How can I tell if my study is exempt, and what categories of exemption can I choose from?

Frequently Asked Question

Does my study qualify for exemption?

Federal regulations allow some kinds of research which pose very minimal risk to subjects to be exempt from IRB review.  However, UW policy states that the IRB office, not the investigator, must make this determination.  To find out about the federally-defined categories of exemption, please see Exemption Guidance .

Federal regulations also define “research” and “human subjects.”  Although these are not technically exemption categories, projects that either do not meet the definition of research or do not involve human subjects as defined in the regulations do not fall within the IRB’s purview and are exempt from IRB review.  For information about these determinations, please see Guidance on Exemption: Not Human Subjects Research .

Case reports:  Case reports involving three (3) or fewer patients generally do not require review by a UW-Madison IRB because they are not viewed as meeting the definition of research under the Common Rule or HIPAA Privacy Rule.  Case reports involving more than three patients are more likely to meet the criteria for research and require IRB review.  For guidance about case reports, please see Case Reports and Case Series Guidance .

Keywords:FAQ, type of exemption, exemption type, case reports, survey, qi, qa, quality improvement, project evaluation   Doc ID:21355
Owner:Faye L.Group:Health Sciences IRBs
Created:2011-11-21 13:48 CDTUpdated:2015-10-13 15:16 CDT
Sites:Health Sciences IRBs
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