Regulations on Human Trials Article 9
The Review Board, if discovering any of the following matters in the audit referred to in the preceding paragraph, may order the Human Trial to be improved within a prescribed period of time or terminated:1. where the contents of the Human Trial are altered without the approval of the Review Board or central competent authority as required by law.2. where the rights, interest, or safety of the Trial Subject is obviously affected.3. where the frequency or seriousness of the occurrence of adverse events is abnormal.4. where the existence of an occurrence is sufficient to affect the evaluation of Human Trial results.5. where specific facts exist before the completion of the Human Trial proving that the Human Trial has no actual benefits, higher risks than potential benefits, or actual benefits that are disadvantageous to the control group.The central competent authority when learning of the adverse event(s) referred to in the preceding paragraph may order the Human Trial to be terminated.
中文原文 人體試驗管理辦法第9條
審查會對其審查通過之人體試驗應每年至少查核一次。
前項查核發現有下列情事之一者，得令其限期改善或終止人體試驗：
一、未依規定經審查會通過或中央主管機關核可，自行變更人體試驗內容。
二、顯有影響受試者權益、安全之事實。
三、不良事件發生數或嚴重度顯有異常。
四、有足以影響人體試驗成果評估之事件。
五、人體試驗未完成前，有具體事實證明並無實益、風險高於潛在利益，或顯有實益致不利於對照組。
中央主管機關知有前項情事，得令其終止人體試驗。
前項查核發現有下列情事之一者，得令其限期改善或終止人體試驗：
一、未依規定經審查會通過或中央主管機關核可，自行變更人體試驗內容。
二、顯有影響受試者權益、安全之事實。
三、不良事件發生數或嚴重度顯有異常。
四、有足以影響人體試驗成果評估之事件。
五、人體試驗未完成前，有具體事實證明並無實益、風險高於潛在利益，或顯有實益致不利於對照組。
中央主管機關知有前項情事，得令其終止人體試驗。