If you have determined that your study does qualify as "human subject research", and is not eligible for one of the 5 "Exempt Categories" listed in Step 2, you are conducting research regulated under federal legislation 45 CFR 46, which requires continuing COMIRB oversight over the life of the study.
The accordion folders at the bottom of this page will help you determine if you are eligible for one of the 7 "Expedited Categories" that would allow your study to be reviewed by only a panel Chair Member, or if your study requires review by the Full Board Panel. Your study must be "minimal risk" to qualify for Expedited review. All research that is greater than "minimal risk" must be reviewed by a Full Board Panel.
Before you review the accordion folders, please review the following bullet points that may include information relevant to your study:
- If you are conducting research that involves a biologic, drug, or medical device, you may be subject to different regulations under the Food and Drug Administration. Please see the accordion folder labeled 'Am I conducting "human subject research" regulated by the U.S. Food and Drug Administration?' at the bottom of Step 1.
- Your study may be subject to additional regulatory requirements if it includes specific vulnerable populations (prisoners, children, pregnant women, neonates), or if your study includes veterans.
Please review the accordion folders below to determine if your study qualifies for Expedited review: