Quality Improvement vs. Research
October 27, 2011Patrice Griffith BSMT(ASCP), MBA
QI/QA vs. Research
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QI/QA Activitie
s
Research
Activities
Activities Requiring IRB Review
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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
QI/QA vs. Research
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All CS&E project teams complete and submit a two part checklist at the project start and review at major changes and at graduation
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.
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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?
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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?
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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.