摘要
为配合医院开展干细胞临床研究机构及项目备案,武汉市中心医院伦理委员会对干细胞临床研究伦理审查工作做了相关的准备,并按照国家省市文件要求开展干细胞临床研究伦理审查工作。但在伦理委员会实际伦理审查工作运行中,存在干细胞供者知情同意告知、受试者风险告知不充分,伦理委员干细胞研究专业背景不够等问题。因此,在开展干细胞临床研究伦理审查过程中,应当调整伦理委员会组织架构,加强知情同意审查,落实跟踪审查责任,完善培训机制,以促进干细胞临床研究的开展。
In order to cooperate with the hospital to carry out stem cell clinical research institutions and project filing,the ethics committee of Wuhan Central Hospital made relevant preparations for the ethical review of stem cell clinical research and carried out ethical review of stem cell clinical research in accordance with the requirements of national and provincial documents.However,in the actual operation of the ethics review work of the ethics committee,there are problems,such as insufficient informed consent of stem cell donors,insufficient risk information of subjects,and lack of professional background of stem cell research of the ethics committee.Therefore,this paper believed that in the process of conducting ethical review of stem cell clinical research,the organizational structure of the ethics committee should be adjusted,the review of informed consent should be strengthened,follow-up review responsibility should be implemented,and the training mechanism should be improved to promote the development of stem cell clinical research.
作者
冯姝
黄磊
程雨蒙
张静
FENG Shu;HUANG Lei;CHENG Yumeng;ZHANG Jing(Department of Medical,the Central Hospital of Wuhan Affiliated to Tongji Medical College of Huazhong University of Science and Technology,Wuhan 430014,China;Ethics Committee,the Central Hospital of Wuhan Affiliated to Tongji Medical College of Huazhong University of Science and Technology,Wuhan 430014,China)
出处
《中国医学伦理学》
2021年第3期319-322,共4页
Chinese Medical Ethics
基金
2015年武汉市卫生健康委医学科研项目“武汉市级医院伦理委员会现状调查及建设构想”(WG15B07)资助。
关键词
公立医院
干细胞临床研究
伦理审查
伦理委员会
Public Hospitals
Stem Cell Clinical Research
Ethics Review
Ethics Committee
