Variability of the Institutional Review Board Process Within a National Research Network

    loading  Checking for direct PDF access through Ovid

Abstract

Objective.

To determine the variability of the institutional review board (IRB) process for a minimal risk multicenter study.

Methods.

Participants included 24 Continuity Research Network (CORNET) sites of the Academic Pediatric Association that participated in a cross-sectional study. Each site obtained individual institutional IRB approval. An anonymous questionnaire went to site investigators about the IRB process at their institution. Results Twenty-two of 24 sites (92%) responded. Preparation time ranged from 1 to 20 hours, mean of 7.1 hours. Individuals submitting ≤Ü3 IRB applications/year required more time for completion than those submitting >3/year (P < .05). Thirteen of 22 (59%) study sites received approval with “exempt” status, and 6 (27%) approved as “expedited” studies.

Conclusions.

IRB experiences were highly variable across study sites. These findings indicate that multicenter research projects should anticipate barriers to timely study implementation. Improved IRB standardization or centralization for multicenter clinical studies would facilitate this type of practice-based clinical research.

Related Topics

    loading  Loading Related Articles