上海市儿童生物医学研究知情同意执行情况调查  

Investigation on the Execution of Informed Consent in Biomedical Research for Children in Shanghai

作　　者：杨红荣[1,2] 唐燕 何蕾[1] 奚益群 Yang Hongrong(Children's Hospital of Shanghai Jiaotong University,Children,Hospital of Shanghai,Shanghai,200062)

机构地区：[1]上海市儿童医院,上海交通大学附属儿童医院,上海200062 [2]上海交通大学医学院儿科学院,上海200025

出　　处：《医学与社会》2020年第1期60-64,共5页Medicine and Society

基　　金：上海市医院协会医院管理研究基金2017年青年项目“涉及儿童的生物医学研究知情同意体系的构建”,编号为201702023

摘　　要：目的:分析上海市儿童生物医学研究知情同意的执行情况,为规范儿童生物医学的科学研究提供参考。方法:采用自编问卷对上海市伦理委员会、伦理委员和研究者进行儿童生物医学研究知情同意的执行情况调查。结果:知情同意是儿童生物医学研究伦理审查的关键内容之一,有33%的项目不能一次通过伦理审查,其中72.3%的项目属于知情同意不规范。伦理委员和研究者对儿童生物医学研究知情同意执行情况和关注角度不同。结论:应从伦理委员会、伦理委员、研究者三个方面充分保障受试者的权益,尽快完善儿童生物医学研究知情同意书的撰写标准,提高儿童生物医学研究知情同意质量。Objective:To analyze the execution of informed consent in biomedical research for children in Shanghai,and to provide reference for regulating children's biomedical research.Methods:Questionnaire survey was conducted to investigate the implementation of informed consent of children's biomedical research in Shanghai by ethics committees,ethical members and researchers.Results:In formed consent was the key to ethical review of biomedical research for children,33%of the projects could not pass the ethical review at one time,and 72.3%of the project's informed consent was not standardized.Ethics committees and researchers had different perspectives on the implementation of informed consent for children's biomedical research.Conclusion:The rights and interests of subjects should be fully protected from the ethics committee,ethical members and researchers.Improving the standards for the informed consent in biomedical research for children as soon as possible,so as to promote the level of informed consent forms for children's biomedical research.

关 键 词：生物医学研究 知情同意 伦理学 儿童 上海 

分 类 号：R197.31[医药卫生—卫生事业管理]