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Institutional Review Board (IRB)

3 Levels of Risk

DU’s IRB recognizes three levels of research risk, Exempt, Expedited, and Full Board Review, based on the US Department of Health and Human Services' regulations known as 45 CFR 46

This research includes minimal risks to human subjects.There are 6 categories of exempt research that involve firsthand data collection
This research is also low-risk, but it requires annual review if the project extends beyond one year. If your participants can’t be anonymous, your project may be reviewed at the expedited level. There are 9 categories of expedited research.
Research that involves more than minimal risk to human subjects may require a more thorough and lengthy review by DU’s IRB. If your research doesn’t fit into the exempt or expedited categories; if it includes minors and/or specially protected populations; if it puts your participants under physical or mental stress, fear, or discomfort; if you collect biomedical samples from your human subjects, your project will need to go through a full IRB review.