临床研究中多种电子知情同意模式比较分析  

Comparative analysis of multiple models of electronic informed consent in clinical research

作　　者：左旭 李悦[1] 黄樱硕[1] Zuo Xu;Li Yue;Huang Yingshuo(Department of Science and Technology,Beijing Friendship Hospital,Capital Medical University,Beijing 100050,China)

机构地区：[1]首都医科大学附属北京友谊医院科技处,100050

出　　处：《中华医学科研管理杂志》2023年第3期194-199,共6页Chinese Journal of Medical Science Research Management

基　　金：北京友谊医院科研启动基金(yyqdktgl2021-5)。

摘　　要：目的:为临床研究中电子知情同意的选择和推广提供决策支持,为更好地保护受试者权益、促进临床研究质量和效率提升奠定理论基础。方法:本文学习了电子知情同意相关法律法规,分析临床研究中应用电子知情同意的优势与挑战。梳理目前国内临床研究中几种主要电子知情同意模式,分析其操作流程和应用情况,讨论其优势及局限性。结果:目前国内临床研究中主要使用3种模式的电子知情同意,它们在操作方便性、数据安全性、受试者隐私保护程度、成本投入及可推广程度等方面呈现出各自的优势和局限性。结论:无论是何种模式的电子知情同意,需要相关法规和制度的不断完善,需要临床研究各个利益相关方共同的努力。申办方和研究者需充分考虑到成本、安全性、可行性等,根据自身需求进行选择。Objective To provide decision-making support for electronic informed consent selection and promotion in clinical research,and lay a possible theoretical foundation for better protection of subjects′rights and interests,as well as promotion of clinical research quality and efficiency.Methods This paper summarized the relevant laws and regulations of electronic informed consent,analyzed the advantages and challenges of the application of electronic informed consent in clinical research,sorted out several common electronic informed consent modes in domestic clinical research,explored their operational processes and applications,and discussed their advantages and limitations.Results At present,three electronic informed consent modes were mainly used in domestic clinical studies.Each had their own advantages and limitations in terms of convenience of operation,data security,privacy protection of subjects,cost input,popularization degree and so on.Conclusions Electronic informed consent needs continuing improvement of relevant laws and regulations and the joint efforts of all stakeholders engaged in clinical research.The sponsor and the researcher should take full consideration of the cost,safety,security,feasibility,and ofters,and make the selection according to the actual needs of the research.

关 键 词：临床研究 电子知情同意 比较分析 

分 类 号：R-052[医药卫生]