CITIKOREA CITI NAME FOR ASIAN COUNTRIES Key West

CITI-KOREA “CITI 硏究倫理 敎育課程” : NAME FOR ASIAN COUNTRIES Key West, Fl. , May 2009 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 bichoe@catholic. ac. kr

The Korea Recent Developments in Clinical Trials in Korea – B. I. C. 2

12 Regional CTCs in Korea Recent Developments in Clinical Trials in Korea – B. I. C. 3

Two IRBs in Korea � Agent oriented, not Subject oriented �IRB for Drug & Medical Device trials �IRB for Genetic research � No governing laws or directives for research involving human subjects � Only government certified institutions can and must operate IRB Recent Developments in Clinical Trials in Korea – B. I. C. 4

Regional Clinical Trial H/R Development Centers � Course development program for � Investigator � Clinical Pharmacologist � Clinical Research Coordinator � Monitor � PK/PD professionals � Statistician / Data managers � Clinical trial pharmacist � Development of integrated online education program for; � HRPP � RCR � IRB � IACUC Recent Developments in Clinical Trials in Korea – B. I. C. 5

New phase of Animal welfare in Korea Recent Developments in Clinical Trials in Korea – B. I. C. 6

Animal Protection Law � Enacted Jan 2008 � All institution using animals must be registered � All institution must be reviewed by IACUC � All institution must conduct 8 hours course on animal welfare for both Investigators and Members of IACUC � Mandatory annual report � Lab Animal Law : K-FDA, enacted in 2009 Recent Developments in Clinical Trials in Korea – B. I. C. 7

KAIRB � Korea Association of IRBs �An independent foundation of Korean IRBs �Members : 49 institutions (IRBs) �Funded by Ministry of Health, Welfare and Family Affairs � Development of Educational Programs �Investigators : off-line course �IRB reviewers : off-line course �CITI-Korea : on-line course Recent Developments in Clinical Trials in Korea – B. I. C. 8

CITI-Korea and the Authorities � RCR : �Ministry of Education � Human Subject Protection : �Ministry of Health �K-FDA � Animal Research & IACUC : �Ministry of Food, Agriculture, Forestry and Fisheries. �K-APHIS �K-FDA Recent Developments in Clinical Trials in Korea – B. I. C. 9

Must Show the proof ! � Authorities are demanding �the proof of education for �investigators, �members of review boards � But, educational resources are LIMITED ! �Everybody is expert �No consolidated programs �No assessment tools Recent Developments in Clinical Trials in Korea – B. I. C. 10

B. I. Choe, M. B. A. , LL. M. , Ph. D. Director, CITI-Korea The Catholic University of Korea bichoe@catholic. ac. kr Thank You ! Recent Developments in Clinical Trials in Korea – B. I. C. 11