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.
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