摘要
保护受试者的权益是临床研究机构的责任。针对临床研究项目的全流程监管,构建适合医院的人类研究保护体系,可以逐步提高临床研究伦理审查的质量,为参加临床研究的受试者和潜在受试者提供更全面的保护措施,将受试者保护贯穿于临床研究全过程。结合中医药临床研究及伦理审查的特点,介绍了突出中医药特色人类研究保护体系的构建。同时,系统分析了人类研究保护体系内各委员会及部门的分工职责与沟通合作,以保障整个人类研究保护体系的有效运行,提高中医药临床研究的质量以及人类研究保护体系的水平,达到促进临床研究健康、有序、科学发展的目标。
It is the responsibility of a clinical research institution to protect the rights and interests of research subjects.For the full process supervision of clinical research projects,the construction of a Human Research Protection Program(HRPP)which is suitable to the hospital's situation can gradually improve the ethical review quality,and provide comprehensive protection measures for participants and potential participants throughout the entire clinical research process.Combined with the characteristics of clinical research and ethical review of Traditional Chinese Medicine(TCM),this paper introduced the construction of an HRPP system that highlights TCM characteristics.At the same time,this paper systematically analyzed the division of responsibilities,communication and cooperation of different committees and departments within the HRPP system to ensure the effective operation of the entire HRPP system,improve the quality of TCM clinical research and the protection level of the HRPP system,in order to achieve the goal of promote the healthy,orderly and scientific development of clinical research.
作者
王晶
WANG Jing(Ethics Committee, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing 100010, China)
出处
《中国医学伦理学》
2022年第5期499-502,517,共5页
Chinese Medical Ethics
基金
北京市医院管理中心2021年北京市属医院科研培育计划项目“中医医联体模式下临床研究HRPP体系建设及效果评估”(PG2021019)
2021年度北京中医药大学教育科学研究课题“中医药临床专业学生科研伦理素养提升研究”(XJY21108)
北京市医院管理中心2018年度(第四批)“青苗”计划专项经费资助项目“基于中医医联体模式的市属中医院区域伦理委员会建设与研究”(QML20181004)。
关键词
人类研究保护体系
中医药
临床研究
伦理审查
Human Research Protection Program
Traditional Chinese Medicine
Clinical Research
Ethical Review
