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KMID : 1011120160100010129
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Bioethics Policy Studies
2016 Volume.10 No. 1 p.129 ~ p.156
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A Study on the Legal Standards and Policy about the Expedited Review by the Institutional Review Board
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Kim Eun-Ae
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Abstract
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For the research review to protect the research participants, the Institutional Review Board (“IRB”) has been using two procedures: one is the review procedure by full institutional review board (“full board review procedure”) as the principled research review procedure, the other is the expedited review procedure as the exceptional research review procedure. Both procedures are recognized internationally, and they have been introduced by significant numbers of Korean IRBs. But, despite the legal requirement of the research review under the Bioethics and Safety Act, there is almost nothing about the legal standards and policy related to the expedited review unlike the full board review. Operating the expedited review procedure can greatly contribute to improved IRB task efficiency because it is possible to relatively reduce the burden on the operation of the full board review procedure relatively and make it possible to make appropriate review on the research that needs the full board review because of its risk, participation of vulnerable persons, sensitiveness of collected information and so on. Besides, the review result can be derived quickly by the expedited review procedure. Therefore, to recognize the expedited review officially, to assess the appropriateness of the actual operation, to prevent abuse and misuse of the expedited review procedure, and to make the expedited review procedure used properly, the legal standards and policy about the expedited review should be established. So in this article, I propose some considerations for establishing the legal standards and policy about the expedited review such as the level and types of research risk, vulnerability of the research participant and so on.
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KEYWORD
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Institutional Review Board, Research Review procedure, Expedited Review, Bioethics And Safety Act, Research Risk, Minimal Risk, Human Research, Human Material Research
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