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Question:

目前用微信发布的临床试验受试者招募广告越来越多,形式各样、制作精美,内容也具有一定的鼓动性。请问,受试者招募广告递交伦理委员会审批的时候,是否需要同时说明招募广告的发布途径?


Answer:

根据我国国家药品监督管理局《药物临床试验伦理审查工作指导原则》受试者的招募是伦理审查的主要内容的,除了招募广告的内容,招募形式、以及招募材料的样本都应该提供和伦理委员会审查。

如果需要同时遵守US FDA法规,可参考Recruiting Study Subjects - Information Sheet  A. Media Advertising When direct advertising is to be used, the IRB should review the information contained in the advertisement and the mode of its communication, to determine that the procedure for recruiting subjects is not coercive and does not state or imply a certainty of favorable outcome or other benefits beyond what is outlined in the consent document and the protocol. The IRB should review the final copy of printed advertisements to evaluate the relative size of type used and other visual effects. When advertisements are to be taped for broadcast, the IRB should review the final audio/video tape”)。

另外,友情提醒,无论何种媒介发布的受试者招募广告,内容均需要和伦理委员会批准的版本一致。