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.