Facilitating Timely Institutional Review Board Review: Common Issues and Recommendations

Abstract

Review of clinical research by institutional review boards (IRBs) is integral to the protection of human subjects and necessary for the conduct of legal and ethical research. Because such review is time and resource intensive, it is critical to identify common issues that contribute to delayed review and approval of research. Hence, the aim of this quality improvement project was to identify factors associated with long delays in IRB approval and identify potential strategies to streamline the review process. In collaboration with the human subjects research protection program at a large academic health center in the northeastern United States, we conducted a content analysis of minutes of convened IRB meetings for every new protocol (initial submission) approved between January and September 2019 that required greater than or equal to two full board reviews prior to approval (<i>n</i> = 33). We also examined characteristics of new protocols that were reviewed less than twice at convened meetings during the same time frame (<i>n</i> = 244). Using χ² or Fisher's exact tests, the characteristics of protocols with multiple reviews by the convened IRBs were compared with those protocol submissions reviewed by the convened IRBs only once. Three factors significantly associated with increased delays were researcher conflict of interest (30% vs. 12%, respectively, <i>p</i> < .01), need for radiation safety evaluation (36% vs. 20%, respectively, <i>p</i> = .03), and protocols that were clinical trials (73% vs. 60%, respectively, <i>p</i> < .01). Other factors associated with delayed IRB approval were excessive technical jargon (93.94%, <i>n</i> = 31), inadequate description of data security or inability to meet data security requirements of the institution (75.76%, <i>n</i> = 25), protocol design affecting patient safety (57.58%, <i>n</i> = 19), and lack of clarity regarding compensation and payment or study duration (<i>n</i> = 18, 54.54% each). Approaches to mitigate delays in approval and increase the efficiency and efficacy of the IRB process are recommended.

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