1. IRB ,

2. IRB

(Institutional Review Board, EthicsCommittee )

3. The main tasks of the IRB/EC

WHO guideline

Toassess the scientific meritsof the research

To verify that the research is inconformity with the laws and regulation , especially in relation with the protection of human subjects

To evaluate theethical acceptabilityof the research

4. IRB /

Regulation

• • Good Clinical Practice

Ethics

Science

5. ,Clinical Trial

6.

96 7 17 0960223088 7. (2005/01/07) Good Clinical Practice GCP

ICH E6Guidance for Industry E6 Good Clinical Practice

8. (2005/01/07)

, , ,

9. Helsinki Declaration

1

2

3

4

5

6

10.

11. -- 12. IRB/EC Subject protection Autonomy Beneficence Justice Informed consent Good clinical practice 13. Whats Science?

Measurable

Reproducible

Comparable

14. 15. ( )

.

JIRB IRB IRB 16. ( ) IRB 17. ( ) 18. ( ) 19. ( ) 20.

( )

21.

• 9666

22. 23. DOH96.6.6

,

:

24. DOH96.6.6

:

25.

26. (SAE)

(Serious Adverse Event) SAE

SAE

27. (SAE)

15 7

(SUSAR, suspect unexpected severe adverse reaction)

28.

29.

2

30.

monitor

• sponsor, CRO

audit

• IRB,third party

inspection

• regulatory authority

31. audit 32. IRB Monster or Partner? 33. JIRB http://www.jirb.org.tw 34. Contact us: CSMUH Chinese Medicine Clinical Trial Center http://www.csh.org.tw/into/herb James Cheng-Chung Wei, MD, PhD ( )[email_address]