iAGREE: A Multi-Center, Networked Patient Consent Study

项目总结/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，因此我们正在开发 一个患者平台“iAGREE：一个多中心，网络化的患者同意研究”，由国家支持， 人类基因组研究所（NHGRI），以促进数据共享。然而，iAGREE解决了患者- 面对一个更大的系统的部分，其中包括病人和他们的机构之间的“合同”， 授权与特定方共享数据。因此，我们在这项补充研究中建议， 面向机构和研究人员的流程，这些流程以数据使用的形式跨机构协商 协议（DUA）和谅解备忘录（MOU）。具体而言，我们计划开发/评估一个数据 交付分类帐系统，以确保在多中心共享的EHR和基因组数据 研究是一致的，符合规定的，并尽快交付。因此，制作这些文档的系统 计算机可执行和人类可审计将大大提高iAGREE的价值，使其成为一个更完整的 系统我们将重点关注伦理/法律的数据交付文件，如机构审查委员会（IRB） 批准、谅解备忘录和DUA。我们将开发一个创新的、分散的系统， 记录数据共享交易，在不同机构的研究办公室之间执行协议，以及 允许授权用户轻松验证所有交易。我们的目标包括（a）开发一个分布式， 社区拥有的数据交付的不可变分类账，以及（B）使用智能 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生物伦理学的完整性/可靠性， 我们资助的父R 01项目的范围。该系统可以支持证据库的开发， 新的区块链技术为临床/基因组数据共享提供未来患者隐私政策方向 跨机构。这一系统开发成功后，可为联合国系统内广泛的利益攸关方提供支持， 基因组学和医疗保健领域。此外，这项补充研究可让社会人士“拥有”一个新的 资源，使规模扩大研究活动，而不增加成本，同时坚持 涉及研究的伦理和法律的影响的所有指南、规则和法规， 二次使用临床数据。

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.