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Susan Steinberg

Publications and source records attributed to Susan Steinberg.

Integrated Research Plan to Assess the Combined Effects of Space Radiation, Altered Gravity, and Isolation and Confinement on Crew Health and Performance: Implementation Strategy

This document supplements the white paper titled CBS Integrated Research Plan: Problem Statement. The Problem Statement describes why it is important to implement a fully integrated research plan to derive risk estimates for the combined, potentially synergistic, effects of the three major spaceflight hazards (space radiation; isolated, confined, and extreme environments; altered gravity). These risk estimates will help establish acceptable maximum decrement or change in a physiological or behavioral parameter during or after spaceflight, and the acceptable limit of exposure to the combined spaceflight hazards. This Implementation Strategy describes how the research plan will accomplish the CBS Integrated Research Plan goals. The Implementation Strategy includes approaches to evaluate relationships among biological responses underlying three risks that are managed by three of NASA’s Human Research Project (HRP) organizational “elements”. This CBS (Acute effects of radiation on CNS, BMed, Sensorimotor) Integrated Research Plan also identifies strategies to monitor and mitigate decrements to operationally relevant performance. Currently, the strategy that was initiated in 2018, includes an eight-year research plan and a four-year validation plan that extend to the year 2030. Once the monitoring tools and countermeasures are developed, they will be validated and refined during four years of early exploration missions. The planned tasks and their associated research products and deliverables have been mapped to the individual research emphases to clearly demonstrate how each research area helps ensure crew health and safety during exploration missions.

Susan Steinberg

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