研究者发起的临床研究中知情同意书签署情况现状分析  

Analysis of problems related to informed consent in investigator-initiated clinical researches

作　　者：李会娟[1] 宋玫 王美容[1] 王岩 武阳丰[1] LI Hui-juan;SONG Mei;WANG Mei-rong;WANG Yan;WU Yang-feng(Peking University Clinical Research Institute,Beijing 100191,China;Beijing Municipal Health Commission,Beijing 100053,China)

机构地区：[1]北京大学临床研究所,北京100191 [2]北京市卫生健康委员会,北京100053

出　　处：《中国新药杂志》2019年第20期2529-2532,共4页Chinese Journal of New Drugs

基　　金：首都卫生发展科研专项(首发2018-管-01)

摘　　要：目的:拟分析研究者发起的临床研究中存在的知情同意书签署问题。方法:对北京市2016年立项的所有三甲医院首发专项(capital’s fund for health improvement and research,CFH)资助的临床研究项目进行了核查,对出现的所有知情同意问题进行归类判定。结果:本研究纳入的临床研究项目共计198项,出现知情同意签署问题的项目数为86项(43.4%)。其中,未签署知情同意书的项目49项(24.8%),签署不规范的项目65项(32.8%),两类问题都存在的项目数为28项(14.1%)。所有随机对照临床试验(RCT)均设计了知情同意书,13.1%其他类型研究缺乏知情同意书,但RCT研究其他签署细节问题更严重(47.2%vs27.6%,P<0.05)。结论:研究者发起的临床研究中,知情同意书签署问题较多,需引起相关部门的足够重视,加强立法和人员培训等。Objective:To analyze the problems related to informed consent in investigators-initiated clinical researches.Methods:This study checked the clinical research projects funded by capital’s fund for health improvement and research(CFH)approved in 2016 in all 3 A hospitals in Beijing.All informed consent-related problems were classified and analyzed.Results:A total of 198 clinical research projects were included in this study.Among all the projects,86(43.4%)had problems related to informed consent,including 49(24.8%)without informed consent,65(32.8%)with ill-formed informed consent,and 28(14.1%)with both problems.Informed consents were designed in all randomized controlled clinical trials(RCTs),while 13.1%of other types of researches lacked informed consent.But other problems about signing details of informed consents were more frequent for RCTs(47.2%vs 27.6%,P<0.05).Conclusion:There are many problems in the informed consent in investigatorinitiated clinical researches.It is necessary to attract sufficient attention from relevant departments and strengthen legislation and personnel training.

关 键 词：临床研究 知情同意 受试者保护 首发专项 

分 类 号：R95[医药卫生—药学]