QI/QA Activities Research Activities Activities Requiring IRB Review

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Transcript QI/QA Activities Research Activities Activities Requiring IRB Review

Quality Improvement vs. Research
October 27, 2011
Patrice Griffith BSMT(ASCP), MBA
QI/QA vs. Research
Activities Requiring IRB Review
QI/QA vs. Research
• QI/QA Activities
– Aimed at improving local systems of care or
improving the performance of institutional practice
– Designed to bring about immediate improvements
in health care delivery
– Intended to compare a program/process/system to
an established set of standards such as standard of
care, recommended practice guidelines, or other
QI/QA vs. Research
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
– 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
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?
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
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
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