人工智能在中医药临床研究中的应用及伦理审查考量

[中图分类号]R-052 [文献标志码]A [文章编号]1001-8565（2025）09-1227-06

DOI：10.12026/j.issn.1001-8565.2025.09.18

Applicationand ethical review considerations for artificial inteligence in clinical research of

traditionalChinesemedicine

WANG Jing

（Office ofEthics Commitee，Beijing Hospital ofTraditional Chinese Medicine，Capital Medical Uniersity， Beijing 100010，China）

Abstract： The application of artificial intelligence（AI） in theclinical diagnosisand treatment of traditional Chinese medicine（TCM） can promote the inteligent and modern development of TCM clinical diagnosis and treatment.Applying AI technology to scientific research in multiple aspects of TCM，such as ancient book research，new drug research，diagnostic research，and therapeutic eficacy evaluation，brings new opportunities and challenges to the research and development of TCM.AI is applied to the clinical research of TCM to optimize the design of research protocols and collct medical data information.In the ethical review process， when applying AI to TCM clinical research，attention should be paid to isues such as information leakage， algorithmic bias，algorithmic black boxes，training datasets，digital divide，informed consent，ethical awareness，and review supervision. Clinical research risks emerging from the rapid development of AI warrant attention，and solutions should be actively sought.

Keywords： clinical research；artificial inteligence；informed consent；ethical review

0引言

人工智能（artificial intelligence，AI）以计算机科学为基础，在最少的人为干预下使用计算机模拟、延伸、扩展、实现AI技术和方法，无需人工对每个步骤进行明确的编程。（剩余9946字）