Human Subjects Protection Program (HSPP)

Does the HSPP provide any other training for investigators about the IRB?

Yes! The HSPP offers a variety of training opportunities including workshops and Office Hours. For training details, please visit the IRB Training Opportunities webpage. If you are interested in requesting training on a specific topic or having an HSPP member present at a class, lab, or faculty meeting, please contact the general inbox at VPR-IRB@arizona.edu

I'm using Banner Health resources. What do I need to know?

Prior to IRB submission, all projects that will utilize Banner Health resources (i.e., facilities, patients, employees) must be entered into the University of Arizona Health Sciences (UAHS) Research Administration Portal (RAP). Upon submission to the IRB, please upload RAP approval to eIRB. In addition, the IRB also requires that the UA Medical Consent Form be used when Banner Health resources will be utilized.

How do I report an unanticipated complication and/or adverse event?

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 our guidance on Reporting New Information

Does my research require IRB approval?

IRB review and approval is 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 knowledgebase in the field) done so while intervening or interacting with living individuals or their identifiable data. For additional information, please see our guidance on What is Human Research and watch our pre-recorded 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.