摘要
受试者知情同意是医药学研究人体试验中最重要的伦理问题。通过分析某三甲医院2012-2019年期间进行伦理审查的项目,包括药物临床试验项目、器械临床试验项目和科研项目。以这些审查项目的知情同意书、伦理审查档案记录及资料为调查对象,通过知情同意的形式审查,会议审查和跟踪审查三个方面,调查该伦理委员会对涉及人的医药学研究的知情同意伦理审查的情况,统计相关数据进行分析,探讨审查中存在的问题。最终,提出加强伦理审查的制度建设、伦理委员会建设、对研究者的伦理培训以及伦理委员会监管机制的解决对策。
Informed consent of subjects is one of the most important ethical problems in medical research on human trials.Through the analysis of ethical review projects of one tertiary hospital from 2012 to 2019,including drug clinical trial projects,device clinical trial projects and scientific research projects,this study took the informed consent forms,ethical review file records and data of these review projects as investigation objects,through the three aspects of informed consent review,meeting review and follow-up review,to investigate the situation of the ethics committee’s ethical review of the informed consent of medical research involving people,to analyze the relevant data and explore the existence of review problems.Finally,the study put forward the countermeasures to strengthen the construction of the ethical review system,the construction of ethical committee,the ethical training for researchers and the supervision mechanism of ethical committee.
作者
杨舒珺
YANG Shujun(Office of Scientific Research,Second Hospital of Tianjin Medical University,Tianjin 300211,China)
出处
《中国医学伦理学》
2020年第12期1475-1479,共5页
Chinese Medical Ethics
关键词
医药学研究
伦理审查
伦理委员会
知情同意
Medicine and Drug Research
Ethical Review
Ethics Committee
Informed Consent
