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COMIRB

Tools for Navigating the IRB


​*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 COMIRB website has many helpful links and documents to help you navigate your IRB submission.
  • On the forms page you can access applications, continuing review forms, decision trees, guidance documents and more.
  • The COMIRB training page has many valuable how-to videos and printable guidelines.
  • NIH has a helpful guide outlining HIPAA Privacy Rule and accessing PHI for research.
  • InfoEd 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
 

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.

 

Quality Assurance and Process Improvement Projects

Use the COMIRB guidance "QA Program Evaluation tool" 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 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.

General information about InfoEd:
  • COMIRB has several training modules on how to use and submit through InfoEd.
  • 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 COMIRB forms page.
  • 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 InfoEd.
  • The application for Exempt studies can be found on the COMIRB forms page.
 

Exempt Protocols

  • Exempt studies must be submitted electronically through InfoEd.

  • The application for Exempt studies can be found on the COMIRB forms page.

 
Quality Assurance and Process Improvement Projects

Documentation

  1. Complete the applicable check boxes on this COMIRB QA/PI Guidance (it's under the "Guidance" section).
  2. 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.
  3. Save written documentation that this project was delegated or endorsed by a superior at the institution hosting the project.
  4. 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

  1. Complete either the paper or electronic Exempt/Expedited application (see Exempt category above).
  2. If you used the QA/PI Guidance referenced above, include this with your submission.
 
 

Questions? Contact the Dept. of Radiology Research Coordinator or Research Administrator.

All personnel listed on a protocol must have up-to-date Conflict of Interest (COI) and CITI training.
 

CITI

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 Monica Devine (x41011) at COMIRB regarding your CITI/HIPAA training.

 

COI

Click here to update your Conflict of Interest. If you are having trouble, use this how-to guide. This must be updated annually.