Practicalities of Impracticability: An Interim Review of Randomized Controlled Trials

Roma Dhamanaskar, W. Feldman, J. Merz
{"title":"Practicalities of Impracticability: An Interim Review of Randomized Controlled Trials","authors":"Roma Dhamanaskar, W. Feldman, J. Merz","doi":"10.1177/15562646221092663","DOIUrl":null,"url":null,"abstract":"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.","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":"17 1","pages":"329 - 345"},"PeriodicalIF":1.7000,"publicationDate":"2022-04-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"1","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Empirical Research on Human Research Ethics","FirstCategoryId":"98","ListUrlMain":"https://doi.org/10.1177/15562646221092663","RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"ETHICS","Score":null,"Total":0}
引用次数: 1

Abstract

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.
查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
不切实际的可行性:随机对照试验的中期回顾
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。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 去求助
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.
期刊最新文献
Ready, Set, Sort! A User-Guide to Card Sorts for Community-Engaged Empirical Bioethics. Understanding of Key Considerations for Effective Community Engagement in Genetics and Genomics Research: A Qualitative Study of the Perspectives of Research Ethics Committee Members and National Research Regulators in a low Resource Setting. Vulnerable Research Participant Policies at U.S. Academic Institutions. Considerations for the Design of Informed Consent in Digital Health Research: Participant Perspectives. Public Perspectives on Consent for and Governance of Biobanking in Japan.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1