Non-regulated research are activities that do not involve a prospective research plan that incorporates data collection, either quantitative or qualitative, and data analysis to answer a research question. These activities do not involve a predetermined method for studying a specific topic, answering a specific question, testing a hypothesis, or developing theory.
To determine if a project constitutes human subjects research involves multiple factors. Although Non-regulated activities may involve human participants, most are not considered research that requires IRB review. This is an important distinction to make because it determines whether IRB review and oversight of a project is needed.
Researchers may request a determination that an activity is Non-Regulatory Research, but the final determination will be made by the IRB Office