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某传染病医院伦理协作审查机制的实践与探索

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多中心临床研究数量快速增长,对伦理审查质量和效率提出新的要求,伦理协作审查在多中心临床研究开展中发挥了重要的作用.为满足多中心临床研究开展需求,中心伦理审查、单一伦理审查、区域伦理委员会、伦理审查互认联盟等协作审查模式应运而生,然而这些审查模式依然面临监管责任不明确、审查标准不统一、机构间不易达成共识等多重挑战.本文介绍某传染病医院伦理协作审查机制运行情况,运用SWOT模型对其跨区域伦理互认联盟建设探索的优势、劣势、机会与威胁进行全面分析,并提出跨区域的专科伦理审查互认联盟发展策略.
The practice and exploration of ethical cooperation review mechanism in an infectious disease hospital
The number of multi-center clinical research is increasing rapidly,and ethical cooperation review plays an important role in the development of clinical research.In order to meet the rapid development of multi-center clinical research,the central ethical review,the single ethical review,the regional ethical committee,the ethical review mutual recognition alliance and other collaborative review models emerged;however,they still face multiple challenges,including unclear regulatory responsibilities,inconsistent review standards and difficulties in reaching consensus.This paper introduces the operation of the mechanism of ethical cooperation and review in an infectious disease hospital,and comprehensively analyzes on the advantages,disadvantages,opportunities and threats of the construction of inter-regional ethical mutual recognition alliance using SWOT analysis,putting forward the development strategy of inter-regional professional ethics review and mutual recognition alliance.

collaborative reviewquality and efficiencyspecialty allianceSWOT analysis

周运翱、张如意、杨志云

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首都医科大学附属北京地坛医院,北京 100015

协作审查 质量与效率 专科联盟 SWOT分析

2024

中国新药杂志
中国医药科技出版社 中国医药集团总公司 中国药学会

中国新药杂志

CSTPCD北大核心
影响因子:1.039
ISSN:1003-3734
年,卷(期):2024.33(23)