Human Subjects Research Act Article 23

Where a research entity’s IRB or independent IRB violates any of the following provisions, the responsible ministry of central government may fine the research entity or independent IRB a penalty in the amount of not less than NT$60,000 nor more than NT$600,000, and order amelioration within a specified period of time; where such amelioration is not timely completed, the IRB may be ordered dissolved; where the violation is grievous, the IRB may be ordered to cease operations for not less than one month nor greater than one year.1. Violation of Paragraph 1 of Article 72. Violation of Paragraph 3 of Article 7 as to IRB review processes and scope, conflicts of interest principle, supervision, administration or other matters3. Violation of Article 17, for failure to supervise and audit IRB approved research protocol.4. Violation of Paragraph 3 of Article 18