药物临床试验电子知情同意及受试者补助电子发放的实施探索  

Pilot study on implementation of electronic informed consent and electronic payment of subject compensation in drug clinical trials

作　　者：黄樱硕[1] 崔焱[2] 单姗[3] 赵连晖 左旭 马红[3] 尤红[3] 付小龙 郭子婕 卢鸣 董瑞华 贾继东[3] HUANG Ying-shuo;CUI Yan;SHAN Shan;ZHAO Lian-hui;ZUO Xu;MA Hong;YOU Hong;FU Xiao-long;GUO Zi-jie;LU Ming;DONG Rui-hua;JIA Ji-dong(Research Ward,Beijing Friendship Hospital,Capital Medical University,Beijing 100050,China;Biomedical Ethics Committee,Beijing Friendship Hospital,Capital Medical University,Beijing 100050,China;Liver Research Center,Beijing Friendship Hospital,Capital Medical University,Beijing Key Laboratory of Translational Medicine on Liver Cirrhosis,National Clinical Research Center for Digestive Diseases,Beijing 100050,China;China Brii Biosciences(Beijing)Co.,Limited,Beijing 100192,China;Beijing Tsinghua Industrial R&D Institute,Beijing 100084,China)

机构地区：[1]首都医科大学附属北京友谊医院研究型病房,北京100050 [2]首都医科大学附属北京友谊医院生命伦理委员会,北京100050 [3]首都医科大学附属北京友谊医院肝病中心,肝硬化转化医学北京市重点实验室,国家消化系统疾病临床医学研究中心,北京100050 [4]腾盛博药医药技术(北京)有限公司,北京100192 [5]北京清华工业开发研究院,北京100084

出　　处：《中国新药杂志》2021年第18期1698-1702,共5页Chinese Journal of New Drugs

基　　金：国家“重大新药创制”科技重大专项资助项目:消化系统炎性疾病新药临床评价技术平台建设(2018ZX09201016);肝病创新药物早期临床试验关键技术规范研究资助项目(Z191100007619037);北京市研究型病房建设示范单位项目(BCRW202010)。

摘　　要：目的:探索及评价电子知情同意(electronic informed consent)和受试者补助电子发放(electronic payment of subject compensation,简称2E)在新药临床试验中的应用情况。方法:在2项新药临床试验中应用2E技术。实施电子知情同意流程如下:在电脑端添加临床试验信息,受试者在个人手机端绑定注册,研究者进入临床项目后对该受试者进行电子知情,双方电子签名后生成电子知情同意书存档;实施受试者补助电子发放流程如下:受试者通过公众号绑定银行卡,临床研究协调员提交申请,研究者进行审核,系统管理员再次审核后发放补助。分别由工作人员和受试者对2E技术进行评价。结果:补助发放所需时间最短3 min,最长不超过24 h;工作人员和受试者对2E技术均给予好评。结论:2E技术可提高临床研究的速度和质量,使更多的受试者获益。Objective: To explore and evaluate the application of electronic informed consent and electronic payment of subject compensation(2 E) in clinical trials of innovative drugs. Methods: We conducted 2 E in two clinical trials of innovative drugs. The electronic informed consent process was conducted as: the investigators registered trial information on PC, the subjects completed registration via mobile phone, the investigator selected certain subject to finish electronic informed consent process, the subject and the investigator signed their electronic signatures, then the signed informed consent was archived in the system. The e-payment of subject compensation process was conducted as: the subjects uploaded their bank card information via official account of Wechat, the CRC submitted application, the investigator confirmed the compensation, then the system dispatched the compensation after re-verification. The 2 E technology was evaluated by the staffs and subjects respectively. Results: The compensation time has been shortened to a minimum of 3 minutes and a maximum of 24 hours. The staffs and the investigators all praised 2 E technology. Conclusion: 2 E technology can improve the efficiency and quality of clinical trials and benefit more subjects.

关 键 词：药物临床试验 电子知情同意 受试者补助电子发放 伦理 受试者权益 

分 类 号：R969.4[医药卫生—药理学]