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 IRB Submission and Approval Process Flowchart.
Step 1: Does your project require IRB review?
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 submit the Determination of Human Research Form for an official IRB determination.
If your project is human subjects research, proceed to Step 2.
Step 2: Complete Required Trainings
All study team members engaged in human subjects research for your project 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 must complete the CITI Social Behavioral and Native American Research modules. For biomedical projects, researchers must complete the CITI Biomedical and Native American Research modules. 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.
Step 3: Obtain Ancillary Approvals
Ancillary approvals, as applicable, may be needed depending on the nature of your project. These should be obtained prior to IRB submission. Ancillary approvals may include:
- University of Arizona Health Sciences (UAHS) Research Intake Application (RIA): If your project is utilizing Banner Health resources, your project must first be submitted to UAHS through the RIA. UAHS will also perform Contract, Budget, and Coverage Analysis review, if applicable. You will receive correspondence from UAHS regarding this matter. Please visit our Collaborative Activities with Banner Health webpage for more information. For questions about this process, please contact firstname.lastname@example.org. Include the RIA approval email with your submission materials to the IRB.
- University of Arizona Cancer Center (UACC) Scientific Review Committee (SRC): If your project is oncology-related or utilizing UACC, SRC approval is required. This will either be in the form of a signature on your IRB application from Dr. Linda Garland, or UACC SRC will issue an approval letter. For questions about this process, please email UACC-SRC@uacc.arizona.edu. Include Dr. Linda Garland’s signature/attestation or SRC-issued approval letter with your submission materials to the IRB.
- Export Control: If your project involves working with or having access to export-controlled technical data, information, materials, and equipment, Export Control review may be needed. For questions about this process, please contact email@example.com. If applicable, include a copy of Export Control approval or correspondence with your submission materials to the IRB.
- UA Travel Registry: If you are traveling outside of the United States, UA Travel Registry review and approval is required. Include a screenshot of your approval with your submission materials to the IRB.
- RLSS Biosafety Program: If your project involves the use of recumbent DNA, stem cells, and/or infectious material, RLSS review and approval may be needed. For questions about this process, please contact firstname.lastname@example.org. If applicable, include a copy of the RLSS Biosafety Program approval or correspondence with your submission materials to the IRB.
- RLSS Chemical Program: If your project involves the use of hazardous chemicals, regulated explosives, controlled substance, and/or toxic/compressed gasses, RLSS review and approval may be needed. For questions about this process, please contact email@example.com. If applicable, include a copy of the RLSS Chemical Program approval or correspondence with your submission materials to the IRB.
- RLSS Radiation Safety Program: If your project involves radiation (ionizing or non-ionizing) exposure to subjects, RLSS review is required. For questions about this process, contact Keith Carsten at 520-626-5469 or firstname.lastname@example.org. Include a copy of the RLSS Radiation Safety Program approval with your submission materials to the IRB.
- Clinical and Translational Sciences Research Center (CATS): If your project does NOT involve Banner Health resources AND will utilize CATS, approval from CATS to use their facilities and resources is required. Approval is obtained from Maria Gordan: email@example.com. Include a copy of the CATS approval letter with your submission materials to the IRB.
- School District: If your project will take place in a public school (e.g., TUSD), district approval is required upon submission to the IRB. The IRB will also ask for Principal approval from each school within the district where your study will take place. Include a copy of the school district approval with your submission materials to the IRB.
- Tribal Approval: If your project will take place on a Native American reservation or involve a specific Native American tribe, official approval from the tribe is required. Include a copy of the Tribal Approval with your submission materials to the IRB.
- eDoc Number: If your project is industry-funded or has a single IRB mandate where the UA will be the IRB of record, the UA HSPP charges for review. If a charge applies, IRB review will not begin until the fee is paid. Please visit our Fees for Human Research guidance for pricing and instructions on how to submit payment prior to submission to the IRB. Include the UA Financial eDoc Number in your submission materials to the IRB.
Prior to submission to the IRB, please review our guidance on Other Approvals Required Before IRB Submission for more information.
Step 4: Draft Required Forms
For a new project submission, the HSPP requires the most current version of our forms be downloaded and completed.
The following HSPP forms and other documents are typically required for any new project submission to the IRB:
- Application for Human Research
- List of Research Personnel
- CV or Resume of PI/Co-PI(s)
- Informed Consent Form(s) - If you’re using Banner resources, the UA Medical ICF template is REQUIRED upon submission
- Data Collection Tools
- Recruitment Materials
- HSPP Appendices (as applicable)
The Application for Human Research, List of Research Personnel, 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 webpage for more information on multi-site research and associated forms.
Note: The UA HSPP REQUIRES Microsoft Word® documents of Informed Consent Forms, Data Collection Tools, and Recruitment Materials.
Step 5: Obtain Required Signatures on your Application for Human Research Form
Upon submission to the IRB, applicable signatures or attestations are required before the IRB will review your project. This includes signatures from the:
- Principal Investigator
- Advisor (IF PI is a student or resident)
- Scientific/Scholarly Review
- Department/Center/Section Review
- Responsible Physician (IF PI is conducting medical procedures for which he/she is not clinically certified to perform)
In lieu of wet signatures, the IRB accepts, and prefers, email approvals from the signatories identified above. However, upon submission, PLEASE CLEARLY IDENTIFY WHO IS SIGNING 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 email by stating, for example, “I approve as both the Advisor and Scientific/Scholarly Reviewer for this project.” The submission will be returned if it is unclear who is signing for what.
Step 6: Submit IRB Materials and Applicable Ancillary Approvals to HSPP
Once you’ve obtained the applicable ancillary approvals and signatures/attestations and completed all required and applicable HSPP forms and study documents, submit your IRB materials, in one email, to VPR-IRB@email.arizona.edu.
Tips on submitting documents to the IRB for review:
- Do NOT submit handwritten IRB forms or other study documents. These will be returned for electronic formatting.
- Submit only completed documents for review.
- The submission email should contain:
- IRB # (if assigned);
- Principal Investigator’s last name;
- Type of Submission (new project); and
- List of documents being submitted in the body of the email.
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!
Step 7: HSPP/IRB Review Begins
Once you’ve submitted your IRB materials, you will get a notice of receipt. If you did not get the notice, we did not receive your submission.
Your project is triaged internally depending on the risk level. 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 email and phone calls, 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.
Step 8: All Approvals Obtained
Once your project is approved by the IRB Chair or Full Committee, you will receive an official approval email. It will include an official approval letter, copies of your approved, stamped Informed Consent Form(s), and guidance on what your responsibilities are after receiving IRB approval, including submitting reportable item events and requirements for amending your project. Please read the approval email carefully; it may include information about additional requirements you may need to fulfill before you can officially begin your research.
Step 9: Start Your Research!
Let the ethical conduct of research begin!
If you have any questions or concerns during the course of your study, please contact VPR-IRB@email.arizona.edu.