ORIGINAL ARTICLE ISSN 1598-9100(Print) • ISSN 2288-1956(Online)
http://dx.doi.org/10.5217/ir.2015.13.3.274 Intest Res 2015;13(3):274-281
Institutional Board Review for Clinical Investigations on Inflammatory Bowel Diseases: A Single-Center Study Sinyoung Park1, Yang Hee Noh1, Sun Young Rha1,2, Won Ho Kim3, Jae Hee Cheon3 Human research Protection Center, Severance Hospital, Yonsei University Health System1, Seoul, Department of Internal Medicine and Institute of Oncology2, Department of Internal Medicine and Institute of Gastroenterology3, Yonsei University College of Medicine, Seoul, Korea
Background/Aims: The growing volume and the diversity of clinical research has led to related laws and regulations as well as the Institutional Review Board (IRB) approval process becoming more stringent. To conduct clinical research efficiently and while following regulations, information about the IRB approval process and feedback is important for investigators. This has yet to be studied. Methods: We included 381 gastrointestinal disease research proposals (79 with inflammatory bowel disease [IBD], and 302 with non-IBD) reviewed by the IRB of Severance Hospital between January 2009 and December 2013. We retrospectively analyzed research characteristics including research risk levels, results of initial reviews, frequencies of continuing review, numbers of IRB comments, frequencies of IRB comments, and durations from submission to approval. Results: Investigators’ decisions on risk level were higher in the IBD group than in the non-IBD group (P
http://dx.doi.org/10.5217/ir.2015.13.3.274 Intest Res 2015;13(3):274-281
Institutional Board Review for Clinical Investigations on Inflammatory Bowel Diseases: A Single-Center Study Sinyoung Park1, Yang Hee Noh1, Sun Young Rha1,2, Won Ho Kim3, Jae Hee Cheon3 Human research Protection Center, Severance Hospital, Yonsei University Health System1, Seoul, Department of Internal Medicine and Institute of Oncology2, Department of Internal Medicine and Institute of Gastroenterology3, Yonsei University College of Medicine, Seoul, Korea
Background/Aims: The growing volume and the diversity of clinical research has led to related laws and regulations as well as the Institutional Review Board (IRB) approval process becoming more stringent. To conduct clinical research efficiently and while following regulations, information about the IRB approval process and feedback is important for investigators. This has yet to be studied. Methods: We included 381 gastrointestinal disease research proposals (79 with inflammatory bowel disease [IBD], and 302 with non-IBD) reviewed by the IRB of Severance Hospital between January 2009 and December 2013. We retrospectively analyzed research characteristics including research risk levels, results of initial reviews, frequencies of continuing review, numbers of IRB comments, frequencies of IRB comments, and durations from submission to approval. Results: Investigators’ decisions on risk level were higher in the IBD group than in the non-IBD group (P
