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The Journal of KAIRB

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원저(original article) 전문보기
Institutional Review Board 심의 결과 분석을 통한 효율 적 심사 및 합리적 운영에 대한 개선안 모색
이윤진1, 장혜윤1, 장정희1,2
1계명대학교 동산병원 임상연구보호센터, 1,2계명대학교 의과대학 약리학교실
Suggested Improvement Strategies for the Efficient Review and Rational Operation of Institutional Review Board (IRB) Based on the Analysis of IRB Review Results
Yoon Jin Lee1, Hye Yun Jang1, Jung-Hee Jang1,2
1Human Research Protection Center, Keimyung University Dongsan Hospital, Daegu, Korea 2Department of Pharmacology, School of Medicine, Keimyung University, Daegu, Korea
To suggest future directions for the improvement in the Institutional Review Board (IRB) review process and efficient operation of
IRB, we have analyzed the IRB review results from 460 new research proposals submitted to the Review by the Convened IRB of the Keimyung University Dongsan Hospital IRB from January 2019 to July 2021. IRB is an independently established institutional committee to protect the human subjects by reviewing the research protocol in ethical as well as scientific aspects, so it is
necessary to continuously contemplate the ethical versus scientific dilemma of 'what is ethical or scientific and what can actually
protect human subjects.' Particularly, in this process, it is necessary to consider diverse ways to strengthen self-supervision
through continuous Internal Audit rather than simple reporting outcomes. In addition, if it does not directly affect the protection of the human subjects, the discussion with the committee members is needed so that the comments such as administrative and typographical errors can be reduced as much as possible. Furthermore, as statistical analysis methods can have a significant impact on the safety of human subjects, if a legal basis and/or support related to statistics is provided for the composition of IRB members, a more specialized IRB review will be achieved.
Keyword :
Institutional Review Board, Review results, Protection of human subjects, Improvement strategies

Journal of KAIRB 2022년 2월 4권1호 5 – 15

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