IRB Guidance: Research vs. Quality Improvement/Program Evaluation
This page provides an overview of research vs. quality improvement (QI)/program evaluation.
Determining whether a project constitutes human subjects research rather than QI or program evaluation involves multiple factors.
Research vs. QI/Program Evaluation
The Institutional Review Board (IRB) is responsible for protecting the rights and welfare of human subjects in research. As a result, the first question a researcher should consider with respect to IRB review requirements is whether the project fits the definition of research. The federal definition of research is “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes.” This is an important distinction to make because it determines whether IRB review and oversight of a project is needed because IRB oversight is limited to human subjects research. If the project includes a research question/hypothesis, an intent to publish, present or contribute to generalizable knowledge, or the project would not be conducted in the same way or at all if there was no potential for publication/presentation, the project is most likely considered research and an IRB application should be submitted.
Some activities are typically outside the realm of research (e.g. internal management activities such as QI, quality assessment and program evaluation). If there are no plans to publish or present a QI or program evaluation project and the sole intent is to evaluate or improve a process or function within a program or institution, IRB review is most likely not required. However, if you believe that your project does not constitute research, but you are required by UW-Madison policy, an outside entity, or a publisher to obtain a formal IRB determination, then an IRB application will need to be submitted in order to receive a formal IRB determination that the project falls outside of the federal definition of research. Please note, this is generally true for access to academic records or the requirements outlined by FERPA. For example, the Registrar's office or an outside entity (e.g. Department of Public Instruction) could want a formal IRB determination and, as stated above, an IRB application would need to be submitted in order to receive a formal determination from the IRB that the project falls outside of the federal definition of research.
Often, determining whether a project constitutes research under federal and institutional regulations can be a complex process that involves assessing the project intent, design, mandates, expected outcomes, and dissemination of results. The tool outlined below is intended to assist study teams in determining whether a project requires submission to the IRB as a research project involving human subjects. If the project involves some characteristics of a research project, submission to the IRB for review is expected.
IRB QI/Program Evaluation Self-Certification Tool
This tool allows study teams to make the decision about whether their project constitutes the definition of research under the Common Rule (45 CFR 46) independent of the IRB. The tool is designed to help determine whether the project constitutes research or whether it is quality improvement or program evaluation, such that IRB review isn’t required.