Assessing Patient and Community Engagement in Data Governance

评估患者和社区对数据治理的参与

• 批准号: 10592230
• 负责人: Kirsten Bibbins-Domingo
• 金额: $ 13.7万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-08-15 至 2026-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10592230
• 关键词: Accountability; Address; Advisory Committees; Area; Artificial Intelligence; Bioethics; Biomedical Research; California; Charge; Clinical; Clinical Research; Clinical Sciences; Committee Members; Communities; Community Participation; Consensus; Consent; Consult; Data; Decision Making; Disclosure; Ensure; Ethics; Family; Feedback; Fostering; Future; Generations; Goals; Health; Health Benefit; Health Sciences; Health system; Individual; Infrastructure; Institutes; Institution; Institutional Policy; Institutional Review Boards; Interview; Investigation; Knowledge; Learning; Machine Learning; Medical; Mission; Modeling; Nature; Participant; Patient Participation; Patients; Perception; Policies; Policy Making; Privacy; Procedures; Public Participation; Regulation; Research; Research Design; Resources; Risk; San Francisco; Schedule; Secure; Shapes; Structure; Systems Development; Translational Research; Trust; United States National Institutes of Health; Universities; Vision; base; big-data science; clinical care; community engagement; community involvement; data sharing; design; dynamic system; experience; health data; improved; innovation; interest; meetings; member; novel strategies; patient engagement; patient health information; tool; translational scientist; trustworthiness

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.

抽象的 加州大学旧金山大学（UCSF）临床和转化科学研究所（CTSI）有一个 建筑基础设施，确保资源以及培养和支持潜水者的良好记录 跨学科的劳动力有愿景和使命，以加速研究以改善健康。现在 CTSI是其最新续签的第一年，正在朝着（a）完全合并的相关目标努力 社区利益相关者参与临床和翻译研究，（b）创建一个负责任的社区 - 知情的监管框架，用于指导使用个人健康信息进行研究。这些努力 最近呼吁数据监督机制的呼吁，这些机制仅针对专注于关注的局限性 根据个人同意和风险披露，作为保护患者和研究参与者的策略。新的 方法包括共同的治理模型，其中多个利益相关者（包括患者和） 代表社区 - 有助于有关共享和使用临床和患者数据的决策。 共同的治理承诺更大的问责制和透明度，但对尝试的尝试知之甚少 它实际上包括机构因素如何启用和/或限制有意义的患者和社区 参与。这种生物伦理学补充剂将通过密切研究UCSF的数据文化来扩展CTSI的目标 分享。数据共享的文化是利益相关者群体，他们的利益和规则的动态系统， 规范和工具指导如何生成，维护和使用患者数据。这个项目的目标 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，以及（b）帮助指导UCSF和其他健康科学机构共同治理。 我们将通过严格的经验和正常目标来实现这些目标。首先，a 定性研究将检查与患者数据有关的机构价值，优先级和实践，以及 患者和社区参与数据治理的程度和质量。然后，研究结果将 用于开发一个框架，详细介绍培养的特定承诺，行动和关系 公众参与以及更具包容性和值得信赖的数据共享文化。框架将增加 UCSF CTSI为制定共享数据治理的努力，并将帮助进行转化的机构 科学研究与学习卫生系统发展融合了重要而有意义的公众 参与数据政策决策。