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KMID : 0391020060140020142
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Journal of Korean Society for Clinical Pharmacology and Therapeutics
2006 Volume.14 No. 2 p.142 ~ p.151
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Current Status of the Joint Institutional Review Boards in Foreign Countries and Suggestion for Operating in Korea
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Lee Seung-Mi
Kim Ock-Joo
Park Byung-Joo
Kim Seon-Ha
Kim Hwa-Jung
Bae Kyun-Seop
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Abstract
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As the number of multicenter clinical studies has been increased very rapidly in recent years, the necessity of joint institutional review board (IRB) gets realized for making review process more efficiently. Large private joint IRBs such as Western IRB have been established and providing wide range of IRB activities in the United States. In Taiwan, Joint IRB was founded as a non-profit institute, which has been performing the review activities for premarketing multicenter clinical trials. In the United Kingdom, multicenter clinical studies should be reviewed by Multi-centre Research Ethics Committee. It is institutionalized that any IRB recognizes and accepts the review result of other Institution’s IRB in Australia. The profit IRB, non-profit IRB, ad hoc IRB, regional IRB, or mutual recognition can be considered as models of joint IRB in Korea.
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KEYWORD
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Joint institutional review board, Multicenter Ccinical studies
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