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KMID : 1011120070010020141
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Bioethics Policy Studies
2007 Volume.1 No. 2 p.141 ~ p.156
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A Study on Improving Institutional Bioethics Review Board by Comparison of Institutional Review Board
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Baik Su-Jin
Kwon Bok-Kyu
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Abstract
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Institutional Review Board and Institutional Bioethics Review Board are primary Research Ethics Committees in Korea.
Institutional Review Board(IRB) is the mandatory organization which reviews and has authority to approve, secure approval, or disapprove IND (Investigational New Drug) clinical research activities conducted in the institution(most hospitals) covered by Korea Good Clinical Practice(KGCP). Institutional Bioethics Review Board(IBRB) is the committee which reviews research activities conducted in the institution(Institutions related to Production Embryo, Cloning by somatic cell nuclear transfer, Dealing with Gene, and Human Tissue Bank etc.) regulated by the Law on Bioethics and Biosafety.
IRB and IBRB in Korea have a similar structure and function. Nevertheless, there are some differences.
IBRBs focus on the review of ethical perspective of the particular scientific research, whereas IRBs emphasize on the protection of the human subject.
These roles and status of these two committees play an important role in determining how these two committees should be managed in both legal and institutional frameworks.
This study, through the comparison of IRB and IBRB, seek to find a way to prepare standard of practice, development of educational program for investigators and IRB members, development of accreditation program, which will contribute to the promotion of IRB.
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KEYWORD
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IRB, Institutional Review Board, Institutional Bioethics Review Board, IBRB, Research Ethics Committees, Accreditaion, IRB members
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