PHWR Public Health Weekly Report

Vol.13 No.6, February 06, 2020 Article TypeEpidemiology and Surveillance

• Epidemiology and Surveillance 2020-02-06

  0 64 26

  The operational results of the Institutional Review Board (IRB) of the Korean Centers for Disease Control and Prevention (KCDC) in Korea, 2019

  Lee Ho-dong, Han Rina, Son Ilyong

  Public Health Weekly Report 2020; 13(6): 305-310

  

  

  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.

• Epidemiology and Surveillance 2020-02-06

  0 86 29

  Registration status of Institutional Review Boards (IRBs) in Korea, 2019

  Lee Ho-dong, Son soonyoung, Son Ilyong

  Public Health Weekly Report 2020; 13(6): 311-316

  Abstract

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  According to Korea’s Bioethics and Biosafety Act (enforced in February 2013), the establishment of a self-regulatory institutional review board (IRB) is obligatory for all institutions performing human subject research. Since 2013, the Division of Life Science Research Management within the Korean Centers for Disease Control and Prevention (KCDC) operated an IRB on-line registration system. According to the findings of this study, a total of 852 IRBs (828 institutions) registered by December 31st, 2019; an increase of 42 IRBs from the previous year. Of the 852 IRBs registered, 662 were self-operated and 190 were commissioned in agreement with other IRBs. Of the 828 institutions, 472 were individual operations operated by one IRB, and 356 were operated by integrating two or more IRBs. There were 1,526 IRB cases, which included 655 (42.9%) cases of human subject research; 529 (34.7%) cases of human biospecimen research; 154 (10.1%) fertility clinics, 71 (4.7%) biobanks; 80 (5.2%) cases of human embryonic stem cell research; 34 (2.2%) embryonic research institutes; and 3 (0.2%) cases of somatic cell nuclear transfer (SCNT) research. This study determined that the number of IRBs is expected to continue to increase. Therefore, this study suggested that the online registration system be improved for the efficient registration and management of bioethics and biosafety-related information.