Survey of Risk Evaluation in the Clinical Research for IRB Members and Researchers

임상시험심사위원회 위원과 연구자를 대상으로 연구의 위험평가 설문조사

  • Choi, Yong-Sung (Department of Pediatrics, Kyung Hee University Hospital) ;
  • Lee, Sun Ju (Department of Urology, Kyung Hee University Hospital) ;
  • Yim, Hyeon Woo (Department of Preventive Medicine, College of Medicine, The Catholic University of Korea) ;
  • Choe, Byung-in (Nicolas Cardinal Cheong Graduate School for Life, The Catholic University of Korea) ;
  • Lee, Jae Won (Department of Statistics, Korea University) ;
  • Oh, Sang-cheul (Department of Oncology, Korea University Guro Hospital) ;
  • Shin, Im Hee (Department of Medical Statistics and Informatics, School of Medicine, Daegu Catholic University) ;
  • Huh, Jung-Sik (Department of Urology, Jeju National University Hospital) ;
  • Kwon, Ivo (Ewha Womans University, School of Medicine) ;
  • Kim, Jin Seok (Division of Hematology, Department of Internal Medicine, Yonsei University College of Medicine, Severance Hospital) ;
  • Yoo, Soyoung (Department of Convergence Medicine, Asan Medical Center) ;
  • Cho, Hyunin (Samsung Medical Center) ;
  • Lee, Mi-Kyung (Department of Laboratory Medicine, Chung-Ang University College of Medicine) ;
  • Shin, Hee-Young (Department of Biomedical Sciences, Chonnam National University Medical School) ;
  • Kim, Duck-An (Department of Laboratory Medicine, Hanyang University Medical Center)
  • 최용성 (경희대학교병원 소아청소년과) ;
  • 이선주 (경희대학교병원 비뇨의학과) ;
  • 임현우 (가톨릭대학교 의과대학 예방의학교실) ;
  • 최병인 (가톨릭대학교 생명대학원) ;
  • 이재원 (고려대학교 통계학과) ;
  • 오상철 (고려대학교 구로병원 종양내과) ;
  • 신임희 (대구가톨릭대학교 의과대학 의학통계학교실) ;
  • 허정식 (제주대학교병원 비뇨의학과) ;
  • 권복규 (이화여자대학교 의과대학) ;
  • 김진석 (연세의대 세브란스병원 혈액내과) ;
  • 유소영 (서울아산병원 융합의학과) ;
  • 조현인 (서울삼성병원 피험자보호감독실) ;
  • 이미경 (중앙대학교 의과대학 진단검사의학교실) ;
  • 신희영 (전남대학교 의과대학 의생명과학교실) ;
  • 김덕언 (한양대학교병원 진단검사의학과)
  • Published : 2019.02.28

Abstract

Purpose: Institutional review board (IRB) classifies risks of clinical trials into less than minimal risk, minor increase over minimal risk, and more than minimal risk. Based on classification and evaluation for risk, IRB decides whether permitting consent exemption or asking additional protection for clinical research subject or not. The purpose of this study is to analyze how IRB members evaluate minimal risk by sending questionnaire survey with 12 predetermined scenarios. Methods: IRB members and researchers (pediatrician, gastroenterologist, neurologist, and neurosurgeon) in 11 different hospitals were asked to answer survey questions via email or online. We analyzed the differences of answers among several subgroups in each predetermined scenarios. Result: Responders were 212 personnel(110 researchers and 102 IRB members) from 11 centers. There were significant differences between IRB members and researchers in response such as blood sampling, skin prick test, one time catheterization in a girl, spinal tapping in child, non-enhance MRI in child, non-enhance MRI with chrolal hydrate in a child, spinal tapping without anesthesia in adult, bioequivalence test, gastric endoscopy, and non-enhance CT. significant differences between medical IRB members and non-medical members were also revealed in one time catheterization in a girl, spinal tapping in a child, non-enhance MRI in a child, bioequivalence test. Depending on researchers' department, they responded differently in several questionnaires as well. Conclusions: We have found that IRB members and researchers evaluate the risks differently. Researchers compared to IRB members, medical IRB members compared to non-medical members answered less than minimal risk in many cases. In assessing and evaluating the risks associated with the study, medical IRB members answered predetermined scenarios as less dangerous compared to non-medical IRB members. Difference among researchers where also revealed significantly. Researchers answered predetermined scenarios as less dangerous compare to other department researchers, especially in predetermined scenarios containing procedures they are familiar with.

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