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.  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.

All new projects (New Study Application or Non Human Subject Research Request) are submitted via the IRBOnline system.


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:

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