Submitting a Protocol

All submissions are submitted using Cayuse IRB and will be pre-screened by the Human Subjects Research Specialist (HSRS) to ensure completeness prior to review.

If you have an old protocol you cannot find in Cayuse IRB, contact us before you start a new study.

Visit Cayuse IRB (now called Human Ethics)

For general instructions on submitting protocols view the Cayuse IRB (now called Human Ethics) Submission Guide

For more complete instructions, including screenshots, view the Cayuse IRB (now called Human Ethics) Quick Start Guide

Review Process

View the steps you need to take in order to submit your protocol.

Create a Study

A new protocol can be created in Cayuse IRB by clicking on the "+ New Study" button in the upper right corner of Cayuse IRB's dashboard. Someone other than the PI can start a study. Within the study, click on "+ New Submission" to continue.

Submission Types

Initial

The first submission that also serves as the protocol for a study.

Modification

To revise the protocol of a study. This submission will include a section asking you to describe your changes and the most current version of the protocol. You will need to edit the protocol to reflect the changes you wish to make.

Renewal

To extend the study past an approval expiration date. Researchers with access to the protocol will receive an emailed notification if there study is about to expire.

Legacy

To transfer protocols into Cayuse IRB that were active before this submission system was implemented. This serves as the protocol instead of the initial submission.

Incident

To submit reports of unexpected incidents related to your study. If urgent, please contact the REC office instead.

Closure

To request that a active study is closed out and archived.

Withdrawal

To request that an initial submission is withdrawn from review and closed out.

In-Draft

Once the submission type has been selected, you will enter all of the details. For an initial submission, please make sure the following items are present to help avoid delays:

CITI training verification
Consent documents including recruitment flyers, consent scripts, and debriefing statements, if required
Site permissions, if required
Surveys, interview questions, instruments
Transcription service confidentiality agreements (if applicable)

There may be additional requirements depending on the location, population, data collection methods, etc. There will be information in the submission itself to guide you. PIs should use this checklist to assist with verifying the protocol is ready for certification. Protocols that are incomplete will be returned to the PI without review.

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The submission is ready for the PI to certify it, which then moves the submission to Pre-Review.

Pre-Review

The HSRS will conduct a pre-review to ensure the submission is ready for review and will notify the PI if any items are incomplete. If the PI does not respond to the HSRS within 30 days, the submission will be administratively withdrawn.

Under Review

If determined to be ready, the submission is then reviewed by either the HSRS or IRB, depending on the review level.

Principal investigators will receive notices from Cayuse IRB to log in via email, including updates on review status, approval letters being posted, and notifications regarding expiration dates.

Levels of IRB Review

Exempt determinations will be made by the HSRS directly. Expedited and full review studies will be routed through the appropriate process.

Learn About IRB Levels of Review