???? IRB

1
?????????

• ???? IRB
• ??? ??
• 97?9?30?

2
??????

• ????8???????,???????????????????????????????????
• ????????????????????????????????

3
Human Subject

• A living individual about whom an investigator
  (whether professional or student) conducting
  research obtains
• Data through intervention or interaction with the
  individual, or
• Identifiable private information
• -- HHS regulation at 45 CFR 46.102(d)

4
18 HIPAA Identifiers

• Names
• Geographic subdivisions smaller than a State
• Dates (except year) directly related to patients
• Telephone numbers
• Fax numbers
• E-mail addresses
• Social security numbers (ID)
• Medical record numbers
• Health plan beneficiary number
• 10. Account numbers

5
18 HIPAA Identifiers

1. Certificate/License numbers
2. Vehicle identifiers and serial numbers
3. Device identifiers and serial numbers
4. Web URLs
5. Internet Protocol (IP) address numbers
6. Biometric identifiers, including finger and voice
   prints
7. Full face photographic images and any comparable
   images
8. Any other unique identifying number,
   characteristic, or code, except as permitted
   under HIPAA to re-identify data

6
??????????
????96?7?17??????0960223088???

• ??????????,???????,???????????????????????????????
  ???,???????????????
• ??????????????????,???????????????????,????????,??
  ??????????????????????????????????????,?????????
  ???????????

7
??
????
??????????????????
????????????
????
?????
??????
????????????????
????????(???)
???
??????????
?????(???)
???????????????
?????
????? GLP
??????????????(??)
IRB ??
??????
??????
???
????GMP?GTP
????
????????????
??????GTPGMP
?????????
??????? GCPcGMP
???????????(??)
?????????
???????? GTP
???? GTP
????? GTP
????????
8
???????

• ????????????,?????????,???????????????????????????
  ???

(?,2008)
9
??????????????????

• ??????92.11.12 ??????????????????
• ???????????????????
• ????????????
• ???????????
• ????????????????

10
??????????????????

• ??? ??
• ??? ?????????????
• ??? ????????????
• ??? ?????
• ??? ?????
• ??? ??
• ??? ??

11
The main tasks of the IRB/EC

• WHO guideline
• To assess the scientific merits of the research
• To verify that the research is in conformity with
  the laws and regulation, especially in relation
  with the protection of human subjects
• To evaluate the ethical acceptability of the
  research

12
???????
13
Basic Ethical Principles

• Respect for persons informed consent
• Beneficence risk/benefit assessment
• Justice subject selection

14
????????(GCP)

• ???????????????????????????,???????????????????,??
  ???????????????????
• ???????????(??)
• ????????????(??)

15
????????(GCP)

• ?????
• (???)

• ?????
• (??????)

??????????????
????????????
???????????????????,????????,???????????????,?????
?
16
GCP????

• ??????
• ???????????????
• ???????
• ???????????????
• ????????????????

17
???????????DOH96.6.6

• ????????????????????
• ???????????,?????????????
• ????????????????????
• ???????????
• ???????????
• ??????????
• ??????????
• ??????????
• ????????
• ?????????
• ???????????

18
???????????DOH96.6.6

• ???????????????????
• ??????????????????????
• ????????????????????????
• ??????????????????,?????????????
• ???????????????????
• ?????????????????????????
• ????????????????????????
• ????????????????????????
• ?????????????????????

19
???????

• ?????????????????????????????????????????????????,
  ??????(?)????????????,??????????????????
  (????????????????????,???????,??,????,????,????,??
  ????????????,????????????????????)
• ????????????????????,?????????????????
• (??ISO??)

20
???????

• ????????????????,?????????????????
• ?????????????????,????????
• ????????????????????????(????????),???????????????
  ??????????,????????

21
??????

• ?????????????? (??????)
• ?????(?????)???
• ?????
• ????????(??????????)
• ??????(??????????)
• ??????????
• ?????????????????
• ??(??)???

22
??????

• ????????????(???????)
• ???????,????????(???????)
• ???????????(??????????/????????)
• ??????????????????/???????????????(?????????/?????
  )
• ???????(?????????)
• ?????/?/?????/????????????????????(????3?????)

23
??????

• ??????
• ????????????????????????,????????,??????????????
• ?????????????,????????????????
• ?????????,????????????????

24
??????

• ??????????????????????
• ?????,?????????????????
• ???????????,???????????(???????????)?????????????
  ??(????)???????????????
• ??????????????????????????????
• ????????????????????????
• ?????????????(?????????????????????????????????),?
  ??????,??,????,????,????,???????????????

25
Exceptions for expedited review

• Recommendations from FERCAP
• Sensitive (privacy and confidentiality) issues
• Vulnerable subjects

26
Vulnerable subjects

• Those groups that may contain some individuals
  who have limited autonomy institutionalized, low
  socioeconomic, elderly, terminally ill, student,
  employees groups.
• Children, mentally incapacitated, individuals
  with dementia and other cognitive disorders,
  prisoners.
• Pregnant women.

27
????

• ?????????,???????????,?????????
• ???????????????????????????????????,???????,?????
  ????,??????????
• ?????????????????????????? ,???????,??????????
  ,??????????
• ?????????????,???????????????????

28
??????
????????? ????????????????
????????? ??????????,????????????????????
????????? ??????????????
????????? ??????????
????????? ????????????????????????
????????? ????????????????,??????????????
????????? ????????????????
????????? ????????????????????????
????????? ???????????????
29
??????
???????? ?????????????(???????????????????????????)?
???????? ???????????,???????????????????????
???????? ???????????????
???????? ????????????
???????? ????????????
???????? ????????????????????
30
??????
????? ????????,??????????????(?????,???????????????????)?
????? ?????????????????????
????? ????????????????,?????????????
????? ????????????????(??)?????????
????? ???????????????
????? ???????????????????????????????????????
31
??????
????????? ??????????????
????????? ??????????????????????
????????? ????????????????????????(?????????????????)?
????????? ??????????????,????????????????????
????????? ?????????????????????????????????????
????????? ??????????????????????
32
??????
???? ??????????????(????????)???
???? ????????????????????????
??????,????????????????,?????????? ??????,????????????????,??????????
33
????
34
?????

• ??????????????,???????,???????????????????????????
  ???????????
• ????????????,?????????????????
• ???????
• ?????????
• ?????????,????????????????????

35
????

• ??????????????????????????????,???????????
• ??????????????????
• ?????
• ??????
• ???????????
• ??????????,?????????????

36
??????(SAE)??

• ??????(Serious Adverse Event),??SAE
• SAE???????

• ??
• ????
• ????
• ???????

1. ????
2. ??????????
3. ?????
4. ??

37
??????(SAE)??

• ??????????????????15??????????????????????,???????
  ????,???7????
• ????????????,????????????????????

38
????

• ????????????2?????????
• ?????
• ?????
• ??????
• ???????????
• ??????????,?????????????

39
IRB ??
http//www.tzuchi.com.tw
40
(No Transcript)
41
???? IRB??
42
(No Transcript)
43
CITI?????????
44
The Collaborative Institutional Training
Initiative (CITI Program)

• CITI Program???????????????,??????????(JIRB)??????
  ???????????????????,?????? ???????????????????CITI
  Program?????module ?????module????,?10-20???????M
  odule??????(quiz),?????module?????????module??????
  ???? ????(quiz)???????

45
??1. Register
??1.
46
??2. Institution?Participating Institutions??Joint
Institutional Review Board-Taiwan
47
??3. ?????Username?password
48
??4. ?????e-mail
49
??5. ????????? Department?????????????
50
??6. ????????module??
51
??7. ??Grade book????module??????(quiz)?module????
????????(quiz)?????????
52
??8. ??????complete reports form,?????????????????
??????????Module???
53
(No Transcript)
54
? ?Thanks
??????????!