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University of Colorado Denver

Colorado Multiple Institutional Review Board
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Submissions

Colorado Multiple Institutional Review Board


Please follow the links below or to the left for submission-specific instructions.

All submissions to COMIRB must be made electronically via the eRA(InfoEd) system.​

If you have questions about your COMIRB submission please contact COMIRB at 303-724-1055 or COMIRB@ucdenver.edu. You may also contact the Clinical Research Support Center, which is dedicated to supporting investigators, at 303-724-1111 or ClinicalResearchSupportCenter@ucdenver.edu.

If it would be helpful to discuss your study with an IRB Chair and senior staff, please check the COMIRB Office Hours schedule. If you would like to discuss COMIRB training for larger groups, please contact COMIRB@ucdenver.edu.

Additional training resources are available here.​

 Initial Submissions (New Studies)

  1. Before you submit to COMIRB, all investigators and research coordinators must complete the required education courses, gain access to the eRA(InfoEd) website, and complete several other tasks. Click here for instructions on how to complete these tasks. These tasks can take several days to complete, so we suggest you factor that into your planning. When these tasks are completed, you will be ready to continue with the submission process.

    Note, if you plan to submit for a Non Human Subject Research determination, personnel do not need to complete the CITI Training Courses or a Conflict of Interest disclosure because this type of determination is a request for confirmation that the proposed project does not meet the criteria to require COMIRB oversight. However, all personnel still need to gain access to COMIRB's electronic submission system, the eRA(InfoEd) website.

  2. Determine if you need to submit for institutional approval - COMIRB's affiliated institutions each require investigators to submit for institutional approval in prior to submitting to COMIRB. For each site involved with your research, please contact the appropriate institutional research office:

    • CU Denver Anschutz Medical Campus and University of Colorado Hospital - Your research may need to be submitted through the Human Subject Research portal to gain institutional approval. If your research involves either site, click here for more information.
    • Denver Health Medical Center - Contact Amanda.Breeden@dhha.org
    • Denver Health Medical Center SPARO Office - Contact Sparo@dhha.org
    • Children's Hospital Colorado - Contact Aaron.Mobley@childrenscolorado.org. Any study taking place at CHCO should be submitted to the Clinical Research Management System (CRMS). For more information click here.
    • University of Colorado Cancer Center - Contact the Protocol Review and Monitoring System Office at prmc.uchsc@ucdenver.edu
    • Denver VA Medical Center - Contact the Research Administrative Office at 303-399-8020 ext. 2755
    • CU Denver Downtown Campus - Research conducted solely on the Downtown Denver Campus does not require any institutional approval in addition to COMIRB review. COMIRB review is still required.
  3. Complete the Application for Protocol Review Form, which can be downloaded by clicking here.

  4. Compile supporting documents – A list of possible supporting documents is provided HERE​. These documents should be printed with the PI's name, page numbers, the protocol number (which will be assigned during the electronic submission process), and a version date. COMIRB electronically stamps consent documents and local advertisements in the top right-hand corner which covers any content in that area. Please do not place content in the top right-hand corner of these documents.

    If you are looking for templates, please check the COMIRB Forms Page.

  5. Submit the materials to COMIRB via the eRA(InfoEd) website

    Click here for an instructional video on how to use the eRA(InfoEd) website to submit for review. If you previously began a submission and would like to continue working on it, click here​ for an instructional video.

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 Amendment (Change) Request for a Currently-Approved Study

Complete the following 5 steps to submit your new study to COMIRB for an Amendment (study change)

  1. If you are adding personnel to your study, newly-added personnel must have  access to the eRA(InfoEd) website. If they do not have access, ask them to obtain a POI number HERE. New personnel should complete COMIRB CITI Instructional Courses, submit a Conflict of Interest Disclosure with CU Denver, and possibly upload a CV. Click here for instructions on how to complete these tasks. Important note: personnel changes need to be reflected both on the ​​Application for Protocol Review Form for your study and the Personnel Form within the eRA(InfoEd) website. 

  2. Create new study documents and/or make necessary revisions to all relevant study documents to reflect requested changes to your study (e.g. add a new advertisement, add a new survey, revise the Application for Protocol Review Form and/or the protocol to reflect changes in research procedures, revise advertisements to include a change in contact information).

    Please make sure to include the protocol number, the PI's name, and page numbers on all documents and update the version date. Also, COMIRB electronically stamps consent documents and advertisements in the top right-hand corner which covers any content in that area. Please do not place content in the top right-hand corner of these documents.

    Information relevant to your requested change could appear on multiple documents. For instance, if you needed to make changes to a survey for your study, that may involve revising sections of your Application for Protocol Review Form, your narrative protocol, and the survey itself because all of those documents could include information relevant to changes in your survey. Only new documents for your study and documents that are being revised need to be submitted with the Amendment submission.

  3. Complete the Change Form, which can be downloaded by clicking here. Please be detailed the study changes (including personnel who were added or removed), and include a rationale for the changes.

  4. Compile the necessary documents - If you are making changes to documents that were previously submitted to and approved by COMIRB, it is necessary to upload 2 copies of the revised version of each document you are amending. One copy of the revised document should be a marked-up version using Microsoft Office’s “track-changes” feature to show changes made, and the second document should be the clean (no markup) version for stamping. If the “track-changes” feature is not available, please submit a highlighted (in yellow or green) version, or provide a detailed list of changes. Important note: it is not possible to track changes or highlight the smart PDF version of the Application for Protocol Review Form.​

  5. Submit the materials to COMIRB via the eRA(InfoEd) website

    Click here for an instructional video on how to use the eRA(InfoEd) website to submit for review.

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 Continuing Review of a Currently Approved Study

COMIRB is required to conduct a Continuing Review of active Expedited and Full Board research at least once per year to ensure research is being conducted in compliance with relevant requirements.

Complete the following 3 steps to submit your study to COMIRB for Continuing Review.

Important note: if you plan to request any changes to your study (including personnel changes) in addition to requesting Continuing Review of your study, you must submit those change requests in an Amendment submission separate from your Continuing Review. That is, you will be making two separate submissions to COMIRB via the eRA(InfoEd) website: a Continuing Review submission to request that your study be authorized for another year, and an Amendment submission to request the changes to your study. 

  1. Review the Training of Your Study Personnel

    Open the Personnel form on your submission. If any study personnel need to renew their CITI training, please ask them to do so. This will prevent delays in renewing your approval. CITI training requirements are listed HERE​.

  2. Annual Conflict of Interest Disclosures

    Ask your study personnel if they have submitted their annual COI disclosure in the past 12 months. This will prevent delays in renewing your approval. Information on the COI disclosure requirements and process can be found HERE.

  3. Review COMIRB Requests from the Previous Year

    Review COMIRB approval letters over the past year and make sure you have responded to any requests.

  4. Complete the Continuing Review Form, which can be downloaded by clicking here.

  5. Compile all supporting documents relevant to your study - A list of possible supporting documents is provided HERE​.

  6. Submit the materials to COMIRB via the eRA(InfoEd) Information about Continuing Review requirements can be found by clicking here. If you previously began a submission and would like to continue working on it, click here​ for an instructional video.

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 Unanticipated Problem Reports

An unanticipated problem is any event or information that was unforeseen and indicates that the research procedures caused harm (including physical, psychological, economic, or social harm) to participants or others or indicates that participants or others are at increased risk of harm than was previously known or recognized.

Events that meet the definition of an unanticipated problem must be reported to COMIRB within 5 working days of their occurrence. Click here for a list of reportable problems.

Events that do not meet the definition of an unanticipated problem may be reported in summary form at continuing review, but need not be reported using the Unanticipated Problem Form. External safety reports and adverse events should be reviewed by the local PI prior to submission to determine whether the event meets the definition of unanticipated problem. For further guidance in reporting external events (events at an non-affiliated institution), refer to the Safety Report Decision Tree.

Unanticipated problems are first reviewed by a COMIRB chair. The chair may note the report, require minor modifications, or defer the report to the Full Board for review. The investigator will receive notification of the chair's decision. If the report is deferred to Full Board, the investigator must respond to any questions raised by the chair, then resubmit for further review.

It is important to include as part of your submission:

  • Communication from the sponsor (if applicable)
  • IND Safety reports (if applicable)
  • Revised Investigator Drug Brochure or Package Insert (if applicable)
  • DSMB / DMC / Safety Officer reports (if applicable)

Complete the following 3 steps to submit the Unanticipated Problem Report

  1. Complete the Unanticipated Problem Report Form, which can be downloaded by clicking here.

  2. Compile all supporting documents relevant to Unanticipated Problem Report - For example: Audit Reports, DSMB Reports, Safety Reports, Sponsor Letters. A list of possible supporting documents is provided HERE​.

  3. Submit the materials to COMIRB via the eRA(InfoEd) website

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 Closing a Study

For Exempt Studies:

If you would like to close an open Exempt study, please email your request to COMIRB@ucdenver.edu​. Please make sure to include in your email the name of the Principal Investigator and the COMIRB protocol number.

For Full Board and Expedited Studies:

To close an open protocol, please submit a Continuing Review submission and outline in your cover letter the reasons you would like to close/re-open the protocol. If the protocol has been closed or expired for a significant amount of time, please contact COMIRB at 303-724-1055.

  1. Complete the Continuing Review Form, which can be downloaded by clicking here.

  2. Compile all supporting documents relevant to your study - A list of possible supporting documents is provided HERE​.

  3. Submit the materials to COMIRB via the eRA(InfoEd)

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