Miller Franklin G, Kim Scott Y H
Kennedy Inst Ethics J. 2015 Dec;25(4):419-35. doi: 10.1353/ken.2015.0024.
The idea of a "learning health care system"--one that systematically integrates clinical research with medical care--has received considerable attention recently. Some commentators argue that under certain conditions pragmatic comparative effectiveness randomized trials can be conducted ethically within the context of a learning health care system without the informed consent of patients for research participation. In this article, we challenge this perspective and contend that conducting randomized trials of individual treatment options without consent is neither necessary nor desirable to promote and sustain learning health care systems. Our argument draws on the normative conception of personal care developed by Charles Fried in a landmark 1974 book on the ethics of randomized controlled trials.
“学习型医疗保健系统”的理念——即一种将临床研究与医疗保健系统整合的理念——最近受到了广泛关注。一些评论家认为，在某些情况下，务实的比较效果随机试验可以在学习型医疗保健系统的背景下，在未经患者知情同意参与研究的情况下，符合伦理地进行。在本文中，我们对这一观点提出质疑，并认为在未经同意的情况下对个体治疗方案进行随机试验，对于促进和维持学习型医疗保健系统而言既无必要也不可取。我们的论点借鉴了查尔斯·弗里德在1974年一本关于随机对照试验伦理的里程碑式著作中提出的个人护理的规范概念。
