中医院伦理委员会运行管理及审查质量持续改进措施分析

Analysis of Continuous Improvement Measures for the Operation Management and Review Quality of Ethics Committee of Chinese Medicine Hospital

伦理委员会在临床研究全过程中对保护受试者的权益起着重要的作用。在医疗卫生机构临床研究项目申报和立项逐渐增多的实际情况下,中医院伦理委员会需要明确自身职责,通过完善管理制度,按照国际国内的相关法律法规,不断修订完善标准操作规程,使伦理委员会的运行管理各方面有章可循。高质量伦理审查是提高伦理审查效率的前提。伦理委员会通过定期的自我质量评估,提出持续质量改进计划,并切实监督执行。伦理委员会通过接受上级部门的监督检查或独立的第三方评估,可以对自身的运行管理和项目的审查质量等进行全方位的综合评价。伦理委员会运行管理及审查质量的持续改进,还需要得到医疗卫生机构在人员配置、资金支持、存档空间、软件系统等多方面的支持。同时,伦理办公室在日常工作中,需要与项目实施者及药物临床试验机构(GCP)办公室、科研处科研项目的行政管理部门进行有效的沟通交流,不断提高伦理跟踪审查的力度和执行力。

The Ethics Committee(EC)plays an important role in protecting the rights and interests of subjects throughout clinical research.In the actual situation that the application and establishment of clinical research projects in medical and health institutions are gradually increasing,the EC should clarify its own responsibilities,through improving the management system.In accordance with the relevant international and domestic laws and regulations,constantly revise and improve the standard operating procedures,so that the EC operation and management of all aspects of the rules.High-quality ethical review is the prerequisite of the improvement of the ethical review efficiency.The EC proposed continuous quality improvement plans through regular self-quality assessments,and effectively monitors implementation.By accepting the supervision and inspection of the superior department or the independent third-party evaluation,the EC can comprehensively evaluate its own operation management and the quality of the project review.The continuous improvement of the management and review quality of the EC also needs the support of medical institutions in staffing,financial support,archiving space,software systems and so on.Meanwhile,in the daily work,the EC office needs to communicate effectively with the project implementer and the GCP office and the scientific research department,so as to continuously improve the strength and execution of the ethics tracking review.