HEAL Collaboratory Resource Coordinating Center (PRISM) (U24): Bioethics Supplement

项目摘要/摘要 已经提出了许多论点，支持广泛分享已确认身份的参与者- 临床试验数据水平。然而，在实用临床试验(PCT)的背景下，数据共享 带来了特殊的挑战。例如，之前关于数据共享的辩论基本上 关注单个研究参与者的风险，但共享来自PCT的数据也可能带来 对卫生系统及其内部临床医生的风险-临床医生可能没有做出 积极主动地决定参加PCT，在某些情况下，谁可能是研究对象 他们自己。此外，许多PCT是在放弃或更改通知的情况下进行的 同意，限制了将共享决定与那些人的价值观和偏好保持一致的能力 将共享其信息的个人。 PCT的资助者，包括NIH HCS合作实验室，NIH Hear Initiative和患者- 以成果研究所为中心，最近制定了政策和相关政策 鼓励数据共享的资源。但这些政策是如何在 个别PCT，以及这些政策对PCT数据在 事实，被重复使用，仍然鲜为人知。 拟议的研究将开发基于经验的证据来支持责任人 PCT数据共享。在目标1中，我们将开发一个概念模型，说明 可能影响数据共享的风险-收益计算的PCT环境。此型号将向您提供 我们的目标2工作，将探索PCT中数据共享带来的权衡，如 由负责监督、创建和未来使用PCT数据的人员理解。在AIM 3，我们将使用带有专家咨询小组的虚拟会议来评估 现有的和拟议的促进数据共享的政策是针对PCT特定的 考虑因素。这项研究的贡献将是重大的，因为它将为 关于PCT数据共享的有效指导的基本基础。这项基础工作将 推进美国国立卫生研究院卫生保健系统研究合作实验室致力于 PCT的最佳做法，以最大限度地增加国家卫生研究所在以下方面的投资 嵌入式健康研究，并最终加快整个学习的步伐 国家的医疗保健系统。

PROJECT SUMMARY/ABSTRACT Numerous arguments have been advanced for the broad sharing of deidentified, participant- level clinical trial data. However, data sharing in the context of pragmatic clinical trials (PCTs) presents particular challenges. For example, prior debates about data sharing have largely focused on risks for individual research participants, yet sharing data from PCTs can also carry risks for health systems and for the clinicians within them—clinicians who may not have made a proactive decision to participate in the PCT, and who, in some cases, may be research subjects themselves. Furthermore, many PCTs are conducted with a waiver or alteration of informed consent, limiting the ability to align sharing decisions with the values and preferences of those individuals about whom information will be shared. Funders of PCTs, including the NIH HCS Collaboratory, NIH HEAL Initiative and the Patient- Centered Outcomes Research Institute, have recently developed policies and related resources to encourage data sharing.Yet how such policies are being implemented within individual PCTs, and the implications of these policies for the likelihood that PCT data will, in fact, be reused, remains poorly understood. The proposed research will develop empirically grounded evidence to support the responsible sharing of PCT data. In Aim 1, we will develop a conceptual model of the specific features of the PCT context that may influence the risk-benefit calculus for data sharing. This model will inform our Aim 2 work, which will explore the trade-offs presenting by data sharing in PCTs, as understood by those responsible for the oversight, creation, and future use of PCT data. In Aim 3, we will use a virtual conference with an expert advisory panel to evaluate the extent to which existing and proposed policies to promote data sharing are responsive to PCT-specific considerations. The contribution of this research will be significant because it will lay the essential groundwork for effective guidance regarding sharing of PCT data. This groundwork will advance the NIH Health Care Systems Research Collaboratory’s commitment to developing best practices for PCTs so as to maximize the National Institute of Health’s investments in embedded health research, and, ultimately to accelerate the pace of learning throughout the nation’s healthcare system.