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Clinical pediatrics · Jun 2014
Variability of the institutional review board process within a national research network.
- Muhammad A Khan, Michelle S Barratt, Scott D Krugman, Janet R Serwint, Marilyn Dumont-Driscoll, and CORNET Investigators.
- 1Children's National Medical Center, Washington, DC, USA.
- Clin Pediatr (Phila). 2014 Jun 1; 53 (6): 556-60.
ObjectiveTo determine the variability of the institutional review board (IRB) process for a minimal risk multicenter study.MethodsParticipants 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.ResultsTwenty-two of 24 sites (92%) responded. Preparation time ranged from 1 to 20 hours, mean of 7.1 hours. Individuals submitting ≤3 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.ConclusionsIRB 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.
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