This page is intended for Faculty, Fellows, and Residents of the Department of Radiology at UC Denver. This is not an official COMIRB webpage
Make certain everyone listed on your application has updated COI and CITI Training; Investigators must also have current CV's on file.
If your study qualifies as Human Subject Research you must submit it for COMIRB review. Use this COMIRB guidance on determining if a study qualifies as Human Subject Research.
Use the COMIRB guidance "QA Program Evaluation tool" under the "Guidance" section to assess whether your study falls under this category:
To help determine if your study qualifies as Exempt or Expedited, use this decision tool from the COMIRB website.
Retrospective reviews could qualify as Exempt or Expedited IF they pose minimal risk to participants. If your data is completely de-identified, in other words you are not retaining any of the 18 Patient Health Identifiers, and any link to re-identify is destroyed, your study may qualify as Exempt. If you de-identify your data but retain a re-identifying key, your study most likely qualifies as Expedited.
If your study poses more than minimal risk, you must submit for a Full Board Review.
If you complete all these steps, you do not have to submit your project to COMIRB. If you would like COMIRB's official approval that your study does qualify as QA or PI, follow the steps below:
CITI training must be completed before your name can be listed on a research protocol and must be renewed every 3 years. Review the University's CITI training guide and requirements if you have any questions.
Contact Michelle Carr in the Radiology Department regarding your CITI/HIPAA training.