Quality Improvement and Non-Human Research
There are activities that do not meet the federal definition of human subjects research. The distinction is important when navigating the IRB process.
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Quality Improvement and Non-Human Subject Research Projects
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 generalizable knowledge." This means that a project or study is research if it:
- Is conducted with the intention of drawing conclusions that have some general applicability and
- Uses a commonly accepted scientific method.
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.
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 (NHSR). Projects involving elements of human subjects research must be reviewed by the IRB prior to beginning any research activities.
Common Examples Not Considered Human Research
Quality improvement, program evaluation, and class projects/assignments. Quality improvement and program evaluation activities often DO meet the definition of human subjects but, DO NOT meet the definition of research. For further information about quality improvement projects and research, please watch this presentation.
Research with data or specimen that has been completely de-identified where the research team has no way to link it to an individual may not be human subjects research. The HSPP has developed a resource guide [PDF] to further explain the different categories that research with existing data/specimen may be categorized.
Case reports [PDF] 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 [form] 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.
Scholarly and journalistic activities, such as oral histories, typically do not meet the definition of human subjects research and are therefore excluded from IRB review. Exclusion from IRB review is predicated on the idea that oral history has its own code of ethics and principles of consent. The Oral History Association provides additional resources. The UofL Libraries have information available for use if a researcher plans to donate any of their materials to the UofL archives.