University of Colorado Denver

Any changes to an approved project require COMIRB review and approval prior to their implementation, except when necessary to eliminate apparent immediate hazards to the subject. Any changes directed by COMIRB do not need to include a Change Form. 

Changes to the research may not be implemented until the investigator has received documentation of COMIRB approval, except when necessary to eliminate apparent immediate hazards to the subject. In this case, the deviation must be reported to COMIRB within 5 days using the Unanticipated Problem form. For VA research, the VA R&D committee reviews amendments after COMIRB approval, but R&D approval is not required prior to implementation.​ There is currently no fee for review of amendments. Click here​ for further guidance on Amendments.

Instructions for how to submit an Amendment:

1. Complete the Change Form. (*Please note that if you plan to submit electronically, the Change Form is built into the eRA(InfoEd) system and you should complete it when you are ready to submit to COMIRB.) The requested change(s) must be described in sufficient detail for the reviewer to fully understand the changes, their impacts on the study procedures, and their impact on the study's risks and benefits. Please note that if you plan to submit electronically, the Change Form is built into the submission process; however, not all submissions can be made electronically. The accordion folders at the bottom of this page will help you decide if you can submit electronically for your protocol.

2. Newly-added personnel must complete COMIRB CITI Instructional Courses, submit a Conflict of Interest Disclosure with CU Denver, and gain access to the eRA(InfoEd) system, and possibly upload a CV. Click here for instructions on how to complete these tasks.

3. Make necessary to revisions to the documents.

4. Compile 2 copies of each document you plan to revise: 

• (A) First compile submission packets of all revised documents and highlight (track changes) of all the changes made in the documents, so that the reviewer will easily be able to tell what changes have been made to the documents.
• (B) Then compile clean (un-highlighted) copies of all revised document. You should now have 2 copies of each revised document: an un-highlighted copy of the revised document, and a copy that has the revised sections highlighted.
• Important Note: If, and only if, you plan to revise the "Smart PDF" version of the Application Form (the version found here) and plan to submit electronically, there are some special instructions for revising this document (please note that this does not apply to the Microsoft Word version of the Application form, or the version of the Application Form generated by the eRA(InfoEd) system):
• (i) Compile a revised version of the Application Form and an un-revised version of the Application Form. You should now have 2 copies of the Application Form: one that includes your revisions, and one that does not include the revisions. Submit both versions electronically. This is necessary because the "Smart PDF" Application Form cannot be highlighted, and we have special software that can compare the revised version of the Application Form to the un-revised (original) version.
• (ii) For all other documents that you are making revisions to (your protocol, advertisements, etc.) other than the "Smart PDF" Application Form, please follow the instructions in bullets A and B above.

5. Submit the materials to COMIRB. Please note that if your protocol was originally submitted for Full Board review, but has since been moved to Expedited review, your ability to submit via ePaper depends upon  the Panel you’re originally submitted to (i.e. where your protocol "lives"). Please click here​ for instructions on how to find out where your protocol "lives": your protocol either lives with the Expedited/Exempt Team, or with one of our Full Board Panels.