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.

暴露组，包括各种生命历程暴露并受到结构性不平等的影响，例如 系统性种族主义，理论上与生物、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) 风险和恢复力的可改变因素。这 使用参与者居住史，差异对齐的暴露组与生物健康结果最佳相关 - 美国隐私法将其称为“受保护的健康信息”或 PHI，并受到严格的监管。这 PHI 数据带来了复杂的法律、行政和技术研究基础设施挑战 ADRD 相关暴露组研究存在重大障碍，导致目前大多数国家的生物制品 存储库和资源仅管理非 PHI 数据，从而禁止直接对齐差异的暴露指标 连锁。由于数据安全问题，包括机构承担的重大网络安全风险 来自所在机构外部的 PHI 数据存储，没有现有资源来链接特定地理区域 全国范围内 ADRD 结果的暴露程度。许多人不了解这项任务的复杂性或 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 团队 已经构建了此类基础设施作为 R01AG070883 的一部分。拟议的补充将扩大覆盖范围 母公司 R01 的基础设施扩展，并通过解决所需的基础设施扩展消除暴露科学的障碍 将关键的 NIA 国家数据和生物样本库资源连接到需要 PHI 的暴露指标，同时进行屏蔽 这些 NIA 研究基础设施摆脱了 PHI 管理的负担。拟议的申请 在母 R01 范围内进行的基础设施补充直接响应 NOT-AG-22- 022 以及导致这些资金分配的国会语言；具体来说，支持 能够将生命全程暴露因素与生物结果联系起来的基础设施，其特点是 通过机械的健康差异镜头。我们的研究小组在这些方法方面一直处于领先地位， 包括精确的地理定位。我们的长期目标是建立 PHI 管理研究基础设施 允许非 PHI 存储 NIA 核心资源的暴露组链接和共享，对齐并寻址 NOT-AG-22-022 中概述的隐私需求。我们的具体提案目标是建立这样的基础设施 R01AG070883 中的 22 个 ADRC，包括开发新暴露组的数据摄入和链接流程 指标（污染）。我们将加强、完善和建立持久、道德和社区一致的行政管理体系 持续 PHI 和暴露数据流摄入的法律协议、流程和协调基础设施 和非 PHI 暴露组数据流出；制定数据采集、摄入、链接和管理流程 其他与 ADRD 差异一致的暴露指标（例如污染）；开发 Expo-AD 数据共享 安全的综合暴露组研究；并实施道德采购、标准化的最佳实践， 以公平、监管和隐私合规的方式进行数据质量控制、整合和分析。