CITI-Korea “ CITI 硏究倫理 敎育課程 ” : name for Asian countries
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Key West, Fl., May 2009 B.I. Choe B.I. Choe, M.B.A., LL.M., Ph.D. , M.B.A., LL.M., Ph.D. Associate Professor of Bioethics Associate Professor of Bioethics Nicholas Cardinal Cheong Graduate School for Nicholas Cardinal Cheong Graduate School for Life Life Catholic Institute of Bioethics Catholic Institute of Bioethics The Catholic University of Korea The Catholic University of Korea [email protected] [email protected]
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Key West, Fl., May 2009. CITI-Korea “ CITI 硏究倫理 敎育課程 ” : name for Asian countries. B.I. Choe , M.B.A., LL.M., Ph.D. Associate Professor of Bioethics Nicholas Cardinal Cheong Graduate School for Life Catholic Institute of Bioethics The Catholic University of Korea [email protected]. - PowerPoint PPT Presentation
Transcript of CITI-Korea “ CITI 硏究倫理 敎育課程 ” : name for Asian countries
Key West, Fl., May 2009
B.I. ChoeB.I. Choe, M.B.A., LL.M., Ph.D., M.B.A., LL.M., Ph.D.
Associate Professor of BioethicsAssociate Professor of BioethicsNicholas Cardinal Cheong Graduate School for LifeNicholas Cardinal Cheong Graduate School for LifeCatholic Institute of BioethicsCatholic Institute of BioethicsThe Catholic University of KoreaThe Catholic University of [email protected]@catholic.ac.kr
2Recent Developments in Clinical Trials in Korea –
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12 Regional CTCs in Korea12 Regional CTCs in Korea
33Recent Developments in Clinical Trials in Korea – B.I.C.Recent Developments in Clinical Trials in Korea – B.I.C.
Two IRBs in KoreaTwo IRBs in Korea
Agent oriented, not Subject orientedAgent oriented, not Subject orientedIRB for Drug & Medical Device trialsIRB for Drug & Medical Device trialsIRB for Genetic researchIRB for Genetic research
No governing laws or directives for No governing laws or directives for research involving human subjectsresearch involving human subjects
Only government certified institutions Only government certified institutions can and must operate IRBcan and must operate IRB
44Recent Developments in Clinical Trials in Korea – B.I.C.Recent Developments in Clinical Trials in Korea – B.I.C.
Regional Clinical Trial H/R Regional Clinical Trial H/R Development CentersDevelopment Centers Course development program forCourse development program for
Investigator Investigator Clinical PharmacologistClinical Pharmacologist Clinical Research CoordinatorClinical Research Coordinator MonitorMonitor PK/PD professionalsPK/PD professionals Statistician / Data managersStatistician / Data managers Clinical trial pharmacistClinical trial pharmacist
Development of integrated online education program Development of integrated online education program for;for; HRPPHRPP RCRRCR IRBIRB IACUC IACUC
Recent Developments in Clinical Trials in Korea – B.I.C.Recent Developments in Clinical Trials in Korea – B.I.C. 55
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Animal Protection LawAnimal Protection Law
Enacted Jan 2008Enacted Jan 2008 All institution All institution using animals using animals must be must be
registeredregistered All institution All institution must be reviewed by IACUCmust be reviewed by IACUC All institution All institution must conduct 8 hours course must conduct 8 hours course
on animal welfare for both Investigators on animal welfare for both Investigators and Members of IACUCand Members of IACUC
Mandatory annual reportMandatory annual report Lab Animal Law : K-FDA, enacted in 2009Lab Animal Law : K-FDA, enacted in 2009
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KAIRBKAIRB
Korea Association of IRBsKorea Association of IRBsAn independent foundation of Korean IRBsAn independent foundation of Korean IRBsMembers : 49 institutions (IRBs) Members : 49 institutions (IRBs) Funded by Ministry of Health, Welfare and Funded by Ministry of Health, Welfare and
Family AffairsFamily Affairs
Development of Educational ProgramsDevelopment of Educational ProgramsInvestigators : off-line courseInvestigators : off-line courseIRB reviewers : off-line courseIRB reviewers : off-line courseCITI-Korea : on-line courseCITI-Korea : on-line course
88Recent Developments in Clinical Trials in Korea – B.I.C.Recent Developments in Clinical Trials in Korea – B.I.C.
CITI-Korea and the AuthoritiesCITI-Korea and the Authorities
RCR : RCR : Ministry of EducationMinistry of Education
Human Subject Protection : Human Subject Protection : Ministry of HealthMinistry of HealthK-FDAK-FDA
Animal Research & IACUC : Animal Research & IACUC : Ministry of Food, Agriculture, Forestry and Ministry of Food, Agriculture, Forestry and
Fisheries. Fisheries. K-APHISK-APHISK-FDAK-FDA
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Must Show the proof !Must Show the proof !
Authorities are demanding Authorities are demanding the proof of education for the proof of education for investigators,investigators,members of review boardsmembers of review boards
But, educational resources are LIMITED But, educational resources are LIMITED !!Everybody is expertEverybody is expertNo consolidated programsNo consolidated programsNo assessment toolsNo assessment tools
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B.I. ChoeB.I. Choe, M.B.A., LL.M., Ph.D., M.B.A., LL.M., Ph.D.
Director, CITI-KoreaDirector, CITI-KoreaThe Catholic University of KoreaThe Catholic University of Korea
[email protected]@catholic.ac.kr
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