IRB 국제인증 SIDCER Recognition Program 구영모 Ph

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

SIDCER-recognized Korean IRBs • 2006 – IRB Seoul National University Hospital, Seoul – IRB 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 2018 -03 -16 2

SIDCER-recognized Korean IRBs • 2009 – – IRB Kangbuk Samsung Hospital, Seoul IRB Inha 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 2018 -03 -16 3

SIDCER-recognized Korean IRBs • • • 2010 경북대병원 IRB 계명대동산병원 IRB 영남대병원 IRB 강동성심병원 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 2018 -03 -16 4

2011 SIDCER surveys in Korea • May 15 -21 – Re-surveys: 대구가톨릭의료원 IRB, 한림대성심병원 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, 가천의대길병 원 IRB 2018 -03 -16 5

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WHO-TDR & SIDCER • Promoting and protecting the health of the people • TDR, 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. 2018 -03 -16 7

FERCAP • The Forum for Ethical Review Committees in Asia and the Western Pacific FERCAP • The Forum for Ethical Review Committees in Asia and the Western Pacific Region • WHO – SIDCER (Strategic Initiative for Developing Capacity in Ethical Review) 2018 -03 -16 8

Objective & scopes of the survey • Objective: To evaluate the IRB for SIDCER Objective & scopes of the survey • Objective: To evaluate the IRB for SIDCER recognition • Scopes: the survey covers SIDCER recognition requirements I. III. IV. V. 2018 -03 -16 structure and composition of IRB adherence to specific policies completeness of its review process after review process archiving 9

Reference documents to be used § § § § § Applicable national laws and 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 2018 -03 -16 10

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IRB Documents to be reviewed § § § § § Applicable National Laws and 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 2018 -03 -16 12

The method of survey Interview IRB members- the chairperson, secretary, other members. § Review 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 2018 -03 -16 13

IRB office visit 2018 -03 -16 14 IRB office visit 2018 -03 -16 14

The method of survey Interview IRB members- the chairperson, secretary, other members. § Review 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 2018 -03 -16 15

Review of the IRB SOPs Creation / revision § Approval / implementation § Historical Review of the IRB SOPs Creation / revision § Approval / implementation § Historical SOPs § SOPs deviation § 2018 -03 -16 16

Review of review procedures § § § § Elements of the review Condition for 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 2018 -03 -16 17

The method of survey Interview IRB members- the chairperson, secretary, other members. § Review 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 2018 -03 -16 18

Observing a board meeting 2018 -03 -16 19 Observing a board meeting 2018 -03 -16 19

Closing meeting § § § Thanks IRB for their help Summary of areas surveyed 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 2018 -03 -16 20

Survey summary 2018 -03 -16 21 Survey summary 2018 -03 -16 21

Follow up actions § § § § Visit certificate to the IRB Report with 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 followup visit 2018 -03 -16 22

Survey visit certificates 2018 -03 -16 23 Survey visit certificates 2018 -03 -16 23

Survey report 2018 -03 -16 24 Survey report 2018 -03 -16 24

Survey reply (2006. 8. ) 2018 -03 -16 25 Survey reply (2006. 8. ) 2018 -03 -16 25

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Category of recognition § First time applicants § § Renewing applicants § § 5 Category of recognition § First time applicants § § Renewing applicants § § 5 months before the end of the 3 -year recognition period, the IRB will reapply and be visited Reports § § Full recognition Preliminary recognition Recognition pending Annual reports for review and monitoring by the SIDCER committee Recognition certificate 2018 -03 -16 27

2011 FERCAP Conferences • 11 th FERCAP Annual Meeting • 2011. 23. (수) • 2011 FERCAP Conferences • 11 th FERCAP Annual Meeting • 2011. 23. (수) • 인터불고호텔, 대구 2018 -03 -16 28

Things to consider to receive survey § § § § SOP & procedural manual 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 2018 -03 -16 29

 • • • SIDCER-FERCAP Recognition Q&A Discussion 2018 -03 -16 30 • • • SIDCER-FERCAP Recognition Q&A Discussion 2018 -03 -16 30




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