OBJECTIVE: To explore the current operation model of the ethics committee of clinical trial, and discuss the direction of its construction and development. METHODS: The advantages and disadvantages of the institutional ethics committee and the regional ethics committee were analyzed through reviewing efficiency, reviewing standards and quality, investigating the implementation of projects and conflict of interest. The direction and suggestions were put forward for the construction and development of them. RESULTS & CONCLUSIONS: Usually, the institutional ethics committee could fully understand the specific implementation of the project, but there were some problems such as low efficiency, inconsistent review standard, low review quality and hard to avoid the conflict of interest. In contrast, the regional ethics committee review had high efficiency, consistent review standard, high review quality and can avoid conflicts of interest effectively, but it was hard to fully grasp the project implementation. Actually, the two kinds of ethical review mode still can not replace each other, but should play their respective advantages to complement each other. The institutional ethics committee should be constantly improved and perfected so as to supervise the normal development of clinical trials. However, the regional ethics committee should pay attention to the ethical review of special clinical trials, and focus on the construction and development of ethical committees in the region.
关键词
区域伦理委员会机构伦理委员会伦理审查优势与不足建设与发展
Keywords
Regional ethics committeeInstitutional ethics committeeEthical reviewAdvantages and disadvantagesConstruction and development