Chapter 4 Administration of Research Protocols
Research entities shall ensure necessary supervision throughout conduct of the research protocol approved; where any significant non-conformity occurs, they shall order cessation or order termination of the research.
The IRB shall, for every approved research protocol, throughout the conduct thereof, provide at least one annual audit.
Where the IRB discovers any of the following conditions in the conduct of a research protocol, they shall order the research protocol into cessation for amelioration within a specified period of time, or to be terminated, and shall notify the research entity and the responsible ministry of central government:
1. Where a required IRB approval was not obtained, and amendments were undertaken in the research protocol without prior permission
2. Any matter materially affecting research subject rights or safety
3. Abnormal frequency of adverse events or irregular degrees of severity
4. Sufficient evidence evinces the research is not necessary
5. Any other matter arises affecting the research risks and benefits analysis
After the research protocol is completed, should any of the following conditions arise, the IRB shall undertake an investigation, and notify the research entity and central competent authority of relevant entities:
1. Serious late onset adverse events
2. Any violation of law or act contrary to the research project’s contents
3. Any serious adverse effect on human subject’s rights
The responsible ministry of central government shall routinely inspect IRBs, and publish the inspection results.
The preceding inspection may be conducted as delegated by the responsible ministry of central government to a private professional entity or group.
Where an IRB fails to pass inspection, they may not approve any research protocols.
After completion of a research protocol, or expiration of the date of preservation in accordance with Subparagraph 8, Paragraph 1 of Article 14, all research materials shall be immediately destroyed. But where the affected individual consents otherwise, or delinkage of the materials has been completed, this provision shall not apply.
Where any use of non-delinked research materials beyond the permitted scope of written consent, then in accordance with the provisions of Article 5 and Article 12 through Article 15, IRB review shall be conducted and the procedures to give notification and obtain appropriate consent shall be completed.
Where non-delinked research materials will be provided for specified research purposes overseas, besides notifying the human subjects and obtaining their written consent, the overseas research entity shall sign a Certification of Guarantee to follow our domestic regulations and research material scope of permitted uses, for review by the IRB, and after approval thereby, for consideration by the competent authority, prior to conduct of any such use.
Where the responsible ministry of central government deems conduct of the research protocol as posing a risk of infringement of human subjects’ rights, they may audit or review research information at anytime; research entities and related personnel shall not impede, refuse, or avoid such audit or review.
The principal investigator and research personnel shall not disclose any confidential matter obtained in the course of the research or any information relating to the human subjects.