Sharing of data from clinical trials has the potential to increase transparency and reproducibility in medical research, enable secondary analyses, decrease selective reporting, and accelerate translation of high-quality evidence into clinical care (1–3). Several solutions have been proposed to encourage the sharing of analyzable research data sets (4–8); however, the conceptual framework is rooted in explanatory clinical trials, which typically obtain explicit informed consent from participants and collect research-specific data focused on a narrow range of outcomes. Pragmatic research embedded in health systems often involves different data sources and data collection methods: It often involves a waiver of patient consent; uses data from the electronic health record; and may include information that could identify patients, health care providers, and health care facilities or organizations. Even if study data would not allow identification of individual participants, the potential for disclosure of sensitive information regarding providers or health systems may be substantial.

共享临床试验中的数据有可能增加医学研究的透明度和可重复性，实现二次分析，减少选择性报告，并加速将高质量证据转化为临床护理（1-3）。为了鼓励共享可分析的研究数据集，已经提出了几种解决方案（4-8）；但是，概念框架扎根于解释性的临床试验中，该试验通常会从参与者那里获得明确的知情同意，并收集针对狭窄结果的特定于研究的数据。嵌入卫生系统的务实研究通常涉及不同的数据源和数据收集方法。使用电子健康记录中的数据；并可能包含可以识别患者，医疗保健提供者，和医疗保健机构或组织。即使研究数据不允许识别单个参与者，也可能泄露有关提供者或卫生系统的敏感信息的潜力。