Does my study need IRB approval?
Description
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 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.
Decision-making
OPRS and the IRB use the following guidances to determine if a project is or is not human subject research:
- DHHS Human Subject Regulations Decision Charts
- DHHS/OHRP Guidance on Engagement of Institutions in Human Subjects Research
- DHHS Quality Improvement Activities FAQ
- Centers for Disease Control and Prevention (CDC) guidance on Distinguishing Public Health Research and Public Health Nonresearch
Related Documents
- Non-Human Subjects Research Review Request
- New Study Application Form
- RGD: Secondary Analysis of Public Use Datasets
Related Research Topics
- Non-Human Subject Research
- Class Projects or Assignments
- Program Evaluation
- Quality Improvement/Quality Assurance (QI/QA)
- Scholarly and journalistic activities
- Ethnography