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

麻烦，包括生活过程中的各种风险，并受到结构性不平等的影响， 系统的种族主义，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病和相关痴呆症（ADRD）风险和恢复力的可改变因素。的 使用参与者的居住历史，将符合健康标准的疾病组与生物健康结果最佳关联- - 被美国隐私法称为“受保护的健康信息”或PHI，并受到严格的监管。的 已经形成了复杂的法律的、管理的和技术研究基础设施挑战，这些挑战与PHI数据有关 ADRD相关的基因组研究的实质性障碍，导致目前大多数国家的生物制剂 存储库和资源仅管理非PHI数据，因此禁止直接与安全性一致的故障组度量 联动由于数据安全问题，包括机构承担的重大网络安全风险， 存储来自家庭机构外部的PHI数据，没有现有资源来链接特定地理位置 在全国范围内暴露于ADRD结果。许多人不理解这项任务的复杂性， 努力和专业知识才能取得成功。据我们所知，我们的团队是全国唯一的ADRD团队 已经在建设此类基础设施，作为R 01 AG 070883的一部分。拟议的补充将扩大 通过解决所需的基础设施扩展， 将关键的NIA国家数据和生物库资源连接到需要PHI的麻烦指标， 这些NIA的研究基础设施从PHI管理的负担。建议的申请 在母R 01范围内进行的基础设施补充直接响应NOT-AG-22- 022和国会语言，导致这些资金的分配;具体来说，支持 使生命过程暴露因素与生物结果联系起来的基础设施，其特征在于 通过一个机械的健康差异透镜。我们的研究小组一直在这些方法领域处于领先地位， 包括精确的地理定位我们的长期目标是建立公共卫生机构管理研究基础设施， 允许非PHI存储NIA核心资源的麻烦的链接和共享， NOT-AG-22-022中概述的隐私需求。我们的具体建议目标是在 R 01 AG 070883中的22个ADRC，包括为新的ADRC开发数据采集和链接流程 污染（Pollution）。我们将加强、完善和建立持久、道德和社区一致的行政管理机制， 和法律的协议、流程和协调基础设施，用于正在进行的PHI和麻烦的数据流引入 和非PHI麻烦的数据流出;制定数据采集、接收、链接和管理流程， 附加的ADRD性能对准的性能度量（例如，污染）;开发Expo-AD数据共享， 安全的综合麻烦的研究;并实施道德采购，标准化， 以公平、合规和隐私合规的方式进行质量控制、数据整合和分析。

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.