Human Subjects Protection Program

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.

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.

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.

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:

1. IRB: Biomedical Research Investigators (required for FDA-regulated research or projects involving accessing medical records); OR
2. IRB: Social & Behavioral Research Investigators

Visit our Training Requirements webpage for more information.

Human Subjects Training Handout

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.

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.

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