Variation in Institutional Review Board Responses to a Standard, Observational, Pediatric Research Protocol

• Published in: Academic emergency medicine Vol. 14; no. 4; pp. 377 - 380
• Main Authors: Mansbach, Jonathan, Acholonu, Uchechi, Clark, Sunday, Camargo, Carlos A.
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 01.04.2007
• Subjects: Health Insurance Portability and Accountability Act; institutional review board; multicenter studies; Privacy Rule
• ISSN: 1069-6563; 1553-2712
• DOI: 10.1197/j.aem.2006.11.031

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.