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Laws & Regulations Database of The Republic of China (Taiwan)

Print Time:2022/11/29 03:45
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Chapter Law Content

Title: Human Subjects Research Act CH
Category: Ministry of Health and Welfare(衛生福利部)
Chapter 5 Penal Provisions
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 approval
2. 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 period
3. 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.
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 7
2. Violation of Paragraph 3 of Article 7 as to IRB review processes and scope, conflicts of interest principle, supervision, administration or other matters
3. Violation of Article 17, for failure to supervise and audit IRB approved research protocol.
4. Violation of Paragraph 3 of Article 18
Article 24
Research entities or their affiliated principal investigator, or other personnel who are subject to any of the following conditions, may be fined by the responsible ministry of central government a penalty of no less than NT$50,000 nor greater than NT$500,000, and ordered to adjourn or terminate the research project:
1. Violation of Article 12 or Article 13
2. Violation of Article 14, for having failed to ensure understanding of the required disclosure items, or having obtained consent through duress, solicitation or other improper means
3. Violation of Paragraph 1 of Article 15
4. Violation of Article 16, for failure to ensure adequate supervision of an IRB approved research protocol
5. Violation of Paragraph 3 of Article 19, for failure to obtain approval from the competent authority, prior to provision of study materials for overseas use
6. Violation of Article 20, for obstructing, refusing or avoiding auditing or provision of information therefor
7. Violation of Article 21, for disclosure of confidential matters relating to research subjects obtained in the course of the research or disclosing information related to research subjects.
Article 25
Where a research entity shall have been penalized in accordance with the provisions of Article 22 or the preceding Article, a penalty may be jointly assessed against the principal investigator or affiliated personnel on the same basis. Where the violation is grievous, after the penalty has become finally effective as to the violator, for a period of one year thenceforth, the violator may not apply to any government agency nor to any government funded foundation for research grant assistance.
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