A central pillar of the Belmont Report is that a bright line must be drawn between medical practice and biomedical research. That line may have been brighter 50 years ago. Today, the typical physician is likely to work for a corporation or health system that styles itself as a learning health system. Such systems increasingly emphasize the (research-like) use of data to measure quality, encourage efficiency, ensure safety, and guide a standardized approach to clinical care. While these activities are not considered research, they pose many of the same risks or conflicts of loyalty. In research, the doctor's fiduciary loyalty to the patient is compromised by a loyalty to the scientific process. In learning health systems, the doctor's loyalty is compromised by loyalty to the system and its metrics. In this world, it is not clear that research-as conceptualized by the Belmont Report, codified in the Common Rule, and overseen by IRBs-is a uniquely risky activity deserving of such uniquely strict oversight. Perhaps, instead, the divided loyalties and conflicts of interest faced by everyday clinicians working in learning health systems demand a protective framework similar to the one that we now have for the activities that we designate as "research." This article compares the risks of the various activities that might be called "research" and suggests a unified system of oversight for all of them.

中文翻译：

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贝尔蒙特报告和创新临床研究

贝尔蒙特报告的一个核心支柱是必须在医学实践和生物医学研究之间划清界限。这条线在 50 年前可能更亮。今天，典型的医生很可能为一个将自己定位为学习型医疗系统的公司或医疗系统工作。此类系统越来越强调（类似研究）使用数据来衡量质量、鼓励效率、确保安全并指导临床护理的标准化方法。虽然这些活动不被视为研究，但它们会带来许多相同的风险或忠诚度冲突。在研究中，医生对患者的信托忠诚会因对科学过程的忠诚而受到损害。在学习卫生系统中，医生的忠诚度会因对系统及其指标的忠诚度而受到损害。在这个世界上，尚不清楚研究——由贝尔蒙特报告概念化、编入共同规则并由 IRB 监督——是一种独特的风险活动，值得这种独特的严格监督。也许相反，在学习型卫生系统中工作的日常临床医生所面临的忠诚度分裂和利益冲突需要一个保护框架，类似于我们现在为我们指定为“研究”的活动所拥有的框架。本文比较了可能被称为“研究”的各种活动的风险，并建议对所有这些活动建立统一的监督系统。在学习型卫生系统中工作的日常临床医生所面临的忠诚度分裂和利益冲突需要一个保护框架，类似于我们现在为我们指定为“研究”的活动所拥有的框架。本文比较了可能被称为“研究”的各种活动的风险，并建议对所有这些活动建立统一的监督系统。在学习型卫生系统中工作的日常临床医生所面临的忠诚度分裂和利益冲突需要一个保护框架，类似于我们现在为我们指定为“研究”的活动所拥有的框架。本文比较了可能被称为“研究”的各种活动的风险，并建议对所有这些活动建立统一的监督系统。