Differentiating research and quality improvement activities: A scoping review and implications for clinical scholarship.

Background: Differentiating activities that are research or quality improvement (QI) is challenging.

Purpose: Compare tools that distinguish research from QI and evaluate the utility of tools to determine whether institutional review board (IRB) approval is required for a test-project.

Methods: Scoping review of the literature to identify tools that distinguish QI from research. Two reviewers independently screened records in PubMed, Embase, Cumulative Index to Nursing and Allied Health Literature, Web of Science and Google Scholar and extracted information from tools. Inclusion criteria were English language peer-reviewed publications or publicly available tools with scoring systems to differentiate between research and QI. The reporting of this review follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses. We then applied a test-project to evaluate the utility of the tools.

Findings: One-hundred forty sources were reviewed; 13 met inclusion criteria. Tools consistently used project intent/purpose, design and intervention as differentiating criteria; additional criteria varied. Five studies described tool development, and one reported that the tool had been tested. Our application of a test-project proved challenging as tools commonly presented research and QI as discrete activities.

Discussion: Based on the core criteria common across tools to distinguish research from QI, we propose a simple four-criteria decision tool for assessing the need for IRB submission.