Under the Common Rule and UW-Madison HRPP Policy, IRB review is required for all human subjects research, defined as:

• A systematic investigation designed to contribute to generalizable knowledge, and
• Involves obtaining information or biospecimens from a living individual through either interaction or intervention, with the individual or access to the individual’s private information, including protected health information (PHI).

In addition, the FDA requires IRB review for the use of de-identified human specimens in clinical investigations of medical devices when the research may generate or collect data that may be submitted to the FDA for review.