示范性研究型病房建设中的伦理委员会工作探索

Exploration on the practice of Institutional Review Boards in the construction of demonstration research ward in Beijing

为提升全市临床研究能力,提高临床研究质量,增强医药健康产业高质量发展的溢出效应,2020年北京市推行示范性研究型病房建设并从工作机制和受试者保护方面对伦理委员会工作提出了需求。作为研究型病房建设的服务支撑,伦理委员会应在推进多中心临床研究伦理审查结果互认、加强受试者招募管理上积极探索,持续改进。

In order to enhance Beijing’s clinical research capabilities,improve the quality of clinical research,and enhance the spillover effect of the high-quality development of the pharmaceutical and health industry.In 2020,Beijing promoted the construction of demonstration research wards,and put forward requirements for the working mechanism of Institutional Review Boards (IRBs) and the practice of subject protection.IRBs,as services supporting for the construction of research ward,should be committed to promoting mutual recognition of Ethical Review on multi-center clinical research,and reinforcing the management of subject recruitment,which needs to improve continuously.