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KMID : 0370920130300020073
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Yeungnam Univercity Journal of Medicine
2013 Volume.30 No. 2 p.73 ~ p.78
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Mission and Operation of Institutional Review Board
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Kim Yong-Jin
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Abstract
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An institutional review board (IRB) should independently safeguard the right, safety, and well-being of all clinical trial subjects. It should consist of members who are qualified and experienced to review and evaluate the science, medical aspects, and ethics of the proposed trial. They have to pursue continuing efforts to improve the standards of review. The levels of review include the full board review, expedited review, continuing review, or exempt from review, while the levels of decision-making include approval, conditional approval, deferred approval, and disapproval. Investigators must follow the approved protocols and regulations honestly, and it is the IRB’s mission to audit clinical trial sites as well.
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KEYWORD
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Research ethics committees, Institutional review board
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