Initial Submissions (New Studies)

Complete the following steps to submit your new study

Before you begin, please note that all investigators and research staff must complete the required education courses, gain access to the InfoEd eRa website, and complete several other tasks. These tasks can take several days to complete, so please factor that into your planning.

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.
  • Denver Health and Hospital Authority: Contact the SPARO Office at
  • University of Colorado Cancer Center: Your research may need to be submitted to PRMS before COMIRB review.
  • 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.


Complete the application for protocol review form

If your research involves only the collection and analysis of data or biological specimens which were originally collected for another purpose, you are requesting a waiver of consent, and you will not contact subjects to participate in other parts of your project, your study may qualify for use of the Secondary Research Application. Download this form for more information on Secondary Research, or to see if your study qualifies.


Compile supporting documents

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.


Submit the materials to COMIRB via the InfoEd eRA website

First-time users are encouraged to attend our Beginner's Guide to InfoEd eRa course (CTSA33); View the calendar of available courses.

To obtain a COMIRB number (21-XXXX) and create a new protocol submission: select the Denver campus from the InfoEd eRA login page. Then, click Human Protocol, and Create New Human Protocol. 


For help with your submission or the submission process, please contact our help desk at