Research Resources

Submitting an IRB Protocol

The current number of IRB submissions in the queue awaiting review is 32 (updated on 09/20/2021). 

Click each step below to see additional instructions.

 

Step 1: Plan Ahead to Allow Sufficient Time for Review

  • Investigators must plan in advance for a review and a potential revision period, which can range from 2 weeks to 2 months or more during high volume periods. This review period is consistent with high-activity IRBs nation-wide. High volume periods typically include the first two months of fall and spring semesters. You can review the current number of protocols in the IRB's Queue at the top of this webpage. A queue of 50 or more is considered a high-volume period. 
  • Every protocol submission is considered "priority" by its investigator regardless of the protocol's risk level or complexity. To maintain equity for all researchers, all submissions are reviewed in the order received. One submission cannot be moved ahead of other investigators' submissions in the queue. All investigators are students needing to complete research for graduation, faculty needing to conduct research for publication and tenure, or researchers needing to fulfill grant/sponsor deadlines. Please be respectful of your colleagues' needs and plan ahead for your own project.
  • There is no "fast-track" for exempt, expedited, or minimal risk studies since their review type/level cannot be determined until it reaches the front of the queue for initial review. In addition, the majority of submissions recieved by the IRB are in these categories.
  • Quality, well-written protocols will proceed through the review process at a faster rate. Protocols that are incomplete or lacking details will need to be returned to the PI and/or Faculty Advisor for revision, which can further delay the approval process. Review the guidance for the IRB's Criteria for Approval and what to include for various Types of Research to evaluate the readiness of your protocol for review by the IRB. Faculty Advisors must be aware of their full mentoring and oversight responsibilities and work with students to prepare quality protocol submissions.
  • Protocols with greater complexity will take more time for review and approval, for example: multi-site studies, collaborations with non-UTA sites/personnel, school/ISD permissions, external data transfers, FDA-regulated studies, procedures considered greater than minimal risk, studies involving hazards, or special lab/facility requirements.
  • For student-led research:
    • Student investigators must plan in advance to ensure there will be enough time for IRB review/revision, conducting the actual research (recruiting, enrolling, and collecting data), analyzing collected data, and writing up results.
    • Master's students should submit at least one semester in advance of planned graduation.
    • Doctoral students should submit at least 9 months in advance of planned graduation.
    • IRB protocols submitted in the same semester of planned graduation are not guaranteed to complete the IRB review process in sufficient time.

Step 2: Complete All Required Training

All UTA protocol personnel must complete Human Subjects Protection Training, which is located in our Profiles IRB System. It must be retaken every 3 years. 

Non-UTA Collaborators must provide a certificate of completion for Human Subjects Protection Training through CITI, NIH, or another approved method –   email us if you need a free option.

NSF-funded projects require all protocol personnel complete Responsible Conduct in Research Training, which is located in our Profiles IRB System. It must be retaken every 4 years.

NIH-funded or FDA regulated projects require all protocol personnel complete   Good Clinical Practice Training; requirements are located on our IRB Website for GCP Training. It must be retaken every 3 years.

Greater than Minimal Risk and Full Board project protocol personnel must complete a Conflict of Interest Disclosure, which is located in Mentis. It must be recertified every year.

Step 3: Complete All Required IRB Forms and Templates

Visit the IRB Website for Forms and Templates and complete the appropriate version of the IRB Application Form in its entirety with information about your study. The application form will direct you to other types of documents that you may need. For more information about what documents may be needed for your protocol, download our Required Documents Chart.

Step 4: Start a New Protocol in Mentis

All studies must be submitted through our Mentis IRB SystemWe cannot accept any IRB submissions over email. Click the "Start a New Protocol" button and answer the initial questions, then you will be taken to your main IRB protocol page.

Step 5: Complete the Mentis Protocol Page in its Entirety

Fill out all the sections including the PI, Faculty Advisor (required if you are a student), Study Personnel (all UTA personnel who will be part of the research team), the Title, and a very brief Research Summary.

Anyone who will consent participants; who will administer any research procedures to the human participants or who will assist in data collection from the subjects; and anyone who will have access to the individually identifiable data from human participants after it has been collected must be listed as personnel on your IRB Application Form, whether they are affiliated with UTA or not.

Individuals who are not affiliated with UTA must also complete and sign the Non-UTA Collaborator Form.

Step 6: Upload All Study-related Documents in Mentis

You must include a completed IRB Application Form and any supplemental forms and documents related to your study (customized Informed Consent documents, data collection tools, recruitment materials, permission letters from external sites, Form 4, etc.)

If you are unsure which documents may be needed for your protocol, download our required documents chart.

To upload all required forms and documents, type the name of the document in the white box and then click the green “Browse / Upload” button and select the desired form. Your files will not upload correctly if the file name is not typed in the white box first.

Step 7: Save and Submit for Review

All content submitted to Mentis will be autosaved.

UTA students: Click the button to “Submit to Faculty Advisor”. Your Faculty Advisor must review and approve your submission before it is sent to the IRB Coordinator. Once approved (please note they may send it back to you for revisions) they will click the button to “Submit to IRB Coordinator”. At this point, your protocol will be in the IRB Inbox for review.

Note that the IRB Office does NOT see your study until your Faculty Advisor clicks the button to “Submit to IRB Coordinator”.

UTA faculty or staff: Click the button to “Submit to IRB Coordinator”. At this point your protocol will be in the IRB Inbox for review.

Step 8: IRB Review Process

All IRB submissions are reviewed under a specific Review Pathway according to funding/regulatory status and risk level. You can check on the status of your protocol in the Mentis IRB System under “Pending Protocols”.

Once the IRB Coordinator has conducted an initial review of your study, if clarification or revisions are needed, we will return it to you in the Mentis IRB System – you will receive an email from the “ERA Help Desk” which will let you know your protocol has been returned. Please complete the revisions in their entirety ASAP and resubmit the revised documents within the Mentis IRB System.

Step 9: Official Approval

Once you receive notice from Mentis that your protocol has been approved, you are good to go! You can find a copy of your IRB Approval Letter uploaded to your protocol in Mentis.

Note that you cannot start your study (including recruiting human subjects or collecting human subject data) until the IRB has officially approved your IRB protocol.

***After Initial Approval: Remember to Submit ALL Requested Changes for IRB Approval!!!***

After your protocol is approved by the IRB, you cannot implement any changes to your study without submitting a modification request in the electronic submission system and obtaining IRB approval for the changes beforehand.  Failure to obtain prior IRB approval for changes to a study / study documents is considered noncompliance with the IRB protocol and will be subject to citation, possible investigation, & corrective actions.