What Is “Key Information”? Consideration of the Reasons People Do or Do Not Take Part in Research

Q2 Social Sciences Ethics & human research Pub Date : 2024-04-17 DOI:10.1002/eahr.500210
Kara Berwanger, Jon F. Merz
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引用次数: 0

Abstract

We performed a qualitative review of 50 consent forms posted on Clinicaltrials.gov, examining the content of key information sections. We found that key information disclosures are typically focused on procedures, risks, potential benefits, and alternatives. Drawing upon reviews of the large literature examining the reasons people do or do not take part in research, we propose that these disclosures should be based more directly on what we know to be the real reasons why people choose to take part or refuse participation. We propose key information language for consideration by researchers and institutional review boards.

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什么是 "关键信息"?考虑人们参与或不参与研究的原因
我们对 Clinicaltrials.gov 上发布的 50 份同意书进行了定性审查,检查了关键信息部分的内容。我们发现,关键信息披露的重点通常是程序、风险、潜在益处和替代方案。通过查阅大量研究人们参与或不参与研究的原因的文献,我们建议这些信息披露应更直接地基于我们所知的人们选择参与或拒绝参与研究的真正原因。我们提出了关键信息语言,供研究人员和机构审查委员会参考。
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来源期刊
Ethics & human research
Ethics & human research Social Sciences-Health (social science)
CiteScore
2.90
自引率
0.00%
发文量
35
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