iAGREE: A Multi-Center, Networked Patient Consent Study

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，因此我们正在开发 国家支持的患者平台iAGREE：一项多中心、网络化的患者同意研究 人类基因组研究所(NHGRI)，以促进数据共享。然而，iAGREE解决了患者- 面对更大系统的一部分，其中包括患者和他们的机构之间在以下方面的“合同” 授权与特定各方共享数据。因此，我们在这项补充研究中建议改善 各机构之间以数据使用的形式协商的面向机构和研究人员的流程 协定(DUA)和谅解备忘录(MOU)。具体地说，我们计划开发/评估数据 确保电子病历和基因组数据在多中心共享的交付分类帐系统 研究是一致的、合规的，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极大地提高iAGREE的价值，使其更加完整 系统。我们将重点关注道德/法律数据交付文件，如机构审查委员会(IRB) 批准、谅解备忘录和DUAS。我们将开发一个创新的、去中心化的系统，创造一个不变的 数据共享交易的记录，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)开发分布式、 社区拥有的不可更改的数据交付分类账，以及(B)使用SMART开发自动数据交付 合同。该系统将使数据权限的交叉检查变得更容易。 这项补充研究可以补偿和增强内部完整性/可靠性的生物伦理能力 我们资助的母公司R01项目的范围。该系统可以通过以下方式支持证据库的开发 新的区块链技术可为临床/基因组数据共享的未来患者隐私政策方向提供信息 跨机构。该系统在成功开发后，可以支持 基因组学和医疗保健领域。此外，这项补充研究将使社会“拥有”一个新的 能够在不增加不成比例的成本的情况下扩展研究活动的资源，同时坚持 与研究的伦理和法律影响有关的所有准则、规则和条例，涉及 二次利用临床资料。

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.