Suver Christine, Harper Jeremy, Loomba Johanna, Saltz Mary, Solway Julian, Anzalone Alfred Jerrod, Walters Kellie, Pfaff Emily, Walden Anita, McMurry Julie, Chute Christopher G, Haendel Melissa
Research Governance & Ethics, Sage Bionetworks, Seattle, WA, USA.
Owl Health Works LLC, Indianapolis, IN, USA.
J Clin Transl Sci. 2023 Nov 14;7(1):e252. doi: 10.1017/cts.2023.681. eCollection 2023.
The National COVID Cohort Collaborative (N3C) is a public-private-government partnership established during the Coronavirus pandemic to create a centralized data resource called the "N3C data enclave." This resource contains individual-level health data from participating healthcare sites nationwide to support rapid collaborative analytics. N3C has enabled analytics within a cloud-based enclave of data from electronic health records from over 17 million people (with and without COVID-19) in the USA. To achieve this goal of a shared data resource, N3C implemented a shared governance strategy involving stakeholders in decision-making. The approach leveraged best practices in data stewardship and team science to rapidly enable COVID-19-related research at scale while respecting the privacy of data subjects and participating institutions. N3C balanced equitable access to data, team-based scientific productivity, and individual professional recognition - a key incentive for academic researchers. This governance approach makes N3C research sustainable and effective beyond the initial days of the pandemic. N3C demonstrated that shared governance can overcome traditional barriers to data sharing without compromising data security and trust. The governance innovations described herein are a helpful framework for other privacy-preserving data infrastructure programs and provide a working model for effective team science beyond COVID-19.
国家新冠队列协作组织(N3C)是在新冠疫情期间建立的公私政府合作伙伴关系,旨在创建一个名为“N3C数据专区”的集中数据资源。该资源包含来自全国参与医疗保健机构的个人层面健康数据,以支持快速协作分析。N3C已在美国一个基于云的数据专区内,对来自超过1700万人(包括感染和未感染新冠病毒的人)的电子健康记录数据进行分析。为实现共享数据资源这一目标,N3C实施了一项共享治理策略,让利益相关者参与决策。该方法利用数据管理和团队科学的最佳实践,在尊重数据主体和参与机构隐私的同时,迅速推动大规模的新冠相关研究。N3C平衡了数据的公平获取、基于团队的科研生产力以及个人专业认可,这是学术研究人员的关键激励因素。这种治理方法使N3C的研究在疫情初期之后仍具可持续性和有效性。N3C表明,共享治理可以克服数据共享的传统障碍,同时不损害数据安全和信任。本文所述的治理创新为其他保护隐私的数据基础设施项目提供了有益的框架,并为新冠疫情之外的有效团队科学提供了一个可行模式。