»IRB Application System (Cayuse IRB)

Authentication is needed for investigators who have never submitted for IRB review or are receiving the message, "We're sorry. This account has been disabled on the Cayuse424 system,"upon login. To obtain access in Cayuse IRB, investigators need to request authentication in Cayuse IRB and email the following information to the IRB at irb@chapman.edu:

• First and Last Name
• Chapman email address (e.g. NAME100@chapman.edu)
• Status (faculty, staff, student, unaffiliated, etc., as appropriate)
• Chapman University College and Department (e.g. Crean and Psychology)

Investigators can log into Cayuse IRB after their information is added and after Cayuse IRB completes its nightly sync process.

• For student-directed studies, a list of student names and their above information must be submitted to the IRB. 
• Authentication is not required for studies that include student research assistants who will be engaged in but who will not direct the study. Student research assistant names can be listed in Section 2 Personnel under "Other Chapman Researchers (Investigators)," along with others engaged in the research. 

If your information was incorrectly entered, you can correct your information by emailing the IRB at irb@chapman.edu.

• How to sign in, navigate, and submit new applications (pptx)
• How Chairs and Deans complete organizational approval (pptx) by certifying or returning submissions
• How to navigate through reviewers' comments
• How to create additional submissions (pptx) (e.g., renewal, modification, incident, withdrawal)
• How to submit a reliance agreement (pptx) (e.g., Chapman is relying on an external IRB, Chapman is the IRB of Record)

Below is a list of items that should be ready before starting a Cayuse IRB submission.

• Study materials saved as separate documents (e.g., informed consent forms, letters of support from study sites, recruitment documents, survey questions, interview questions)
  • Visit the Templates and Forms page to download templates and forms for your study's use.
• Copies of CITI completion certificates/reports from each member of the research team
  • Visit the Training and Continuing Education for more information on CITI certifications
• All users "authenticated" in Cayuse IRB
  • See the Authentication tab for more information.

Initial

This is the first submission that you create when you enter a new study in the system. The initial submission describes the research you intend to do and the methodology you intend to use. The initial submission must be approved before any research can begin.

Withdrawal

A withdrawal submission notifies the Integrity Office that you no longer wish to submit your initial submission and want to withdraw the study. Withdrawn studies are marked as finalized and can no longer be modified. You may create a withdrawal submission at any point once an initial submission has been created, until it has been approved. If the initial submission has been approved, you must create a closure submission in order to close the study if you no longer wish to conduct the research.

Modification

If you wish to change any of the details of the study after it has been approved, you must submit a modification which must be approved before you can proceed with the changes. Modifications will only be available after initial approval is issued.  Modifications will be linked with the initial application and you will make revisions to the initial application based on the modifications you are requesting.

Renewal

When a study is nearing its expiration date, you must submit a renewal request in order to continue with the research. Expiration notices will be emailed from Cayuse.  Renewals, like modifications, will only be available after initial approval is issued.

Incident

You must submit an incident report to inform the Integrity Office of any adverse incidents, as required by your institution. Incident reports may be submitted at any time after a study has been approved, including after it has been closed. More than one incident report may be created for a given study, as needed.

Closure

A closure submission indicates that the research is complete and will not be continuing. Closed studies are marked as finalized and can no longer be modified.

Exempt and Expedited submissions (studies with minimal risk) can be submitted via Cayuse IRB at any time.

Full Board submissions including new, continuing reviews and amendments (more than minimal risk) are reviewed on the dates listed below when a quorum is present.  Submit applications via Cayuse IRB before the due dates listed below.

Remember: Official determination of full board review is made AFTER the application has been received and reviewed.

 

*To ensure submission completeness prior to IRB review, the IRB office may request revisions and supplemental materials. Supplemental materials include but are not limited to consent/assent forms, surveys/questionnaires, interview questions, recruitment advertisements, HIPAA authorization or waivers of authorization, certification of human subjects protection training, etc.