摘要
在全球新型冠状病毒肺炎疫情的背景下,电子知情同意书应用为临床试验的知情同意提供了一种新的方法和思路。它有着便捷、高效等优点,极大提高了临床试验的入组效率。目前国内对于这一概念还未提出明确的定义,但国外已有明确概念。已有国家展开了多种试验、制定了多方面的法规,进一步规范化了电子知情同意书。本文基于国内对于电子知情同意书的现状,分析电子知情同意书的设计和实施相关环节,总结国内外相关法律法规,提出电子知情同意书的机遇和挑战及我国实施该技术需要做的相关准备。
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.
作者
董昱
覃龙
吴卫平
唐纯志
龙文杰
杨忠奇
凌莉
陆丽明
无
DONG Yu;QIN Long;WU Weiping;TANG Chunzhi;LONG Wenjie;YANG Zhongqi;LING Li;LU Liming;无(Medical College of Acu-Moxi and Rehabilitation,Guangzhou University of Chinese Medicine,Guangzhou 510000,P.R.China;School of Public Health,Sun Yet-Sen University,Guangzhou 510000,P.R.China;Eclincloud(Shenzhen)Technology Co.,Ltd,Shenzhen 518038,P.R.China;South China Research Center for Acupuncture and Moxibustion,Clinical Research and Data Center,Guangzhou University of Chinese Medicine,Guangzhou 510000,P.R.China;Department of Gerontology Department of Clinical Research,The First Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangzhou 510000,P.R.China;The First Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangzhou 510000,P.R.China;Committee of Clinical Evaluation of Transitional Clinical Trial;Chinese Pharm Aceutical Association)
出处
《中国循证医学杂志》
CSCD
北大核心
2021年第7期851-857,共7页
Chinese Journal of Evidence-based Medicine
基金
国家科技重大专项“重大新药创制”项目(编号:2018ZX09734003)
广州中医药大学青年科研培育项目(编号:2019QNPY02)
2020年度广东省普通高校重点领域专项(新一代信息技术)(编号:2020ZDZX3024)。
关键词
电子知情同意书
临床试验
伦理委员会
隐私保护
法律法规
Electronic informed consent
Clinical trial
Ethics committee
Privacy protection
Law and regulation
