Frequently Asked Question
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 Exemptions.
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.