Research vs. Quality Improvement
Is your project research?
Sometimes individuals may not be sure if the project they plan to undertake is research, which does require THMA IRB review and approval, OR, quality improvement, which does not require THMA IRB review and approval.
A checklist has been developed to help researchers/ project leaders determine if the project will require IRB review or not:
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 “Research on Human Participants” column, this indicates that there are components of human 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.
If upon completion of the checklist it reveals that your project is a quality/process improvement project, please email the signed form to MHSSMIRB@mercyhealth.org for clearance to begin your project. Retain a copy of the completed checklist within your project files for future reference.
If you want to discuss the results of your completed checklist you may contact the IRB Office at: MHSSMIRB@mercyhealth.org.