Determining whether a project constitutes human subjects research rather than quality improvement or program evaluation involves multiple factors. 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.

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 QI/Program Evaluation Self-Certification Tool is designed to assist study teams in determining whether a project requires submission to the IRB. If the project involves some characteristics of a research project, the Tool will let you know that IRB review is required. If the project does qualify as program evaluation/QI, the Tool will provide you with a certification confirming this. This certification can be printed off and used as documentation that the project does not constitute research and further IRB review is not required.

NOTE: This tool is not designed to determine all cases when a project falls outside of the IRB’s purview. This tool is only for determining if a project is QI/Program Evaluation, rather than research. The tool should not be used for public health surveillance projects.

A journal or conference may not accept the certification as proof your project does not require IRB approval. In such cases, you will need to submit an application in ARROW to obtain a formal IRB determination.