临床试验的伦理审查:医疗器械

国家对医疗器械实行分类管理,第一类医疗器械无需临床试验,第二类、第三类医疗器械生产注册之前应当通过临床试验(临床试用或临床验证)。医疗器械临床试验的伦理审查要点主要包括:试验的科学设计;试验的风险和受益评估,区分重大风险临床试验和非重大风险临床试验;知情同意;受试人群的选择;受试者的医疗和保护等。医疗器械临床试验的批准标准和医疗器械紧急使用都应该符合相应的标准。

Ethic review in clinical research:medical devices

Medical devices are administered according to certain classification by the state,and Class I medical devices need not be evaluated by clinical trial,while clinical evaluation must be conducted forboth Class II and Class III medical devices before they are put into production.Main points to considerwhen reviewing clinical trial with medical devices are as follows: scientific design of clinical trial;benefits and risks of the trial,differentiating clinical trial of significant risk and that of nonsignificant risk;informed consent;selection of subjects group;medical care and protection of subjects,etc.The criteria forapproval must be meet when approve a clinical trial of medical device,emergency use of medical devices should also meet corresponding standard.