关于京津冀医学伦理审查结果互认工作的探索与思考

—— 基于天津市三级医疗卫生机构的推进

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[关键词]多中心临床试验；伦理委员会；伦理审查结果互认；审查质量和效率 【中图分类号]R-052 [文献标志码]A [文章编号]1001-8565（2025）08-0989-07 DOI：10.12026/j.issn.1001-8565.2025.08.05

Exploration and reflection on the mutual recognition of medical ethical review results in the BeijingTianjin-Hebei region： based on the promotion of tertiary medical and health institutions in Tianjin SONG Lei1， ZHANG Wenxiao²，LI Bin³，XUE Chen²，CUI Wei1.2.4

（1.Medical Ethics Committee，Tianjin People's Hospital/the First Afliated Hospital of Nankai University， Tianjin 3Ool21， China;2. Ofice ofDrug Clinical Trial Institution，Tianjin People's Hospital/the First Affiliated Hospital ofNankai University，Tianjin 300l21，China;3.Office of the Dean，Tianjin People's Hospital/the FirstAffiliated Hospital ofNankai University，Tianjin 3OOl21，China;4.Professional Committeefor Clinical Trial Ethics Review，Tianjin Pharmaceutical Association，Tianjin 3OOO40，China）

Abstract： The construction of medical ethical review is the basic guarantee for strengthening the ethical goverance of medical science and technology，and mutual recognition of ethical review results serves as a pivotal approach to accelerate the construction of ethical review. This paper conducted a questionnaire survey on 3O tertiary medical and health institutions with clinical trial qualifications in Tianjin，based on the exploration of the implementation of the Notice on the Implementation of Mutual Recognition of Medical Ethics Review Results in the Beijing-Tianjin-Hebei Region jointly issued by the Health Committees of the three regions in Tianjin’s tertiary medical and health institutions.By investigating and analyzing the situation of clinical trials，ethics commitees，and mutual recognition from 2O2l to 2O23，the regular reasons afecting the promotion of mutual recognition of ethical review results in the Beijing-Tianjin-Hebei region were identified，and reasonable recommendations were proposed. These aimed to offer references for the Tianjin region in depening the integration of Beijing-Tianjin-Hebei development and accelerating thepromotion of regional ethical mutual recognition work，thereby advancing the construction anddevelopment ofmedical ethical review.

Keywords： multicenter clinical trial;ethical committee;mutual recognition of ethical review result; review quality and efficiency

随着科学技术的深度和广度不断增加，多中心、跨领域、跨学科的临床试验在新药研发项目中的比例也在逐年增长[1]。（剩余9460字）