임상약리학회지 (Journal of Korean Society for Clinical Pharmacology and Therapeutics)

대한임상약리학회 (Korean Society for Clinical Pharmacology and Therapeutics)
권호 표지

IRB 상호인정제 운영 방안에 관한 연구

Institutional Review Board (IRB) Mutual Recognition Program and Its Feasibility in Korea

  • 정혜림 (가톨릭대학교 가톨릭중앙의료원 연구윤리사무국) ;
  • 임현우 (가톨릭대학교 의과대학 예방의학교실) ;
  • 최병인 (가톨릭대학교 가톨릭중앙의료원 연구윤리사무국) ;
  • 김영인 (가톨릭대학교 서울성모병원 신경과)
  • Cheong, Hye-Rim (Office of Human Research Protection, Catholic Medical Center, The Catholic University of Korea) ;
  • Yim, Hyeon-Woo (Department of preventive medicine, College of Medicine, The Catholic University of Korea) ;
  • Choe, Byung-In (Office of Human Research Protection, Catholic Medical Center, The Catholic University of Korea) ;
  • Kim, Yeong-In (Department of Neurology, Seoul St. Mary's Hospital, The Catholic University of Korea)
  • 투고 : 2011.12.04
  • 심사 : 2011.12.22
  • 발행 : 2011.12.30
⟨ 이전 논문 다음 논문 ⟩

초록

Background: The use of Cooperative Institutional Review Board (Co-IRB) has become subject to continuous discussion. As a result, leading mainly by the Korea Association of Institutional Review Boards (KAIRB), "IRB mutual recognition program (MR-IRB)" was proposed. However operational methods of the program are still controversial. The object of this research is to examine domestically feasible scope and operation methods of MR-IRB by conducting survey. Methods: 71 survey data was collected from chairman or specialist of each IRB and 29 IRB members of one institution running Central IRB was included. Results: 76.5 % of respondents selected phase 3 multi-national, multi-center clinical Sponsor Initiated Trial as a suitable subject of MR-IRB, but only 50 % supported Investigator initiated trials, and answered early-stage clinical trials such as phase 1 clinical trials or biological agent trials are unsuitable due to relatively insufficient knowledge on risk level. In order to operate MR-IRB, standardized review criteria and agreement of institutions in building mutual trust is essential. Also it was learned from the survey that the most desirable way to adopt MR-IRB is to be initiated by the representing organization such as KAIRB based on mutual trust from institutional agreement. Conclusion: MR-IRB was recognized as one of Co-IRB. A suitable subjects of MR-IRB were preferred the phase 3 multi-national, multi-center clinical sponsor initiated trials to all kinds of clinical trials. This study suggests that based on real operation experience from MR-IRB pilot study, further study should be conducted to analyze pros and cons of MR-IRB and identify domestically eligible model to facilitate MR-IRB.

키워드

과제정보

연구 과제 주관 기관 : 식약청

참고문헌

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