iAGREE: A Multi-Center, Networked Patient Consent Study

iAGREE：一项多中心、网络化的患者同意研究

• 批准号: 10594207
• 负责人: LUCILA OHNO-MACHADO
• 金额: $ 10.51万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-05-01 至 2022-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10594207
• 关键词: Address; Administrator; Adopted; Adoption; Agreement; Automation; Awareness; Bioethics; Biomedical Research; Clinical; Clinical Data; Communities; Complement; Computers; Consent; Consumption; Contracts; Data; Data Set; Decentralization; Development; Documentation; Electronic Mail; Ensure; Ethics; Funding; Future; Genomic medicine; Genomics; Guidelines; Healthcare; Human; Human Resources; Information Technology; Infrastructure; Institution; Institutional Review Boards; Legal; Mediation; Monitor; National Human Genome Research Institute; Parents; Patients; Policies; Privacy; Process; Property; Protocols documentation; Regulation; Research; Research Activity; Research Personnel; Resources; Secure; Security; Site; System; Technology; Testing; Time; Transact; base; biomedical data science; blockchain; computer program; cost; data sharing; design; design and construction; digital; distributed ledger; encryption; evidence base; genetic information; genomic data; improved; innovation; legal implication; open source; parent project; patient privacy; response; scale up; Address; Administrator; Adopted; Adoption; Agreement; Automation; Awareness; Bioethics; Biomedical Research; Clinical; Clinical Data; Communities; Complement; Computers; Consent; Consumption; Contracts; Data; Data Set; Decentralization; Development; Documentation; Electronic Mail; Ensure; Ethics; Funding; Future; Genomic medicine; Genomics; Guidelines; Healthcare; Human; Human Resources; Information Technology; Infrastructure; Institution; Institutional Review Boards; Legal; Mediation; Monitor; National Human Genome Research Institute; Parents; Patients; Policies; Privacy; Process; Property; Protocols documentation; Regulation; Research; Research Activity; Research Personnel; Resources; Secure; Security; Site; System; Technology; Testing; Time; Transact; base; biomedical data science; blockchain; computer program; cost; data sharing; design; design and construction; digital; distributed ledger; encryption; evidence base; genetic information; genomic data; improved; innovation; legal implication; open source; parent project; patient privacy; response; scale up

Project Summary/Abstract Biomedical data science innovations rely heavily on multicentric data sharing, and therefore we are developing a patient platform “iAGREE: A Multi-Center, Networked Patient Consent Study,” supported by the National Human Genome Research Institute (NHGRI), to facilitate data sharing. However, iAGREE addresses patient- facing portions of a larger system, which includes “contracts” between the patient and their institution in terms of authorizing data to be shared with specific parties. We therefore propose in this supplement study to improve the institution- and researcher-facing processes that are negotiated across institutions in the form of Data Use Agreements (DUA) and Memoranda of Understanding (MOU). Specifically, we plan to develop/evaluate a data delivery ledger system in a way that ensures that the EHR and genomic data that are shared in multicentric studies are consistent, compliant, and delivered as soon as possible. Thus, a system making these documents computer-executable and human-auditable will greatly enhance the value of iAGREE, making it a more complete system. We will focus on ethical/legal data delivery documents such as Institutional Review Board (IRB) approvals, MOUs and DUAs. We will develop an innovative, decentralized system that creates an immutable record of data sharing transactions, executes agreements across research offices in different institutions, and permits easy verification of all transactions by authorized users. Our aims include (a) developing a distributed, community-owned immutable ledger of data delivery, and (b) developing automated data delivery using smart contracts. This system will make it easier to cross-check data permissions. This supplementary study can compensate and augment the bioethical capacity of the integrity/reliability within the scope of our funded parent R01 project. This system can support the development of an evidence base via new blockchain technology to inform future patient privacy policy directions for clinical/genomic data sharing across institutions. This system, when successfully developed, can support a broad array of stakeholders in the field of genomics and healthcare. Moreover, this supplementary study will enable the community to “own” a new resource that enables scaling up research activities without disproportionally increasing costs, while adhering to all guidelines, rules and regulations that relate to the ethical and legal implications of research involving secondary use of clinical data.

项目摘要/摘要 生物医学数据科学创新在很大程度上依赖于多中心数据共享，因此我们正在发展 患者平台“ Iagree：多中心，网络患者同意研究”，由国家支持 人类基因组研究所（NHGRI），以促进数据共享。但是，iagree解决了患者 - 面对较大系统的部分，其中包括患者与其机构之间的“合同” 授权要与特定方共享的数据。因此，我们在这项补充研究中提出了改善 以数据使用形式在机构之间进行谈判的机构和面向研究人员的过程 协议（DUA）和谅解备忘录（MOU）。具体来说，我们计划开发/评估数据 交付分类帐系统以确保多中心共享的EHR和基因组数据 研究是一致的，合规的，并尽快进行。那是制作这些文档的系统 计算机可观和人类被审计将大大提高iagree的价值，使其变得更加完整 系统。我们将重点介绍道德/法律数据交付文件，例如机构审查委员会（IRB） 批准，莫斯和DUAS。我们将开发一个创新的，分散的系统，创造一个不变的 数据共享交易的记录，跨不同机构的研究办公室执行协议以及 允许轻松验证授权用户的所有交易。我们的目标包括（a）开发分布式， 社区拥有的数据传输分类帐，以及（b）使用SMART开发自动数据传递 合同。该系统将使交叉检查数据权限变得更加容易。 这项补充研究可以补偿和增强完整性/可靠性的生物伦理能力 我们资助的父级R01项目的范围。该系统可以通过 新的区块链技术，以告知未来的患者隐私政策指示临床/基因组数据共享 跨机构。该系统成功开发时，可以支持各种各样的利益相关者 基因组学领域和医疗保健领域。此外，这项补充研究将使社区能够“拥有”一个新的 能够扩展研究活动而不会过分增加成本的资源，同时遵守 与涉及的研究的道德和法律意义相关的所有指南，规则和法规 临床数据的第二使用。