Regulations for Good Clinical Practice Article 24
The subject’s legally acceptable representative can not represent the subject to provide consent to participate in non-therapeutic trials, except for those non-therapeutic trials with the following conditions are fulfilled:1.The objectives of the trial can not be met by means of a trial in subjects who can give informed consent personally.2.The foreseeable risks to the subjects are low.3.The negative impact on the subject’s well-being is minimized and low.4.The trial is not prohibited by law.5.The written approval of the Ethics Committee.Under the exceptional circumstances referred to in the preceding paragraph, those trials shall be conducted in patients having a disease or condition for which the investigational product is intended. Subjects in these trials shall be particularly closely monitored and shall be withdrawn if they appear to be unduly distressed.
中文原文 藥品優良臨床試驗作業準則第24條
法定代理人或有同意權之人不得代理受試者同意參與非以治療為目的之臨床試驗。
但符合下列所有條件者，不在此限：
一、無法由有能力簽署受試者同意書之受試者達成試驗目標之臨床試驗。
二、臨床試驗對受試者之可預期危險很低。
三、對受試者利益之負面影響很小。
四、法律未禁止。
五、人體試驗委員會之書面核准。
前項但書之情形，應選擇試驗藥品所治療疾病之病患參與試驗。
受試者應特別嚴密監測，如有過度不適情形，應即退出臨床試驗。
但符合下列所有條件者，不在此限：
一、無法由有能力簽署受試者同意書之受試者達成試驗目標之臨床試驗。
二、臨床試驗對受試者之可預期危險很低。
三、對受試者利益之負面影響很小。
四、法律未禁止。
五、人體試驗委員會之書面核准。
前項但書之情形，應選擇試驗藥品所治療疾病之病患參與試驗。
受試者應特別嚴密監測，如有過度不適情形，應即退出臨床試驗。