The federal Common Rule identifies eight categories of research that may be eligible for exemption from IRB review (45 CFR 46.104(d) (1-8)). UW-Madison currently allows projects that fall into exemption categories 1-6 and are no more than minimal risk to qualify for an exempt determination. Exemptions do not apply to FDA-regulated research or research involving prisoners (45 CFR 46, Subpart C).

Research that qualifies as exempt must satisfy UW-Madison’s ethical standards for the protection of human research participants. The HIPAA Privacy Rule (45 CFR Parts 160 and 164) applies to all exempt research that uses protected health information (PHI).

Before preparing your application, refer to HRP 312 – WORKSHEET – Exemption and Limited IRB Review to help you determine whether your project may qualify for an exempt determination. The Exemption Category Tool also can assist you in assessing what exemption category may apply to your study.

If you believe your project falls into one of these exemption categories, you must submit an application to the IRB since only the IRB can determine whether the research is exempt from review.