摘要
电子知情同意系统是电子化、智能化技术现代化发展的产物,在疫情防控背景下,它能够适应疫情防控的要求,具有跨时空优势。通过介绍电子知情同意系统的概念、呈现形式和使用情况等内容,分析电子知情同意系统所面临的接受度、理解、同意和信息安全等方面所面临的挑战。在此基础上提出应加强电子知情同意系统相关人员的培训,加强和完善电子知情同意系统的功能以及完善电子知情同意系统的相关法律法规等建议,以期为未来电子知情同意的研究和应用提供参考。
The electronic informed consent(eIC)system is a product of modernization development of electronic and intelligent technology.In the context of COVID-19,the eIC system can adapt to the epidemic prevention and control requirements,showing its time-space advantages.By introducing the concept,form and the use of eIC system,this paper analyzed the challenges of acceptance,understanding,consent and information security faced by the eIC system.Based on this,some suggestions were put forward,including strengthening the training of the relevant personnel involved in the eIC system,enhancing and improving the functions of the eIC system,and perfecting the relevant laws and regulations of the eIC system,so as to provide reference for the future research and application of eIC.
作者
谭心
王晓敏
卢晓然
刘星
TAN Xin;WANG Xiaomin;LU Xiaoran;LIU Xing(School of Literature and Journalism,Central South University,Changsha 410075,China;Center of Clinical Pharmacology/Research Center for Clinical Trial,the Third Xiangya Hospital of Central South University,Changsha 410013,China;Medical Ethics Committee,Xiangya Hospital of Central South University,Changsha 410008,China;Institute of Hospital Administration,Central South University,Changsha 410008,China)
出处
《中国医学伦理学》
2023年第1期11-16,共6页
Chinese Medical Ethics
关键词
电子知情同意系统
临床研究
伦理审查
电子签名
Electronic Informed Consent System
Clinical Research
Ethical Review
E-signature
