协作审查模式下“年轻”伦理委员会面临的挑战

Challenges Faced by“Young”Ethics Committees under the Mode of Collaborative Review

在探索规范、高效的多中心药物临床试验伦理审查模式过程中,伦理审查联盟应运而生。相对于已较成熟的伦理委员会,协作审查模式对“年轻”伦理委员会提出了更高的要求。通过分析伦理审查联盟中“年轻”伦理委员会在审查工作中存在的问题,探讨提升“年轻”伦理委员会审查质量和促进联盟规范、高效运行的措施,为提升伦理审查均质化、加快创新药物临床研究进程提出对策和建议。

In the process of exploring standardized and efficient ethical review models for multi-center drug clinical trials,the ethical review alliance emerged as the times require.Compared with mature ethics committees,higher requirements have been put forward for the"young"ethics committees.By analyzing problems existing in review work of"young"ethics committees in the ethics review alliance,this paper discussed the measures to improve the review quality of"young"ethics committees and promote the standardized and efficient operation of the alliance,and put forward countermeasures and suggestions for improving the homogenization of ethics review and accelerating the clinical research process of innovative drugs.