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Whether you are a veteran or novice researcher, or a student, faculty, or staff, this section is designed to help you prepare your study for IRB review. In this section you’ll find tools and basic information to get started, including training requirements, ancillary approval requirements, necessary forms, and the IRB submission, review, and approval process. Familiarizing yourself with these fundamental points will save you time and reduce effort down the road. We are here to assist you at each step in the process!
For a visual overview of how to get started with your submission to the IRB, view our submission process flowchart:
The UA IRB provides ethical oversight to all activities that meet the definition of human subjects research. Please refer to our guidance on What is Human Research for more information. If you are still unsure, you can complete the IRB Protocol for Determination of Human Research in eIRB for an official IRB determination.
If your project is human subjects research, proceed to Step 2.
All study team members engaged in human subjects research are required to complete the University of Arizona human subjects component of the Collaborative Institutional Training Initiative (CITI) online training program. For social/behavioral projects, researchers should complete the CITI Social Behavioral Investigators Basic Module Course. For biomedical projects and clinical trials, researchers should complete the CITI Biomedical Investigators Basic Course. Both the Social Behavioral and Biomedical courses also include the Native American Research module, which is required training for all researchers.
As of June 1, 2022, the HSPP requires all studies conducting FDA-regulated research or projects accessing Medical Records to complete the Biomedical Research Investigators Basic Course. For non-FDA regulated studies and projects not accessing medical records, HSPP will accept either the Biomedical or the Social Behavioral human subjects research training courses.
Additional training may be required; please check with your department. For example, for projects that involve Banner Health electronic medical records (EMR), researchers must also complete the UA HIPAA Privacy training. All researchers are required to complete Conflict of Interest (COI) training.
Please visit our Training Requirements webpage for more information.
Additional approvals, as applicable, may be needed depending on the nature of your project. These should be obtained prior to submitting your project in eIRB. Additional approvals may include:
Prior to submitting your study in eIRB, please review our guidance on Other Approvals Required for more information.
For a new project submission, the HSPP requires the most current version of our forms to be completed and uploaded to eIRB.
The following HSPP forms and other documents are typically required for any new project submission eIRB:
The IRB Protocol templates, Informed Consent Form(s), and HSPP Appendices can be found on our HSPP Forms webpage. Other documents listed above would need to be created by the study team.
If the UA IRB will be the IRB of Record for a multi-site study, additional forms and documents are needed upon submission. Please visit our Single IRB Research and Forms webpage for more information on multi-site research and associated forms.
Note: The UA HSPP REQUIRES Microsoft Word® documents of IRB Protocol templates, Informed Consent Forms, Data Collection Tools, and Recruitment Materials.
eIRB can be accessed here: https://eirb.arizona.edu/IRB. Utilize the How-To Videos and User Guides found on the eIRB Information webpage as well as in the eIRB Help Center for assistance with creating submissions in eIRB.
Upon submission to the IRB, applicable approvals are required before the IRB will review your project. This includes approvals from the:
In lieu of wet signatures, the IRB accepts approvals in the following format in eIRB:
PLEASE CLEARLY IDENTIFY WHO IS APPROVING FOR WHAT. For example, if your advisor is signing for both the Advisor and Scientific/Scholarly Review, your advisor must clearly indicate this in his/her approval by stating, for example, “I approve as both the Advisor and Scientific/Scholarly Reviewer for this project.” The submission will be returned to you if it is unclear who is signing for what.
Once you've created the submission in eIRB, obtained the applicable approvals, and completed all required and applicable HSPP forms and study documents, the PI or PI Proxies submit the study in eIRB. Note that only the PI or PI Proxies can submit submissions to the IRB in eIRB.
Tips on submitting documents in eIRB for review:
Please see our Top 10 Tips page for common pitfalls to avoid when completing your study documents to ensure the most efficient and smooth IRB review!
Please review our New Submission Review Flow Chart for an overview of the IRB intake and review process.
Once you’ve submitted your IRB materials in eIRB, the submission will enter a "Pre-Review" state. This means that you have successfully submitted your submission to the HSPP office.
Your submission first enters a "triage" phase of HSPP review where it is reviewed for completeness, required pre-approvals, and other local submission requirements outlined in the steps above. If it's determined that your submission has not met the local HSPP submission requirements (i.e., missing required HSPP forms, pre-approvals, etc.), the submission will be returned to you in eIRB outlining exactly what is needed from you to move the submission forward to IRB review. You will work directly with the IRB Intake Coordinator to resolve any outstanding items. Once your submission satisfies all local HSPP submission requirements, it formally enters the workflow for IRB review. A reviewer will be assigned, and you can expect to hear from them within 3-5 business days of your submission. You will work with this reviewer, via eIRB, to get your IRB materials ready for either the IRB Chair or Full Committee’s review. You will be informed by the reviewer as to who will approve your project. To expedite review times, please rely on eIRB system notifications. When an action is required on the submission, you’ll receive a notification to your university-issued email.
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:
Once your project is approved by the IRB Chair or Full Committee, you will receive an eIRB approval notification. It will include an official approval letter, information on where to go in eIRB to review your approved documents, and references to guidance on what your responsibilities are after receiving IRB approval, including submitting Reportable New Information (RNI) and requirements for modifying your project. Please read the approval notification and letter carefully; it will include information about additional requirements you may need to fulfill before you can officially begin your research.
You can start your research after you receive your IRB Approval letter. If you have any questions or concerns during the course of your study, please contact VPR-IRB@arizona.edu.
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