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 IRB Application
Submit IRB Application and all appendix materials as Word attachments to the IRB using email (IRBsubmit@tcu.edu)
2. Administrative Pre-Review
Research Compliance will conduct a pre-review of the protocol. During this pre-review, Research Compliance may ask the PI for revisions, clarifications, and modifications to the protocol to ensure application completeness and to accelerate the IRB’s substantive review of the protocol.
3. IRB Review
The IRB reviews projects using one of three methods, depending on the protocol’s level of risk to human subject participants:
– Exempt from further IRB Review
– Expedited Review
– Full Board Review
The PI may recommend the review category, but final the IRB makes determines the final review category.
4. Communicate Outcome
Once all requirements are met for approval, Research Compliance will issue an approval letter to the PI via email. Data collection cannot begin until the PI receives the approval letter from Research Compliance.
Deadlines and Estimated Timeline for Review
Full Board Reviews. The TCU IRB meets monthly during the academic year and only once during the summer to conduct Full Board Reviews. PIs should submit new protocol and/or protocol modification requests 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 request in a timely manner may result in protocol expiration and/or research suspension.
Exempt and Expedited Reviews. If the TCU IRB deems a new protocol/modification request eligible for exemption or expedited review, then the new protocol/modification request will be reviewed by the IRB through the Designated Member Review process on a rolling basis. Exempt and Expedited reviews take approximately two weeks 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 Research Compliance for the protocol or click here.