title: Variation in institutional review board responses to a standard, observational, pediatric research protocol.
abstract: 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.
authors.affiliation: Department of Medicine, Children's Hospital Boston, Boston, MA, USA. jonathan.mansbach@childrens.harvard.edu
authors.forename: Jonathan
authors.initials: J
authors.lastname: Mansbach
authors.forename: Uchechi
authors.initials: U
authors.lastname: Acholonu
authors.forename: Sunday
authors.initials: S
authors.lastname: Clark
authors.forename: Carlos A
authors.initials: CA
authors.lastname: Camargo
mesh_terms: D001988:Bronchiolitis / Q000628:therapy*; D002985:Clinical Protocols / Q000592:standards*; D004636:Emergency Service, Hospital; D028744:Ethics Committees, Research / Q000592:standards*; D020408:Health Insurance Portability and Accountability Act; D006801:Humans; D015337:Multicenter Studies as Topic / Q000592:standards*; D010372:Pediatrics; D012107:Research Design; D014481:United States