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KMID : 1172020150160020085
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Journal of Korean Bioethics Association
2015 Volume.16 No. 2 p.85 ~ p.108
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A study on the evaluation and accreditation of the Institutional Bioethics Committee under the 「Bioethics and Safety Act」
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Kim Hyeon-Cheol
Kim Eun-Ae
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Abstract
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The Institutional Bioethics Committee(hereinafter referred to as "IBC") is the representative official organization that contributes to the protection of the research participants" rights and welfare and the ethical research conduct because it reviews the researches such as the human researches and human material researches, investigates and supervises them, serves the education program for the researchers and so on under the 「Bioethics and Safety Act(hereinafter referred to as "Act")」. So, it is very important that the IBC must observe the legal standards related to its composition and operation as well as play its roles appropriately. For this reason, this Act has applicable provisions about the IBC evaluation and accreditation system(hereinafter referred to as "IBC EA system") for its composition and operation. From 2013 to 2015, the IBC demonstration evaluation project has conducted by the Korea National Institute for Bioethics Policy, and from 2016, the IBC EA system will begin in earnest. Therefore, in this articles, we confirmed the contents of the applicable provisions about the IBC EA system, especially the evaluation criteria and came to grasp the current situation of the IBC demonstration evaluation project. Also, we surveyed the international IBC EC system focusing on the AAHRPP accreditation system and FERCAP recognition system and analyzed the imperfections of the Korean IBC EA system comparing with these systems, especially the evaluation criteria and the practical methods. Finally, for the establishment of the Korean IBC EA system, we suggest not only the way to improve or complement the related applicable provisions but also the institutional considerations for the evaluation criteria and the practical methods.
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KEYWORD
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research, Bioethics and Safety Act, Institutional Bioethics Committee, evaluation, accreditation, human research, human material research, international accreditation/recognition system, evaluation of documents, evaluation by site visiting
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