摘要
本文从我国伦理审查中存在伦理委员会组织机构建设不断加强、工作制度不断完善和审查能力逐步提高的现状入手,分析我国伦理委员会目前存在的主要问题,包括伦理委员会难以保证独立性、公正性和科学性的审查能力,薄弱的监督管理环节和抓不住伦理审查的重点内容等。提出进一步完善伦理委员会的监督管理以加强伦理委员会监管,强化委员的伦理培训,聘用独立顾问或建立独立顾问库,结合我国国情建立区域性的伦理委员会和参加国际伦理认证等对策以解决目前临床研究伦理审查中存在的问题。以逐步规范我国伦理委员会的建设和发展,保证临床研究伦理审查的独立性、公正性、科学性和统一性。
This article analyzes current situations of the ethics committee in our country,such as the continuously strengthened ability of ethics committee organization construction,constantly improved the work system perfect and the increased ethical review ability. There are still some problems in ethics committee including difficult to guarantee the independence,impartiality and scientific review ability of ethics committee,weak supervision,and unable to grasp the key content of ethical review.There are several suggestions for solving current problems as follows: to further improve the ethics committee supervision and training ethics members; to hire independent consultants; to establish a regional ethics committee according to Chinese national conditions; to participate in international ethical certification. The gradual standardization of the construction and development of the ethics committee will ensure the independence,impartiality,scientificalnessand unity of the ethical review for clinical research.
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2017年第4期365-368,共4页
The Chinese Journal of Clinical Pharmacology
基金
国家自然科学基金面上基金资助项目(81471040)
关键词
临床研究
伦理委员会
伦理审查
现状
对策
clinical research
ethics committee
ethical review
current situation
countermeasure