《科学》 2026年10月1日 · 中文解读
美国人类受试者保护规则即将修改,伦理学家忧心忡忡
Impending changes to U.S. human subject protections put ethicists on edge · Sara Reardon
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这篇讲什么
美国卫生与公众服务部宣布将修订《共同规则》,以减轻低风险研究的监管负担,此举可能削弱部分临床试验中对受试者的保护。该规则自1991年实施,涵盖知情同意、数据共享以及对囚犯、孕妇等弱势群体的特殊保护,2017年最后一次更新。多位生物伦理学家担心,新规更注重减少行政负担而非保障受试者权益,可能带来信任代价。
原文开头
HHS plan to revise the Common Rule focuses on easing regulatory burden for lower risk studies SARA REARDON The Trump administration appears poised to weaken protections for people enrolled in some clinical trials. In a little-noticed posting on a government website tracking agency regulations, the U.S. Department of Health and Human Services (HHS) announced an upcoming “de-regulatory” move that would revise the Common Rule, a federal policy that governs aspects of human research including informed consent, data sharing, and special protections for vulnerable participants such as prisoners or pregnant people. …
摘自《科学》(Science)2026年10月1日,Sara Reardon。仅引用开头一小段供了解文章,版权归原刊所有,全文请阅读原刊。

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