Implementation of an impact assessment tool to optimize responsible stewardship of genomic data in the cloud

实施影响评估工具以优化云中基因组数据的负责任管理

• 批准号: 10721762
• 负责人: Vasiliki Rahimzadeh
• 金额: $ 16.13万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-01 至 2028-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10721762
• 关键词: Acceleration; Address; Algorithms; Assessment tool; Bioethics; Bioethics Consultants; Biomedical Research; Calibration; Clinical; Cloud Computing; Cloud Service; Committee Members; Communities; Competence; Complex; Computer software; Consensus; Data; Data Collection; Data Protection; Data Science; Data Scientist; Data Security; Data Set; Delphi Study; Development Plans; Engineering; Ensure; Environment; Ethnic Population; FAIR principles; Funding; Future; Genomic medicine; Genomics; Goals; Health; Health Policy; Human; Individual; Institution; Institutional Practice; International; Knowledge; Laws; Life Cycle Stages; Measures; Medical Ethics; Medical center; Mentored Research Scientist Development Award; Mentors; Methods; Modeling; National Human Genome Research Institute; Outcome; Outcome Measure; Output; Participant; Patients; Persons; Policies; Population; Privacy; Provider; Published Comment; Reporting; Research; Research Design; Research Personnel; Scientist; Secure; Security; Software Engineering; Strategic vision; Surveys; System; Technology; Testing; Time; Training; Translating; Woman; career; career development; cloud based; cognitive interview; computerized tools; data access; data infrastructure; data management; data privacy; data resource; data sharing; design; diverse data; ethical, legal, and social implication; evidence base; genome repository; genome resource; genomic data; health data; implementation tool; improved; innovation; interest; meetings; migration; novel; pilot test; precision medicine; preference; prevent; privacy preservation; public trust; racial minority population; repository; scale up; service providers; tool; trustworthiness; usability

PROJECT SUMMARY/ABSTRACT The goals of the proposed research address the NHGRI strategic vision of improving how publicly funded genomic repositories measure and report the impacts of their stewardship in novel computing environments. More genomic and related health data are generated than can be securely accessed and shared, preventing scientists’ ability to drive innovations that improve human health. New platforms powered by cloud technologies are transforming how repositories FAIRify data at scale, making data more findable, accessible, interoperable and reusable for otherwise compliant biomedical research. Moving repositories beyond regulatory compliance to responsible stewardship of public data resources means aligning institutional practices for data release with the values and interests of diverse stakeholders (e.g. data producers, users and contributors). The impacts of genomic data stewardship have been challenging to capture in the cloud so far because we lack understanding of what stewardship outcomes matter most to key stakeholders and how to measure these outcomes over time. It is expected that most largescale genomic data collections will soon migrate to the cloud. The time is now for developing a reliable tool that can track progress on genomic data stewardship ahead of these major infrastructural upgrades. The proposed K01 Mentored Research Scientist Development Award is designed to build Dr. Rahimzadeh’s foundational knowledge in privacy engineering and law, and to develop core competencies in impact assessment necessary to launch an independent research career at the nexus of genomics, bioethics and data science. Dr. Rahimzadeh is an applied bioethicist with scientific training in genomics. Her long-term career goal is to inform governance decisions which sustain public trust in and maximize the scientific value of genomic data resources across the research lifecycle. The integrated training and career development plan will be coordinated at the Center for Medical Ethics and Health Policy and leverages the expertise of an interdisciplinary team of bioethicists, genomic researchers, privacy engineers and data scientists. Dr. Rahimzadeh will partner with international data stewards responsible for managing genetically diverse data collections across repositories represented in the Global Alliance for Genomics and Health, H3Africa and the Native BioData Consortium to achieve the following specific aims: (AIM 1) Characterize essential outcomes and develop assessment criteria for genomic data stewardship in the cloud using a modified Delphi study design; Validate a stewardship impact assessment tool with experts in cloud infrastructure design (AIM2A) and pilot test the tool’s implementation with managers across cloud-native repositories (AIM2B).

项目概要/摘要 拟议研究的目标涉及 NHGRI 改善公共资助方式的战略愿景 基因组存储库测量并报告其管理在新型计算环境中的影响。 生成的基因组和相关健康数据超出了安全访问和共享的范围，从而阻碍了 科学家推动创新以改善人类健康的能力。由云技术支持的新平台。 正在改变存储库大规模公平化数据的方式，使数据更易于查找、访问和互操作 并可重复用于其他合规的生物医学研究。使存储库超越法规合规性。 对公共数据资源进行负责任的管理意味着将数据发布的机构实践与 不同利益相关者（例如数据生产者、用户和贡献者）的价值观和利益。 到目前为止，由于我们缺乏了解，在云中捕获基因组数据管理一直具有挑战性 哪些管理成果对关键利益相关者最重要，以及如何随着时间的推移衡量这些成果。 预计大多数大规模基因组数据收集将很快迁移到云端。 开发一个可靠的工具，可以在这些专业之前跟踪基因组数据管理的进展 拟议的 K01 指导研究科学家发展奖旨在 建立 Rahimzadeh 博士在隐私工程和法律方面的基础知识，并开发核心知识 开展独立研究职业所必需的影响评估能力 Rahimzadeh 博士是一位接受过科学培训的应用生物伦理学家。 她的长期职业目标是为维持公众信任的治理决策提供信息。 在整个研究生命周期中最大化基因组数据资源的科学价值。 和职业发展计划将在医学伦理和卫生政策中心进行协调 利用由生物伦理学家、基因组研究人员、隐私工程师和 Rahimzadeh 博士将与负责管理的国际数据管理员合作。 全球基因组学联盟代表的各个存储库中的遗传多样性数据收集 Health、H3Africa 和 Native BioData Consortium 旨在实现以下具体目标：（AIM 1）表征 使用修改后的云中基因组数据管理的基本成果并制定评估标准 德尔福研究设计；与云基础设施设计专家一起验证管理影响评估工具 (AIM2A) 并与跨云原生存储库的管理人员一起试点测试该工具的实施 (AIM2B)。