一、國外法規與研究倫理規範
1. Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants (WHO 2011 )
2. International Ethical Guidelines for Health-related Research Involving HumansStandards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants (CIOMS 2016)
3. INTEGRATED ADDENDUM TO ICH E6(R1): GUIDELINE FOR GOOD CLINICAL PRACTICE E6(R2) ( March 2018)
4. Final Concept Paper ICH E8(R1): Revision of General Considerations for Clinical Trials dated 14 November 2017 Concept Paper (14 November 2017)
5. Belmont Report (1979/4/18)
6. Declaration of Helsinki (2013 version) [中文版]
7. DHHS: 45 CFR 46-PROTECTION OF HUMAN SUBJECTS (2009/7/14)
8. FDA
(1) 21 CFR 50-PROTECTION OF HUMAN SUBJECTS (2013/41)
(2) 21 CFR 56-INSTITUTIONAL REVIEW BOARDS (2013/4/1)
(3) 21 CFR 312-INVESTIGATIONAL NEW DRUG APPLICATION (2013/4/1)
(4) 21 CFR 812-INVESTIGATIONAL DEVICE EXEMPTIONS (2013/4/1)
二、國內法規與研究倫理規範
6. 人體研究倫理審查委員會組織及運作管理辦法[中文版] [英文版]
9. 醫療器材管理法
10. 醫療器材管理辦法
11. 醫療器材管理法施行細則
12. 醫療器材優良臨床試驗管理辦法
13. 個人資料保護法
14. 個人資料保護法施行細則
17. 嚴重藥物不良反應通報辦法(2004/8/31) [中文版] [英文版]
18. 人體生物資料庫管理條例 [中文版] [英文版]
19. 人體研究倫理政策指引(2007/7/17)