Non-Regulated Research Including Quality Improvement (QI) and Quality Assurance (QA)
Non-regulated research refers to studies not covered by the HHS Regulations. Activities are non-regulated research if they do not involve a systematic approach involving a predetermined method for studying a specific topic, answering a specific question, testing a hypothesis, or developing theory.
Researchers may request a determination that an activity is “Non-regulated research,” but the final determination will be made by the Office of Research Compliance
Examples of Non-Regulated Research:
- Quality Improvement
- Health Surveillance
- Program Evaluation
Instructions for Submission:
- Complete the “Request for Determination- Non-Regulated Research” form
- Submit the completed form by email to IRB@utrgv.edu
The Office of Research Compliance will review your request and will issue a determination letter within 3-7 business days or upon completion of required items.