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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. 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. 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 sub