Assessing Patient and Community Engagement in Data Governance

摘要 加州大学旧金山分校弗朗西斯科（UCSF）临床和转化科学研究所（CTSI） 在基础设施建设、资源保障以及促进和支持多样化、 跨学科的劳动力谁共享的愿景和使命，以加快研究，以改善健康。现在在 在其最近一次更新的第一年，CTSI正在努力实现以下相关目标：（a）完全纳入 社区利益相关者参与临床和转化研究，以及（B）创建一个负责任的社区， 知情的监管框架，以指导使用个人健康信息进行研究。这些努力 最近呼吁建立数据监督机制，以解决只关注 将个人同意和风险披露作为保护患者和研究参与者的策略。新 方法包括共享的治理模式，其中多个利益相关者-包括患者和 社区代表-参与关于共享和使用临床和患者数据的决策。 共享治理承诺更大的问责制和透明度，但很少有人知道如何尝试把 将其付诸实践，包括制度因素如何促进和/或限制有意义的患者和社区 参与的这生物伦理学补充将扩大CTSI的目标，通过仔细检查加州大学旧金山分校的数据文化 共享数据共享文化是一个由利益相关者群体、他们的利益和规则组成的动态系统， 规范和工具，指导患者数据如何生成、维护和使用。本项目的目标 是（a）阐明数据共享的文化及其如何影响患者和社区参与数据 政策决定，和（B）帮助引导加州大学旧金山分校和其他健康科学机构走向共同治理。 我们将通过经验和规范目标的严格结合来实现这些目标。一是 定性研究将检查与患者数据有关的机构价值观、优先事项和实践， 患者和社区参与数据治理的程度和质量。然后，研究结果将 用于制定一个框架，详细说明具体的承诺、行动和关系， 公众参与以及更具包容性和可信赖的数据共享文化。该框架将扩大 UCSF CTSI努力制定共享数据治理，并将帮助从事翻译的机构 科学研究和学习卫生系统发展纳入重要和有意义的公众 参与数据决策。

ABSTRACT The University of California, San Francisco (UCSF) Clinical and Translational Science Institute (CTSI) has a strong track record of building infrastructure, securing resources, and fostering and supporting a diverse, transdisciplinary workforce who share a vision and mission to accelerate research to improve health. Now in the first year of its most recent renewal, CTSI is working toward the related goals of (a) fully incorporating community stakeholders into clinical and translational research and (b) creating a responsible, community- informed regulatory framework for guiding the use of personal health information for research. These efforts are informed by recent calls for data oversight mechanisms that address the limitations of focusing exclusively on individual consent and risk disclosure as strategies for protecting patients and research participants. New approaches include shared governance models in which multiple stakeholders – including patients and community representatives – contribute to decisions about the sharing and use of clinical and patient data. Shared governance promises greater accountability and transparency, but little is known about attempts to put it into practice including how institutional factors enable and/or limit meaningful patient and community participation. This bioethics supplement will extend CTSI's aims by closely examining UCSF's culture of data sharing. A culture of data sharing is a dynamic system of stakeholder groups, their interests, and the rules, norms and tools guiding how patient data are produced, maintained and used. The objectives of this project are to (a) elucidate the culture of data sharing and how it influences patient and community involvement in data policy decisions, and (b) help guide UCSF and other health sciences institutions toward shared governance. We will accomplish these objectives through a rigorous combination of empirical and normative aims. First, a qualitative study will examine institutional values, priorities and practices pertaining to patient data, and the extent and quality of patient and community involvement in data governance. Then, findings from the study will be used to develop a framework that details the specific commitments, actions and relationships that foster public engagement and a more inclusive and trustworthy culture of data sharing. The framework will augment UCSF CTSI's efforts to enact shared data governance and will help institutions engaged in translational science research and learning health system development incorporate significant and meaningful public involvement in data policy decisions.