Building the Medical Information Commons: Participant Engagement and Policy

 描述(由申请人提供)：许多国家和国际的公共和私人倡议正在形成，以收集和共享大规模数据，用于研究和临床使用。总而言之，这些努力可能导致创建一个医疗信息共享空间，一个网络环境，在这个环境中，大量人口的健康、医疗和基因组数据的不同来源成为广泛共享的资源。这种公地的成功和价值将取决于有效治理的政策和做法的发展，这些政策和做法解决了数据共享的障碍，并在患者和公众的知情意见下制定，他们的数据可能会填充到公有数据中。在NHGRI资助的一项研究(McGuire R01HG006460)中，一个不同的专家小组将一些机构不愿分享数据列为修改后的德尔福进程中17个机构中最重要、但政治上最难处理的政策挑战。这项提案的目的是让专家利益攸关方就有效治理数据共享的政策决策提供信息，同时使用审议方法获得知情的公众意见，以确保其数据可能出现在信息共享空间的个人的价值观、权益和利益得到体现。在目标1中，我们将与一个多学科专家咨询委员会合作，对现有的和正在出现的数据倡议进行系统的景观分析，以总结共同的方法并确定替代模式。在目标2中，我们将对专家利益相关者进行定性访谈，以征求对现有模式和应对关键政策挑战的替代方法的反馈。在目标3中，我们将采用深入审议的方法，即公民小组，征求患者和公众对关键政策问题的知情意见，并提出解决这些问题的模式。这一贡献将是重大的，因为它将为以下方面提供关键的利益相关者投入 为推动公共和私营部门数据倡议的努力建立一个可持续的道德和法律框架的必要基础。这一方法是创新的，它让各种具有代表性的利益攸关方，包括那些参与这些数据倡议并可能对其做出贡献的利益攸关方，确定有效治理的政策挑战和深思熟虑的模式。这项工作在我们手中是可行的，因为我们的老牌研究人员团队在与大规模数据共享相关的伦理和政策问题方面拥有专业知识，并在解决基因组学伦理和政策问题的大型合作项目上取得了成功的记录。

 DESCRIPTION (provided by applicant): Many national and international public and private initiatives are forming to collect and share data on a large scale for research and clinical use. Collectively, these efforts may lead to the creation of a medical information commons, a networked environment in which diverse sources of health, medical, and genomic data on large populations become widely shared resources. The success and value of such a commons will depend on development of policies and practices for effective governance that address barriers to data sharing and are developed with informed input from patients and members of the public whose data may populate it. In an NHGRI-funded study (McGuire R01HG006460), a diverse group of experts ranked reluctance of some institutions to share data as the most important, yet least politically tractable policy challenge among 17 posed in a modified Delphi process. The objective of this proposal is to engage expert stakeholders to inform policy decisions about effective governance for data sharing, while using deliberative methods to obtain informed public input to ensure that the values, rights and interests of individuals whose data may populate the information commons are represented. In Aim 1, we will work with a multi-disciplinary expert advisory committee and con- duct a systematic landscape analysis of existing and emerging data initiatives to summarize common approaches and identify alternative models. In Aim 2, we will conduct qualitative interviews with expert stake- holders to solicit feedback on existing models and alternative approaches to key policy challenges. In Aim 3, we will use intensive deliberative methods, Citizen Panels, to solicit informed input about key policy issues, and proposed models to address them, from patients and members of the general public. This contribution will be significant because it will provide critical stakeholder input to develop the necessary foundation for a sustainable ethical and legal framework for efforts to advance public and private sector data initiatives. The approach is innovative by engaging a diverse and representative group of stakeholders, including those involved with and potentially contributing to these data initiatives, to identify policy challenges and deliberate models for effective governance. The work is feasible in our hands because our team of established investigators have expertise in ethical and policy issues related to large-scale data sharing and a track record of success working together on large collaborative projects addressing ethical and policy issues in genomics.