The Journal of KAIRB (대한기관윤리심의기구협의회지)

Korean Association of Institutional Review Boartds (대한기관윤리심의기구협의회)
권호 표지

Survey of Institutional Review Board Risk Level Classification of Clinical Trials Among Korean University Hospitals

임상시험심사위원회(Institutional Review Board)의 임상시험에 대한 위험평가 분류조사연구

  • Lee, Sun Ju (Department of Urology, Kyung Hee University Hospital) ;
  • Kang, Su Jin (Clinical Trials Education Center, Kyung Hee University Hospital) ;
  • Maeng, Chi Hoon (Division of Medical Oncology-Hematology, Department of Internal Medicine, Kyung Hee University Hospital) ;
  • Shin, Yoo Jin (Asan Institute for Life Science of Asan Medical Center) ;
  • Yoo, Soyoung (Department of Convergence Medicine, Asan Medical Center)
  • 이선주 (경희대학교병원 비뇨의학과) ;
  • 강수진 (경희대학교병원 임상시험교육센터) ;
  • 맹치훈 (경희대학교병원 종양혈액내과) ;
  • 신유진 (서울아산병원 아산생명과학연구원) ;
  • 유소영 (서울아산병원 융합의학과)
  • Received : 2022.08.23
  • Accepted : 2022.09.22
  • Published : 2022.09.30
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Abstract

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.

Keywords

Acknowledgement

이 논문은 2019-2020년도 식품의약품안전처의 연구개발비[19182한국평423 (19182MFD423)]로 수행되었으며 이에 감사드립니다.

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