COMIRB provides a step-by-step guide for new investigators on COMIRB's policies, procedures, and submission guidelines.
COMIRB accepts 5 types of initial submissions for review:
- Non-human subject research determination
- Exempt review
- Expedited review
- Full Board review
- Submissions for Special Cases including: Ceding to another IRB, Humanitarian Use Devices, Compassionate Use of a Device, and Emergency Use of a Drug or Device.(NOTE: If you feel your study falls into one of these "Special Cases", please click the link entitled "Submissions For Special Cases" in the grey column on the left hand side of the screen.)
The type of review your study qualifies for is dependent on many factors of your proposed study determined by applicable state and federal regulations. COMIRB policy is guided by the Ethical Principles and Guidelines for the Protection of Human Subjects of Research (often referred to as the Belmont Report), as well as relevant federal regulations.
The federal regulation that defines most of COMIRB's reviews and activities is:
45 CFR 46, Department of Health and Human Services Protection of Human Subjects
If the study involves testing of a drug, biologic, or medical device, additional regulations from the Food and Drug Administration also apply: 21 CFR 50,21 CFR 56, 21 CFR 312, and 21 CFR 812.
If the study involves the Department of Veterans Affairs, additional regulations apply as well: 38 CFR 16, and the VHA Handbook 1200.05.
Going through the steps provided through links in the grey column on the left of the screen will help you determine which type of submission is appropriate for your study,and whether or not you need to submit your study for review at all.
We understand that this can be a very complicated process. Please be aware that COMIRB reviewers may disagree with your assessment.
If you review the steps and are unsure how to proceed, please feel free to contact the COMIRB Help Line at 303-724-1055. Experienced COMIRB staff are available to help with the submission process; however, this guidance only represents the opinion of staff members. Only COMIRB panel members can make binding decisions regarding study approval.
We strongly suggest you click through the steps one-by-one in the grey column to the left if your submission is not a "Special Case".