【摘要】 为适应创新药物器械临床试验需求,提高多中心临床试验的伦理审查效率,中国目前正在鼓励和推进中心伦理委员会审查工作。但对于中心伦理委员会具体审查模式,国内还在实践中摸索。梳理了几个国家和地区中心伦理审查的主流审查模式,为中国的多中心临床试验开展提供参考:简单地参照其他国家或地区的伦理审查模式是不合适的,只有加强伦理审查人员的意识、提高伦理审查能力,培养专业的伦理从业人员,按照学科建设临床研究的伦理委员会,才能真正使受试者的保护进入一个新的阶段。更多还原

【Abstract】 In order to meet the needs of innovative clinical trials of drug devices and improve the efficiency of ethical review in multi-center clinical trials, China is currently encouraging and promoting the review by the central ethics committee.However, the specific review mode of the central ethics committee is still being explored in practice in China.This paper reviewed the main review mode of some countries and regions central ethics, and provided a reference for the development of multi-center clinical trials in China. It was still inappropriate to simply refer to the ethical review mode of other countries and regions.Only by strengthening the awareness of ethical reviewers, improving the ability of ethical review, cultivating professional ethical practitioners and building ethical committees for clinical research in accordance with disciplines, can the protection of subjects really enter a new stage.更多还原