Operational results of the Institutional Review Board (IRB) of Korea Centers for Disease Control and Prevention in Korea, 2017

Lee Ho-dong, Yun Youngmi, Son soonyoung, Lim Eunjung
Division of Life Science Research Management, Center for Genome Science, KNIH, KCDC

According to the Bioethics and Safety Act to protect the rights, safety, and welfare of human subjects, the Institutional Review Board (IRB) of Korea Centers for Disease Control and Prevention (CDC) has reviewed the research proposals related to human subjects, human derivatives or embryonic stem cell lines, and biobank specimens. The IRB secretariat in the Division of Life Science Research Management is in charge of operation of the IRB in accordance with the standard operating guideline. The main functions of the secretariat are to not only manage the IRB committees but also support IRB-related works on protective measures for vulnerable research subjects and preparing ethical guidelines for researchers. In 2017, the IRB held 12 sessions reviewing a total of 143 research proposals: approval 99 (69.2%), conditional approval 19 (13.3%), review exemption 13 (9.1%), rereview after revision 5 (3.5%), unapproval 4 (2.8%), review suspension 3 (2.1%). The secretariat also conducted the training course twice in 2017 to raise the awareness of bioethics and safety (72 researchers completed the course) and revised standard operating guideline with the amendment of major bioethics-related regulations that researchers ought to comply with. The secretariat will make further efforts to operate the IRB efficiently.

Keywords: Bioethics, Institutional Review Board, Research subject