Human Subjects Protection Program (HSPP)

Investigators are required to report local problems, concerns, serious risks, and failure to follow the protocol to the IRB for all human subjects research. These reports must be submitted to the IRB within ten (10) business days of discovery. Changes made to eliminate risk to subjects must be reported to the IRB within five (5) business days of discovery. Reportable items must be submitted in eIRB as a Reportable New Information (RNI). If the University of Arizona IRB is the IRB of Record for another site, the site must follow the same requirements. For additional information, please see the HSPP guidance on Reporting New Information. 

IRB review and approval are required for research projects involving human subjects.

Human subjects research is a systematic investigation (research question/hypothesis testing), designed to contribute to generalizable knowledge (add to the scientific knowledge base in the field), done so while intervening or interacting with living individuals or their identifiable data. For additional information, refer to the HSPP guidance on What is Human Research and watch our training video: Does Your Project Require IRB Review? 

If you are still unsure whether or not your study is human subjects research, complete and submit the IRB Protocol for Determination of Human Research in eIRB.