Analysis of problems and countermeasures faced by the ethics committee in the context of the 2020 version Good Clinical Practice

VernacularTitle:新版药物临床试验质量管理规范视野下伦理委员会面临的问题分析及对策
Author: Shu WANG ¹ ; Ruxin ZHANG
Author Information

1. 晋中市第一人民医院　030600
Keywords: Good Clinical Practice; Institutional Review Board(IRB); Ethical review
From: Chinese Journal of Medical Science Research Management 2021;34(3):167-171
CountryChina
Language:Chinese
Abstract: Objective:According to the requirements set forth by the " regulations on the management of drug clinical trial institutions" and the 2020 version of Good Clinical Practice, problems faced by the construction of Institutional Review Board (hereinafter referred to as the IRB) in the implementation of the filing system is solved.Methods:According to the study of laws and regulations, combined with problem analysis during the early construction of IRB, problems during the IRB filing are identified and analyzed.Results:The IRB faced many problems that including the organizational structure, continuing review, informed consent and multicenter ethical review. We can gradually improve the ability of ethical review through continuous in-depth study of relevant laws and regulations, so as to ensure the scientific validity and ethical acceptability of drug clinical trials.Conclusions:It is of great significance for the high-quality development of IRB to improve its organizational structure, optimize its review mechanism and improve its review efficiency.