COMIRB
Tools for Navigating the IRB
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This page is intended for Faculty, Fellows, and Residents of the Department of Radiology at UC Denver. This is not an official COMIRB webpage
The website has many helpful links and documents to help you navigate your IRB submission.
- On the you can access applications, continuing review forms, decision trees, guidance documents and more.
- The has many valuable how-to videos and printable guidelines.
- NIH has a outlining HIPAA Privacy Rule and accessing PHI for research.
- is COMIRB's online tool for e-submissions, accessing study documents, and other information pertaining to your study.
Make certain everyone listed on your application has updated COI and CITI Training; Investigators must also have current CV's on file.
COMIRB Offices are on the 3rd floor of Building 500
Questions? Contact the Clinical Research Manager.
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If your study qualifies as Human Subject Research you must submit it for COMIRB review. Use this on determining if a study qualifies as Human Subject Research.
Quality Assurance and Process Improvement Projects
Use the COMIRB guidance "" under the "Guidance" section to assess whether your study falls under this category:
- if you only check boxes in the QA or PI columns then your study most likely qualifies as QA/PI
- You do NOT have to apply to COMIRB if your study qualifies as QA/PI
- You can submit QA/PI to COMIRB as Exempt giving you official documentation that the study is QA/PI
To help determine if your study qualifies as Exempt or Expedited, use this 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 , 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.
General information about InfoEd:
- COMIRB has severalon how to use and submit through InfoEd.
- is a great tool to access your study information and documents for all types of submissions.
Full Board Protocols
- The application for Full Board studies can be found on the
- Completed applications must be dropped off at the COMIRB Office, 3rd Floor, Building 500. Full Board protocols cannot be submitted electronically.
Expedited Protocols
- Expedited studies must be submitted electronically through .
- The application for Exempt studies can be found on the
Exempt Protocols
- Exempt studies must be submitted electronically through .
- The application for Exempt studies can be found on the
Quality Assurance and Process Improvement Projects
Documentation
- Complete the applicable check boxes on this (it's under the "Guidance" section).
- If you consistently select boxes in the QA or PI column and no Research boxes are checked, then your study qualifies as QA or PI.
- Save written documentation that this project was delegated or endorsed by a superior at the institution hosting the project.
- Ask another colleague not involved in the project to go through the guidance as well; if they agree with the QA or PI designation, they should sign the form.
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:
Submitting to COMIRB
- Complete either the paper or electronic Exempt/Expedited application (see Exempt category above).
- If you used the QA/PI Guidance referenced above, include this with your submission.
Questions? Contact the Dept. of Radiology Clinical Research Manager.
All personnel listed on a protocol must have up-to-date Conflict of Interest (COI) and CITI training.
CITI
must be completed before your name can be listed on a research protocol and must be renewed every 3 years. Review the University's if you have any questions.
Contact Michelle Carr​ in the Radiology Department regarding your CITI/HIPAA training.
COI
Click to update your Conflict of Interest. If you are having trouble, use this . This must be updated annually.