Regulations for Good Clinical Practice Article 21
If the subject or the subject's legal representative and legally acceptable representative. is unable to read, an impartial witness shall be present during the entire informed consent discussion.The impartial witness should read the informed consent form and any other written information to be provided to subjects and attests that the information were accurately explained by the investigator or designated person, and were fully understood by the subject or by the subject's legal representative and the legally acceptable representative.Under the circumstances referred to in paragraph 1, the subject or the subject's legal representative and legally acceptable representative. shall still sign and date the informed consent form. Finger print is an acceptable substitute for signature.After finishing the work described in paragraph 2, the impartial witness attests that informed consent was freely given by the subject or the subject's legal representative and legally acceptable representative. by signing and dating the informed consent form.Trial staff shall not acts as the impartial witness.
中文原文 藥品優良臨床試驗作業準則第21條
受試者、法定代理人或有同意權之人皆無法閱讀時，應由見證人在場參與所有有關受試者同意書之討論。
見證人應閱讀受試者同意書及提供受試者之任何其他書面資料，以見證試驗主持人或其指定之人員已經確切地將其內容向受試者、法定代理人或有同意權之人為解釋，並確定其充分了解所有資料之內容。
第一項情形，受試者、法定代理人或有同意權之人，仍應於受試者同意書親自簽署並載明日期。
但得以指印代替簽名。
見證人於完成第二項之行為，並確定受試者、法定代理人或有同意權之人之同意完全出於其自由意願後，應於受試者同意書簽名並載明日期。
試驗相關人員不得為見證人。
見證人應閱讀受試者同意書及提供受試者之任何其他書面資料，以見證試驗主持人或其指定之人員已經確切地將其內容向受試者、法定代理人或有同意權之人為解釋，並確定其充分了解所有資料之內容。
第一項情形，受試者、法定代理人或有同意權之人，仍應於受試者同意書親自簽署並載明日期。
但得以指印代替簽名。
見證人於完成第二項之行為，並確定受試者、法定代理人或有同意權之人之同意完全出於其自由意願後，應於受試者同意書簽名並載明日期。
試驗相關人員不得為見證人。