Building the Medical Information Commons: Participant Engagement and Policy

建立医疗信息共享：参与者参与和政策

• 批准号: 9054592
• 负责人: Robert Mullan Cook-Deegan
• 金额: $ 72.94万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-14 至 2018-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9054592
• 关键词: Address; Advisory Committees; Affect; Clinical; Data; Data Sources; Decision Making; Development; Duct (organ) structure; Effectiveness; Ensure; Environment; Ethics; Feedback; Foundations; Funding; General Population; Genomics; Geographic Locations; Goals; Health; Individual; Institution; International; Interview; Laws; Lead; Legal; Medical; Methods; Modeling; National Human Genome Research Institute; Participant; Patients; Policies; Population; Precision Medicine Initiative; Privacy; Private Sector; Process; Public Health; Public Sector; Research; Research Personnel; Resistance; Resource Sharing; Resources; Rights; Source; United States; Work; clinical application; data sharing; development policy; ethical legal social implication; experience; improved; innovation; interest; member; novel strategies; programs; public health relevance; public-private partnership; success; systematic review

 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.

 描述（由申请人提供）：许多国家和国际公共和私人倡议正在形成，以收集和共享大规模的研究和临床使用的数据。总的来说，这些努力可能会导致创建一个医疗信息共享，一个网络化的环境中，不同来源的健康，医疗和基因组数据的大量人口成为广泛共享的资源。这种共享的成功和价值将取决于有效治理的政策和实践的发展，这些政策和实践解决了数据共享的障碍，并在患者和公众成员的知情投入下发展，他们的数据可能会填充它。（McGuire R01HG 006460），一个不同的专家组将一些机构不愿意分享数据列为最重要的因素，但在修改后的德尔菲程序中提出的17项政策挑战中，政治上最不容易处理的。该提案的目的是让利益攸关方专家参与就数据共享的有效治理作出政策决定，同时使用审议方法获取知情的公众意见，以确保其数据可能会成为信息共享内容的个人的价值观、权利和利益得到体现。在目标1中，我们将与多学科专家咨询委员会合作，对现有和新兴数据计划进行系统的景观分析，以总结常见方法并确定替代模型。在目标2中，我们将与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，我们将使用密集的审议方法，公民小组，征求病人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，因为它将提供关键的利益攸关方投入， 为可持续的道德和法律的框架奠定必要的基础，以努力推进公共和私营部门的数据举措。这一方法具有创新性，它让各种具有代表性的利益攸关方群体参与进来，包括那些参与这些数据举措并可能为之做出贡献的利益攸关方，以确定政策挑战并审议有效治理的模式。这项工作在我们手中是可行的，因为我们的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具有专业知识，并且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。