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Social value, clinical equipoise, and research in a public health emergency

机译:社会价值,临床平衡,以及公共卫生紧急情况的研究

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摘要

The 2016 CIOMS International ethical guidelines for health-related research involving humans states that 'health-related research should form an integral part of disaster response' and that, 'widespread emergency use [of unproven interventions] with inadequate data collection about patient outcomes must therefore be avoided' (Guideline 20). This position is defended against two lines of criticism that emerged during the 2014 Ebola outbreak. One holds that desperately ill patients have a moral right to try unvalidated medical interventions (UMIs) and that it is therefore unethical to restrict access to UMIs to the clinical trial context. The second holds that clinical trials in contexts of high-mortality diseases are morally suspect because equipoise does not exist between a standard of care that offers little prospect of clinical benefit and a UMI that might offer some clinical advantage.
机译:2016年CIOMS涉及人类的卫生相关研究的国际道德准则,即“与健康有关的研究”应成为灾难响应的组成部分,而且,对患者结果的数据收集不足的普遍存在的紧急使用[未经证实的干预措施]必须 避免'(指南20)。 在2014年Ebola爆发期间出现的两条批评,这种职位是针对两条批评的辩护。 一个人认为绝望的患者有道德权利,可以尝试未经验证的医疗干预措施(UMIS),因此,限制对临床试验环境的访问权限是不道德的。 第二种持有高死亡疾病的背景下的临床试验在道德上是怀疑,因为在临床福利的临床效益和UMI的展望很小之间不存在Equipoise之间不存在,可能提供一些临床优势。

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