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. More information about the required training can be found here. These tasks can take several days to complete, so please 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 Not 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.
1. Determine if you need to submit for institutional approval. COMIRB's affiliated institutions each require investigators to submit for institutional approval prior to submitting to COMIRB. Please contact the appropriate institutional research office for each of the following sites involved with your research:
- CU Denver Anschutz Medical Campus, University of Colorado Hospital, Children’s Hospital Colorado, or Highlands Ranch Hospital: Your research may need to be submitted through the Human Subject Research portal to gain institutional approval. Click here for more information on the HSR portal.
- Denver Health and Hospital Authority: Contact the SPARO Office at email@example.com
- Children's Hospital Colorado: Contact firstname.lastname@example.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 email@example.com
- 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. However, COMIRB review is still required.
2. Complete the Application for Protocol Review Form, which can be downloaded by clicking here or on the COMIRB Forms Page.
If your research involves only the collection and analysis of data or biological specimens which were originally collected for another purpose, your study may qualify for use of the Secondary Research Application. For more information on Secondary Research and to see if your study qualifies click here.
3. Compile supporting documents.
A list of possible supporting documents is provided here. These documents should be labeled with the PI's name, page numbers, the protocol number (assigned during the electronic submission process), and 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.
4. Submit the materials to COMIRB via the eRA(InfoEd) website. First-time users are encouraged to attend our Beginner's Guide to eRA InfoEd course (CTSA33); register here. If you have questions or need assistance, please contact COMIRB at 303-724-1055 (firstname.lastname@example.org) or stop by Office Hours.
Complete the following 5 steps to submit your new study to COMIRB for an Amendment (study change)
Click here for a PDF of these instructions5
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.
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).
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.
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.
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.
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.
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.
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. Complete 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 for changes.
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.
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
Click here for a PDF of these instructions7
Complete the Unanticipated Problem Report Form, which can be downloaded by clicking here.
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.
Submit the materials to COMIRB via the eRA(InfoEd) website
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 Study Closure 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.
Complete the Continuing Review Form, which can be downloaded by clicking here.
Compile all supporting documents relevant to your study - A list of possible supporting documents is provided HERE.
Submit the materials to COMIRB via the eRA(InfoEd)