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권복규,Kwon, Ivo 대한기관윤리심의기구협의회 2022 대한기관윤리심의기구협의회지(JKIRB) Vol.4 No.2
The goal of the military medicine is not as same as that of the civil medical practice, and consequently the characteristics of military biomedical researches have their own uniqueness. In front of the prerogative of national defense, some of the human rights ordinarily ensured in normal researches with human subjects are not to be fully guaranteed. The hierarchic system of the military would complicate the issue when the soldiers are enrolled as human subject for the research. Some researches could be classified as a military secret, therefore, the confidentiality issues need to be well addressed. Institutional Review Board and review procedure should be modified for the military purposes. So, it is necessary to establish the appropriate regulatory system for the military biomedical researches with human subject to manage the complicated issues involved in them.
임상시험심사위원회(Institutional Review Board)의 임상시험에 대한 위험평가 분류조사연구
이선주,강수진,맹치훈,신유진,유소영,Lee, Sun Ju,Kang, Su Jin,Maeng, Chi Hoon,Shin, Yoo Jin,Yoo, Soyoung 대한기관윤리심의기구협의회 2022 대한기관윤리심의기구협의회지(JKIRB) Vol.4 No.2
Purpose: The purpose of this study is to evaluate how university hospital Institutional Review Boards (IRBs) in Korea classify risk when reviewing clinical trial protocols. Methods: IRB experts (IRB chairman, vice chairman, IRB administrator) in the university hospitals obtaining a Human research protection program (HRPP) or IRB accreditation in Korea were asked to fill out the Google Survey from September 1, 2020 to October 10, 2020. Result: Among the 23 responder hospitals, 8 were accredited by the American Association for Human Research Protection Program (AAHRPP) and 8 were accredited by the HRPP of Ministry of Food and Drug Safety (MFDS). Seven were accredited by Forum for Ethical Review Committees in Asia and the Western Pacific or Korea National Institution for Bioethics Policy. Thirteen of 23 hospitals (56.5%) had 4 levels (less than minimal, low, moderate, high risk), 4 hospitals had 3 levels (less than, slightly over, over than minimal risk), 1 hospital had 5 levels (4 levels plus required data safety monitoring board), and 1 hospital had 2 levels (less than, over than minimal risk) risk classification system. Thirteen of 23 hospitals (56.5%) had difficulty classifying the risk levels of research protocols. Fourteen hospitals (60.9%) responded that different standards among hospitals for risk level determination associated with clinical trials will affect the subject protection. Six hospitals (26.1%) responded that it will not. Three hospitals (13.0%) responded that it will affect the beginning of the clinical trial. To resolve differences in standards between hospitals, 14 hospitals (60.9%) responded that either the Korean Association of IRB or MFDS needs to provide a guideline for risk level determination in clinical trials: 5 hospitals (21.7%) responded education for IRB members and researchers is needed; 3 hospitals (13.0%) responded that difference among institutions needs to be acknowledged; and 1 hospital (4.3%) responded that there needs to be communication among IRB, investigator, and sponsor. Conclusion: After conducting a nationwide survey on how IRB in university hospital determines risk during review of clinical trials, it is reasonable to use 4-level risk classification (less than minimal, low, moderate, high risk); the most utilized method among hospitals. Moreover, personal information and conflict of interest associated with clinical trials have to be considered when reviewing clinical trial protocols.