Martin M-T Fuh MD, DMSci. Institutional Review Board China Medical University Hospital

1. The Recent Status of Institutional Review Boards and Clinical Investigators in Medical Centers with Well-Equipped General Clinical Research Center Martin M-T Fuh MD, DMSci. Institutional Review Board China Medical University Hospital China Medical University Taichung, Taiwan, ROC

2. The IRB Forum The IRB is and appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects. An IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects.

3. Human Protection in Human Research What, Why, How, When and Where The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. IRBs use a group process to review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research.

4. IRB Review Process revised version Martin M-T Fuh MD, DMSci.

7. 確認資料，收取費用並開立收據 檢送申請案件，同時繳交審查費用 委員進行初審 回覆審查意見 進入審查會議 委員複審 通過發予證明 通報衛生署 存檔列管 稽查/定期追蹤 人體試驗委員會 廠商/主持人 新案/修訂案/延長試驗案申請審查作業流程 快速審查約七天通過。 一般審查平均約一個月通過

8. Approval Letter

9. Approval Letter

10. Submission Note

11. https://register.clinicaltrials.gov/ chinamuh cmuh cmuh66

17. The Institutional Review BoardForum What is expedited review? Expedited review is a procedure through which certain kinds of research may be reviewed and approved without convening a meeting of the IRB. The Agency's IRB regulations [21 CFR 56.110] permit, but do not require, an IRB to review certain categories of research through an expedited procedure if the research involves no more than minimal risk.

18. The Institutional Review Board Forum What is expedited review? The IRB may also use the expedited review procedure to review minor changes in previously approved research during the period covered by the original approval. Under an expedited review procedure, review of research may be carried out by the IRB chairperson or by one or more experienced members of the IRB designated by the chairperson. The reviewer(s) may exercise all the authorities of the IRB, except disapproval. Research may only be disapproved following review by the full committee. The IRB is required to adopt a method of keeping all members advised of research studies that have been approved by expedited review.

19. The Institutional Review Board Forum CRITERIA FOR QUALIFYING FOR A FAST TRACK DRUG DEVELOPMENT PROGRAM A. Serious or Life-Threatening Condition 1. Whether a condition is serious  2. Whether the drug is intended to treat a serious condition

20. The Institutional Review Board Forum CRITERIA FOR QUALIFYING FOR A FAST TRACK DRUG DEVELOPMENT PROGRAM B. Demonstrating the Potential to Address Unmet Medical Needs 1.  Evaluation of whether the drug development plan addresses unmet medical needs 2. Demonstration of the drug's potential

21. The Institutional Review Board Forum THE SELF-MONITORING ASSESSMENT PROGRAM FOR IRB CONTINUOUS QUALITY IMPROVEMENT (CQI)