Frequently Asked Questions about Human Subjects Protection
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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.
Please visit our Getting Started webpage.
Human subjects training is required for all investigators, faculty, staff, and students conducting research with human subjects at the University of Arizona. There are two CITI training options for investigators to choose from, depending on the type of research:
- IRB: Biomedical Research Investigators (required for FDA-regulated research or projects involving accessing medical records); OR
- IRB: Social & Behavioral Research Investigators
Visit our Training Requirements webpage for more information.
Human Subjects Training Handout
Approval timelines are contingent upon the complexity of a study, the investigator's responsiveness, and whether applicable approvals have been obtained. Average approval timelines are broken down by level of review:
- Non-Committee Review (Minimal Risk/Exempt/Expedite): 14 business days
- Committee Review: 30 business days
For questions that require immediate attention, please email the general inbox at VPR-IRB@arizona.edu. This inbox is continuously monitored, and your questions will be directed to the appropriate individual.
Typically, U of A researchers must receive U of A IRB approval to conduct research with human subjects, regardless of where the research takes place. When collaborative projects are expected to involve researchers from multiple institutions, contact the HSPP to determine next steps. While in some cases each investigator should work with their own institution’s IRB, in other cases, it might be advisable (or required by a funder) to arrange an IRB reliance/institutional agreement (IAA) to designate one IRB to review and approve the research as a whole. Visit the Single IRB Research webpage for details.
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.
If you are traveling outside of the United States to conduct human subjects research, you will need to register your travel with the UA Travel Registry. For more information on conducting international research, see our guidance on International Research.
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 Claudia Nelson at cen@arizona.edu.
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.
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.
More information on how to submit a Modification can be found 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. See 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.
The HSPP does not accept modifications to determinations of human research as these projects are not overseen by an IRB. Investigators may proceed as long as the intent behind the project remains unchanged. If changes are made affecting whether the activities are human research, a new determination request must be submitted for review in eIRB.
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.
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.
Annual continuing review is generally required for protocols approved by the fully convened IRB committee. An annual continuing review may also be necessary for the following types of protocols:
- Projects involving Native American or Indigenous Populations;
- Principal Investigator has received serious or continuing non-compliance determinations in the past two years;
- Projects that involve deception but do not receive the subject’s prior authorization to be deceived before engaging in the deception;
- A Conflict of Interest Management Plan exists;
- FDA-regulated research eligible for Expedited review under Expedite Category 1 on approved drugs or devices;
- Projects deemed Expedited Category 9; or
- As determined by the IRB on a project basis depending on the risks in the research project.
As a courtesy, eIRB notifications are sent to investigators several weeks before the approval end date for protocols needing a continuing review. A continuing review submission must be submitted in eIRB at least 4-6 weeks before the approval end date. If the protocol is not granted continuing approval before expiration, all research activities must pause until reapproval.
Please review HSPP Guidance, Continuing Review of Human Research for more information.