Clinical Care Settings

QIQA vs. HSR

Quality Improvement/Quality Assessment (“QI”) includes systematic, data-guided activities, designed to bring about immediate improvements in health care delivery in particular settings. Initiators of QI projects identify promising improvements, implement small scale changes, monitor results, and decide about additional changes. QI is a core function of good clinical care.

QI is different than research. Studies that include both research and human subjects are considered to be Human Subjects Research (“HSR”). Read more about the definition and discover what does or does not qualify as HSR.  

Note there are many similarities between QI and HSR:

• Both involve methodical procedures that are carefully designed to achieve reliable and valid results.
• Both involve analysis of data.
• Both may result in a presentation or publication.

However, there are key differences between QI and HSR.

• QI projects are often flexible and incremental in design, employing strategies such as a plan-do-study-act (PDSA) cycle.
• QI uses data analysis to find out whether or not the workforce is following best practices and professional guidelines.
• QI implements a new practice or process to improve (for example) workflow, patient safety, staff expertise, cost effectiveness, etc.
• QI interventions often have already been proven to be successful elsewhere and are widely accepted in the profession/discipline. QI projects evaluate the best strategies to implement these interventions locally.
• QI projects can help us characterize a population in order to better serve their needs or improve their care.
• QI projects aim to directly benefit existing patients by implementing immediate local improvements.
• QI projects do not increase risk to patients beyond the risks that are involved in care they are already receiving.
• QI tools are applicable primarily to the unique characteristics of a local setting.
• QI activities are endorsed or mandated by the organization, clinic, care site, or program as part of its operations.
• QI projects are designed specifically to meet the needs of one project site.
• The results of QI projects typically are evaluated by an internal committee or executives who decide whether or not to permanently adopt the new practice.

QIQA Review Process

Use the Quality Improvement/Quality Assessment Query form in TOPAZ to submit your nursing or clinical determination request. The IRB reviews all submissions in the order received. If no indications of HSR are found, the IRB will issue an official “Not HSR” Determination via TOPAZ auto-email. At this point, you are welcome to proceed with your QI project.

Once the determination is issued, you will no longer be able to make changes to your original TOPAZ request.

Presentations and Publications

It is perfectly acceptable to share the effects or conclusions of a QI project. However, do not refer to a QI project or outcomes as "human subjects research" or "Exempt," which has a specific research meaning.

Further, the federal Office of Human Research Protections has stated that the act of presenting or publishing a QI project does not imply broad generalization nor change its classification to be HSR. See other OHRP FAQs regarding QI activities. 

QIQA and HSR Combinations

Some projects contain elements of QI but their focus is developing new, generalizable knowledge. Additionally, activities that start as a QI initiative may evolve into HSR at a later date.

Projects that are both QI and HSR must be approved by the MSU IRB before they are initiated. The HSR elements will undergo normal IRB review processes.