Approval for quality improvement projects

The IRB provides ethical oversight, as per federal regulations (45 CFR 46) for human subjects research. While quality improvement projects are data-driven and may involve human participants, they are designed to improve a process based on existing best practice and do not require IRB oversight. Determining if a project is Research or Quality Improvement (QI) can be challenging. The purpose of this document is to aid in determining which projects are solely QI and a process to ensure review of QI activities within the Department of Pediatrics and St. Louis Children’s Hospital.

The following table summarizes the differences between QI and research.

ResearchQuality improvement
IntentIntent to develop and/or contribute to generalizable knowledge (e.g., testing hypothesis)Intent to improve a practice or process and/or ensure it conforms with expected norms; not designed to contribute to generalizable knowledge
DesignSystematic; follows a rigid protocol that remains unchanged throughout the research; may involve randomizationAdaptive, iterative design; usually does not involve randomization
MandateActivities not mandated by institution or programActivity mandated for all eligible by institution or clinic as part of its operations
Effect on program or practice evaluatedFindings are not expected to directly affect institutional or programmatic practiceFindings are expected to directly affect institutional practice and identify and potential changes needed
PopulationUsually involves a subset of individuals; no obligation to participate; may involve statistical justification of sample size to achieve endpointsRequires participation for all involved in the practice or process; exclusion of some individuals will affect the conclusions
BenefitsParticipants may or may not benefit directly; often a delayed benefit to future knowledge or individualsDirectly benefits a process, program or system; may or may not benefit participants
RisksMay place participants at riskDoes not place participants at risk with the possible exception to risks to privacy or confidentiality of date
AnalysisHold analytics until data collection complete. Statistically prove or disprove hypothesisContinuous analysis and changes made based on ongoing analytics
Dissemination of ResultsIntent to disseminate results generally presumed at outset of project as part of professional expectations, obligations; results expected to develop or contribute to generalizable knowledge by filling a gap in scientific knowledge or supporting, refining or refuting results from other research studiesIntent to disseminate results locally; dissemination beyond the institution not presumed at outset; evaluated; when published or presented to a wider audience the intent is to suggest potentially effective models, strategies, assessment tools or provide benchmarks rather than to develop or contribute to generalizable knowledge
Adapted in part from the University of Wisconsin-Madison Health Sciences IRB: Comparison of the Characteristics of Research, Quality Improvement and Program Evaluation activities.

WUSM Department of Pediatrics and the SLCH Department of Quality, Safety and Practice Excellence has developed a process for review of QI projects. This application includes a QI screening checklist for QI Projects as well as a form to outline the specific methodology of the project (see below). Review of or certification through the IHI modules will facilitate the success of the project design implementation and ultimately to sustain the work. Please upload your key driver diagram to assist with an understanding of the work to be done.

  • SMART Aim
  • Background
  • Sample size and setting
  • Intervention
  • Define measures (Outcome, Process and Balancing)
  • Data collection methods
  • Data analytics
  • Dissemination of results
  • Follow-up action plan

This form also contains the elements to fulfill the requirements for application for American Board of Pediatrics Maintenance of Certification (ABP MOC) credits. A summary of the certification requirements for this process can be found in Appendix A.

Completed applications will be reviewed bi-monthly (at a minimum) and can be submitted to:
Joan Smith (, Dan Willis ( and Bev Brozanski (

It is expected that a project summary will be submitted twice yearly, as well as a project presentation at the Quality and Patient Safety Coordinating Subcommittee (QSCS) of the Medical Executive Committee of St. Louis Children’s Hospital (within 18 months of project submission). The project summary should include the RUN charts, SPC charts, and other tools that may have been developed, in order to illustrate the process and outcome.

Providers participating in QI projects should use this Maintenance of Certification (MOC) attestation form. Forms must be signed by both the participating physician and the project leader and can be submitted to Kelly Funk.

Standards for reporting QI initiatives have been developed and published by the SQUIRE Development Group. Individuals intending to publish the results of their project should review these Squire 2.0 guidelines.