1. IRB 국제인증 : SIDCER Recognition Program
구영모 Ph.D., CIP
울산의대 인문사회의학교실
FERCAP local coordinator

2. SIDCER-recognized Korean IRBs
2006
IRB Seoul National University Hospital, Seoul
IRB Asan Medical Center, Seoul
2007
IRB Kangnam St. Mary’s Hospital, Seoul
IRB Chonnam National University Hospital, Gwangju
IRB Busan Paik Hospital, INJE University, Busan
2008
IRB Hallym University Sacred Heart Hospital, Anyang
IRB Daegu Catholic University Medical Center, Daegu
IRB Kyunghee University Hospital, Seoul
IRB Ajou University Hospital, Suwon

3. SIDCER-recognized Korean IRBs
2009
IRB Kangbuk Samsung Hospital, Seoul
IRB Inha University Hospital, Incheon
IRB Chungnam National University Hospital, Daejeon
IRB International Vaccine Institute, Seoul
*Renewed Recognition
IRB Seoul National University Hospital, Seoul
IRB Asan Medical Center, Seoul

4. SIDCER-recognized Korean IRBs
2010
경북대병원 IRB
계명대동산병원 IRB
영남대병원 IRB
강동성심병원 IRB
국립암센터 IRB
분당차병원 IRB
부산동아대병원 IRB
고대안암병원 IRB
*Renewed Recognition
IRB Chonnam National University Hospital, Gwangju
IRB Busan Paik Hospital, INJE University, Busan

5. 2011 SIDCER surveys in Korea
May 15-21
Re-surveys: 대구가톨릭의료원 IRB, 한림대성심병원 IRB
August 20-26
Re-survey: 아주대병원 IRB
Surveys: 순천향부천병원 IRB, 고대구로병원 IRB, 가천의대길병원 IRB

7. WHO-TDR & SIDCER Promoting and protecting the health of the people
TDR, the special program for Research and Training in Tropical Diseases based at the WHO, recognized this need in 1999 and began efforts to strengthen this much needed protection. Out of this was born SIDCER.
SIDCER not only helps build in-country human subjects protection programs, but is also a way to measure and provide accountability for the quality and effectiveness of ethical review worldwide.

8. FERCAP
The Forum for Ethical Review Committees in Asia and the Western Pacific Region
WHO – SIDCER (Strategic Initiative for Developing Capacity in Ethical Review)

9. Objective & scopes of the survey
Objective: To evaluate the IRB for SIDCER recognition
Scopes: the survey covers SIDCER recognition requirements
structure and composition of IRB
adherence to specific policies
completeness of its review process
after review process
archiving

10. Reference documents to be used
Applicable national laws and regulations
WHO: operational guidelines for EC that review biomedical research
WHO: surveying and evaluating ethical review practices
ICH guideline for GCP (E-6)
SIDCER guideline for surveying EC
SIDCER recognition requirements and process
SIDCER SOP for planning, conducting, reporting, follow-up survey of EC
SIDCER format for report writing
SIDCER surveyors checklist

12. IRB Documents to be reviewed
Applicable National Laws and Regulations for the IRB
List of IRB members
IRB member CVs
IRB standard operating procedures
IRB forms for communication with applicants, regulatory authorities, or the authority under which the IRB is established
Agenda and minutes of the IRB committee meetings
Documents for reviewing serious adverse events (SAEs)
IRB policy and procedures for follow-up review
A representative sample of protocol reviewed in the past 3 years

13. The method of survey
Interview IRB members- the chairperson, secretary, other members.
Review documents
SOPs, protocols, minutes,
reports of SAE, agendas,
CV of IRB members,
history SOP,
decision letters, etc
Observe an IRB board meeting

14. IRB office visit

15. The method of survey
Interview IRB members- the chairperson, secretary, other members.
Review documents
SOPs, protocols, minutes,
reports of SAE, agendas,
CV of IRB members,
history SOP,
decision letters, etc
Observe an IRB board meeting

16. Review of the IRB SOPs Creation / revision Approval / implementation
Historical SOPs
SOPs deviation

17. Review of review procedures
Elements of the review
Condition for expedited review
Decision-making procedures
Procedures for communicating decision
Minutes
Follow-up review (SAEs etc.)
Documentation & archiving

18. The method of survey
Interview IRB members- the chairperson, secretary, other members.
Review documents
SOPs, protocols, minutes,
reports of SAE, agendas,
CV of IRB members,
history SOP,
decision letters, etc
Observe an IRB board meeting

19. Observing a board meeting

20. Closing meeting Thanks IRB for their help Summary of areas surveyed
Guidelines / regulations being followed
Review of survey findings
Opportunity for IRB to ask questions and comments
Any recommendation for actions required to be undertaken by IRB and time period for their accomplishment

21. Survey summary

22. Follow up actions Visit certificate to the IRB
Report with recommendations for recognition, follow-up action or a follow-up visit
Follow-up action: FERCAP will forward the corrective measures to IRB and a response timeline.
IRB will accept timeline or ask for additional time.
IRB is responsible for addressing corrective actions within the agreed time frame
Follow-up visit: FERCAP will communicate need for this with the IRB and the corrective measures requested within a specified time frame.
IRB will address corrective actions and prepare for the follow-up visit

23. Survey visit certificates

24. Survey report

25. Survey reply ( )

27. Category of recognition
First time applicants
Full recognition
Preliminary recognition
Recognition pending
Renewing applicants
5 months before the end of the 3-year recognition period, the IRB will reapply and be visited
Reports
Annual reports for review and monitoring by the SIDCER committee
Recognition certificate

28. 2011 FERCAP Conferences 11th FERCAP Annual Meeting 2011. 11. 23. (수)
인터불고호텔, 대구

29. Things to consider to receive survey
SOP & procedural manual : implementation
Documentation for everything and archiving
Member related issues : composition, documents
Pre-review of protocols before the meeting
Endurance
Role of chairperson and secretary
Budget & time

30. SIDCER-FERCAP Recognition Q & A Discussion