Is this Project Research?
When evaluating a specific project, it is important to designate if the project is “research”. To be considered research, a project must (1) involve a systemic investigation and (2) the design-meaning goal, purpose, or intent of the investigation is to develop or contribute to generalizable knowledge.
Once the project has been considered “research”, the next step is to determine whether the project involves “human subjects” as defined in DHHS 45 CFR 46. This Code of Federal Regulations states that: Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual or (2) identifiable private information.
In order for a project to require IRB review, it must both be research and involve human subjects. A decision chart may provide the best analysis for making that determination. Students may wish to view the FAQ on quality improvement activities.