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Introduction of Institutional Review Board
The Institutional Review Board (IRB) of the KMUH was officially established in 1987. As the demand for human research protocol review grows, the IRB was renamed to Institutional Review Board-I in August of 2009, and the Institutional Review Board-II was also added. The two IRBs operate together to improve the quality of human research protocol reviews and efficiency. 

The main responsibilities of the IRB are to review and supervise all human research protocol applications under the KMUH medical system and contracted review institutions. The operation of the IRB is in line with all domestic and foreign GCP regulations and legislatures. The IRB has passed the audit of the Ministry of Health and Welfare’s (formerly the Department of Health) IRB for Human Subject Research, allowing the principal investigators in the KMUH medical system to participate in the FDA’s cross-border academic research and collaboration projects.

Recent domestic and foreign accreditations/certifications:

2007 passed the IRB qualification review of the Department of Health
2007 passed the FERCAP international certification
2009 passed the IRB/Human Subject Research qualification review of the Department of Health
2010 passed the FERCAP continuous certification
2012 passed the IRB for Human Subject Research qualification review of the Department of Health
2016 passed the IRB for Human Subject Research qualification review of the Ministry of Health and Welfare
2018 AAHRPP Final Accreditation Status Full Accreditation


Awards:
.Received the 2014 c-IRB Contribution Award from the Ministry of Health and Welfare
.Received the 2015 c-IRB Contribution Award from the Ministry of Health and Welfare
.Received the 2016 c-IRB Contribution Award from the Ministry of Health and Welfare

To ensure the rights and safety of the human research participants (test subjects) and to assist the principal investigators in successfully passing the review process, the IRB committee members and review experts undergo regular GCP education trainings. The IRB also regularly evaluates review performances to maintain the quality of review. Additionally, the administrative staff of the IRB is trained to serve our clients with the utmost in courtesy, responsibility and professionalism. We hope that through our excellent quality of review and professional administrative staff, we can fulfill our duty to protect the rights and benefits of the human research participants, and further improve the quality of our clinical trials and human research.

 



 

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