Medical Care Act Article 79
This English translation was last updated on 2023-06-28, but the Chinese text was amended on 2026-09-23. Later amendments may not be reflected in the translation — please refer to the Chinese text.
When conducting human research, medical care institutions shall pay necessary attention to medical procedures, and first obtain a written consent from the research subjects. The subjects of human research must be adults with disposing capacity. The preceding provision however does not apply to human research that is apparently beneficial to the health of specific population or patients with a special disease.Where a research subject in the proviso of the preceding paragraph is a person with limited disposing capacity, the consents of both the subject and his/her legal representative are required; where the research subject is a person with no disposing capacity, the consent of his/her legal representative is required.The medical care institution shall clearly state the following on the written consent referred to in the preceding paragraph, and shall inform the subject or his/her legal representative in a manner comprehensible to him/her before obtaining his/her consent:1. Purpose and method of research;2. Possible risks and side effects;3. Expected results;4. Explanation of other possible treatment methods;5. Subject’s right to withdrawal of consent at any time;6. Research-related compensation for damages or insurance coverage;7. Confidentiality of the subject’s personal information; and8. The preservation and reutilization of the subject’s biological samples, personal data or derivatives thereof.With respect to informing the subjects and obtaining written consent mentioned in the preceding paragraph, the medical care institution shall give the research subjects ample time to consider and shall not use coercion or other improper methods.When a doctor carries out human research in accordance with the preceding four provisions, causing death or injury of a patient because of unforeseeable factors in the research, the provisions concerning intentional or negligent offence as set down in Article 13 or 14 of the Criminal Code shall not apply.
中文原文 醫療法第79條
醫療機構施行人體試驗時，應善盡醫療上必要之注意，並應先取得接受試驗者之書面同意；接受試驗者以有意思能力之成年人為限。
但顯有益於特定人口群或特殊疾病罹患者健康權益之試驗，不在此限。
前項但書之接受試驗者為限制行為能力人，應得其本人與法定代理人同意；接受試驗者為無行為能力人，應得其法定代理人同意。
第一項書面，醫療機構應至少載明下列事項，並於接受試驗者或法定代理人同意前，以其可理解方式先行告知：
一、試驗目的及方法。
二、可預期風險及副作用。
三、預期試驗效果。
四、其他可能之治療方式及說明。
五、接受試驗者得隨時撤回同意之權利。
六、試驗有關之損害補償或保險機制。
七、受試者個人資料之保密。
八、受試者生物檢體、個人資料或其衍生物之保存與再利用。
前項告知及書面同意，醫療機構應給予充分時間考慮，並不得以脅迫或其他不正當方式為之。
醫師依前四項規定施行人體試驗，因試驗本身不可預見之因素，致病人死亡或傷害者，不符刑法第十三條或第十四條之故意或過失規定。
但顯有益於特定人口群或特殊疾病罹患者健康權益之試驗，不在此限。
前項但書之接受試驗者為限制行為能力人，應得其本人與法定代理人同意；接受試驗者為無行為能力人，應得其法定代理人同意。
第一項書面，醫療機構應至少載明下列事項，並於接受試驗者或法定代理人同意前，以其可理解方式先行告知：
一、試驗目的及方法。
二、可預期風險及副作用。
三、預期試驗效果。
四、其他可能之治療方式及說明。
五、接受試驗者得隨時撤回同意之權利。
六、試驗有關之損害補償或保險機制。
七、受試者個人資料之保密。
八、受試者生物檢體、個人資料或其衍生物之保存與再利用。
前項告知及書面同意，醫療機構應給予充分時間考慮，並不得以脅迫或其他不正當方式為之。
醫師依前四項規定施行人體試驗，因試驗本身不可預見之因素，致病人死亡或傷害者，不符刑法第十三條或第十四條之故意或過失規定。