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!
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 training. All researchers are required to complete Conflict of Interest (COI) training.
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:
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University of Arizona Health Sciences (UAHS) Research Administration Portal (RAP): If your project is utilizing Banner Health resources, your study must first be submitted to UAHS through the RAP. UAHS will also perform Contract, Budget, and Coverage Analysis (CA) 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, contact crc@arizona.edu.
For non-funded research, UAHS will provide the research team with feasibility review approval. A copy of this approval must be uploaded to eIRB before the study is submitted to the IRB. This approval is required before the IRB will begin its review.
For funded research, after the CA has been approved, UAHS will provide feasibility review approval, which includes the UAR Institutional Proposal (IP) number. Before submitting in eIRB: 1) researchers must link their funding in eIRB using the IP number provided by UAHS, and 2) upload a copy of the feasibility review approval to eIRB. This approval is required before the IRB will begin its review.
- 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 the SRC Chair, or UACC SRC will issue an approval letter. For questions about this process, email UACC-SRC@uacc.arizona.edu. Upload the SRC approval letter or Chair signature/attestation to eIRB.
- 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, contact export@arizona.edu. Upload Export Control approval or correspondence to eIRB.
- RLSS Biosafety Program: If your project involves using recumbent DNA, stem cells, and/or infectious material, RLSS review and approval may be needed. For questions about this process, contact rlss-help@arizona.edu. Upload RLSS Biosafety Program approval or correspondence to eIRB.
- RLSS Chemical Program: If your project involves using hazardous chemicals, regulated explosives, controlled substance, and/or toxic/compressed gasses, RLSS review and approval may be needed. For questions about this process, contact rlss-help@arizona.edu. Upload RLSS Chemical Program approval or correspondence to the eIRB.
- RLSS Radiation Safety Program: If your project involves ionizing radiation (i.e., bone scan, bone mineral analyzers - DEXA, DXA, QCT, radioactive source - CT, PET, MUGA, mammogram, X-Ray/radiography, radiotherapy machines, fluroscopy, radiopharmaceuticals/radioisotope/radionuclide) or non-ionizing radiation (i.e., lasers, radiofrequency) exposure to subjects, RLSS review is required. For questions about this process, contact Leon Harris at harris23@arizona.edu. Upload RLSS Radiation Safety Program approval to eIRB.
- 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: cats-med@arizona.edu. Upload CATS approval to eIRB.
- 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. Upload school district approval to eIRB.
- Tribal Approval: If your project will involve a specific Native American tribe or International Indigenous population, or will take place on land under the control or jurisdiction of a sovereign tribe, official approval from the tribe is required. Visit the University of Arizona's Native Peoples Technical Assistance Office for additional resources. Upload documentation of Native Nation or Indigenous community consultation and approval to eIRB.
- 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 IRB charges for review. If a charge applies, IRB review will not begin until the fee is paid. Please review the Fees for Human Research guidance for pricing and instructions on submitting payment to the IRB. Note that a new IRB Fee Schedule is effective for projects approved after 6/30/24. Include the UA Financial eDoc Number in your IRB Protocol document in eIRB.
Before 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:
- IRB Protocol (as applicable)
- CV or Resume of PI
- Informed Consent Form(s) - If you’re using Banner resources, the UA Medical ICF template is REQUIRED upon submission
- Data Collection Tools
- Recruitment Materials
- Participant Materials
- Institutional Approvals - See Step 3 above
- HSPP Appendices (as applicable)
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.
Utilize the How-To Videos and User Guides on the eIRB Information webpage and in the eIRB Help Center for assistance 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:
- Principal Investigator (PI) or PI Proxy
- 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 approvals in the following format in eIRB:
- Email approvals uploaded to eIRB
- Attestation Forms uploaded to eIRB
- Comments logged 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 Proxy submits the study in eIRB. Only the PI or designated PI Proxies can submit in eIRB!
Tips on submitting documents in eIRB for review:
- Do NOT upload incomplete IRB forms.
- Do NOT upload handwritten study documents. These will be returned for electronic formatting.
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 your submission has not met the 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. 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:
- Non-Committee Review (Minimal Risk/Exempt/Expedite): 14 business days
- Committee Review: 30 business days
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.