不切实际的可行性:随机对照试验的中期回顾

Roma Dhamanaskar, W. Feldman, J. Merz
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引用次数: 1

摘要

不可行性是研究中放弃知情同意的伦理标准。我们在一组36个已完成的随机对照试验(RCTs)中检验了不可行的标准在多大程度上得到了满足,这些试验获得了一些受试者或LARs的同意,并使用了豁免来招募其他人。这些试验是在155项随机对照试验中确定的,这些随机对照试验使用了从7个系统评价中抽取的方便样本的同意弃权。36项试验中有19项的招募数据可用,显示平均41.6%的受试者(范围0.2-98.7%,95% CI: 24.8-58.4%)未经同意入组。6项试验在未经同意的情况下招募了不到10%的受试者,9项重叠试验在某些地点寻求所有受试者或LARs的同意,而在其他地点放弃同意。我们质疑这些试验在没有豁免的情况下是否可行,并确定供研究者和伦理审查委员会考虑的问题。
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Practicalities of Impracticability: An Interim Review of Randomized Controlled Trials
Impracticability is an ethical standard for waiver of informed consent in research. We examine how well the criterion of impracticability appears to have been fulfilled in a set of 36 completed randomized controlled trials (RCTs) that secured consent from some subjects or LARs and employed waivers to enroll others. These trials were identified among 155 RCTs using waivers of consent in a convenience sample drawn from 7 systematic reviews. Recruitment data were available for 19 of the 36 trials, revealing an average of 41.6% of subjects (range 0.2–98.7%, 95% CI: 24.8–58.4%) were enrolled without consent. Six trials enrolled less than 10% of subjects without consent and an overlapping set of 9 trials sought consent from all subjects or LARs at some sites while waiving consent at other sites. We question whether these trials were practicable without waivers and identify issues for consideration by investigators and ethics review boards.
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来源期刊
CiteScore
3.50
自引率
7.70%
发文量
30
审稿时长
>12 weeks
期刊介绍: The Journal of Empirical Research on Human Research Ethics (JERHRE) is the only journal in the field of human research ethics dedicated exclusively to empirical research. Empirical knowledge translates ethical principles into procedures appropriate to specific cultures, contexts, and research topics. The journal''s distinguished editorial and advisory board brings a range of expertise and international perspective to provide high-quality double-blind peer-reviewed original articles.
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