Variability in obtaining institutional review board approval for quality improvement activities in residency programs

住院医师培训项目中质量改进活动获得机构审查委员会批准的难易程度存在差异

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Abstract

INTRODUCTION: Quality improvement (QI) activities are an important part of residency training. National studies are needed to inform best practices in QI training and experience for residents. The impact of the Institutional Review Board (IRB) process on such studies is not well described. METHODS: This observational study looked at time, length, comfort level, and overall quality of experience for 42 residency training programs in obtaining approval or exemption for a nationally based educational QI study. RESULTS: For the 42 programs in the study, the time period to IRB approval/exemption was highly variable, ranging from less than 1 week to 56.5 weeks; mean and median time was approximately 18 weeks (SD, 10.8). Greater reported comfort with the IRB process was associated with less time to obtain approval (r  =  -.50; P < .01; 95% CI, -0.70 to -0.23). A more positive overall quality of experience with the IRB process was also associated with less time to obtain IRB approval (r  =  -.60; P < .01; 95% CI, -0.74 to -0.36). DISCUSSION: The IRB process for residency programs initiating QI studies shows considerable variance that is not explained by attributes of the projects. New strategies are needed to assist and expedite IRB processes for QI research in educational settings and reduce interinstitutional variability and increase comfort level among educators with the IRB process.

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