Is My Project Human Subjects Research?

IRB review is required when an activity meets the definition of research and includes human participants. 

  • Research is defined as "a systematic investigation, including research development, testing and evaluation, designed to contribute to generalizeable knowledge."
  • Human subject is defined as a living individual about whom an investigator conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

The following examples may be activities that are not considered human subjects research

  • Case reports by University of Louisville definition are medical information collected and presented on up to five patients to highlight an interesting treatment, presentation, or outcome. Based on local policy, researchers developing case reports must use the Case Report Self-Certification Decision Tool to certify that their project meets the definition of a case report and as a notification to the IRB of the activity. If your proposed activity does not meet the definition of a case report, you must submit to the IRB be submitted to the IRB for review via iRIS

Researchers unsure of whether or not their project meets either definition should submit their project details to the IRB on a non-human subjects research form. Projects involving elements of human subjects research must be reviewed by the IRB prior to beginning any research activities.