医学教育管理 ›› 2017, Vol. 3 ›› Issue (6): 452-457.doi: 10.3969/j.issn.2096-045X.2017.06.012

• 临床科研 • 上一篇    下一篇

临床科研项目伦理管理中的问题与对策

张卓然1,李小莹1,李晓玲2 ,王香平3   

  1. 1. 首都医科大学宣武医院医务处,北京 100053;2. 首都医科大学宣武医院药剂科,北京 100053;3. 首都医科大学宣武医院伦理委员会,北京 100053
  • 收稿日期:2017-11-14 出版日期:2017-12-20
  • 通讯作者: 王香平

Problems and countermeasures in the ethical management of clinical research

Zhang Zhuoran1, Li Xiaoying1, Li Xiaoling2, Wang Xiangping3   

  1. 1. Medical Administration Division, Xuanwu Hospital, Capital Medical University, Beijing 100053, China; 2. Department of Pharmacy, Xuanwu Hospital, Capital Medical University, Beijing 100053, China; 3. Ethics Committee, Xuanwu Hospital, Capital Medical University, Beijing 100053, China
  • Received:2017-11-14 Online:2017-12-20
  • Contact: Wang Xiangping

摘要: 伦理审查是临床科研项目伦理管理的主要手段。本文通过分析科研项目各阶段伦理审查中的常见问题,提出了联动相关部门、施行“四审制”、加强研究者培训的解决对策,旨在提高科研伦理的质量,提升临床研究受试者的保护水平。

Abstract: Ethical reviewis the main means of ethical management for clinical research.Thispaper analyzedthe problems of each phase of ethical review for clinical research,and put forward the corresponding countermeasures, including the cooperation of relevant departments, the implementation of four-level system of ethical review, strengthening training for investigators. It aimed to improve the quality of ethical review for clinical research and to enhance the level of protection of subjects.