Administrative Supplement to Establish National Exposome Alzheimer's Disease and Related Dementias (ADRD) Infrastructure (Expo-AD)

建立国家阿尔茨海默氏病和相关痴呆症 (ADRD) 基础设施 (Expo-AD) 的行政补充

• 批准号: 10658250
• 负责人: Barbara Brigitta Bendlin
• 金额: $ 345.15万
• 依托单位: UNIVERSITY OF WISCONSIN-MADISON
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-03-01 至 2026-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10658250
• 关键词: Address; Administrative Supplement; Agreement; Alzheimer' s Disease; Alzheimer' s disease related dementia; Amyloid; Behavioral; Biological; Biology; Brain; Collection; Communities; Consent; Data; Data Analyses; Data Commons; Data Linkages; Data Security; Economics; Elements; Ensure; Ethics; Exposure to; Foundations; Funding; Goals; Health; Health Disparities Research; Health Insurance Portability and Accountability Act; Home; Individual; Information Management; Infrastructure; Institution; Institutional Racism; Intake; Investments; Language; Laws; Legal; Life Cycle Stages; Lifting; Link; Names; National Institute on Aging; Neighborhoods; Nerve Degeneration; Outcome; Parents; Participant; Pollution; Privacy; Process; Quality Control; Recording of previous events; Regulation; Research; Research Infrastructure; Resources; Risk; Science; Secure; Security; Source; Standardization; biobank; cyber infrastructure; cyber security; data acquisition; data ecosystem; data infrastructure; data management; data resource; dementia risk; genetic linkage analysis; health disparity; lens; neighborhood disadvantage; repository; resilience; response; social culture; tau Proteins; tool

The exposome, comprising the variety of life-course exposures and influenced by structural inequities such as systematic racism, is theorized to interact with biological, behavioral, sociocultural, and economic mechanisms as a modifiable factor influencing Alzheimer’s Disease and Related Dementias (ADRD) risk and resilience. The disparities-aligned exposome is optimally linked to biologic health outcomes using participant residential history- - denoted by US privacy law as ‘protected health information’ or PHI and subject to stringent regulation. The complicated legal, administrative, and technical research infrastructure challenges with PHI-data have formed substantial barriers to ADRD-aligned exposome study, leading to a present state in which most national biologic repositories and resources curate only non-PHI data thus prohibiting direct disparities-aligned exposome metric linkage. Due to data security concerns including the substantial cybersecurity risk an institution assumes in storage of PHI-data from outside the home institution, there are no existing resources to link geo-specific exposures to ADRD outcomes on a national scale. Many do not understand the complexity of this task or the effort and expertise required to succeed. To our knowledge, our team is the only ADRD group in the nation already building such infrastructure as part of R01AG070883. The proposed supplement will extend the reach of the parent R01 and remove barriers in exposome science by addressing the infrastructure expansion needed to connect key NIA national data and biorepository resources to PHI-requiring exposome metrics while shielding these NIA research infrastructures from the burden of PHI management. The proposed application for an infrastructure supplement conducted within the scope of the parent R01 is directly responsive to NOT-AG-22- 022 and the Congressional language that led to the allocation of these funds; specifically, to support infrastructure that enables the linkage of life-course exposure factors to biological outcomes, characterized through a mechanistic health disparities lens. Our research group has been leading the field in these approaches, including precision geo-targeting. Our long-term goal is to establish PHI-management research infrastructure to allow for exposome linkage and sharing for non-PHI storing NIA core resources, aligning with and addressing the privacy needs outlined in NOT-AG-22-022. Our specific proposal goal is to build such infrastructure across the 22 ADRCs in R01AG070883, including developing data intake and linkage processes for new exposome metrics (pollution). We will enhance, refine and establish enduring, ethical and community-aligned administrative and legal agreement, process and coordination infrastructure for on-going PHI and exposome data flow intake and non-PHI exposome data outflow; enact data acquisition, intake, linkage and management processes for additional ADRD disparities-aligned exposome metrics (e.g., pollution); develop the Expo-AD data commons for secure integrative exposome research; and implement best practices for ethical sourcing, standardization, quality control, integration and analysis of data in a FAIR, regulatory and privacy compliant manner.

接触，完成多种生活方式暴露，并受结构不平等的影响，例如 从理论上讲，有系统的种族主义与生物学，行为，社会文化和经济机制相互作用 作为影响阿尔茨海默氏病和相关痴呆症（ADRD）风险和韧性的一种可修改因素。这 使用参与者的居民历史与生物健康结局相关联的差异一致性杂物体 - - 由美国隐私法表示为“受保护的健康信息”或PHI，并受到严格的监管。这 PHI-DATA的复杂法律，行政和技术研究基础设施挑战已经形成 ADRD结盟的杂物组研究的实质性障碍，导致了当前的国家，大多数国家生物学 存储库和资源仅策划非PHI数据，因此禁止直接分布与分布式的外汇指标 连锁。由于数据安全问题，包括机构假设的实质网络安全风险 从家庭机构外部存储phi-data，没有现有的资源可以链接特定于地理的 在全国范围内暴露于ADRD的结果。许多人不了解此任务的复杂性或 成功所需的努力和专业知识。据我们所知，我们的团队是全国唯一的ADRD团体 已经将这种基础设施作为R01AG070883的一部分建立。拟议的补充剂将扩大范围 通过解决所需的基础设施扩展，将父r01的r01和消除裸露科学的障碍 将关键的NIA国家数据和生物座席资源连接到屏蔽时要求的exposome指标 这些NIA研究基础设施从PHI管理的燃烧中。提议的申请 在父r01范围内进行的基础设施补充剂直接响应于NOT-AG-22-- 022和导致这些资金分配的国会语言；具体来说，支持 可以使生命过程与生物学结果联系起来的基础设施，以表征 通过机械健康差异镜头。我们的研究小组一直在这些方法中领导领域， 包括精确的地理目标。我们的长期目标是建立Phi-Managementing研究基础设施 允许进行非phi存储NIA核心资源的剥离链接和共享，与之保持一致并解决 NOT-AG-22-022中概述的隐私需要。我们的具体建议目标是跨越 R01AG070883中的22个ADRC，包括开发新的Exposome的数据摄入和链接过程 指标（污染）。我们将增强，完善并建立持久，道德和社区一致的行政 以及正在进行的PHI和外汇数据流摄入量的法律协议，过程和协调基础架构 和非Phi Exposome数据出口；颁布数据获取，进气，链接和管理流程 附加与ADRD差异的外汇指标（例如污染）；开发用于 安全的集成企业组研究；并实施道德采购，标准化， 质量控制，集成和分析数据以公平，法规和隐私的方式进行。