医患双方视角下的电子知情同意在临床研究中的应用探析  

Analysis of the Application of Electronic Informed Consent in Clinical Research from the Perspective of Doctor and Patient

作　　者：张如意 韩杰 周运翱 彭迎春[3] ZHANG Ruyi;HAN Jie;ZHOU Yunao;PENG Yingchun(Ethics Committee Office of Beijing Ditan Hospital,Capital Medical University,Beijing,100015,China;不详)

机构地区：[1]首都医科大学附属北京地坛医院伦理委员会办公室,北京100015 [2]复旦大学附属上海市浦东医院科研部,上海201399 [3]首都医科大学医学人文学院,北京100069

出　　处：《中国社会医学杂志》2024年第6期762-766,共5页Chinese Journal of Social Medicine

基　　金：北京市医院管理中心培育计划项目(PG2020033);北京市教育委员会社科计划一般项目(SM202010025006);北京市卫生健康科技成果和适宜技术推广项目(BHTPP2022056)。

摘　　要：目的“互联网+医疗”给研究中心开展临床试验带来了新的机遇和挑战,探讨电子知情同意模式应用可行性路径,为促进“互联网+医疗”发展提供参考意见。方法通过目的抽样法在北京市和上海市对57名居民和52名医生进行半结构化个人访谈,采用主题框架法对访谈资料进行定性分析。结果医患双方对电子知情同意应用接受程度较高,34名居民(59.65%)和45名医生(86.54%)认为该模式可以促进临床研究的提质增效。同时也提出了电子知情存在风险挑战,41名居民(71.93%)和39名医生(75.00%)提出其应用范围有限;12名居民(21.05%)和27名医生(51.92%)担忧其应用的合规性;31名居民(54.39%)和27名医生(51.92%)表现出对个人隐私保护的信任度不足。结论多数调查对象认可电子知情同意实现了跨越时空招募,增强双方交流,为临床研究提质增效;然而,也指出电子知情同意面临着缺乏法规支持其合规性发展、适用场景和人群存在限制,其形式及体验感有待完善,个人隐私泄露风险增加等挑战。应从完善法律政策、评估应用场景、增强互联网技术、强化医疗机构伦理委员会审查等多层面着手,有效推动电子知情同意在临床研究中的规范应用及多方共赢。Objective"Internet+Medical"has brought new opportunities and challenges for research centers to carry out clinical trials.The traditional informed consent procedure has restricted the development of clinical research.The aim of this study was to explore the feasibility of the application of electronic informed consent model and provide reference for its development.Methods 57 residents and 52 doctors in Beijing and Shanghai were interviewed by objective sampling,and the data were analyzed qualitatively by thematic framework.Results Both physicians and patients showed a high acceptance of the application of electronic informed consent,with 34 residents and 45 doctors believing that it can improve the quality and efficiency of clinical research.At the same time,there were also identified risks and challenges associated with the use of electronic informed consent.41 residents and 39 doctors pointed out limitations in its scope of application,while 12 residents and 27 doctors expressed concerns about its compliance.Furthermore,31 residents and 27 doctors lacked confidence in the protection of personal privacy.Conclusion Both physicians and patients acknowledged that electronic informed consent facilitates the recruitment of participants across time and space,enhances communication between both parties,and improves the quality and efficiency of clinical research.However,it also faces challenges such as a lack of regulations to support its compliance,limitations in its applicability and target population,and potential risks of privacy breaches.In order to stan-dardize the application of electronic informed consent,it is necessary to address the issue from multiple aspects,such as improving legal policies,evaluating its application scenarios,enhancing internet technology,and strengthening the review of medical ethics committees.This will effectively promote the application of electronic informed consent in clinical research and achieve a win-win situation for all parties involved.

关 键 词：电子知情同意 临床研究 受试者保护 质性研究 

分 类 号：R197.323[医药卫生—卫生事业管理]