Regulations for Organization and Operation of Human Research Ethics Review Board Article 13
Pursuant to Paragraph 1, Article 17 of this Act, the IRB shall conduct at least one regular audit on the execution of the approved research project; an immediate audit shall be carried out in case of any one of the following situations:1.Any matter that may affect the rights, safety or well-being of the research subjects.2.Occurrence of any severely adverse event or response on the part of the research subjects.3.Occurrence of important matters or information that may influence the risk and benefit assessment of the project.The aforesaid audit may be conducted in writing or by means of an on-site investigation.
中文原文 人體研究倫理審查委員會組織及運作管理辦法第13條
審查會應依本法第十七條第一項規定，每年至少一次定期查核研究計畫之執行情形；研究計畫有下列情形之一者，審查會應即查核：
一、足以影響研究對象權益、安全或褔祉之情事。
二、研究對象發生嚴重不良事件或反應。
三、出現影響計畫風險利益評估之重要事件或資訊。
前項查核，得以書面或實地查證方式為之。
一、足以影響研究對象權益、安全或褔祉之情事。
二、研究對象發生嚴重不良事件或反應。
三、出現影響計畫風險利益評估之重要事件或資訊。
前項查核，得以書面或實地查證方式為之。