Guidance on Exemption Categories under the Revised Common Rule

Version Date: January 2019

As of January 21, 2019, revisions to the federal regulations governing human subjects research (called the Common Rule) are in effect. The revisions include an expansion of exemption categories. The Health Sciences IRBs will apply the revised Common Rule to any non-FDA regulated studies that are under review or have been submitted for review on or after January 21, 2019.

The tool below is intended to assist study teams in determining whether their human subjects research projects may qualify for exemption under one or more of the revised exemption categories and whether limited IRB review is required.

NOTE: If your project falls under FDA regulations, it cannot be exempt. Please review the Guidance on Research vs. Quality Improvement and Program Evaluation, Guidance on Exemption: Not Human Subjects Research, and Engagement in Human Participants Research at UW–Madison for information about the federal exemption categories. 

Exemption Categories under the Revised Common Rule

This tool allows study teams to first identify whether their project is eligible for review under the exemption categories the UW currently permits. If the eligibility criteria are met, then the tool is designed to help determine under which revised category or categories the project may qualify as exempt. Study teams can navigate among the categories by clicking on each category on the left-hand side of the decision tool. At the end of the survey, study teams will receive a summary of their results.

For assistance answering the questions in the Exemption Category Tool, please contact the HS IRBs Office. 


NOTE: The above materials are guidance documents for study teams and do not guarantee that a project will be reviewed as exempt.

Additional information about projects that do not constitute human subjects research is available at Guidance on Research vs. Quality Improvement and Program Evaluation, Guidance on Exemption: Not Human Subjects Research, and Engagement in Human Participants Research at UW–Madison



Keywords:exemption, exempt, decision tree, decision tool, categories, benign, revised, common rule   Doc ID:79052
Owner:Monica E.Group:Health Sciences IRBs
Created:2018-01-08 12:25 CSTUpdated:2019-03-11 10:32 CST
Sites:Health Sciences IRBs
Feedback:  0   0