iAGREE: A Multi-Center, Networked Patient Consent Study

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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.