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从医学伦理到临床转化OA

From medical ethics to clinical translation:insights from the Ethical Guidelines for Artificial Intelligence Research in Medical Imaging

中文摘要英文摘要

2026年8月,国家科技伦理委员会医学伦理分委员会发布《人工智能医学影像研究伦理指引》,为人工智能医学影像的算法研究、技术研发、临床验证和转化应用提供了伦理参考.本文聚焦诊断和辅助决策类研究,简介伦理审查的基本内容,并分析数据可信性、模型可信性对研究的影响,探讨技术进入临床应用后可能遇到的临床转化和性能漂移等潜在问题,同时关注责任可追溯、利益冲突管理等全流程管理中的协同治理问题.本文通过深入探讨如何将《指引》合理用于研究全流程管理,并使研究结论及转化范围与现有证据相匹配,从而为保护研究参与者和病人权益、推动负责任创新提供参考.

In August 2026,the Medical Ethics Subcommittee of the National Science and Technology Ethics Committee issued the Ethical Guidelines for Artificial Intelligence Research in Medical Imaging,providing ethical guidance for algorithm research,technology development,clinical validation,and translational application of artificial intelligence(AI)in medical imaging.Focusing on studies of diagnosis and decision support,this article briefly introduces the basic elements of ethical review,analyzes the effects of data trustworthiness and model trustworthiness on research,explores potential issues such as clinical translation and performance drift that may arise after technologies enter clinical application,and also addresses collaborative governance issues in whole-process management,including accountability and traceability and conflict-of-interest management.By examining how the Guidelines can be appropriately applied to whole-process research management,and how research conclusions and the scope of translation can be aligned with the available evidence,this article provides a reference for protecting the rights and interests of research participants and patients,and promoting responsible innovation.

刘英佳;刘学焕;刘筠

天津市医学科学技术信息研究所《国际医学放射学杂志》编辑部,天津 300070天津市人民医院(南开大学第一附属医院)放射科天津市第四中心医院放射科

医药卫生

人工智能医学影像医学伦理临床转化

Artificial intelligenceMedical imagingMedical ethicsClinical translation

《国际医学放射学杂志》 2026 (5)

497-505,9

国家自然科学基金项目(12174203)国家工信部高端医疗装备推广应用项目(2025TGYY27)天津市科技计划项目(2026KPXCRC00180)

10.19300/j.2026.A23276

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