肿瘤临床试验受试者知情同意质量的研究进展  

Research progress on the quality of informed consent of participants in cancer clinical trials

作　　者：康斯寒 陆宇晗[1] 庞冬[3] 张杰 KANG Sihan;LU Yuhan;PANG Dong;ZHANG Jie(Key Laboratory of Carcinogenesis and Translational Research(Ministry of Education/Beijing),Nursing Department,Peking University Cancer Hospital&Institute,Beijing,100142,China)

机构地区：[1]北京大学肿瘤医院暨北京市肿瘤防治研究所护理部,恶性肿瘤发病机制及转化研究教育部重点实验室,北京市100142 [2]北京大学肿瘤医院暨北京市肿瘤防治研究所乳腺预防治疗中心,恶性肿瘤发病机制及转化研究教育部重点实验室,北京市100142 [3]北京大学护理学院,北京大学医学部循证护理研究中心

出　　处：《中国护理管理》2023年第9期1431-1436,共6页Chinese Nursing Management

摘　　要：肿瘤临床试验是推动肿瘤治疗和学科发展的重要组成部分,其中知情同意是保护受试者权益和促进临床试验顺利进行的关键要素。文章从肿瘤临床试验知情同意的概念、知情同意质量评估工具、现状及影响因素4个方面综述国内外研究进展,以期引起医护人员对肿瘤临床试验受试者知情同意质量的关注,为进一步提升质量及开展相关研究提供参考。Cancer Clinical trials are an essential part of advancing oncology treatments and disciplines,where informed consent is a critical element in protecting the rights of participants and facilitating the smooth conduct of clinical trials.However,the quality of informed consent of domestic clinical trial participants is often neglected at present.In this article,we review the progress of domestic and international research on the concept of informed consent in cancer clinical trials,the tools for assessing the quality of informed consent,the current situation,and the influencing factors,in order to draw the attention of healthcare professionals to the quality of informed consent of subjects in cancer clinical trials and to provide a reference for further improving the quality of cancer clinical trials and conducting related research.

关 键 词：肿瘤 临床试验 知情同意 护理 综述 

分 类 号：R47[医药卫生—护理学] R197[医药卫生—临床医学]