When Does QI Need IRB Review and Approval?


Problem Statement 
At our institution, people often ask whether a project represents QI or research. Much confusion exists regarding the distinction between QI activities and research and the regulatory framework aiming to provide guidance is lacking specificity, leaving researchers and staff to wonder whether or not to submit an application to the IRB for a formal determination. Our IRB realized that we needed to take a step back and ask ourselves, when does a QI project need IRB review? This poster will examine how we reviewed and revised our institutional policies, developed guidance sheets, and communicated with staff to facilitate better guidance regarding the differences and similarities between QI and research. 

Description of the Project
The regulatory guidance separating QI activities from research activities is notoriously confusing. Research is defined as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.” QI, unlike research, focuses on translating existing knowledge into practice to improve the quality of a program or a process. Today, as healthcare institutions aim to collect, analyze, and learn from patient-level data and evidence-based practice decisions, the lines between the two categories are becoming even more unclear. 

To meet the need for clarification, we first reviewed federal guidelines and institutional policies aimed at determining levels of review and ethical oversight. Then, we created a visual tool to help identify the differences and similarities between research activities and QI projects. We created a new “Human Subjects Research” determination form that was implemented with our electronic research management system. Then, we educated staff, expedited reviewers, and department managers in affected research departments on how to use the new tools.