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.
| Research | Quality improvement | |
|---|---|---|
| Intent | Intent 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 |
| Design | Systematic; follows a rigid protocol that remains unchanged throughout the research; may involve randomization | Adaptive, iterative design; usually does not involve randomization |
| Mandate | Activities not mandated by institution or program | Activity mandated for all eligible by institution or clinic as part of its operations |
| Effect on program or practice evaluated | Findings are not expected to directly affect institutional or programmatic practice | Findings are expected to directly affect institutional practice and identify and potential changes needed |
| Population | Usually involves a subset of individuals; no obligation to participate; may involve statistical justification of sample size to achieve endpoints | Requires participation for all involved in the practice or process; exclusion of some individuals will affect the conclusions |
| Benefits | Participants may or may not benefit directly; often a delayed benefit to future knowledge or individuals | Directly benefits a process, program or system; may or may not benefit participants |
| Risks | May place participants at risk | Does not place participants at risk with the possible exception to risks to privacy or confidentiality of date |
| Analysis | Hold analytics until data collection complete. Statistically prove or disprove hypothesis | Continuous analysis and changes made based on ongoing analytics |
| Dissemination of Results | Intent 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 studies | Intent 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 |
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 (joanrs@bjc.org), Dan Willis (dwillis22@wustl.edu) and Bev Brozanski (beverly.brozanski@wustl.edu).
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.