Definition of "minimal risk":
That the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily
life or during the performance of routine physical or psychological examinations or tests.
If your study does not meet the definition of "minimal risk", than it must be submitted for full board review and you can proceed to Step 4.
Please be aware that your interpretation of "minimal risk" may not be the same as our Panel members.
If your study does meet the definition of "minimal risk", proceed to next accordion folder to determine if your study is eligible for Expedited review based upon the 7 "Expedited Categories" outlined in the federal regulations.
The following link includes a document that outlines the 7 "Expedited Categories" by which an initial submission of a study can be approved. Click here to access that document.
Important Note: Certain types of research do not qualify for initial Expedited review and must be reviewed by a full board:
- Research involving human genetic testing
- Research involving prisoners
- Research involving major deception in which the researcher misleads subjects about their health status, the researchers, or research purpose.
Further Available Resources:
If you are unsure whether or not your study qualifies for an exemption. This decision tree from the Office of Human Research Protection may be helpful. Please call the COMIRB Help Line at 303-724-1055 with
If you have determined that your study is eligible for Expedited review, please check the accordion folder below entitled "Does my study include vulnerable populations?" to see if
your study is subject to any additional regulations, then click the accordion folder entitled "How to submit for Expedited review".
If you have determined that your study is not eligible for Expedited review please check the folder below to see if any special regulations apply based upon the
inclusion of "vulnerable populations, then proceed to Step 4 by scrolling to the top of this page and clicking the link in the grey column to the left of the page.
"Vulnerable populations" include those individuals whose status may create additional risk for study participation or undue coercion, such as: children,
prisoners, pregnant women, neonates, mentally disabled persons, adults who lack the ability to consent, or economically or educationally disadvantaged persons.
COMIRB will determine if appropriate additional safeguards are in place to protect the rights and welfare of subjects if they are likely to be members of a vulnerable
If COMIRB reviews research that involves categories of participants vulnerable to coercion or undue influence, the review process will include one or more individuals who are
knowledgeable about or experienced in working with these participants. For example, COMIRB will include one or more individuals who are knowledgeable about or experienced in
working with children, prisoners, or adults with limited decision-making capacity, when reviewing research that involves individuals from these populations.
45 CFR 46 has additional subparts designed to provide extra protections for vulnerable
populations which also have additional regulatory requirements:
Subpart B - Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
Subpart C - Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects
Subpart D - Additional Protections for Children Involved as Subjects in Research
If your study potentially includes any of vulnerable populations, please review the following links for guidance from COMIRB:
Select the appropriate instructions below for information on how to proceed:
My study is not eligible for one of the 7 "Expedited Categories" listed in the accordion folder above:
Please proceed to Step 4 for information on how to submit your study for Full Board review by scrolling to the top of the page and clicking the link in the grey column on the left
side of the page.
I believe my study qualifies for one of the 7 "Expedited Categories" listed in the accordion folder above:
Complete the following 4 steps to submit your study to COMIRB for Expedited review:
1. Before you may submit to COMIRB, you must complete the required education courses, gain access to the eRA(InfoEd) system, 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.
2. Complete the Application Form, which can be downloaded by clicking here. *To prevent problems, make sure to use Adobe Reader to open and edit the "Smart PDF" Application Form. Click here to download a free copy of the newest version of Adobe Reader.
3. Compile supporting documents printed with the PI's name and page numbers:
- A. A cover letter listing what documents are included in the submission.
- B. Grant application (if funded by a federal grant)
- C. Data collection tools.
- D. Surveys, diaries, questionnaires, interview guides, scripts used with subjects (if applicable).
- E. Recruitment materials, advertisements, invitations to participate, informational materials subjects (if applicable).
- F. VA or Denver Health clearance letter (if research is conducted at or involves employees of these sites).
- G. Consent forms, assent forms, verbal consent scripts (Standard consent and assent language templates can be found in an accordion folder on the COMIRB Forms page by clicking
- H. Protocol (A standard protocol template can be found by clicking here).
- I. HIPAA Authorization A Form which allows a potential research subject to authorize their health care provider, who is uninvolved in a study, to release PHI to a study
investigator for the purpose of recruitment (if applicable).
- J. HIPAA Authorization B Form allows a potential research subject to authorize the use of their PHI for the purposes of a study. (if applicable, Note: the authorization
language included on this form is usually incorporated into the consent form, unless the study involves the VA).
- K. Other committee approvals (if applicable).
- L. Documentation of Investigational Device Exemption (if applicable).
- M. Conflict of interest management plan (if a potential conflict of interest has been identified).
- O. Complete the billing information on the final page of the Application. Current fees are posted here. Requests for a fee waiver or reduction must be
accompanied by the Fee Waiver Form that is built into the Application Form.
4. Submit the materials to COMIRB.
- A. If submitting electronically via the eRA(InfoEd) system, click here for instructions.
- B. If submitting a paper application, submit one copy of all documents to COMIRB (please submit to the Anschutz Campus unless you are located on the Downtown Campus):
Anschutz Medical Campus
MS F490 (Building 500)
13001 E. 17th Place, Room N3214
Aurora, CO 80045
1380 Lawrence Street Building [LSC], Room 300
Campus Box 120
Denver, CO 80204
Expedited applications are reviewed on a continual basis, in the order they are received. The investigator will be notified of the review findings by email. Research may not begin
until the investigator has received documentation of COMIRB approval. If the research involves the VA, the project may not begin until it is approved by COMIRB and then the VA R&D
We strongly recommend you review the following COMIRB documents which highlight the continuing responsibilities of investigators for approved studies: