中国临床试验参与者对电子知情同意的知识和态度:一项横断面研究。

IF 1.7 4区 哲学 Q2 ETHICS Journal of Empirical Research on Human Research Ethics Pub Date : 2022-07-01 Epub Date: 2022-01-28 DOI:10.1177/15562646221075884
Zhanqing Hu, Chenxi Ouyang, Jessica Hahne, Kaveh Khoshnood, Jinqiang Zhang, Xiyu Liu, Ying Wu, Xiaomin Wang
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引用次数: 0

摘要

本研究旨在探讨临床试验参与者和潜在参与者对电子知情同意的认知和态度。我们于2021年3月在中国湖南省进行了一项基于调查的横断面研究。本研究共纳入547名受访者。在评估参与者对电子知情同意知识的8项调查中,至少有70%的参与者正确回答了所有问题。在态度得分方面,大多数参与者(86.3%)认为电子知情同意比纸质知情同意书更方便,超过一半(51.2%)的受访者认为电子知情同意书可以完全取代纸质知情同意书。答复表明,关于电子知情同意的共同关切是其安全性和保密性、法律利益以及对权利保护的影响。
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Knowledge and Attitudes of Research Participants in China Toward Electronic Informed Consent in Clinical Trials: A Cross Sectional Study.

This study aims to investigate the knowledge and attitudes of participants and potential participants in clinical trials toward electronic informed consent. We conducted a survey-based cross-sectional study in Hunan Province, China in March 2021. A total of 547 respondents were included in this study. All questions in an 8-item survey section assessing participants' knowledge of electronic informed consent received correct answers from at least 70% of participants. In terms of attitude scores, most participants (86.3%) believed that electronic informed consent is more convenient than the paper-based version, and more than half (51.2%) believed that electronic informed consent could completely replace the paper-based version. Responses indicated that common concerns about electronic informed consent were its security and confidentiality, legal benefits, and implications for rights protection.

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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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