IRB Review Process
#1. Submit your application to [email protected].
The [email protected] email address is monitored daily during school hours by the Office of Research Integrity (ORI). When applications are received, they are logged into a central database, assigned an IRB #, and saved to an electronic file.
For Exempt Applications:
ORI will review the application to confirm that the Exempt Designation selected is appropriate. Investigators may be contacted with requests for clarifications, additions, or revisions. Should ORI determine that Expedited Review is required, the investigator will be notified and asked to complete an Expedited Application.
For Expedited Applications:
ORI will conduct an initial review of the application to check for completeness and obvious errors. At this point, investigators can expect to receive an email that notifies them that their application was received and either needs to be corrected and resubmitted or has been forwarded to the committee for review. Applications will be forwarded to two committee members (selected on a rotating basis) for review. Any application may be bumped to Full Board Review at the reviewers' discretion.
#2. Monitor your email daily and respond promptly to any questions and revision requests.
Any reviewers' concerns will be consolidated into an Action Letter which will be emailed to the Principal Investigator and faculty advisor, if appropriate. Revisions should be made as outlined and resubmitted to the [email protected] email address. This process may repeat until all reviewers' concerns have been addressed.
The following checklists are utilized by the ORI and the IRB to facilitate protocol review. You may find it helpful to review these checklists as you prepare your application.
#3. You will receive an approval letter letting you know you've been approved.
No research may proceed before the IRB office has notified the applicant that the research is approved and/or designated as Exempt. There is no such thing as an emergency exemption/approval and no university official other than the IRB Chair or his/her designee may designate research as exempt or approve an application.
For Exempt Applications:
The PI and the Faculty Advisor, if appropriate, will receive an Exemption Designation Letter from ORI, confirming that the project falls into one of the categories of Exemption as described in the Common Rule. At this time, the research outlined in the IRB application may begin.
For Expedited Applications:
Once all reviewers agree that the application is satisfactory, the PI and faculty advisor, if appropriate, will be emailed an official approval letter. At this time, the research outlined in the IRB application may begin.
Remember: Allow adequate time for your application to be reviewed and approved!
The length of the review process depends on several factors including when the application is received by the IRB, the type of review, and the quality of the application. Exempt reviews generally take about three to five days from the time the application is received by ORI. Expedited reviews are usually completed within 2 - 3 weeks of receipt, and full board reviews can take up to 5 weeks. The IRB Chair and Committee at UTC are not full-time staff. As such, submissions received prior to holidays and other times when faculty are very busy (Spring Break, midterms, finals) may experience delays.
Be advised that incomplete applications represent one of the main reasons applications are delayed. Be sure you have fully completed the application, included appropriate attachments, have completed the required CITI training, and have acquired the needed signatures.