Non-Regulated Research

Non-Regulated Research projects do not require IRB approval. However, we strongly encourage you to submit a brief description using our short form so that we can make an official determination.  You may find this useful if you plan on submitting your research to a journal or professional meeting.

Activities are not 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 specific hypothesis, or developing theory.

The purpose of the project does not include hypothesis testing, theory development or replication of another research study.  In addition, the project should not be be described as research in grants, public presentations, academic dossier or other representations.  Finally, a federal (DHHS) grant cannot have been awarded to conduct this project as human subjects research.

Examples include:

  • Scholarly and journalistic activities
  • Public Health Surveillence
  • Criminal Justice Activities
  • Federally Authorized Operations
  • Routine Quality Improvement
  • Medical Quality Assurance
  • Program Evaluation
  • Customer Satisfaction Survey
  • Case Reports
  • Community Outreach

Submit the form to IRBmail@uthscsa.edu for an IRB determination of non-regulated research.

-Non-Regulated Research Determination Request Form