Regulations for Good Clinical Practice Article 88
A clinical trial is to be carried out with the consent of the subject’s legally acceptable representative, the Ethics Committee should ensure that the proposed protocol and other document(s) adequately addresses relevant ethical concerns.
中文原文 藥品優良臨床試驗作業準則第88條
依受試者以外具有同意權之人同意，而進行臨床試驗時，人體試驗委員會應確定試驗計畫書及其他文件資料充分提及相關之倫理考量。