【摘要】 文章以一项多中心随机双盲中医临床试验伦理审批工作为背景,介绍医院的机构伦理委员会(IRB)和项目的数据与安全监察委员会(DSMB)的组成和职能;阐述本项目的伦理审批方式;推行动态伦理,在不同时期对项目的不同侧重点进行审查,初期审查侧重试验设计的科学性与合理性,着眼于研究方案等材料内容的制定,中期审查关注研究进度与研究质量,审核研究方案、病例报告表、知情同意书的优化,结题审查侧重项目的安全性和有效性,聚焦试验的活产率及严重不良事件,实现对项目全过程的监控。鉴于多分中心伦理审批工作的低效性和复杂性,建议采取以项目承办单位审批为主,其余分中心施行快速审查的方式,以减少时间成本,提高中医临床试验效率。更多还原

【Abstract】 Taking an ethical approval work for a multi-center randomized double-blind clinical trial as background, we introduced the composition and functions of the institutional review board and the data and safety monitoring board of the hospital. we elaborated the ethical approval method of the project and promoted the dynamic ethics, in which we emphasized different points in different phases. In the initial stage, the review should attach importance to the scientificity and rationality of the experimental design, focusing on the development of material content such as research programs. In the mid-term review, we should pay attention to the research progress and research quality, and strictly review the research program, case report form, informed consent. At the last, we should review the safety and effectiveness of the project, focus on live births and serious adverse events, and monitor the entire process of the project. Because of the inefficiency and complexity of ethical approval, we suggested to adopt the way in which the project will be mainly reviewed by the organizer and the remaining will be implemented a quick review in the branch center, in order to reduce the time cost and improve the efficiency of clinical trials in TCM.更多还原