药物临床试验知情同意过程中的常见问题及对策  

The Common Problems and Countermeasures in the Process of Informed Consent of Drug Clinical Trials

作　　者：谢江川 郭薇 谢林利 李明红 潘辛梅 曹丽亚 陈勇川 XIE Jiangchuan;GUO Wei;XIE Linli;LI Minghong;PAN Xinmei;CAO Liya;CHEN Yongchuan(Department of Pharmacy,the First Affiliated Hospital of the Army Medical University,Chongqing 400038,China)

机构地区：[1]陆军军医大学第一附属医院药学部,重庆400038

出　　处：《中国医学伦理学》2021年第7期835-838,共4页Chinese Medical Ethics

基　　金：重庆市软科学研究计划“基于临床研究体系设计与实施的我市医药创新生态系统的构建”(cstc2018jsyj-zdcxX0079)。

摘　　要：药物临床试验是确定新药是否安全有效的重要环节,知情同意书是临床试验中保障受试者权益的重要文件。根据实际工作,结合临床试验项目知情同意书签署中存在的问题进行讨论。从知情同意书本身存在问题,以及申办方、研究者、伦理委员会、受试者在知情同意书签署时应该注意的问题进行分析。规范和改善知情同意中存在的问题,以期为临床实验的发展作出贡献。Drug clinical trial is an important link to determine whether a new drug is safe and effective.Informed consent is an important document to protect the rights and interests of subjects in clinical trial.Based on its own work and combined with clinical trials projects,this paper discussed the problems existing in the signing of informed consent and analyzed the problems existing in the informed consent form and the problems that bidders,researchers,ethics committee and subjects should pay attention to when signing the informed consent form.To standardize and improve the problems of informed consent signing in order to contribute to the development of clinical trials.

关 键 词：药物临床试验 知情同意 研究者 受试者 伦理委员会 

分 类 号：R-052[医药卫生]