电子知情同意的应用及推广

Q4 Medicine 中国循证医学杂志 Pub Date : 2021-01-01 DOI:10.7507/1672-2531.202102042

Y. Dong, L. Qin, W. Wu, C. Tang, W. Long, Z. Yang, L. Ling, L. Lu

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引用次数: 1

摘要

在COVID-19全球大流行的背景下，电子知情同意(eConsent)利用技术为临床试验提供了新的方法和思路。它具有方便快捷的优点，大大提高了临床试验的效率。目前国内还没有提出这一概念，而国外已经明确了这一概念，一些国家已经开展了各种试点，制定了各种法规，进一步规范eConsent。本研究基于eConsent在中国的现状，分析了eConsent的设计与实施，总结了国内外相关法律法规，提出了电子知情同意技术在中国实施的机遇与挑战以及相关准备工作。©2021华西医科大学。版权所有。

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The application and promotion of electronic informed consent

Under the background of the global COVID-19 pandemic, electronic informed consent (eConsent) utilizes technology to provide a new method and idea for clinical trials. It has the advantages of convenience and efficiency, which greatly improves the efficiency of clinical trials. At present, this concept has not been put forward in China while it has been clarified clearly abroad, and some countries have launched a variety of trials and formulated various regulations to further standardize the eConsent. Based on the current situation of eConsent in China, this study analyzed the design and implementation of eConsent, summarized relevant domestic and foreign laws and regulations, and proposed opportunities and challenges for electronic informed consent as well as the relevant preparations for the implementation of this technology in China. © 2021 West China University of Medical Science. All rights reserved.

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来源期刊

中国循证医学杂志 Medicine-Medicine (all)

CiteScore

0.50

自引率

0.00%

发文量

4677

期刊介绍： The Chinese Journal of Evidence-Based Medicine is the official Chinese language journal of the Cochrane China. The journal aims to present the newest research results and promote the international understanding and development of evidence-based medicine, including decision-making, research, practice, and education. Papers in any of the following fields will be considered: editorial, commentary, systematic review, clinical trial and register, methodology, policy-making and management, drug safety, education, patient safety, and knowledge translation. The journal encourages submissions from interdisciplinary studies and all manuscripts are blind peer reviewed.