Regulations for Good Clinical Practice Article 20
Prior to a subject’s participation in the trial, the informed consent form shall be signed and personally dated by the subject or by the subject's legal representative and the legally acceptable representative.Before informed consent may be obtained, the investigator, or a person designated by the investigator, should provide the subject or the subject's legally acceptable representative ample time and opportunity to inquire about details of the trial.All questions about the trial should be answered to the satisfaction of the subject or the subject's legal representative and the legally acceptable representative.Informed consent forms shall be signed by all parties mentioned in paragraph 2.In clinical trials of emergency cases, prior consent of the subject or the subject’s legally representatives could be waived only when the emergency procedures are well described in the protocol. When consent of the subject or the subject's legal representative and the legally acceptable representative is possible, the consent shall be obtained immediately.
中文原文 藥品優良臨床試驗作業準則第20條
受試者同意書，應由受試者、法定代理人或有同意權之人於參加試驗前，親自簽署並載明日期。
取得受試者同意書前，試驗主持人或其指定之人員，應給予受試者、法定代理人或有同意權之人充分時間與機會，以詢問臨床試驗之細節。
關於臨床試驗計畫之所有問題，應給予受試者、法定代理人或有同意權之人滿意之回答。
第二項之人員應於受試者同意書簽名。
用以治療或處置緊急病況之臨床試驗，預期無法預先取得受試者、法定代理人或有同意權之人同意，若於試驗計畫書中詳列緊急事件處理程序，得於取得受試者、法定代理人或有同意權之人書面同意前，先進行試驗。
但若能取得受試者、法定代理人或有同意權之人書面同意時，應立即為之。
取得受試者同意書前，試驗主持人或其指定之人員，應給予受試者、法定代理人或有同意權之人充分時間與機會，以詢問臨床試驗之細節。
關於臨床試驗計畫之所有問題，應給予受試者、法定代理人或有同意權之人滿意之回答。
第二項之人員應於受試者同意書簽名。
用以治療或處置緊急病況之臨床試驗，預期無法預先取得受試者、法定代理人或有同意權之人同意，若於試驗計畫書中詳列緊急事件處理程序，得於取得受試者、法定代理人或有同意權之人書面同意前，先進行試驗。
但若能取得受試者、法定代理人或有同意權之人書面同意時，應立即為之。