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KMID : 1143420200130060305
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Public Health Weekly Report
2020 Volume.13 No. 6 p.305 ~ p.310
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The operational results of the Institutional Review Board (IRB) of the Korean Centers for Disease Control and Prevention (KCDC) in Korea, 2019
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Lee Ho-Dong
Han Ri-Na
Son Il-Yong
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Abstract
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In accordance with Korea’s ‘Bioethics and Biosafety Act’ (enacted in 2004), the Institutional Review Board (IRB) protects and secures human rights, safety, and welfare by conducting reviews, investigations, and supervisions concerning research involving humans, human biomaterial specimens and personal information. This study reviewed the 2019 operational results of the Korean Centers for Disease Control and Prevention (KCDC) IRB. This study examined the results of research projects related to human subjects, human derivatives or embryonic stem cell lines, and bio-banking. In accordance with standard operating guidelines, the Secretariat of the Life Science Research and Management Division is in charge of IRB operations. The Secretariat supports not only the operation of the IRB but also the activities related to establishing protective measures for vulnerable research subjects and the preparation of ethical guidelines for researchers. In 2019, the IRB held a total of 11 meetings, including six regular and five expedited face-to-face reviews, and completed a total of 144 case reviews, including 76 face-to-face and 68 written reviews. In addition, the IRB conducted two training sessions to raise awareness of bioethics and biosafety to a total of 53 researchers, revised the 2013 regulations and the reference casebook that researchers refer to for major bioethics compliance. In conclusion, this study suggested that the secretariat make continuous improvements to operate the IRB more efficiently.
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KEYWORD
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Institutional Review Board (IRB), bioethics, research subjects, humans
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