主管:国家卫生健康委员会
主办:国家卫生健康委医院管理研究所
中国科技核心期刊(中国科技论文统计源期刊)
中国科学引文数据库(CSCD)核心库期刊
《中文核心期刊要目总览》核心期刊

中国护理管理 ›› 2023, Vol. 23 ›› Issue (9): 1431-1436.doi: 10.3969/j.issn.1672-1756.2023.09.029

• 综述 • 上一篇    下一篇

肿瘤临床试验受试者知情同意质量的研究进展

康斯寒 陆宇晗 庞冬 张杰   

  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,100142 北京市(康斯寒,陆宇晗);乳腺预防治疗中心(张杰);北京大学护理学院,北京大学医学部循证护理研究中心(庞冬)
  • 出版日期:2023-09-15 发布日期:2023-09-15
  • 通讯作者: 陆宇晗,硕士,主任护师,护理部主任,E-mail:lu_yuhan@sina.com
  • 作者简介:康斯寒,硕士在读

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

KANG Sihan, LU Yuhan, PANG Dong, ZHANG Jie   

  1. Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Nursing Department, Peking University Cancer Hospital & Institute, Beijing, 100142, China
  • Online:2023-09-15 Published:2023-09-15
  • Contact: E-mail:lu_yuhan@sina.com

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。

关键词: 肿瘤;临床试验;知情同意;护理;综述

Abstract: 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.

Key words: neoplasm; clinical trial; informed consent; nursing; review

中图分类号:  R47;R197