IRB Protocol Submission

Plan in Advance

Submit your IRB application through Cayuse IRB

Please plan ahead to allow a sufficient amount of time for submission, review and approval of your study. The current review timeline is posted in a message in the Cayuse system and will depend on the volume of submissions received by the IRB office. The turnaround time for IRB protocol approvals can be impacted by many variables and will vary throughout the year. Protocols are reviewed on a rolling basis, in the order that they are received. Protocols of greater complexity or risk will take more time to review. Please reach out to the office if you have questions regarding the posted review timeline. If the current review timeline will place undue burden on your research, please contact our team at untirb@unt.edu immediately to discuss the situation.

Protocols that are incomplete or lack details will be returned to the Principal Investigator (PI), further delaying the review and approval processes. Please review all of the IRB Resources for Researchers to assess the readiness of your study documents for review.

  • Complete Training and Education

    All Researchers, Key Personnel, and Collaborators on the research team working with human subjects must complete required Human Subjects Protection Training before receiving IRB approval. Human Subjects Protection Training must be retaken every 3 years.

    To complete the required Human Subjects Protection training, follow the directions located in the Training and Education section. Proof of training completion (for example: Completion Certificate) for all study personnel is required to be included with study submissions in Cayuse.

  • Begin Submission in Cayuse

    To get access to the electronic submission portal, Cayuse, you must complete the access request form. Please note that it takes approximately 2-3 business days to get access to the system.

    Once you have Cayuse access, you can access the Cayuse system to begin your IRB study submission: unt.cayuse424.com/rs/irb/

    FIREFOX is the preferred browser for the Cayuse IRB System.

    Cayuse IRB - Quick Step Guide for a New Study Submission

    1. Log into Cayuse IRB by going to unt.cayuse424.com/rs/irb/ and
    2. Use your current EUID and EUID password to log in.
    3. In the upper right hand corner, click blue button “+ New Study”
    4. Complete the title of your study and click save.
    5. In the upper right hand corner, click blue button “+ New Submission”.
    6. You will now see a pink ribbon that says “Unsubmitted”. You will have the choice to edit, delete, or pdf the submission.
    7. Select Edit.
    8. If you are not the principal investigator of the study, first add yourself as the primary contact in the personnel section, and then edit the personnel to list the appropriate principal investigator.
    9. Continue with the other sections until complete.
    10. The principal investigator will receive a notice to certify the submission.
    11. Once the principal investigator certifies, the submission will be received by the UNT IRB and will undergo review. If you have any questions regarding the software or technical issues, please contact cayusetechsupport@unt.edu. If you have any questions regarding the content of the protocol submission, please contact the UNT IRB at untirb@unt.edu.

    If you have any questions regarding the software or technical issues, please contact cayusetechsupport@unt.edu. If you have any questions regarding the content of the protocol submission, please contact the UNT IRB at untirb@unt.edu.

  • Format and Upload All Study Related Templates

    With your Cayuse IRB Submission, you must include any supplemental forms and documents related to your study (Informed Consent documents, data collection tools, recruitment materials, permission letters from external sites, etc.). If you are unsure which documents may be needed for your protocol, please review the IRB Forms and Templates page. These items must be attached in the appropriate locations within your Cayuse IRB Submission.If you have any questions, please contact untirb@unt.edu.

  • Completion and Certification

    Once you have completed the entirety of your Cayuse submission, a light blue check mark will appear in each section of your Cayuse submission. These light blue checkmarks will show in the dark blue navigation pane as shown here: (insert image)​

    Once a checkmark appears in each section of your IRB submission, Please click the “Complete Submission” button on the bottom left hand side of the dark blue navigation bar. This will appear just below the header named “Section 9.” Once the “Complete Submission” button is pressed, the study will be routed within Cayuse to the Principal Investigator to “Certify” the submission. If you are the Principal Investigator, you must mark “Complete Submission” as well as“Certify.” The study will not be routed to the IRB office for review until the “Certify” button is clicked by the Principal Investigator.

  • IRB Review Process

    Once the Regulatory Analyst has conducted an initial review of your study, if clarification or revisions are needed, we will return the study to you in the Cayuse IRB System for edits. You will receive an email from the Cayuse IRB System, 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 Cayuse IRB System, following the steps above.

  • Approval

    Once you receive an official approval letter from the IRB via the Cayuse IRB System, you are welcome to begin your research activities. Note that you cannot begin research activities (including recruiting human subjects or collecting human subject data) until the IRB has officially issued you an approval letter for your IRB protocol.

    You may find your approved informed consent document on the study details page of your IRB submission. It will be located on the attachments tab at the bottom of the page.

    All approvals are final and nothing may be changed once approval is issued without obtaining IRB approval for the changes. After your protocol is approved, a modification request must be reviewed and approved by the IRB before changes may be implemented. Failure to obtain IRB approval prior to the implementation of changes is considered noncompliance and will be subject to corrective action. This includes, but is not limited to, changes to study documents, personnel, activities, recruitment methods, or to your Cayuse protocol.

  • Submitting a Modification

    After your protocol is approved by the IRB, you must submit a modification request in Cayuse and obtain IRB approval for ANY changes prior to implementation of the changes. Below is a guide to explain how to submit a modification to an approved study.

    Cayuse IRB - Quick Step Guide for a Modification Submission

    1. Log into Cayuse IRB by going to unt.cayuse424.com/rs/irb/
    2. Use your current EUID and EUID password to log in.
    3. Click on the study you would like to modify
    4. In the upper right hand corner, click blue button “+ New Submission" and then select "Modification”
    5. Select Edit.
    6. Complete the modification page, explaining all of the changes you would like to make to your approved study.
    7. Navigate to the affected sections of your study and complete the updates.
    8. Once complete, mark the routing button as “Complete Submission”
    9. The Principal Investigator will receive a notice to “Certify” the submission.
    10. Once the principal investigator certifies, the submission will be received by the UNT IRB and will undergo review. If you have any questions regarding the software or technical issues, please contact cayusetechsupport@unt.edu. If you have any questions regarding the content of the modification submission, please contact the UNT IRB at untirb@unt.edu.
  • Terminating a Research Study

    A “Closure” form should be submitted in Cayuse when ALL study activity has ceased. This may include situations when the investigator chooses not to continue the research, the study activity and data analysis are complete, the study sponsor has requested the study to be terminated, or for a variety of other reasons. The investigator should only submit the Closure form when they would like to completely TERMINATE research activity related to the study. Once a “Closure” form is processed, study activity can no longer commence, and the study is considered terminated.

    Please note: If the study is ongoing, including activity such as interaction with subjects, continued research intervention, and/or data analysis, then you should not submit a “Closure” form in Cayuse. 

    Cayuse IRB - Quick Step Guide for terminating a study

    1. Log into Cayuse IRB by going to unt.cayuse424.com/rs/irb/
    2. Use your current EUID and EUID password to log in.
    3. Click on the study you would like to close
    4. In the upper right hand corner, click blue button “+ New Submission" and select "Closure"
    5. Select Edit.
    6. Complete the Closure page, and attach the completed "IRB Final Report" document.
    7. Once complete, mark the routing button as “Complete Submission”
    8. The Principal Investigator will receive a notice to “Certify” the submission.
    9. Once the principal investigator certifies, the submission will be received by the UNT IRB and will undergo review. If you have any questions regarding the software or technical issues, please contact cayusetechsupport@unt.edu. If you have any questions regarding the content of the modification submission, please contact the UNT IRB at untirb@unt.edu.

     

    For questions about terminating your research study, please contact untirb@unt.edu