Cayuse ‘Animal Oversight’ will replace the LEO ‘IACUC Application’ module. This module will be used by faculty, staff and students who conduct research with animal subjects. This is how a submission will be routed to the Institutional Animal Care and Use Committee (IACUC) for review.
If you are a student and need access to the system, please submit the Cayuse Individual Account Request Form.
Project specific questions should be sent to compliance@ohio.edu.
All active approved IACUC protocols will be transferred from LEO to Cayuse using a “protocol shell” approach. The protocol shell will only contain (1) study title, (2) Principal Investigator’s name, and (3) PDF attachments of submissions approved in LEO during the current approval period. All protocols will keep their current approval and expiration dates as indicated in LEO.
Principal Investigators (PIs) will be able to submit annual reports/continuing reviews without backfilling the application form. PIs must backfill the application form in order to submit an amendment, deviation/event report or to renew the study.
We encourage PIs to backfill the application form at their earliest convenience so that this process does not slow down an urgent amendment request. The Cayuse form asks questions that were not in the LEO form so the backfill may take additional time. The new questions in the Cayuse form will assist the IACUC in maintaining compliance with federal regulations. Submissions where the only purpose is to backfill the application will be reviewed by designated member review.
IACUC staff will host virtual drop-in sessions via Microsoft Teams. We will provide a general overview of the Cayuse Animal Oversight system and answer questions about Cayuse. These sessions are intended to be interactive, so please come prepared to ask questions!
You can find links to the sessions, along with more information about the virtual training sessions on the IACUC website.
“Backfilling the application form” means that the PI completes all questions in the protocol shell. This is done by creating an amendment in Cayuse so that the form is editable and then completing all sections of the application form.
Deferrals will not be migrated to Cayuse. If you want to continue working on the project after the expiration date in LEO, you will need to resubmit in Cayuse.
A ‘Principal Investigator Group’ is one or more study team members that can assist the PI by creating and submitting submissions to the IACUC. NOTE: The PI must still sign off (i.e., certify) before the submission will be routed to the IACUC for review.
To request a PI Group, please email compliance@ohio.edu with the study number and names of research team members to add to the group.
If your study exists as a protocol shell, you must first backfill the application form. This is because only the PI's name has been included in the protocol shell.
Transition Plan for Scenario 1: In this case, you will need to start a new protocol application in Cayuse. For more information, please refer to How to Create a New Submission (opens in a new window). Please be sure to consult with the IACUC Meeting Schedule (opens in a new window), your new protocol will need to be reviewed at a convened meeting. Be sure to submit your protocol before the submission deadline for the meeting you are targeting.
Transition Plan for Scenario 2: Before submitting an amendment in Cayuse, you must first backfill your Cayuse protocol shell. A protocol shell has been created for you in Cayuse, accessible only by the PI of the protocol.
The backfilled protocol shell must be reviewed and approved before you can submit an amendment, with the exception of personnel additions or removals being allowed in the backfill. The backfilling step is essential, protocol shells are incomplete in terms applicable sections and content. The shell must be fully backfilled with all the protocol's components to ensure that the elements of the amendment can be properly incorporated.
This review can occur outside of the IACUC convened meeting, so please allow 3 business days for the review process. Once the backfill is approved, you can create and submit an amendment for review. Please be sure to consult with the IACUC Meeting Schedule (opens in a new window), your amendment will need to be reviewed at a convened meeting. Be sure to submit your amendment before the submission deadline for the meeting you are targeting.
For detailed instructions on how to backfill a protocol shell, refer to the guide linked below. Once your backfilled submission is reviewed and approved, you can proceed with submitting an amendment. Please refer to the guide linked below for further information.
Step 1. How to Backfill a Protocol Shell (opens in a new window)
Step 2. How to Create an Amendment (opens in a new window)
Transition Plan for Scenario 3:
Note: Researchers who report an adverse event or deviation through the interim process are required to complete the backfill of their submission within 30 days of the initial report. During this backfilling process, researchers must incorporate the details of the report into their final submission.
Transition Plan for Scenario 4: To renew your protocol, you need to submit a De Novo (i.e. a renewal) form in Cayuse. Please be sure to consult with the IACUC Meeting Schedule because your De Novo submission will need to be reviewed at a convened meeting. Be sure to submit your protocol before the submission deadline for the meeting you are targeting. To avoid a lapse in approval, please be sure to strive for an IACUC meeting date that is two months before your protocol’s expiration date.
How to Submit a De Novo: Contact compliance@ohio.edu for instructions.
Transition Plan for Scenario 5:
| LEO | Cayuse |
|---|---|
| Annual Report | Continuing Reviews- is an annual review process report that is required for ongoing research protocols. This review ensures that the research is being conducted in compliance with all applicable regulations and standards. Note, this report does not renew the protocol, it is simply a progress report for the IACUC that is due on the first and second anniversary of the protocol’s approval date. |
| Renewal | De Novo Review- occurs every three years and is a more comprehensive review compared to the annual continuing review. This review is required for renewing the protocol. |
The Continuing Review process is one mechanism the IACUC uses to conduct post-approval monitoring. This process will replace the Annual Reporting process in the LEO electronic system.
The Office of Research Compliance would like you to be aware of IACUC Policies & Procedures (opens in a new window), specifically the new policy on continuing review.