健康发展与政策研究2024，Vol.27Issue(5)：390-395,409,7.DOI:10.12458/HDPR.202404066
我国与美国嵌合抗原受体T细胞疗法伦理审查法规对比及启示
Comparison and revelation of ethical review regulations for chimeric antigen receptor T cell therapy in China and the USA
摘要
Abstract
Objective To analyze and compare the regulations for ethical review of chimeric antigen receptor (CAR) T cell therapy in China and the USA,aiming to provide recommendations for improving the ethical review system for this therapy.Method Using the search term "CAR-T cell therapy",search for the relevant regulations,systems,and literature on governmental and medical association websites in China and the USA,as well as databases such as the CNKI,Wanfang,Weipu,SinoMed,PubMed,and Embase,and systematically summarized the findings.Results Key areas of focus in the ethical review of CAR-T cell therapy include the qualifications of research institutions,researchers,and third-party laboratories,informed consent,risk assessment and management,and vulnerable populations.Compared to the USA,China needs to enhance its ethics review system by establishing specific laws and regulations,developing comprehensive technical standards or guidelines covering the entire lifecycle of CAR-T cell therapy products,and refining ethical norms for these therapies.It is also crucial to support the development of cellular immunotherapy research at the national level to accelerate clinical investigation of these products.Conclusions Current regulations regarding the ethical review of CAR-T cell therapy in China are evolving rapidly.However,further refinement of ethical norms is needed to minimize risks and maximize benefits.关键词
嵌合抗原受体T细胞/伦理审查/法规Key words
chimeric antigen receptor T cell/ethical review/regulations分类
医药卫生引用本文复制引用
高雯,胡晓琳,孙红玉,张小丽,孙郡..我国与美国嵌合抗原受体T细胞疗法伦理审查法规对比及启示[J].健康发展与政策研究,2024,27(5):390-395,409,7.基金项目
山东省医药卫生科技发展计划(202203010420) （202203010420）
济南市卫生健康委员会科技计划(2023-1-34) （2023-1-34）
