Skip to main content

Getting Started

Do I need to submit a modification to my approved research study?

Full Committee or Expedite Research

The IRB must review and approve all changes to previously approved Full Committee or Expedite research prior to implementing the changes. For additional information, see our guidance on Modifying Approved Research.

You can find more information on how to submit a Modification on our eIRB Information webpage.

Exempt and Minimal Risk Research

Studies that are Exempt or Minimal Risk (MR) do not need to submit modifications to the IRB for review and approval unless the modifications change the nature of the project from being Exempt/MR. Refer to the Exempt Minimal Risk Research guidance, which outlines when modifications are required.

If a modification is not required, the IRB recommends downloading the relevant approved documents within eIRB, making the necessary changes, and saving them separately in your research files. All modifications not reviewed by the IRB should be documented systematically to maintain an accurate record of all study activities to date.

What does "Exempt" mean? Does this mean I don't have to submit an application for review?

Projects that meet the definition of regulated human research under the Common Rule may fit within one or more categories of “Exempt” research. This does not mean that these studies do not need IRB review. For a research study to be deemed "Exempt", investigators need to submit an application to the IRB. Please note that an "Exempt" determination must be made by the IRB.

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.

I'm conducting human subjects research in a vulnerable population. What do I need to know?

The HSPP considers Children, Cognitively Impaired Individuals, Pregnant Women and Neonates, Prisoners, and Native American or International Indigenous Populations to be vulnerable populations that require additional protections and safeguards. When your targeted study population includes one or more of these vulnerable populations, the appropriate Appendix for Vulnerable Populations is required with your eIRB submission. Please see our guidance on conducting research with these populations.

For specific questions regarding research involving Native American or International Indigenous Populations, contact the Native Peoples Technical Assistance Office (NPTAO), NPTAO@arizona.edu.

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 the HSPP guidance on Reporting New Information