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Variation in institutional review board responses to a standard, observational, pediatric research protocol.

Mansbach J, Acholonu U, Clark S, Camargo CA

Department of Medicine, Children's Hospital Boston, Boston, MA, USA. jonathan.mansbach@childrens.harvard.edu

BACKGROUND: Multicenter studies are becoming more common, and variability in local institutional review board (IRB) assessments can be problematic. OBJECTIVE: To investigate the variability of IRB responses to a multicenter observational study of children presenting to emergency departments. METHODS: The authors collected the original IRB applications, subsequent correspondence, and a survey assessing submission timing and response and the nature of IRB queries. The study was conducted as part of the Emergency Medicine Network (http://www.emnet-usa.org). RESULTS: Of 37 sites initiating the IRB process, 34 (92%) participated in this IRB-approved study. Institutional review boards returned initial applications in a median of 19 days (IQR, 11-34 d), and 91% considered the protocol to be minimal risk. Of 34 submissions, 13 required no changes, 18 received conditional approvals, and 3 were deferred. The median time from initial submission to final approval was 42 days (IQR, 27-61 d). Seven sites did not participate in patient recruitment: two had institutional issues, one obtained IRB approval too late for participation, and four sites (12%) reported that IRB hurdles contributed to their lack of participation. Nonetheless, 68% of sites that recruited patients reported that the overall experience made them more likely to participate in future multicenter research. CONCLUSIONS: There was substantial variation in IRB assessment of a standard protocol in this study. The burden of the application process contributed to some investigators not participating, but the majority of investigators remain enthusiastic about multicenter research. A national IRB may streamline the review process and facilitate multicenter clinical research.

Published 2 April 2007 in Acad Emerg Med, 14(4): 377-80.
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