This document provides a flowchart to determine if an activity qualifies as human subjects research according to 45 CFR 46. It asks a series of yes or no questions to determine if the activity is a systematic investigation designed to develop generalizable knowledge, involves obtaining information about living individuals, and whether that information is individually identifiable or private. If the activity meets all these criteria, it qualifies as human subjects research under 45 CFR 46 and requires IRB review.