Is your project research?
Sometimes individuals may not be sure if the project they plan to undertake is research, which requires SJH/SPHP IRB review and approval, OR, quality improvement, which does not require SJH/SPHP IRB review and approval.
A checklist has been developed to help researcher’s/ project leaders determine if the project will require IRB review or not:
QI vs Research Determination-Checklist
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 outcome, 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 2018 Revised Common Rule definition of research).
When completing the checklist: if any checkmarks (even jusszxt one checkmark) is placed in the “Clinical Research” column this indicates that there are components of clinical research in your 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 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 SJH/SPHP IRB. Retain the completed checklist within your project files for future reference. You may begin your project.
If you have any questions or concerns, or you want to discuss the results of your completed checklist you may contact the SJH/SPHP IRB Office at: 315-744-1186 or IRBSY@sjhsyr.org.
