新形势下涉及人的生物医学研究伦理审查实践——以广东省中医院为例  

Practices of Ethical Review of Biomedical Research Involving Human Subjects: Taking Guangdong Provincial Hospital of Chinese Medicine as Example

作　　者：张茜[1] 蒋璐[1] 李晓彦[1] 梁伟雄[1] 刘军[1] 

机构地区：[1]广东省中医院伦理委员会办公室,广东广州510120

出　　处：《中国医学伦理学》2018年第3期335-337,351,共4页Chinese Medical Ethics

基　　金：国家科技重大专项-重大新药创制项目(2012ZX09303009-003);广东省财政厅专项([2014]157号);广东省中医院中医药科学技术研究专项(YN2015MS15)

摘　　要：根据广东省中医院伦理审查工作的实践,总结出如下经验:与时俱进,不断调整伦理委员会类型以适应医学研究的发展;接受国际国内的各项认证,以认证促建设;增强研究者伦理审查意识和受试者保护意识;对专业组/课题组进行有效的实地访查;多部门沟通协作,促进伦理审查工作的顺利开展等。通过上述实践,该院伦理委员会审查的数量和质量得到了很大的提升,期望该实践经验能够为其他机构的伦理委员会提供参考和借鉴。According the practice of ethical review work in Guangdong Provincial Hospital of Chinese Medicine,this article summarized the following experiences: It should keep pace with the times and constantly adjust the type of Ethics Committee to adapt to the development of medical research; accept international and domestic certification to promote construction by certification; enhance the researchers' consciousness of ethical review and the subjects' protection awareness; conduct effective sites visits to professional group or research group; communicate and collaborate among multi-disciplinary to promote the development of ethical review work and so on.Through the above practices,the quantity and quality of Ethics Committee's ethical review in the hospital had been improved greatly,and it is hoped that these practical experiences could provide reference for ethics committee in other institutions.

关 键 词：伦理委员会 生物医学研究 伦理审查 

分 类 号：R-052[医药卫生]