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KMID : 0363620100310010122
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Journal of Korean Oriental Medicine
2010 Volume.31 No. 1 p.122 ~ p.129
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Current Status of Institutional Review Boards and Approvals of Clinical Research in Oriental Medical Hospitals in Korea: A Survey
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Jung Hee-Jung
Choi Sun-Mi
Park Ji-Eun
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Abstract
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Objective: To investigate institutional review boards and approved clinical trials of Oriental medical hospitals in Korea
Methods: We e-mailed 16 Oriental medical hospitals a survey consisting of questions that addressed two topics, institutional review boards and the clinical trials they approved. The first part included questions about whether each hospital had an institutional review board, that board’s staffing and education, reviews, and expedited reviews. The clinical trials portion covered the number and types of approved clinical trials, treatment methods, whether an investigator or a sponsor initiated the trials, diseases, time frame, and clinical trial fee.
Results: We received a response to our e-mail from 14 hospitals, all of which had an institutional review board. The average number of institutional review board members was 13.57. Of these Oriental medical hospitals, 70% and 49% said that they regularly educated their institutional review board staff and clinical trial, investigators, respectively. 79% of the hospitals claimed to conduct regular reviews, and 50% said that they did so monthly. The number of approved clinical trials increased sharply from 11 in 2005 to 102 in 2008. 68% of these clinical trials were randomized, and the most-used treatment methods were herbal medicine (35%) and acupuncture (29%). The most common target diseases were circulatory (19%), urinogenital (14%), and musculoskeletal (13%) disease.
Conclusions: Despite the rapid increase in clinical research in oriental medical hospitals, many more efforts including raising IRB quality, varying research diseases and increasing clinical trials in the hospitals located in non-metropolitan area, should be made.
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KEYWORD
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Institutional review board, clinical trial, IRB
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