I need to submit a new study
As of February 15, 2024, all NEW studies must be submitted in Cayuse.
Human Ethics (IRB)
Cayuse ‘Human Ethics’ will replace the LEO ‘IRB Application’ module. This module will be used by faculty, staff and students who conduct research with human subjects. This is how a submission will be routed to the Institutional Review Boards for review.
Questions about the system, email cayuse@ohio.edu. Project specific questions, email compliance@ohio.edu.
Timeline
| 2/15/2024: All new studies (initial submissions) must be started in Cayuse. |
| Annual renewal: All continuing expedited and full board studies must be approved in Cayuse before the study expires in LEO. You will be required to recreate the study in Cayuse. Please allow for adequate time for review and approval. |
| Amendment: Expedited and full board studies can continue to submit study amendments up to the time of annual renewal. Exempt studies that require modification should be submitted as a new study in Cayuse. |
| 4/1/2025: Any active, continuing exempt studies must be migrated to Cayuse no later than this date. At this time, all studies in LEO will be closed and LEO will become “read only”. |
Cayuse Transition Timeline FAQ's by Submission/Study Type
I have a new study submission in progress in LEO as of February 15, 2024
Studies that were fully submitted in LEO before this date (meaning all signoffs completed and in the ORC review queue by 11:59 PM EST on February 14, 2024) will continue to be processed in LEO, but they must be approved no later than March 29. If the study is not approved by March 29, you will need to resubmit the study in Cayuse. To avoid this, we request your timely responses to revision requests.
I have an existing expedited or full board study that was approved in LEO and I need to submit a periodic review
If your study expires on or after March 29, 2024, you will need to submit the study as a new study in Cayuse. These studies will be submitted and reviewed as new submissions. It will be helpful if you note the LEO IRB # as well as note any changes from the previously approved LEO protocol. Please plan to allow sufficient time for the review process to avoid a lapse in IRB approval for your study.
If your study expires before March 29, 2024, you may choose to submit a periodic review in LEO or submit as a new study in Cayuse. If you elect to stay in LEO at this time, you will need to submit the study as a new submission in Cayuse at the time of the next periodic review.
I have an existing expedited or full board study that was approved in LEO and I need to submit an amendment, protocol deviation, or adverse event
As noted above, at the time of periodic review/renewal, the study will need to be submitted as a new study in Cayuse. If your study has not expired in LEO, you may continue to submit amendments, protocol deviations, and adverse events in LEO.
I have an existing exempt study that was approved in LEO and does not expire
All exempt studies that are open and active in LEO must be submitted as a new study in Cayuse no later than April 1, 2025. If you need to submit an amendment to an exempt protocol after February 15, 2024, you will need to submit the study as a new study in Cayuse. These studies will be submitted and reviewed as new submissions.
I'm staff but submitting to the IRB as a student
In Cayuse, you will submit using your staff account, but indicate in the application form, Section 8, that the study is a student-led research project.
I have an existing study in LEO that I am ready to close
Completed studies can still be closed in LEO. The Periodic Review button has been replaced with a Close Study button.
Differences from LEO to Cayuse
| CITI Training: You will not need to upload your human subjects CITI training to Cayuse. It will import automatically if your primary email address in CITI is your OU email address. |
| Expedited Studies: Most expedited studies will no longer have an expiration date. There will be a triannual check-in process for studies that don’t expire (including exempt studies). |
| Approval Stamps: Participant-facing documents, such as consent forms and recruitment materials, will have an IRB approval stamp in the lower right corner. |
| Incident Form: There will be one Incident form for submitting protocol deviations, adverse events, and unanticipated problems. |
| No Deferral Form: There is no longer a separate Deferral form; you will use the Initial Submission form to request a Deferral. If more than one OU researcher will be engaged, you can now use one form for all researchers. |
| Students: Students will not automatically appear in the Cayuse database; students who will be listed as study personnel for the first time must request access by filling out the Cayuse Individual Account Request form. If you can access Cayuse via a staff account, you do not need a student account. You can submit to the IRB using your staff account. |
| Disclosures: You will be asked to disclose Outside Interests that are relevant to the study. |
| Closure Form: To close your study with the IRB, you will use the Closure form instead of the Renewal form. |
Recent IRB Procedure Updates
The Office of Research Compliance would like you to be aware of the following IRB template and procedure changes:
- Revised consent form templates have been posted on the IRB webpage. The new template is required at time of progress report and new study submission. These templates have been in place since July 31, 2023.
- As of 2/15/2024, if you will be conducting study procedures with research participants in languages other than English, you will need to include a completed Verification of Translation form. The purpose of the Verification of Translation form is for someone to attest to the accuracy of the translated documents. This can be a qualified member of the research team.
- As of 2/15/2024, undergraduate students can no longer serve as Principal Investigator on new studies submitted for IRB review. Students can still serve as the primary point of contact on submissions. Find more information about roles of investigators on an Ohio University IRB protocol.
Training Sessions
The Office of Research Compliance is hosting virtual drop-in sessions via Microsoft Teams. We will provide a general overview of the Cayuse system, answer questions about Cayuse, and discuss how to handle studies already approved in LEO. These sessions are intended to be interactive, so please come prepared to ask questions! You can find more information on the Human Subjects (IRB) website.