Does my study need IRB approval?


Any project that meets the definition of human subject research must be submitted to the UIUC IRB.  Non-human subject research does not require IRB oversight or approval.

Need advice?

Contact OPRS to discuss whether or not your project meets the definition of Human Subject Research or a Clinical Investigation.

If you wish to secure a formal determination of Non-Human Subject Research from the IRB, you must submit a Non-Human Subject Research Request Form.  If OPRS agrees the project meets the non-human subject research criteria, you will be issued an NHSR determination letter.  This is a good option if you are not sure whether your project is human subject research, and/or to provide documentation of IRB review for any future publications. 

Any project that does meet the definition of Human Subject Research requires IRB review and oversight.  A New Study Application is required for review of Human Subject Research.  There are three types of human subject research: exempt, minimal risk, and greater than minimal risk.  Only OPRS and the IRB can make an exempt, minimal risk, or greater than minimal risk determination at University of Illinois Urbana-Champaign.

DHHS Definition of Research

DHHS Definition of Human Subject

FDA Definition of Clinical Investigation

General Definition of De-Identified

What is Non-Human Subject Research?

Any project that does not involve research, a human subject, or a clinical investigation, as defined above.

What are some examples of Non-Human Subject Research?

Projects that involve:
Quality improvement
Case reports
Program evaluation
Marketing and business-related analysis
Class projects
Surveillance activities,

so long as the project does not involve

  • A systemic investigation designed to develop or contribute to generalizable knowledge using human subjects, or
  • A clinical investigation.

Additionally, use of existing de-identified or publicly available datasets may not be considered human subject research.  For more information, see the Research Guidance Document: Secondary Analysis of Public Use Datasets.


OPRS and the IRB use the following guidances to determine if a project is or is not human subject research:

Related Documents

Related Research Topics

Related Glossary Items

Revised Date