Human Subjects Research Act Article 22

Where any research entity affiliated principal investigator or research personnel are subject to any of the following conditions, the responsible ministry of central government may fine the research entity a penalty in the amount of no less than NT$100,000 nor more than NT$1,000,000;1. Violation of Paragraph 1 of Article 5, Article 8, Article 9, or Article 10, for conduct of any activity without IRB approval2. Violation of Paragraph 1 of Article 19, for failure to destroy non-delinked research materials after the end of the research or expiration of the preservation period3. Violation of Paragraph 2 of Article 19, for use of non-delinked research materials, use beyond the scope of consent, failure to engage in processes to obtain additional IRB review, or failure to notify and obtain additional consent.4. Violation of Paragraph 3 of Article 19, through provision of research materials for overseas uses without obtaining the human subject’s written consent therefor.Where any of the preceding Subparagraphs apply, should the violation be particularly serious, the responsible ministry of central government may terminate the research, and may publish the name of the research entity so penalized.