抄録
The Nagoya University Ethics Committee (NUEC) is responsible for reviewing the appropriateness of research protocols from ethical and scientific points of view. In March 2011, to support and enrich the review process, a system of preliminary reviews was implemented. We analyzed all of the research protocol applications that were submitted to the NUEC between April 2011 and March 2012 (FY2011) and for which a result notification was issued and compared the total review times for FY2009 (between April 2009 and March 2010) and FY2011. In FY2011 and FY2009, 259 and 242 applications, respectively, were received. In 2011, the median preliminary review time and total review time were 28 days and 70 days, respectively. In FY2009, the median total review time was 58 days. The total number of queries received regarding the preliminary review in FY2011 was 5,286. The most common query was related to protocol (n=3,429; 64.9%), and the second most common was related to the informed consent form (n=1,130; 21.4%). Of the 3,429 queries related to protocol, the majority was related to the research methods (n=1,542; 45.0%) such as the evaluation items, selection criteria, and statistical methods of analysis chosen. Our results show that the necessary application materials were not submitted in many cases. Although the total time for review was increased due to the preliminary review process, our results suggest that the preliminary reviews are meaningful and that they allow the ethics committee to conduct its review based on improved applications. However, we must continue to consider how to support clinical research and reduce the total time for review.
(Jpn J Clin Pharmacol Ther 2013; 44(6): 443-450)
