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IRB – Non-Regulatory Activities (QI/QA)

Activities are non-regulated research if they do not involve a prospective research plan that incorporates data collection, either quantitative or qualitative, and data analysis to answer a research question. These activities do not involve a predetermined method for studying a specific topic, answering a specific question, testing a hypothesis, or developing theory.

To determine if a project constitutes human subjects research involves multiple factors. Although Non-regulated activities may involve human participants, most are not considered research that requires IRB review. This is an important distinction to make because it determines whether IRB review and oversight of a project is needed.

Researchers may request a determination that an activity is Non-Regulatory Research, but the final determination will be made by the IRB Office

Examples of Non-Regulated Research Activities:

  • Quality Improvement
  • Class Projects
  • Program Evaluation
  • Case Reports
  • Community Outreach

Instructions for Submission:

  1. Complete the Request for IRB Determination of Non-Regulatory Activity Form
  2. Submit the completed form by email to

The IRB Office will review your request and will issue a determination letter within 5-7 business days or upon completion of required items.