IRB Protocol Submission

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 3 business days, 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 3 business days 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.

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.

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 3 business days, 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 3 business days 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.

UNT's IRB Protocol submission is performed in Cayuse Human Ethics (formerly Cayuse IRB). The 'Log in to Cayuse Human Ethics' 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 Human Ethics
(formerly 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.

Investigators are responsible for obtaining IRB approval before beginning any human subjects research that meets the federal definitions of human subject and research. The Office of Human Research Protections (OHRP) recommends that institutions ensure knowledgeable individuals, in this case Research Integrity and Compliance staff and IRB members, assist investigators in making the appropriate decision about the status of their project, determine if IRB approval is required, 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 a study meets the federal definition of human subjects research and requires IRB approval. For more information and to submit the "Proposed Human Subjects Research Assessment" form, please review the Human Subjects Research Determination page.

Contact untirb@unt.edu with any questions.

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.

Below is a step-by-step summary of how to create, complete, and submit and new study:

1. Log into Cayuse Human Ethics
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.
     

For help submitting a new study (new submission) to the UNT IRB, consult this guidance document. If you still have questions, contact untirb@unt.edu to schedule a meeting with one of our compliance staff who can assist with your submission.

 

Format and Upload All Study Related Templates

With your Cayuse Human Ethics 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 Human Ethics 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.

Review Process

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 Human Ethics
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.

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 Human Ethics
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.