Khan Muhammad A, Barratt Michelle S, Krugman Scott D, Serwint Janet R, Dumont-Driscoll Marilyn
1Children's National Medical Center, Washington, DC, USA.
Clin Pediatr (Phila). 2014 Jun;53(6):556-60. doi: 10.1177/0009922814527504. Epub 2014 Mar 20.
To determine the variability of the institutional review board (IRB) process for a minimal risk multicenter study.
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.
Twenty-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.
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.
确定机构审查委员会（IRB）对一项低风险多中心研究的审查流程的变异性。
参与者包括学术儿科学会的24个连续性研究网络（CORNET）站点，这些站点参与了一项横断面研究。每个站点均获得了各自机构的IRB批准。向各站点的研究人员发放了一份关于其所在机构IRB审查流程的匿名调查问卷。
24个站点中有22个（92%）做出了回应。准备时间从1小时到20小时不等，平均为7.1小时。每年提交≤3份IRB申请的个人完成申请所需时间比每年提交>3份申请的个人更长（P <.05）。22个研究站点中有13个（59%）获得了“豁免”状态的批准，6个（27%）被批准为“快速”研究。
各研究站点的IRB审查经历差异很大。这些发现表明，多中心研究项目应预见到及时开展研究的障碍。改善多中心临床研究的IRB标准化或集中化将有助于此类基于实践的临床研究。
