摘要
我国伦理审查能力相对薄弱的现状已难以完全满足医疗技术迅速发展及公众知情权的需求,伦理审查存在着伦理委员会的独立性无法得到有效保障、缺乏标准操作规程、持续监管缺失、缺乏信息反馈及伦理审查内容不规范等问题。反思我国伦理审查的现状,应从以下几个方面着手改进伦理审查监管体系:建立独立的伦理委员会、完善伦理审查法律法规体系、加强伦理审查委员会的跟踪审查、增强受试者的监督意识、加强伦理委员会成员的培训及规范伦理审查内容。
The status of Chinese ethical review ability has been difficuh to fully meet the demand of medical technol- ogy development and the public＇s right to know. The independence of the institutional review board cannot be effec- tively protected. Also, ethical review standards and specifications are lack of implementation and supervision. Ethical review content is nonstandard. Reflection on the status of the ethical review, the following aspects should be working to improve the ethical review supervision system： the establishment of an independent institutional review board, the im- provement of the legal system of ethical review and the training of members in institutional review board, strengthening institutional review board to supervision, encouraging subjects to supervise ethical review and standardizing ethical re- view content.
出处
《中国医药导报》
CAS
2014年第18期155-158,共4页
China Medical Herald
关键词
伦理审查
监管体系
伦理委员会
Ethical review
Supervision system
Institutional review board
