| Regulation Name | File |
|---|---|
| 1. Medical Care Act | Open / Download |
| 2. Enforcement Rules of the Medical Care Act | Open / Download |
| 3. Human Research Ethics Policy Guidelines (Announcement No. 0960223088) | Open / Download |
| 4. E6 in ICH&GCP | Open / Download |
| 5. IRB Q&A | Open / Download |
| 6. Human Subjects Research Act | Open / Download |
| 7. Declaration of Helsinki (2013 Edition) | Open / Download |
| 8. Regulations Governing Human Trials | Open / Download |
| 9. Regulations for the Organization and Operation of IRB | Open / Download |
| 10. Scope of Human Research Cases Eligible for Expedited Review by IRB | Open / Download |
| 11. Scope of Human Research Cases Exempt from IRB Review | Open / Download |
| 12. Scope of Human Research Cases Exempt from Obtaining Subject Consent | Open / Download |
| 13. Responsibilities of IRB and EGC in Reviewing Research Proposals | Open / Download |
Regulations and Reference Materials
Regulations and References
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4. E6 in ICH&GCP, opens in new window
PDF
261 KB
5. 人體試驗委員會Q&A, opens in new window
PDF
511 KB
7. 赫爾辛基宣言(2013年版), opens in new window
PDF
599 KB
9. 人體研究倫理審查委員會組織及運作管理辦法, opens in new window
PDF
135 KB
