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This document describes UW-Madison's policy and process for determining whether research involving human participants that is not FDA-regulated is exempt from applicable federal, state, and local regulations and the University's policies.
UW–Madison requires that IRBs rather than study teams make determinations regarding whether a potential research study involving human participants qualifies as exempt research.
Exempt human participants research cannot begin until an IRB has notified the study team in writing that the research qualifies as exempt.
UW–Madison IRBs follow the federal Common Rule, which lists six categories of research that are eligible for exemption from IRB review.
UW–Madison IRBs apply these six exemption categories only to studies determined by an IRB reviewer to be no more than minimal risk.
The Common Rule exemptions do not apply to FDA-regulated research.
However, UW–Madison IRBs do apply the FDA regulations exempting from IRB review clinical investigations involving taste and food quality evaluations and consumer acceptance studies and emergency use of test articles.
At UW–Madison, the use of fetal material does not qualify as exempt from IRB review.
Additionally, UW–Madison IRBs apply the following limitations to exemption determinations.
The six exemption categories at 45 CFR 46.101(b)(1)(6) do not apply to research involving prisoners, Subpart C, unless the research is not federally funded and inclusion of prisoners is incidental.
The exemption for research involving survey or interview procedures or observation of public behavior [45 CFR 46.101(b)(2)], does not apply to research with children, Subpart D, except for research involving observations of public behavior when the investigator(s) do not participate in the activities being observed.
The exemption for research and approval of department or agency heads and designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs [45 CFR 46.101(b)(5)], must also satisfy additional OHRP requirements as set forth in OHRP guidance on exempt research.
Research that qualifies as exempt under one of the federal categories must nonetheless satisfy the UW–Madison's ethical standards for the protection of human research participants as outlined in the Belmont Report.
The IRB may require a consent process for research determined to be exempt.
Following a UW–Madison IRB’s determination that a study is exempt, study teams must conduct the study in a manner that maintains the ethical standards under which the IRB made the exempt determination.
At UW–Madison, only the full IRB, IRB member or, professional IRB staff, not the investigator, can determine whether proposed research involving human intervention/interaction, identifiable private information, or coded data or specimens derived from humans is eligible for exemption from IRB review.
The IRB reserves the right to not exempt a protocol and to require full review by the convened IRB or expedited review by an IRB member or subcommittee, particularly if the research may involve a sensitive population or sensitive topic.
The IRB documentation of exemption determinations must include a citation to the specific regulatory category justifying the exemption.
If a study is determined to be exempt from IRB review, the following conditions apply.
Continuing review of the project by an IRB is not required unless the research changes such that the exemption determination no longer applies.
Significant study changes should be discussed with the IRB prior to implementation to ensure that the same exemption determination still applies.
The HIPAA Privacy Rule regulations apply to exempt research using protected health information (PHI) just as they do to other research.
After five years, exempt studies may be administratively closed by the IRB, unless the study team indicates that the study is ongoing.
Adopted By: All Campus IRB
Adoption Date: August 4, 2005
Revised: December 4, 2008
Revised: March 1, 2012
Revised By: Cross-Campus HRPP Committee
Revision Date: July 7, 2015
Revision Date: August 28, 2015
Copyright © 2015 University of Wisconsin System Board of Regents
- Use of Human Fetal Tissue in Research
- Engagement in Human Participants Research at UW–Madison
- Exemption Guidance
- ED/SBS IRB Principal Investigator Responsibilities
- Drugs, Biologics, and Devices: Regulations
- Common Rule (45 CFR 46)
- Control of Test Articles Used in Research Policy
- Review of FDA-Regulated Research Policy
- Emergency Use of Test Articles and of Humanitarian Use Devices Policy
- FDA IRB Regulations (21 CFR 56)
- UW-Madison HIPAA Program
- OPRR Guidance on 45 CFR 46.101(b)(5): Exemption for Research and Demonstration Projects on Public Benefit and Service Programs
- Summary of Investigator Responsibilities