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IRB Submission Process & Deadlines

TCU faculty, students, and staff may not initiate or conduct Human Subject’s Research without first receiving approval for the research by the TCU IRB.

An Outline of the Review and Approval Process

1. Submit Required Documentation

Complete Required CITI Training and be sure to review the Human Subjects Training page.

If you are a volunteer faculty mentor for the TCU School of Medicine, working with a medical student to submit human subject research for review, you may request guest access to Cayuse by completing the form linked here.

If you are a student you may request access to Cayuse account by completing the form linked here.

All TCU faculty and staff will automatically be granted access to Cayuse and will not need to request access.

Submit IRB Application and all appendix materials as Word or PDF attachments to the IRB via Cayuse Human Ethic.

For instruction on how to submit your IRB submission in Cayuse HE, please review the Cayuse tab in the drop-down menu for further instructions.

2. Administrative Pre-Review

Office of Research Compliance will conduct a pre-review of all submissions. During this pre-review, Office of Research Compliance staff will make comments directly in the application where they have questions and may ask the PI for revisions, clarifications, and modifications to the submission to ensure application completeness and to accelerate the IRB’s substantive review of the protocol.

When the submission is returned to the PI, the expectation is all comments will be addressed/resolved. This means you will have to respond to each comment and update the submission itself accordingly with new or revised information. If you respond to comments and do not update that section of the submission Office of Research Compliance staff will send the submission back to the PI to complete.

3. IRB Review

The IRB reviews projects using one of four methods, depending on the protocol’s level of risk to human subject participants:

– Exempt from further IRB Review

– Limited IRB Review (Exempt)

– Expedited Review

– Full Board Review

4. Communicate Outcome

Once all requirements are met for approval, Office of Research Compliance will issue an approval letter to the PI that will be sent via Cayuse HE. Data collection cannot begin until the PI receives the approval letter from Office of Research Compliance.

Deadlines and Estimated Timeline for Review

Full Board Reviews.  The TCU IRB meets monthly during the academic year to conduct Full Board Reviews. PIs should submit new protocol and/or protocol modification submissions that require Full Board Review to the IRB more than two (2) weeks before the next scheduled IRB meeting date if the PI wants their protocol to be reviewed at the coming meeting. Full Board Reviews take approximately one month from submission to approval.

PIs should submit Continuing Review applications of Full Board protocol to the IRB no fewer than thirty days prior to the date on which the protocol will expire.  Failure to submit such a continuing review in a timely manner may result in protocol expiration and require an incident report for minor-non-compliance.

Exempt and Expedited Reviews.  If the TCU IRB deems a new protocol/modification submission eligible for exemption or expedited review, then the new protocol/modification submission will be reviewed by the IRB through the Designated Member Review process on a rolling basis. Exempt and Expedited reviews take approximately two weeks or longer from submission to approval, pending revision requests.

For instructions regarding the submission of Annual Check-in/Progress Reports for protocol that the IRB deemed Expedited, please see the instructions on the original approval letter issued by Office of Research Compliance for the protocol. You can find your initial approval letter in the study detail tab in Cayuse.