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Guidance on Institutional Exemption Categories under Campus Policy

Version Date: February 2018

Starting February 19, 2018, the UW-Madison implemented additional institutional categories of exempt human subjects research for studies that:

  • do NOT fall under FDA regulations,
  • do NOT fall under Veterans Affairs (VA) purview, and
  • are NOT and will NOT be federally supported.

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

NOTE: If your project falls under FDA regulations, it cannot be exempt. If your project falls under VA purview or is or will be federally funded, it may still qualify for exemption under the federal exemption categories but not under the institutional categories at this point. 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.

Institutional Exemption Categories under Campus Policy Tool

This tool allows study teams to first identify whether their project is eligible for review under the institutional exemption categories rather than federal exemption categories. If a project falls under FDA regulations, falls VA purview, and/or is or will be federally supported, only federal exemption categories apply. However, 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   Doc ID:79052
Owner:Tesha Z.Group:Health Sciences IRBs
Created:2018-01-08 13:25 CDTUpdated:2018-02-23 10:14 CDT
Sites:Health Sciences IRBs
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