Regulations for Good Clinical Practice Article 5
The investigator should obtain the informed consent form freely given by the subjects prior to the beginning of the trial.The investigator, or a person designated by the investigator, should fully inform the subject of all pertinent aspects of the trial, including the contents of the informed consent form and the documentations approved by the Ethics Committee. The investigator, or designated person, should ensure the content of inform consent form and other trial-related documentations are well understood, signed and dated by the subject.For the consent mentioned in the preceding two paragraphs, where the subject is incompetent, the consent should be performed by his or her legal representative; where the subject is of limited legal capacity, consent should be obtained from his or her legal representative; where the subject who is neither incompetent nor of limited legal capacity, yet is unable to give consent due to insanity or the absence of discernment, the consent could be given by the subject's legally acceptable representative.The subject's legally acceptable representative refers to the subject’s spouse and cohabiting families.
中文原文 藥品優良臨床試驗作業準則第5條
試驗主持人應於臨床試驗進行前，取得受試者自願給予之受試者同意書。
試驗主持人或由其指定之人員，應充分告知受試者臨床試驗進行之資訊、受試者同意書之內容及所有由人體試驗委員會所核准與臨床試驗相關之書面意見，並使其充分瞭解後親自簽署，並載明日期。
前二項之行為，受試者為無行為能力人者，由法定代理人代為之；受試者為限制行為能力人者，應得法定代理人之同意；受試者雖非無行為能力或限制行為能力者，但因無意識或精神錯亂無法自行為之時，由有同意權之人為之。
前項有同意權人為配偶及同居之親屬。
試驗主持人或由其指定之人員，應充分告知受試者臨床試驗進行之資訊、受試者同意書之內容及所有由人體試驗委員會所核准與臨床試驗相關之書面意見，並使其充分瞭解後親自簽署，並載明日期。
前二項之行為，受試者為無行為能力人者，由法定代理人代為之；受試者為限制行為能力人者，應得法定代理人之同意；受試者雖非無行為能力或限制行為能力者，但因無意識或精神錯亂無法自行為之時，由有同意權之人為之。
前項有同意權人為配偶及同居之親屬。