我国国家食品药品管理总局加入ICH-GCP对伦理委员会的要求

Requirement for Ethics Committee after China Food and Drug Administration Join ICH-GCP

目的概述我国CFDA加入ICH-GCP给伦理委员会建设带来的机遇、挑战和应采取的对策,为促进我国伦理委员会的规范化建设和审查能力提供参考。方法查阅国内有关CFDA加入ICH-GCP对伦理委员会建设要求的文献并综合分析。结果 CFDA加入ICH-GCP有利于加快我国伦理委员会的建设速度,针对伦理委员会规范化建设的挑战,可采用修订政策法规和指导原则以接轨ICH-GCP、建立符合国情的伦理认证体系、明确委员组成、规范操作程序、建立区域性伦理委员会和组长单位审查制;为提高审查能力,可从申办者职责、研究者资质、研究方案、知情同意书、研究者手册和文件资料管理方面强化审查要求。结论 CFDA加入ICH-GCP给伦理委员会带来快速的发展机遇也伴随着挑战,可从规范化建设和提升审查能力着手解决问题,以加快建设符合ICH-GCP要求的伦理委员会。

Objective： To summarize the opportunities, challenges and countermeasures that China Food and Drug Administration （CFDA） joining ICH -GCP will bring to the construction of ethics committee, so as to provide reference for the standardization construction and review ability of ethical committee in China. Methods： We reviewed and comprehensively analyzed the domestic literatures about the requirement for ethics committee after CF- DA join ICH - GCP. Results： CFDA joining ICH - GCP was conducive to speeding up the construction of Chinese ethics committee. Aiming at the challenge of the standardization construction of ethics committee, it could use the revised policy regulations and guidelines to integrate with ICH -GCP, establish ethics certification system in line with the national condition, clear the composition of members, standardize operational procedures, and establish regional ethics committee and leader the review of the unit system ; to improve the review ability, it could strengthen reviewing requirement from the aspects of sponsor responsibilities, researchers qualification, research protocols, in-formed consent, researcher brochures and documents management. Conclusion ： CFDA joining ICH - GCP brings a rapid development opportunity for the ethics committee as well as challenges. We can solve problems from stand-ardization construction and the improvement of review ability, to speed up the construction of ethics committee that meets the requirements of ICH -GCP.