac rhythm problems during prolonged space flight, and 2) Issues related to the risk of orthostatic intolerance during re-exposure to gravity. An emerging area of concern is radiation associated vascular injury. The risk of cardiac rhythm disturbances has emerged based on case reports only. No systematic study of this risk has been published. However, concerns about this risk are heightened by the age range of astronauts, the structural changes in the heart that occur during space flight, and the potential shifts in fluids and electrolytes. The current plan is to use prolonged Holter monitor EKG records made as part of the "Integrated Cardiovascular SMO" in space to determine more about the frequency and magnitude of this problem and to link this data to complementary data from the nutrition group on electrolytes. The SRP was supportive of this approach. The SRP also felt that any data related to cardiovascular risk in space should be better coordinated with the medical screening data that all astronauts undergo at regular intervals. Additionally, while there are potential privacy issues related to this suggestion, many of the current barriers to better coordination of experimental and clinical data appear to reflect longstanding cultural traditions at NASA that need rethinking. The risk of orthostatic intolerance during re-exposure to gravity was seen by the SRP as an area supported by a wealth of published physiological evidence. The SRP also felt that moving forward with the planned approach to countermeasures was reasonable and that extensive additional hypothesis testing on the physiology of orthostatic intolerance was not needed at this time. There was support for developing ground based models of limited (e.g. 1/6 th) G environments on Earth that generated a number of ideas for consideration by NASA investigators.

Joyner, Michael↗
NASA NTRS2006

Radiation-Induced Leukemia at Doses Relevant to Radiation Therapy: Modeling Mechanisms and Estimating Risks

Because many cancer patients are diagnosed earlier and live longer than in the past, second cancers induced by radiation therapy have become a clinically significant issue. An earlier biologically based model that was designed to estimate risks of high-dose radiation induced solid cancers included initiation of stem cells to a premalignant state, inactivation of stem cells at high radiation doses, and proliferation of stem cells during cellular repopulation after inactivation. This earlier model predicted the risks of solid tumors induced by radiation therapy but overestimated the corresponding leukemia risks. Methods: To extend the model to radiation-induced leukemias, we analyzed in addition to cellular initiation, inactivation, and proliferation a repopulation mechanism specific to the hematopoietic system: long-range migration through the blood stream of hematopoietic stem cells (HSCs) from distant locations. Parameters for the model were derived from HSC biologic data in the literature and from leukemia risks among atomic bomb survivors v^ ho were subjected to much lower radiation doses. Results: Proliferating HSCs that migrate from sites distant from the high-dose region include few preleukemic HSCs, thus decreasing the high-dose leukemia risk. The extended model for leukemia provides risk estimates that are consistent with epidemiologic data for leukemia risk associated with radiation therapy over a wide dose range. For example, when applied to an earlier case-control study of 110000 women undergoing radiotherapy for uterine cancer, the model predicted an excess relative risk (ERR) of 1.9 for leukemia among women who received a large inhomogeneous fractionated external beam dose to the bone marrow (mean = 14.9 Gy), consistent with the measured ERR (2.0, 95% confidence interval [CI] = 0.2 to 6.4; from 3.6 cases expected and 11 cases observed). As a corresponding example for brachytherapy, the predicted ERR of 0.80 among women who received an inhomogeneous low-dose-rate dose to the bone marrow (mean = 2.5 Gy) was consistent with the measured ERR (0.62, 95% Cl =-0.2 to 1.9). Conclusions: An extended, biologically based model for leukemia that includes HSC initiation, inactivation, proliferation, and, uniquely for leukemia, long-range HSC migration predicts, %Kith reasonable accuracy, risks for radiationinduced leukemia associated with exposure to therapeutic doses of radiation.

Shuryak, Igor↗
NASA NTRS2011

Methodology for Developing a Probabilistic Risk Assessment Model of Spacecraft Rendezvous and Dockings

In 2007 NASA was preparing to send two new visiting vehicles carrying logistics and propellant to the International Space Station (ISS). These new vehicles were the European Space Agency s (ESA) Automated Transfer Vehicle (ATV), the Jules Verne, and the Japanese Aerospace and Explorations Agency s (JAXA) H-II Transfer Vehicle (HTV). The ISS Program wanted to quantify the increased risk to the ISS from these visiting vehicles. At the time, only the Shuttle, the Soyuz, and the Progress vehicles rendezvoused and docked to the ISS. The increased risk to the ISS was from an increase in vehicle traffic, thereby, increasing the potential catastrophic collision during the rendezvous and the docking or berthing of the spacecraft to the ISS. A universal method of evaluating the risk of rendezvous and docking or berthing was created by the ISS s Risk Team to accommodate the increasing number of rendezvous and docking or berthing operations due to the increasing number of different spacecraft, as well as the future arrival of commercial spacecraft. Before the first docking attempt of ESA's ATV and JAXA's HTV to the ISS, a probabilistic risk model was developed to quantitatively calculate the risk of collision of each spacecraft with the ISS. The 5 rendezvous and docking risk models (Soyuz, Progress, Shuttle, ATV, and HTV) have been used to build and refine the modeling methodology for rendezvous and docking of spacecrafts. This risk modeling methodology will be NASA s basis for evaluating the addition of future ISS visiting spacecrafts hazards, including SpaceX s Dragon, Orbital Science s Cygnus, and NASA s own Orion spacecraft. This paper will describe the methodology used for developing a visiting vehicle risk model.

Farnham, Steven J., II↗
NASA NTRS2012

Astronaut Biography Project for Countermeasures of Human Behavior and Performance Risks in Long Duration Space Flights

This final report will summarize research that relates to human behavioral health and performance of astronauts and flight controllers. Literature reviews, data archival analyses, and ground-based analog studies that center around the risk of human space flight are being used to help mitigate human behavior and performance risks from long duration space flights. A qualitative analysis of an astronaut autobiography was completed. An analysis was also conducted on exercise countermeasure publications to show the positive affects of exercise on the risks targeted in this study. The three main risks targeted in this study are risks of behavioral and psychiatric disorders, risks of performance errors due to poor team performance, cohesion, and composition, and risks of performance errors due to sleep deprivation, circadian rhythm. These three risks focus on psychological and physiological aspects of astronauts who venture out into space on long duration space missions. The purpose of this research is to target these risks in order to help quantify, identify, and mature countermeasures and technologies required in preventing or mitigating adverse outcomes from exposure to the spaceflight environment

Banks, Akeem↗
NASA NTRS2012

Technical Evaluation of the NASA Model for Cancer Risk to Astronauts Due to Space Radiation

At the request of NASA, the National Research Council's (NRC's) Committee for Evaluation of Space Radiation Cancer Risk Model1 reviewed a number of changes that NASA proposes to make to its model for estimating the risk of radiation-induced cancer in astronauts. The NASA model in current use was last updated in 2005, and the proposed model would incorporate recent research directed at improving the quantification and understanding of the health risks posed by the space radiation environment. NASA's proposed model is defined by the 2011 NASA report Space Radiation Cancer Risk Projections and Uncertainties--2010 . The committee's evaluation is based primarily on this source, which is referred to hereafter as the 2011 NASA report, with mention of specific sections or tables. The overall process for estimating cancer risks due to low linear energy transfer (LET) radiation exposure has been fully described in reports by a number of organizations. The approaches described in the reports from all of these expert groups are quite similar. NASA's proposed space radiation cancer risk assessment model calculates, as its main output, age- and gender-specific risk of exposure-induced death (REID) for use in the estimation of mission and astronaut-specific cancer risk. The model also calculates the associated uncertainties in REID. The general approach for estimating risk and uncertainty in the proposed model is broadly similar to that used for the current (2005) NASA model and is based on recommendations by the National Council on Radiation Protection and Measurements. However, NASA's proposed model has significant changes with respect to the following: the integration of new findings and methods into its components by taking into account newer epidemiological data and analyses, new radiobiological data indicating that quality factors differ for leukemia and solid cancers, an improved method for specifying quality factors in terms of radiation track structure concepts as opposed to the previous approach based on linear energy transfer, the development of a new solar particle event (SPE) model, and the updates to galactic cosmic ray (GCR) and shielding transport models. The newer epidemiological information includes updates to the cancer incidence rates from the life span study (LSS) of the Japanese atomic bomb survivors, transferred to the U.S. population and converted to cancer mortality rates from U.S. population statistics. In addition, the proposed model provides an alternative analysis applicable to lifetime never-smokers (NSs). Details of the uncertainty analysis in the model have also been updated and revised. NASA's proposed model and associated uncertainties are complex in their formulation and as such require a very clear and precise set of descriptions. The committee found the 2011 NASA report challenging to review largely because of the lack of clarity in the model descriptions and derivation of the various parameters used. The committee requested some clarifications from NASA throughout its review and was able to resolve many, but not all, of the ambiguities in the written description.

Source record↗
NASA NTRS2015

Using Risk Assessment Methodologies to Meet Management Objectives

Current decision making involves numerous possible combinations of technology elements, safety and health issues, operational aspects and process considerations to satisfy program goals. Identifying potential risk considerations as part of the management decision making process provides additional tools to make more informed management decision. Adapting and using risk assessment methodologies can generate new perspectives on various risk and safety concerns that are not immediately apparent. Safety and operational risks can be identified and final decisions can balance these considerations with cost and schedule risks. Additional assessments can also show likelihood of event occurrence and event consequence to provide a more informed basis for decision making, as well as cost effective mitigation strategies. Methodologies available to perform Risk Assessments range from qualitative identification of risk potential, to detailed assessments where quantitative probabilities are calculated. Methodology used should be based on factors that include: 1) type of industry and industry standards, 2) tasks, tools, and environment 3) type and availability of data and 4) industry views and requirements regarding risk & reliability. Risk Assessments are a tool for decision makers to understand potential consequences and be in a position to reduce, mitigate or eliminate costly mistakes or catastrophic failures.

DeMott, D. L.↗
NASA NTRS2015

Reliability and Probabilistic Risk Assessment - How They Play Together

PRA methodology is one of the probabilistic analysis methods that NASA brought from the nuclear industry to assess the risk of LOM, LOV and LOC for launch vehicles. PRA is a system scenario based risk assessment that uses a combination of fault trees, event trees, event sequence diagrams, and probability and statistical data to analyze the risk of a system, a process, or an activity. It is a process designed to answer three basic questions: What can go wrong? How likely is it? What is the severity of the degradation? Since 1986, NASA, along with industry partners, has conducted a number of PRA studies to predict the overall launch vehicles risks. Planning Research Corporation conducted the first of these studies in 1988. In 1995, Science Applications International Corporation (SAIC) conducted a comprehensive PRA study. In July 1996, NASA conducted a two-year study (October 1996 - September 1998) to develop a model that provided the overall Space Shuttle risk and estimates of risk changes due to proposed Space Shuttle upgrades. After the Columbia accident, NASA conducted a PRA on the Shuttle External Tank (ET) foam. This study was the most focused and extensive risk assessment that NASA has conducted in recent years. It used a dynamic, physics-based, integrated system analysis approach to understand the integrated system risk due to ET foam loss in flight. Most recently, a PRA for Ares I launch vehicle has been performed in support of the Constellation program. Reliability, on the other hand, addresses the loss of functions. In a broader sense, reliability engineering is a discipline that involves the application of engineering principles to the design and processing of products, both hardware and software, for meeting product reliability requirements or goals. It is a very broad design-support discipline. It has important interfaces with many other engineering disciplines. Reliability as a figure of merit (i.e. the metric) is the probability that an item will perform its intended function(s) for a specified mission profile. In general, the reliability metric can be calculated through the analyses using reliability demonstration and reliability prediction methodologies. Reliability analysis is very critical for understanding component failure mechanisms and in identifying reliability critical design and process drivers. The following sections discuss the PRA process and reliability engineering in detail and provide an application where reliability analysis and PRA were jointly used in a complementary manner to support a Space Shuttle flight risk assessment.

Safie, Fayssal M.↗
NASA NTRS2015

Evidence Report: Risk of Acute and Late Central Nervous System Effects from Radiation Exposure

Possible acute and late risks to the central nervous system (CNS) from galactic cosmic rays (GCR) and solar particle events (SPE) are a documented concern for human exploration of space. Acute CNS risks include: altered cognitive function, reduced motor function, and behavioral changes, all of which may affect performance and human health. Late CNS risks include neurological disorders such as Alzheimer's disease (AD), dementia and premature aging. Although detrimental CNS changes are observed in humans treated with high-dose radiation (e.g., gamma rays and protons) for cancer and are supported by experimental evidence showing neurocognitive and behavioral effects in animal models, the significance of these results on the morbidity to astronauts has not been elucidated. There is a lack of human epidemiology data on which to base CNS risk estimates; therefore, risk projection based on scaling to human data, as done for cancer risk, is not possible for CNS risks. Research specific to the spaceflight environment using animal and cell models must be compiled to quantify the magnitude of CNS changes in order to estimate this risk and to establish validity of the current permissible exposure limits (PELs). In addition, the impact of radiation exposure in combination with individual sensitivity or other space flight factors, as well as assessment of the need for biological/pharmaceutical countermeasures, will be considered after further definition of CNS risk occurs.

Nelson, Gregory A.↗
NASA NTRS2015

Risk of Adverse Cognitive or Behavioral Conditions and Psychiatric Disorders

The NASA commitment to human space flight includes continuing to fly astronauts on the ISS until it is decommissioned as well as possibly returning astronauts to the moon or having astronauts venture to an asteroid or Mars. As missions leave low Earth orbit and explore deeper space, BHP supports and conducts research to enable a risk posture that considers the risk of adverse cognitive or behavioral conditions and psychiatric disorders “acceptable given mitigations,” for pre-, in, and post-flight.The Human System Risk Board (HSRB) determines the risk of various mission scenarios using a likelihood (per person per year) by consequences matrix examining those risks across two categories—long term health and operational (within mission). Colors from a stoplight signal are used by HSRB and quickly provide a means of assessing overall perceived risk for a particular mission scenario. Risk associated with the current six month missions on the ISS are classified as “accepted with monitoring” while planetary missions, such as a mission to Mars, are recognized to be a “red” risk that requires mitigation to ensure mission success.Currently, the HSRB deems that the risk of adverse cognitive or behavioral conditions and psychiatric outcomes requires mitigation for planetary missions owing to long duration isolation and radiation exposure (see Table 1). While limited research evidence exists from spaceflight, it is well known anecdotally that the shift from the two week shuttle missions to the six month ISS missions renders the psychological stressors of space as more salient over longer duration missions. Shuttle astronauts were expected just to tolerate any stressors that arose during their mission and were successful at doing so (Whitmire et al, 2013). While it is possible to deal with stressors such as social isolation and to live with incompatible crewmembers for two weeks on shuttle, “ignoring it” is much less likely to be a successful coping mechanism on station. For the longer missions of the ISS, astronauts require a larger, more robust set of coping skills and more psychological support. Evidence of this are the number of BHP’s Operational Psychology (Op Psy) staff who have been awarded silver Snoopys by long duration astronauts†, in the statements of praise for the Op Psy and Family Support Office teams, and in the written and oral statements from flown astronauts regarding difficulty of longer missions and how much Op Psy helped.

Slack, Kelley J.↗
NASA NTRS2016

Characterization of Evidence for Human System Risk Assessment

Understanding the kinds of evidence available and using the best evidence to answer a question is critical to evidenced-based decision-making, and it requires synthesis of evidence from a variety of sources. Categorization of human system risks in spaceflight, in particular, focuses on how well the integration and interpretation of all available evidence informs the risk statement that describes the relationship between spaceflight hazards and an outcome of interest. A mature understanding and categorization of these risks requires: 1) sufficient characterization of risk, 2) sufficient knowledge to determine an acceptable level of risk (i.e., a standard), 3) development of mitigations to meet the acceptable level of risk, and 4) identification of factors affecting generalizability of the evidence to different design reference missions. In the medical research community, evidence is often ranked by increasing confidence in findings gleaned from observational and experimental research (e.g., "levels of evidence"). However, an approach based solely on aspects of experimental design is problematic in assessing human system risks for spaceflight. For spaceflight, the unique challenges and opportunities include: (1) The independent variables in most evidence are the hazards of spaceflight, such as space radiation or low gravity, which cannot be entirely duplicated in terrestrial (Earth-based) analogs, (2) Evidence is drawn from multiple sources including medical and mission operations, Lifetime Surveillance of Astronaut Health (LSAH), spaceflight research (LSDA), and relevant environmental & terrestrial databases, (3) Risk metrics based primarily on LSAH data are typically derived from available prevalence or incidence data, which may limit rigorous interpretation, (4) The timeframe for obtaining adequate spaceflight sample size (n) is very long, given the small population, (5) Randomized controlled trials are unattainable in spaceflight, (6) Collection of personal and environmental data on the astronaut population may create opportunities for advanced analytics and human-environment modeling that goes beyond that achieved in isolated experimental designs; and (7) Translation of relevant research to operations is a complex, transdisciplinary enterprise in which the approach must apply across the physical, biological, behavioral, and social sciences. The approach to synthesizing evidence must address both source and fidelity of data, and reflect the most general attributes of quality of evidence in science and engineering: reliability and validity. The authors are developing a two-factor approach which includes the various kinds of evidence required to understand risks and for the integrated interpretation of all evidence that is essential to develop standards and countermeasures. A unified framework for aggregating and assessing different kinds of evidence provides a consistent, traceable, evidence-based decision-making process to translate research to operations in an environment where engineers, scientists, physicians, and managers all engage in analyzing the trade space of vehicle design, standards, requirements and solutions for spaceflight.

Steinberg, S. L.↗