The Journal of KAIRB (대한기관윤리심의기구협의회지)
- Volume 2 Issue 1
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- Pages.23-31
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- 2020
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- 2734-0724(pISSN)
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- 2671-4388(eISSN)
Survey of Conflict of Interest in the Clinical Research for IRB Members and Researchers
임상시험심사위원회 위원과 연구자를 대상으로 임상연구에서 이해상충에 대한 설문조사연구
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Maeng, Chi Hoon
(Division of Medical Oncology-Hematology, Department of Internal Medicine, Kyung Hee University Hospital) ;
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Kang, Su Jin
(Education Center of Persons Conducting Clinical Trial, Kyung Hee University Hospital) ;
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Lee, Sun Ju
(Department of Urology, Kyung Hee University Hospital) ;
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Yim, Hyeon Woo
(Department of Preventive Medicine, College of Medicine, The Catholic University of Korea) ;
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Choe, Byung-in
(Nicolas Cardinal Cheong Graduate School for Life, The Catholic University of Korea) ;
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Shin, Im Hee
(Department of Medical Statistics and Informatics, School of Medicine, Daegu Catholic University) ;
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Huh, Jung-Sik
(Department of Urology, Jeju National University Hospital) ;
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Kwon, Ivo
(Ewha Womans University, School of Medicine) ;
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Yoo, Soyoung
(Department of Convergence Medicine, Asan Medical Center) ;
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Lee, Mi-Kyung
(Department of Laboratory Medicine, Chung-Ang University College of Medicine) ;
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Shin, Hee-Young
(Department of Biomedical Sciences, Chonnam National University Medical School) ;
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Kim, Duck-An
(Department of Laboratory Medicine, Hanyang University Medical Center)
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맹치훈
(경희대학교병원 종양혈액내과) ;
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강수진
(경희대학교병원 임상시험종사자교육센터) ;
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이선주
(경희대학교병원 비뇨의학과) ;
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임현우
(가톨릭대학교 의과대학 예방의학교실) ;
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최병인
(가톨릭대학교 생명대학원) ;
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신임희
(대구가톨릭대학교 의과대학 의학통계학교실) ;
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허정식
(제주대학교병원 비뇨의학과) ;
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권복규
(이화여자대학교 의과대학) ;
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유소영
(서울아산병원 융합의학과) ;
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이미경
(중앙대학교 의과대학 진단검사의학교실) ;
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신희영
(전남대학교 의과대학 의생명과학교실) ;
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김덕언
(한양대학교병원 진단검사의학과)
- Published : 2020.02.28
Abstract
Purpose: To obtain opinions from Korean Institutional Review Board (IRB) members' self-evaluation on ability to conduct fairness review of clinical trial protocol with presence of conflict of interest and from investigators and IRB members on financial conflict of interest through surveying. Methods: IRB members and researchers in 9 different hospitals were asked to answer survey questions via email. Results: Responders were 115 personnel (IRB Chair/vice 18, medical member 30, non-medical member 28, and researcher 39) from 9 centers. Compared to IRB medical members, IRB chair/vice respondents scored higher with statistically significance on 10 point scale (8.44±1.381 vs. 7.30±1.685, p=0.005) when asked to self-evaluate fairness reviewing a protocol proposed by an investigator from the same department and a protocol from the company that supports the scientific committee of responders. When reviewing a protocol proposed by a hospital director, non-medical members scored statistically significantly higher than medical-members (7.47±1.76 vs. 8.07±2.70, p=0.034). When asked about the limitation of labor fee for principal investigator on phase 3 Human clinical trials of the Investigational new drug, while the responses range was wide, 60% answered that labor cost of principal investigator should be less than 30% of total budget for clinical trials with a budget of 100 million won. 51.3% answered that there is no need to disclose the labor cost of the principal investigator in the consent form. Since every investigator can be influenced unconsciously by conflict of interest, the answer that 'responder agrees that there is need for management' was the most chosen answer (IRB member 61.8%, investigator 64.1%, multiple answers allowed). Conclusion: Considering scores on questions of fairness by IRB members were between 7.23-8.56 on scale of 0 to 10 point when IRB members were asked about reviewing a clinical trial protocol, it cannot be said with absolute certainty that there is no issue regarding fairness in the review process. Therefore, there should be more ways to safeguard fairness for these issues. There is a need that the disclosure amount of honorarium from sponsor should be lower than 100 million Korean won. Considering the results of the survey in which respondents expressed their thoughts, it is likely that more education on the concept of conflict of interest is needed.