When is a Project Quality Improvement?: Navigating QUERI Operations versus Research protocols.

Kilbourne AM, McIvor L, Whatley A, Nelson K, Damschroder LJ, Rubenstein L, Yano E, Burris J. When is a Project Quality Improvement?: Navigating QUERI Operations versus Research protocols. Paper presented at: VA HSR&D / QUERI National Meeting; 2015 Jul 10; Philadelphia, PA.

Abstract: Increasingly, projects sponsored by the VA Quality Enhancement Research initiative (QUERI) program have involved extensive input or direction from VA operational partners and are primarily designed to benefit a VA national or regional program or office. Because QUERI is funded by medical care special purpose funds, these projects are eligible to be considered quality improvement (QI) and not research, and hence, not subject to IRB reviews. However, the boundaries between "research" and "quality improvement" can be difficult to discern and manage over time, especially when the evaluation involves implementation strategies or provider/system-level outcomes. This workshop is designed primarily for QUERI and other investigators who are working with VA operations partners and might have a protocol that could be considered operations, or QI. Particular guidance will be provided on how to discern activities that may constitute research versus QI, ensuring adequate communications regarding QI activities among leadership and frontline providers, and publication opportunities for QI and national evaluation work. Insights will be largely based on the VHA Handbook 1058.05 and guidance from the Central IRB and Office of Research Oversight, as well as key examples from current VA QI and blended QI-research study protocols.