The Blind Review: A quality assessment measure for review standardization of Institutional Review Boards

Abstract

Abstract Background: Standardization of IRB reviews has become increasingly important with the rise in multinational trials. Though inconsistency is often inevitable because of varying opinions on ethics, standardizing and understanding the differences between review results is required to ensure that high IRB review quality is maintained. Therefore, we aimed to develop a quality assessment measure of IRB, named “blind review,” by reviewing the same research protocols followed by multiple IRB panels. We then analyzed the differences between the panels to understand the mechanism of IRB standardization. Methods: Based on the Human research Protection Program (HRPP) Standard Operating Procedures (SOPs), eight blind review results from January 2010 to December 2018 at a single institution with multiple panels, using the Severance Hospital HRPP database as the source, were analyzed. The review scores ranged from 0 to 60 points, including good clinical practice (GCP) requirements and protocol issues Panel agreement was estimated by observed multiple rater agreement. Differences between review scores according to member expertise and IRB member duration were analyzed using the Wilcoxon rank-sum test and Kruskal-Wallis test. Results: The observed multiple raters’ agreement increased from 0.444 (95% CI: 0.167-1.000) in 2010 to 0.479 (95% CI: 0.271-0.708) in 2014-2018, as IRB reviewer experience increased. To analyze the review mechanism, three GCP requirements and three protocol issues were scored (range 0 to 60). The mean values for GCP requirements and protocol issues were 19.25±8.21 and 18.40±9.04, respectively. The mean score of the panels in which experts participated (n=16, 28.13±10.47) was higher than those of the control group (n=32, 25.16±10.96) (p=0.93). According to IRB members’ experience, scores for the group whose career spanned less than 3 years was 25.0±10.0 (n=14), those for the group whose career spanned 3-5 years was 26.3±9.6 (n=23), and those for the group whose career spanned more than 5 years was 27.3±14.2 (n=11). These results were statistically significant (p=0.09). Conclusions: We suggest blind review as an effective measure for overseeing and ensuring IRB review quality and overall GCP compliance.

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