Hastings Cent Rep. 2022 May;52(3):29-31. doi: 10.1002/hast.1393.
This commentary responds to the article "Compulsory Research in Learning Health Care: Against a Minimal Risk Limit," by Robert Steel. Steel acknowledges that our ethics framework for a learning health care system, published in the 2013 special report Ethical Oversight of Learning Health Care Systems , includes an obligation on the part of patients to participate in learning activities, but he argues that this obligation does not go far enough. Steel, who provides an interesting justification for compulsory research participation in learning health care, claims that our obligation is limited to only minimal risk research. We take exception to that characterization insofar as it detracts from what we believe is most relevant for assessing learning activities, which is how much additional risk and burden a learning activity poses compared to clinical care alone. We also clarify that the level of additional risk is not the only morally relevant consideration in determining if a learning activity should be compulsory. Also important is whether the learning activity includes interventions or choices that engage values of importance to patients.
这篇评论是对罗伯特·斯蒂尔（Robert Steel）的文章“学习型医疗保健中的强制研究：反对最小风险限制”的回应。斯蒂尔承认，我们在 2013 年的特别报告《学习型医疗保健系统的伦理监督》中为学习型医疗保健系统制定的伦理框架包括患者有参与学习活动的义务，但他认为这种义务还不够。斯蒂尔为学习型医疗保健中的强制研究提供了一个有趣的理由，他声称我们的义务仅限于最低风险研究。我们反对这种描述，因为它削弱了我们认为最相关的评估学习活动的因素，即学习活动相对于单独的临床护理会带来多少额外的风险和负担。我们还澄清说，在确定学习活动是否具有强制性时，额外风险水平并不是唯一具有道德相关性的考虑因素。同样重要的是，学习活动是否包含与患者重视的价值观相关的干预或选择。
