摘要
临床研究中的伦理问题日益受到关注,从课题申报、临床试验注册到科研论文发表等,都始终贯穿着伦理问题。本文将从中国医学伦理发展、临床研究伦理法律法规制定、医学伦理委员会国际认证、中医临床研究伦理的特点及中医药研究伦理审查体系认证等方面来阐述中国临床研究伦理的发展与变革。
Ethical issues in clinical research are receiving increasing attention. The application of research projects, the registration of clinical trials and the publication of scientific researches have always been involved with ethical issues. This paper elaborates ethical development and changes in Chinese clinical research from the aspects of the development of medical ethics, the establishment of ethics laws and regulations, international certification of medical ethics committee, the advantages, challenges, opportunities and innovation and development of TCM clinical research ethics as well as the certification system of TCM research ethics.
作者
王辉
陈静
李幼平
张永刚
喻佳洁
吴泰相
卞兆祥
商洪才
WANG Hui;CHEN Jing;LI Youping;ZHANG Yonggang;YU Jiajie;WU Taixiang;BIAN Zhaoxiang;SHANG Hongcai(Tianjin University of Traditional Chinese Medicine,Tianjin,300193,P.R.China;Chinese Evidence-based Medicine Center,West China Hospital,Sichuan University,Chengdu,610041,P.R.China;School of Chinese Medicine,Hong Kong Baptist University,Hong Kong,999077,P.R.China;Dongzhimen Hospital,Beijing University of Chinese Medicine,Beijing,100700,P.R.China)
出处
《中国循证医学杂志》
CSCD
北大核心
2018年第8期769-775,共7页
Chinese Journal of Evidence-based Medicine
关键词
中国
临床研究
伦理
发展
变革
China
Clinical research
Ethics
Development
Reform
