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天津市三级医院伦理审查效率及实行伦理审查互认可行性的调查分析 被引量:2

Investigation and analysis on the efficiency of ethical review and the feasibility of implementing mutual recognition of ethical review in tertiary hospitals in Tianjin
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摘要 目的通过对天津市三级医院伦理委员会的基本运行和审查效率等情况进行调查分析,探索天津市三级医院实行伦理审查互认的可行性。方法调查采用问卷星的形式,面向天津市三级医院进行线上调查。主要调查内容为2019—2022年伦理委员会的基本运行与审查情况、伦理审查效率和临床研究管理部门的管理效率、及医院对实行伦理审查互认的态度。调查回收有效问卷29份,最终选取28家调查结果进行统计分析。结果天津市28家三级医院中有16家平均每个月召开一次伦理审查会议,9家实现伦理前置审核;3家实现伦理审查结果互认;5家启用电子信息系统。2019—2021年初始审查的临床试验及IIT研究项目数均呈现上升趋势,多中心临床试验(90%)及多中心IIT研究(75%)的比例都很高。2019—2022年9月临床研究审查意见的效率为18.84~20.69天,临床研究审查批件效率为22.03~23.68天。2019—2022年9月临床试验管理效率为48.42~62.65天,IIT研究管理效率为25.54~28.17天。被调查者认为影响管理效率的主要因素来自于研究机构及申办者。大多数医院对推进伦理审查互认工作表示认可,并支持采用统一的文件递交清单及模板。结论天津市三级医院伦理委员会建设逐步规范;伦理审查效率和临床研究综合管理效率稳步提升,但仍有一定优化空间;各医院对于多中心临床研究伦理审查互认有较高的接受程度,在天津市实行伦理审查互认是完全可行的。 Objective This study aims to explore the feasibility of ethical review and mutual recognition,focusing on the operational efficiency and review processes of the Ethics Committees in Tianjin′s third-level hospitals.Methods A thorough online survey was conducted across tertiary hospitals in Tianjin,utilizing a detailed questionnaire.The survey primarily examined the operations and reviews of Ethics Committees from 2019 to 2022,evaluating the efficiency of ethical reviews,the effectiveness of clinical research administration,and the hospitals′perspectives on mutual recognition of ethical reviews.From 29 collected responses,28 were deemed suitable for in-depth statistical analysis.Results In Tianjin′s 28 surveyed tertiary hospitals,16 routinely hold ethics review meetings monthly.Nine hospitals have established pre-ethics review processes,and three have achieved mutual recognition of their ethical review outcomes.Additionally,five hospitals have integrated electronic information systems.From 2019 to 2021,there has been an increase in clinical trials and Investigator-Initiated Trials(IITs)under initial review,with a significant presence of multi-center clinical trials(90%)and multi-center IIT studies(75%).The timeframe for clinical research review opinions ranged from 18.84 to 20.69 days between 2019 and September 2022,while the duration for clinical research review approvals varied from 22.03 to 23.68 days.During the same period,clinical trial management efficiency spanned from 48.42 to 62.65 days,and IIT study management efficiency was between 25.54 to 28.17 days.Participants identified the main factors influencing management efficiency as stemming from research institutions and sponsors.The majority of hospitals expressed support for the advancement of mutual recognition of ethical reviews and the implementation of a unified submission checklist and template.Conclusions The Ethics Committees in Tianjin′s third-level hospitals have progressively evolved towards standardization.There is a marked improvement in the efficiency of ethical reviews and overall management of clinical research,indicating a positive development towards more streamlined and effective ethical governance in clinical studies.
作者 吴慧珍 张卓然 李晓玲 宋磊 崔桅 岳小林 Wu Huizhen;Zhang Zhuoran;Li Xiaoling;Song Lei;Cui Wei;Yue Xiaolin(Xuanwu Hospital Capital Medical University,Beijing 100053,China;Tianjin People′s Hospital,Tianjin 300121,China)
出处 《中华医学科研管理杂志》 2023年第6期433-438,共6页 Chinese Journal of Medical Science Research Management
基金 北京市卫生健康委员会"京津冀伦理审查互认探索"(京伦2022-4)。
关键词 伦理委员会 伦理审查互认 伦理审查效率 伦理审查质量 Ethics committee Mutual recognition of ethical review Ethical review efficiency Ethical review quality
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