IRB Protocol Submission

Plan in Advance

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.

To request permission to proceed with in-person human subjects research during the COVID-19 University reopening, please follow this guidance.

Accessing Cayuse IRB

IRB Protocol Submission requires access to Cayuse IRB, UNT’s electronic IRB submission portal. If you are new, please start at Step 1 to Request Cayuse Access. Current researchers who have previously logged into Cayuse successfully, please skip to Step 4 to Log into Cayuse IRB.

  • Step 1 : Request Cayuse Access

    Complete Online Cayuse Access Request

    Please submit an online Cayuse Access Request. You will receive a confirmation of successful submission request via email. A Cayuse access request confirmation including all submission information will be emailed to the email address that you provided in your online Cayuse Access Request submission. Please review all submitted information to verify that it is correct.

    Within 72 hours, you will either receive the “Cayuse Welcome Email” correspondence or will be contacted with any incomplete information that may cause a delay in your access.

    If after 72 hours you do not receive the ‘Cayuse Welcome Email’ correspondence, call or email the AITS Helpdesk at 940-369-8183 or CayuseAccess@unt.edu for assistance.

  • Step 2 : Install/update and configure Mozilla Firefox browser for Cayuse

    Cayuse recommends using the current version of the Mozilla Firefox browser. Please call or email the AITS Helpdesk at 940-369-8183 or CayuseAccess@unt.edu for assistance with your browser installation, updates, and configuration.

    In order to log into Cayuse, you will need to first configure your Firefox browser as follows:

    1. Cookies Enabled

      You may use custom settings to accept cookies for only Cayuse while blocking cookies on other websites, click Exceptions and enter "https://unt.cayuse424.com" (with no quotes). Then, click Allow.

    2. Pop-ups Allowed

      You may use custom settings to allow pop-up windows only for Cayuse while blocking pop-ups on other websites, click Exceptions and enter "https://unt.cayuse424.com" (with no quotes). Then, click Allow.

    3. JavaScript Enabled

      If you are not able to change this setting, you may need advanced settings/permissions.

    Recommended browser: Mozilla Firefox

    You may also find additional information for updating Firefox here: https://support.mozilla.org/en-US/kb/update-firefox-latest-release or additional information about your current Firefox version here: https://support.mozilla.org/en-US/kb/find-what-version-firefox-you-are-using.

  • Step 3 : Receive ‘Cayuse Welcome Email’ within 72 hours of your online submission.

    A Cayuse access request confirmation including all submission information will be sent to the email address that you provided in your online Cayuse Access Request submission. Within 72 hours, you will either receive the “Cayuse Welcome Email” correspondence or will be contacted with any incomplete information that may cause a delay in your access.

    If after 72 hours you do not receive the ‘Cayuse Welcome Email’ correspondence, call or email the AITS Helpdesk at 940-369-8183 or CayuseAccess@unt.edu for assistance.

  • Step 4 : Log in to Cayuse IRB.

    UNT’s IRB Protocol submission is performed in Cayuse IRB. The 'Log in to Cayuse IRB' link will take you to the UNT Single Sign-On page where you may log in with your EUID login and password.

    Log in to Cayuse IRB

    Your connectivity to Cayuse is important to us. Call or email the AITS Helpdesk at 940-369-8183 or CayuseAccess@unt.edu for assistance with your browser installation, setup, and settings.

Guidance for Submissions

Once you have successfully accessed Cayuse IRB, please follow the guidance provided below to help you navigate the submission process. If you have any additional questions regarding the contents of your application or requirements for submission, please contact untirb@unt.edu

  • Proposed Human Subjects Research Determinations

    Research projects involving human subjects require review and approval by an Institutional Review Board. The IRB is responsible for assuring that the rights and welfare of human subjects in research are adequately protected. The UNT IRB is responsible for reviewing and overseeing human subjects research conducted by UNT faculty, staff, or students.

    The first question an investigator should consider with respect to IRB review is whether the research project fits the federal definition of human subjects research.

    Definitions:

    • Research is defined as “a systematic investigation, including development, testing, and evaluation designed to develop or contribute to generalizable knowledge.” (45CFR46.102(l))
      • “Generalizable knowledge” is information where the intended use of the research findings can be applied to populations or situations beyond that which was studied.
      • The Belmont Report defines research as “an activity designed to test a hypothesis or answer a research question and permit conclusions to be drawn. Research is usually described in a formal protocol that sets forth an objective and a set of procedures to reach that objective.” (Belmont Report)
    • Human Subject is defined as “a living individual about whom an investigator (whether professional or student) conducting research: (1) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies or analyzes the information or biospecimens or (2) obtains, uses, studies, analyzes or generates identifiable private information or identifiable biospecimens.” (45CFR46.102(e))
      • “Intervention” includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.
      • “Interaction” includes communication or interpersonal contact between investigator and subject.
      • “Private information” includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).
      • “Identifiable private information” is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.
      • “An identifiable biospecimen” is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.
         

    Investigators are responsible for obtaining IRB approval before beginning any human subjects research that meets the definitions above. The Office of Human Research Protections (OHRP) recommends that institutions ensure knowledgeable individuals assist investigators in making the appropriate decision about the status of their project and ensure that an IRB reviews all studies that are determined to be human subjects research. Investigator must err on the side of caution and submit a “Proposed Human Subjects Research Assessment” form to determine if the study meets the federal definition of human subjects research. This process ensures that the requirement of obtaining IRB review and approval for applicable projects is satisfied as required by federal regulations. These decisions should be made by Research Integrity and Compliance staff and not individual investigators.

    • Click Here to Submit the “Proposed Human Subjects Research Assessment” form.

    • Once the form is submitted, the Research Integrity and Compliance staff will determine whether your project meets this federal definition as outlined in the federal regulations, noted above. The staff will issue a formal response for your records and state if further action needs to be taken. These forms must be submitted, reviewed, and determinations issued prior to beginning research activity.
       

    Contact untirb@unt.edu with any questions.

  • 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 located here.

    Proof of training completion (for example: Completion Certificate) for all study personnel is required to be included with study submissions in Cayuse.

  • New Study Submission
    1. Log into Cayuse IRB
    2. Use your current EUID and EUID password.
    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 the 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.
     

    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 checkmark will appear in each section of your Cayuse submission. These light blue checkmarks will show in the dark blue navigation pane.

    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.

    If you are a new researcher, consider watching a recent training video to help get you started.

  • IRB Review and Approval

    Review Process

    All IRB submissions are reviewed in the order that they are received. You can check on the status of your protocol in the Cayuse IRB System from your Cayuse Dashboard.

    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 the implementation of the changes. Below is a guide to explain how to submit a modification to an approved study.

    1. Log into Cayuse IRB
    2. Use your current EUID and EUID password.
    3. Click on the study you would like to modify.
    4. In the upper right-hand corner, click the blue button "+New Submission” and 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.
  • Closing a Research Study

    Projects should only be closed if they are no longer interacting with subjects and all data has been collected, the data has been “cleaned,” analysis of identifiable data is complete, and all identifiers have been removed from data sets. When a study ends, is closed, canceled for any reason, or is prematurely completed you must complete a Closure form. A Closure form serves as notification to the IRB that study activity is no longer being performed.

    DO NOT CLOSE THE PROJECT TOO SOON! Once a Closure Form is processed, no further research related activity can occur and any contact with subjects or access to data for research purposes will no longer be allowed.

    The Principal Investigator is responsible for submitting a closure report, indicating any research findings and/or outcome of the project. All protocols are approved for the time period as stated in the IRB approval letters. Prior to the end of the last year of the protocol, the investigators are required to submit a closure report.

    1. Log into Cayuse IRB
    2. Use your current EUID and EUID password.
    3. Click on the study you would like to Close.
    4. In the upper right-hand corner, click blue button +"Closure"
    5. Select Edit.
    6. Complete the Closure page.
    7. Attach the IRB Final Report Document found on our IRB Forms and Templates page.
    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 content of the protocol submission, please contact the UNT IRB at untirb@unt.edu.

If you have any technical/access questions or technical issues, please contact CayuseAccess@unt.edu.