电子知情同意在药物临床试验中的可行性探讨  

Discussion on feasibility of electronic informed consent in drug clinical trials

作　　者：廖娟[1] 唐红[1] LIAO Juan;TANG Hong(Center of Infectious Diseases,West China Hospital of Sichuan University,Chengdu 610041,China)

机构地区：[1]四川大学华西医院感染性疾病中心,四川成都610041

出　　处：《药物评价研究》2021年第7期1568-1572,共5页Drug Evaluation Research

摘　　要：随着科技的发展,电子化信息技术已深入到当今社会的方方面面。电子知情同意是适应临床试验信息化发展趋势的一种有效知情方式,我国在此领域还处于起步阶段。2020年,由于新型冠状病毒肺炎(COVID-19)疫情,对药物临床试验电子知情同意的需求尤为突出。结合自身的工作经验,浅析传统知情同意过程中存在的问题及电子知情同意在我国目前应用的现状,探讨电子知情同意在药物临床试验中运行的可行性。With the development of science and technology,electronic information technology has penetrated into many aspects of society now.Electronic informed consent is an effective way to adapt to development clinical trial.China is still at an early stage in this field.Affected by the outbreak of COVID-19 in 2020,the demand for electronic informed consent in clinical trial has become more urgent.Based on my own work experience,the author wants to analyze the problems in the traditional informed consent process and the current situations of electronic informed consent in China and explores the feasibility of electronic informed consent in clinical trials.

关 键 词：电子知情同意 药物临床试验 新型冠状病毒肺炎 可行性 

分 类 号：R969.4[医药卫生—药理学]