临床研究科研项目伦理审查工作实践与问题探讨——以浙江中医药大学附属第一医院为例

Discussion on the Practice and Problems of Ethical Review of Clinical Scientific Research Projects: Take the First Affiliated Hospital of Zhejiang Chinese Medical University as an example

结合浙江中医药大学附属第一医院伦理委员会实际工作情况,根据现行版标准操作规程,从临床科研项目的伦理审查的流程、审查方式及目前亟待解决的问题进行了分析,提出了加强科研管理部门和医院伦理委员会的监管力度,提高研究者自身的伦理意识,全面开展院内普及性及专业性的伦理培训,完善科研项目持续审查机制四个方面的对策,在实践中指导临床科研项目伦理审查工作在规范、有序的环境下进行。

Based on the actual work of the ethics committee of the first affiliated hospital of Zhejiang Chinese Medical University and according to the current edition of the standard operating procedures, this paper analyzed the process, mode and problems to be solved of ethical review of clinical scientific research projects at present. Meanwhile, this paper put forward four countermeasures to strengthen the supervision of scientific research management departments and hospital ethics committees, to enhance the ethical awareness of researchers themselves, to carry out all-round ethical training for universality and professionalism in hospitals, and to improve the mechanism of continuous review mechanism of scientific research projects.So as to guide the ethical review of clinical scientific research projects in a standardized and orderly environment in practice.