This document describes UW-Madison's policy and process for determining whether non-FDA-regulated research involving human participants 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 categories of exemption outlined in the federal Common Rule, which lists eight categories of research that are eligible for exemption from IRB review.
- UW-Madison IRBs apply these eight 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 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 derived from an induced abortion or which otherwise meets the criteria for IRB review does not qualify as exempt from IRB review.
- Additionally, UW-Madison IRBs apply the following limitations to exemption determinations.
- The eight exemption categories at 45 CFR 46.104(d)(1-8) do not apply to research involving prisoners, Subpart C, unless:
- The research is not federally funded and inclusion of prisoners is incidental; or
- The research is aimed at involving a broader subject population that only incidentally includes prisoners regardless of funding source.
- For research involving children, to be exempt under 45 CFR 46.104(d)(2), it must meet the following criteria:
- It cannot involve survey or interview procedures;
- Observations of public behavior cannot include participation by the investigator(s); and
- Information collected, if identifiable, cannot put subjects at risk of liability or be damaging to their financial standing, employability, educational advancement, or reputation.
- The exemption at 45 CFR 46.104(d)(3) does not apply to research with children.
- In order for some human subjects research to qualify for exemption, the research must undergo limited IRB review to ensure there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
- If an exempt study underwent limited IRB review and the research team intends to make changes to the study, they are required to submit changes of protocol to allow the IRB to assess whether the conditions under which the exemption was originally granted still apply.
- Personnel changes are not required for studies that undergo limited IRB review.
- For exempt studies that involve the storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research, the limited review also includes determinations regarding whether:
- Broad consent for storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens is obtained in accordance with the requirements for broad consent under the Common Rule;
- Broad consent is appropriately documented or waiver of documentation is appropriate, in accordance with the Common Rule; and
- If there is a change made for research purposes in the way the identifiable private information or identifiable biospecimens are stored or maintained, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
- Limited IRB review is conducted by an IRB member designated by the IRB Chair, which can include experienced IRB staff.
- 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 convened IRB, IRB member or, experienced 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 study and to require 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.
- Significant study changes should be to the IRB for review 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 non-exempt human subjects 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
Revision Date: February 5, 2018
Revision Date: January 3, 2019
Copyright © 2015 University of Wisconsin System Board of Regents
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- Engagement in Human Participants Research at UW–Madison
- 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