1. Quality Improvement vs. Research October 27, 2011 Patrice Griffith BSMT(ASCP), MBA

2. QI/QA vs. Research 2 QI/QA Activities Research Activities Activities Requiring IRB Review

3. 3 QI/QA vs. Research QI/QA Activities –Aimed at improving local systems of care or improving the performance of institutional practice or –Designed to bring about immediate improvements in health care delivery or –Intended to compare a program/process/system to an established set of standards such as standard of care, recommended practice guidelines, or other benchmarks

4. QI/QA vs. Research 4 All CS&E project teams complete and submit a two part checklist at the project start and review at major changes and at graduation

5. QI/QA vs. Research Checklist 1 –Are the patients who receive the intervention expected to benefit? –Will all groups involved in the project receive, at a minimum, standard of care? –Is the purpose to measure performance, determine the effect of a process change, or for submission to a national or state registry/database that is mandated for improving the delivery of clinical care? If answer “yes” to all these questions, IRB review is generally not required. However, Checklist 2 must also be completed. 5

6. QI/QA vs. Research Checklist 2 1.Is the intent of the project either to test a novel hypothesis or to replicate another researcher’s original study? 2.Will the physician be blinded to any element of the patient’s care? 3.Will patients/personnel be exposed to additional risks or burdens beyond standard of care? 4.Does the project involve withholding any aspect of standard of care? 6

7. 7 QI/QA vs. Research Checklist 2 (continued) 5. Does the project seek to test interventions, practices or treatments that are not standard of care (neither consensus-based, nor evidence-based)? 6. Does the project involve a drug or device used outside of usual medical practice, including non-FDA approved agents or the evaluation of any off-label uses of FDA approved drugs/devices? 7. Does the project involve research grant/contract funding, participation by entities outside of the clinical setting or organization, or sponsorship by an entity that requires IRB approval?

8. 8 QI/QA vs. Research Checklist 2 (continued) 8. Will the project be described as research** in public presentations, academic dossier, or other representations? When answering “yes” to any of the questions in Checklist 2, project requires IRB review prior to initiation. ** QI/QA findings, when not the result of a regulated study, may be published but should not be represented as research. The IRB can provide a letter, upon request, to a journal if needed to document that this project was determined to be non-human research.