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If I want to do a case study, do I need to submit to the IRB?

Yes. Our Kuali electronic system has a case study protocol form that must be submitted to the IRB for determination.

Case study projects use human subjects, but do not meet the definition of “Research" under the regulations.  When filling out the Kuali protocol for a case study, the answer to the question “Are you conducting Research” should be “No.”

From the list of reasons why you are not conducting research, select “Case Study” and the case study specific form will auto populate for you to fill out.

SIUE IRB does not consider case studies to meet the definition of research under the regulations because it is not intended to contribute to generalizable knowledge. Case studies generally are retrospective or only involve a few participants. Such a small number cannot generally be extrapolated to larger populations and is meant to be informative as it applies to the small population, but not applicable to broad populations.