iAGREE: A Multi-Center, Networked Patient Consent Study

iAGREE：一项多中心、网络化的患者同意研究

基本信息

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
项目类别：
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

项目摘要

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.

项目概要/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，因此我们正在开发患者平台“iAGREE：一项多中心、网络化患者同意研究”，由国家癌症中心支持人类基因组研究所（NHGRI），以促进数据共享然而，iAGREE 解决了患者的问题。面对更大系统的一部分，其中包括患者与其机构之间的“合同” 因此，我们建议在本补充研究中进行改进。以数据使用形式跨机构协商的面向机构和研究人员的流程具体来说，我们计划开发/评估数据。交付分类账系统确保 EHR 和基因组数据在多中心共享研究是一致的、合规的，并尽快交付，因此，一个制作这些文件的系统。计算机可执行和人工审核将大大提升iAGREE的价值，使其更加完整我们将重点关注道德/法律数据交付文件，例如机构审查委员会（IRB）。我们将开发一个创新的、去中心化的系统，创建一个不可变的系统。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) 开发分布式、社区拥有的不可变数据交付账本，以及 (b) 使用智能开发自动化数据交付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 项目的范围可以通过该系统支持证据库的开发。新的区块链技术将为未来临床/基因组数据共享的患者隐私政策方向提供信息该系统一旦成功开发，可以支持广泛的利益相关者。此外，这项补充研究将使社区能够“拥有”一个新的领域。能够在不过度增加成本的情况下扩大研究活动的资源，同时坚持与涉及研究的伦理和法律影响相关的所有准则、规则和条例临床数据的二次利用。