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.
Sidebar
When is IRB review required?
The IRB is often asked to determine if a project requires IRB oversight. A 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 a project or study is research if it:
- Is conducted with the intention of drawing conclusions that have broad applicability; and
- Uses a commonly accepted scientific method (e.g., testing a hypothesis, establishing clinical practice standards where none currently exist, establishing a registry or database, etc.).
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.
Projects that do not meet both definitions are considered non-human subjects research and do not require IRB review. It is important for research teams to understand how their project activities intersect with these two definitions as projects involving elements of human subjects research must be reviewed by the IRB prior to starting any activity. Failure to receive IRB approval before conducting human subjects research is a violation of federal, state, and local policy.
Non-Human Subjects Research Designation
The IRB may designate a study as Non-Human Subjects Research (NHSR) when the project in question does not meet BOTH definitions of human subjects and research. For example, some quality improvement projects may meet the definition of human subjects through surveys but will not meet the definition of research as the results are not intended to be applied broadly outside of the program.
NHSR projects are not required to be reviewed by the IRB; however, researchers unsure of whether or not their project meets either definition should submit their project details for a formal review in iRIS. The IRB will not grant retroactive approval of an activity that is later determined to be human research. Project teams requesting an IRB determination for publication, funding, or presentation purposes should submit their project in iRIS for a NHSR determination.
Note: A NHSR determination is different than a determination for "IRB exemption." Exempt studies are human subjects research and must be reviewed by the IRB.
Notes About Publication
Intent to publish is an insufficient criterion for determining whether an activity involves research. Even planning to publish a NHSR project does not necessarily mean a project meets the definition of research. When discussing NHSR projects in publications and presentations, do not refer to the project as research. Additionally, results should not be presented in such a way that suggests broad applicability or generalization outside of local context. NHSR submission guidance can be found below.
ARTIFICIAL INTELLIGENCE PROJECTS
Project teams creating, using, validating, or studying an artificial intelligence model or tool should not self-assess their NHSR status. Submit to the IRB for an official determination.
Projects Not Considered Human Subjects Research
Quality improvement/program evaluation (QI/PE) projects consist of systematic, data-guided activities to evaluate the performance of a process, program, or service within an organization with the goal of designing interventions to improve that performance. Such efforts are designed to improve program or service effectiveness. Results are targeted and not applied broadly outside of the team, program, or organization.
Similarly to human subjects research, QI/PE projects may involve:
- data-driven activities
- prospective and retrospective data collection from human subjects
- intent to publish or present results**
Most QI/PE activities do not require IRB review. However, in some cases, these activities are designed to accomplish a research purpose as well. In these cases, IRB approval is required before any project activities may begin. It is important to understand the distinction regarding which activities could qualify as human subjects research. Projects in question should be submitted in iRIS for a Not Human Subjects Research review.
**Intent to publish does not solely qualify a project as human subjects research.
For further information about quality improvement projects and research, please watch this presentation.
Evidence-based practice (EBP) activities are designed to translate research evidence into practice, increase effectiveness of products and services through programs and policy improvements, and encourage consistency of practice based on best research evidence. EBP projects are often considered a quality improvement activity as the intention of the project is to use evidence supported practices to improve a program or process. Results are not broadly applied or used a representative sample of a broader population.
Most EBP activities do not require IRB review. However, in some cases, these activities are designed to accomplish a research purpose as well. In these cases, IRB approval is required before any project activities may begin. It is important to understand the distinction regarding which activities could qualify as human subjects research. Projects in question should be submitted in iRIS for a Not Human Subjects Research review. If IRB review is needed, EBP project teams should use the quality improvement submission guidance and templates when drafting their NHSR application.
In certain cases, de-identified data/specimen projects with no way to ever link to an individual may not meet the definition of human subjects research. Some of these cases include:
- Secondary use of data involving materials (data, documents, records, or specimens) that have been collected or will be collected solely for non-research purposes (such as medical treatment or diagnosis) in which informed consent is not required.
- Investigators will not view or collect any of the 18 HIPAA identifiers (i.e., the data is completely de-identified before the researcher is given access).
- Investigators cannot link the data back to the subject identities (e.g., if the data is coded, the researcher cannot access the link to the subject identities).
- Data was accessed from a publicly available data source where password or member access is not required. Examples of sources can be found on the IRB's Approved Sources of Public Use Data guide.
The University of Louisville defines case reports as 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 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.
Note: HIPAA and institutional policy may still apply to this activity. Please refer to the Privacy Office and hospital research offices as needed.
The activity is limited to investigations or interviews (structured or open-ended) that focus on specific events (current or historical), views, etc. Such investigations or interviews may be reported or published in any medium, e.g., print newspaper, documentary video, online magazine. 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.
These projects are intended to provide an educational experience about the research process or methods. These projects usually occur as part of assigned course/classwork or a requirement of an educational program in order to learn a new technique or pass a course. They do not meet the definition of human subjects research in that they are not designed to develop or contribute to generalizable knowledge. Class or student projects may include individuals as research participants. However, the intent of the subject recruitment is learning how to select and consent subjects.
IRB requirements for research using cadavers and/or decedent data depends on whether the study involves ONLY decedents/decedent data, or data from decedents together with living individuals. Research using decedent-only data is considered non-human subjects research (NHSR) and does not require IRB approval, whereas research using both deceased AND living individuals' data does require IRB review. In addition, other regulations and institutional requirements may still apply to decedent research. Researchers are responsible to ensure compliance with such policies when conducting decedent research.
Projects using cadavers at the University of Louisville must contact the Willed Body Program in the Department of Anatomical Sciences and Neurobiology for more information and further requirements.
NHSR Guidance
In both your submission to the IRB for a NHSR designation and for final publication of your project, ensure you are not aligning your project with human subjects research.
- Avoid using the words "research," "study," and "principal investigator." Instead, use "project," "project leader," and "project team."
- Clearly describe the purpose of the improvement effort, program, or evaluation and what internal processes you intend to improve/assess.
- Do not interchangeably use the terms quality improvement/program evaluation/research/study.
- Limit data collection to the fewest data fields, smallest time periods, and number of participants needed to demonstrate a gap, the impact of the intervention on change, and improvement over time.
- For QI/PE projects, the IRB created templates and submission guidance documents for reference. Please use these references.
- Make sure it is evident you are not doing research.