J Korean Soc Clin Pharmacol Ther.  2011 Dec;19(2):152-165.

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

• Cheong HR
• Yim HW
• Choe B
• Kim YI

Abstract

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.

Keyword

Cooperative institutional review board; IRB mutual recognition program; Central institutional review board (CIRB)

MeSH Terms

Surveys and Questionnaires
Ethics Committees, Research
Humans
Korea
Pilot Projects
Research Personnel
Running
Specialization