Research vs. Quality Improvement
Is your project research or quality improvement?
Sometimes individuals may not be sure if the project they plan to undertake is research, which does require IRB review and approval, OR, quality improvement, which does not require IRB review and approval.
A checklist has been developed to help researchers/project leaders determine if the project will require IRB review or not:
- TH QI vs. Research Determination Checklist (PDF, 1MB)
The checklist is not used for those projects that are known to meet the definition of research, such as, Clinical Trials that test the use of a test article, device or biologic in human subjects.
Definitions
Quality Improvement is the combined and unceasing efforts of everyone – health care professionals, patients and their families, researchers, administrators, payers, planners, educators – to make changes that will lead to better patient outcomes, better system performance, and better professional development.
Research is a systematic investigation in a clinical setting designed to develop or contribute to generalizable knowledge (the Common Rule definition of research).
When completing the checklist, if any checkmarks (even just one checkmark) is placed in the "Clinical Research" column, this indicates that there are components of clinical research in the proposed activity. If an activity such as public health practice, program evaluation, or quality improvement includes a research component, then IRB review should occur under current federal guidance and IRB policies. Go to the "Submissions" tab of the applicable location to see what will need to be submitted to the IRB for review.
If upon completion of the checklist it reveals that your project is a quality/process improvement project, then you do not have to submit anything to the IRB. Retain the completed checklist within your project files for future reference. You may begin your project. NOTE: The IRB is unable to render a decision after a project has been completed.
If you want to discuss the results of your completed checklist you may contact the IRB/Research Compliance Office at:
Ann Arbor: 734-712-5470 / aasjirbsubmissions@trinity-health.org
Grand Rapids: 616-685-6198 / IRBAdministrator@trinity-health.org
Oakland: 248-858-3233 / melody.dankha@trinity-health.org