Human Ethics

Cayuse Human Ethics is the online IRB submission system that UNCG has selected to replace the former online IRB submission system, IRBIS.

The submission applications in Cayuse Human Ethics are intuitive to use and have a more streamlined approach. We anticipate minimal difficulties to your submission process.

The system allows for all IRB submissions to be submitted online. In addition to new studies, renewals, and modifications, protocol deviations/violations and adverse/unanticipated events will also be able to be submitted through the system.

You can log into Cayuse Human Ethics at https://uncg.cayuse424.com.

• Login to the Cayuse Research Suite
• Once on the homepage, click “Cayuse IRB”
• Once on Dashboard , click “New Study”
• Add Study Title
• Click blue check mark on right-hand side of page
• Click “New Submission,” then “initial”
• The New Study application will open for your completion

• Login to the Cayuse Research Suite
• Once on the homepage, click “Cayuse IRB”
• Go to “my studies”
• Click the study number you wish to renew
• Click “new submission”
• Click “renewal”
• Click “complete submission”
• The Renewal application will open for your completion

• Login to the Cayuse Research Suite
• Once on the homepage, click “Cayuse IRB”
• Go to “my studies”
• Click the study number you wish to modify
• Click “new submission”
• Click “modification”
• Click “complete submission”
• The Modification application will open for your completion

• Login to Cayuse Human Ethics
• Click “Cayuse IRB” (Human Studies Compliance)
• Once on your dashboard, go to “my studies”
• Click the study number you wish to close
• Click “new submission”
• Click “closure”
• Click “complete submission”
• Complete the closure application
• When finished, click “Complete Submission” (bottom left-hand side)
• Click “confirm”
• If the PI, click “certify” to certify the submission – click “confirm” to complete the certification
• If a student PI or study team member completing the modification on behalf of the PI, a notification will be sent to the PI/Faculty advisor that they have a submission awaiting certification
• When the PI/faculty advisor logs into the system, they can access the closure submission under “My Studies” or under “Awaiting Authorization” – Click on “closure” – click “certify” – Click “confirm” to finalize certification

• On your Cayuse Human Ethics dashboard – you can click on the study you wish to certify under “My Studies” or under “Awaiting Authorization” – for PIs, Co-investigators, or Faculty Advisors
• Click on “initial,” then click “certify”
• Click “confirm” to finalize certification

**The Study must be certified by all required staff – PI and Co-I for faculty/staff led studies and PI and Faculty advisor for all student-led studies.

Once the study application is approved by all staff, the study will move to the pre-review status where it will await assignment to an IRB staff member.

• On your Cayuse Human Ethics dashboard, click on the study you wish to link under “My Studies”
• Click “Link Proposal”
• All proposals for which you are affiliated with appear, click the “linked” button by the applicable proposal number
• Click “Done” on the right-hand side

**Please note that it is the responsibility of the Principal Investigator to link your IRB application to your Cayuse SP record.

• You will receive an email indicating that a response is required
• Login to Cayuse Human Ethics
• The study will be under “in draft” on your dashboard
• Click the study number
• Click the “edit” button
• You will see a thought bubble next to the sections that have stipulations
• Click the section with the thought bubble
• Once on the page with the stipulation, the thought bubble will appear under the section with the stipulation – click “expand comments”
• Depending on the nature of the stipulation, you will revise the information in the application section or click reply to be provided with a text box in order to provide a response. Please note, if the stipulation specifically requests changes to the section, you must make the revisions to the section.
• Once the stipulation has been addressed, change the status to “addressed” by clicking the down arrow under the stipulation
• Each stipulation must be responded to before the study application can be returned for review
• Once the stipulations have been addressed, click “complete submission” on the left-hand side of the page
• Click “certify,” then “confirm” to finalize the certification
• The study application will then be returned for IRB review

• Click the “attach” button
• Click the “+” sign to search for the file
• Click the “apply” button to upload the attachment

The person who will be the primary contact for the study serves in the role of the primary contact for the application. This can be the PI, or it can be another study team member that is assigned this role. This may be the person who has the primary responsibility for creating submissions, responding to stipulations, and responding to study-related questions. If the primary contact is also the PI, the PI must still list their name as Principal Investigator in the personnel section when completing the application.

The status of your IRB application(s) can be found on your Cayuse Human Ethics dashboard. The statuses are explained below:

• In Draft – Submission is with researchers and is still currently being completed and/or undergoing revisions before being finalized by the PI or Primary Contact (PC). The submission will remain in this status until the “complete submission” button has been clicked and confirmed.
• Awaiting Authorization – Submission is awaiting certification or approval from the PI, Co-investigator (Co-I), or Faculty Advisor as applicable. The submission will remain in this status until the “certify” button has been clicked and confirmed by the applicable study team members (PI, Co-I, faculty advisor)
• Pre-Review – Submission is being prepared for review. Once the submission has been certified by all applicable study team members, the submission will be submitted to the IRB. The submission will remain in this status until it is assigned to an IRB staff member for review.
• Under Review – Submission is with reviewer(s). PLEASE NOTE: When a study application is moved to the “under review” bucket, this means it is in the queue for review – it does not mean the study application is being reviewed at that moment. A submission can remain in “under review” status for several days until it is actually reviewed.

• My Studies – List of all studies that the investigator is affiliated with
• My Tasks – Current list of tasks that need the investigator’s completion – Ex: certify a submission, complete a submission, etc.
• Submissions by Type – current list of the investigator’s IRB submissions by submission type – ex: initial, renewal, modification, closure
• Approved Studies – Current list of the investigator’s approved studies
• Studies Expiring – Current list of the investigator’s studies that are pending expiration – can view in 30, 60, 90-day increments
• Expired Studies – list of studies that have expired – no recruitment or data collection can occur until a renewal has been submitted and approved by the IRB

• Principal Investigator – the person assuming primary responsibility for the conduct of the study and ensures compliance with applicable laws and regulations and institutional policy governing the conduct of the research
• Primary Contact – The person who will be the primary contact for the study – this can be the PI, or it can be another study team member that is assigned this role. This may be the person who has the primary responsibility for creating submissions, responding to stipulations, and responding to study-related questions. If the primary contact is also the PI, the PI must still list their name as Principal Investigator in the personnel section when completing the application.
• Co-Investigator – key personnel who have responsibilities similar to that of a PI on research projects – while the PI has ultimate responsibility for the conduct of a research project, the Co-PI/Co-I is also obligated to ensure the project is conducted in compliance with applicable laws and regulations and institutional policy governing the conduct of sponsored research *
• Faculty Advisor – The faculty member assuming responsibility for the conduct of a student-led study. The faculty advisor oversees the student PI and ensures compliance with applicable laws and regulations and institutional policy governing the conduct of the research *
• Other Personnel – research staff who have contact with study participants or who have contact with/access to identifiable data from subjects (example: research assistant)

Yes, emails will be sent from the Cayuse IRB Human Ethics system.

If you do not receive an email from the Cayuse IRB Human Ethics system, please check your spam folder. If the email is in your spam folder, please be sure to flag the email as an approved sender.

This is a collection of all the notifications for tasks that need to be completed by the researcher. For example, studies awaiting certification, submissions received, studies pending expiration, etc.

Notifications can be viewed by clicking on the bell. Once you click on an individual task, the task will be removed from the list. A collection of your tasks can also be found under “My Tasks” on the Cayuse IRB Human Ethics dashboard.

If you would like to turn the notification feature off, you can do so by clicking on the bell, clicking the ellipses next to the word “notifications” and selecting “mute notifications.”

If you are experiencing technical issues with the Cayuse Human Ethics system, please email Cayuse Tech support at support@cayuse.com.

Please be sure to include your name, contact information, study number, a screenshot of the error (if applicable), and a description of the issue.