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Quality Improvement Activities vs. Research
A.  What's the key difference between Quality Improvement (QI) activities and Research?
Research studies are intended to create new knowledge that can be generalizable to other populations and settings, while QI in health care uses existing knowledge to improve health care outcomes within a local health care institution or setting.
B.  Does my QI project require submission to the Research Ethics Board (REB)?
In general, a quality improvement (QI) project does not need to be submitted to the SRHC Research Ethics Board (REB). However, there are projects that may need an authoritative determination by a REB of whether or not the activity does or does not meet the definition of research involving humans. For example, an REB determination might be required as a condition of a training program or by a journal or conference prior to acceptance of a health care related manuscript for publication or presentation.
C.  What's an REB Exemption Letter and when is it useful?
If a project has been submitted to the REB and ruled out as research, an REB exemption letter can be issued upon request to confirm that the activity is not subject to SRHC standard operating procedures and regulations governing research involving humans.
D.  I want to monitor and collect patient data related to a new program or service. Is this research?
When an activity involves the inclusion of people to test a new, modified, or previously untested intervention, service, or program for which there is insufficient evidence to determine whether it is safe and/or effective, this is research involving humans, and it is subject to REB review and approval.

E.  What if an intervention has been successful at other hospitals but its new and untested at Southlake? Is this research?
No, QI activities can provide important information on the application of existing knowledge and changes (e.g. other hospitals) that may be needed to achieve the best possible clinical outcomes for patients at Southlake Regional Health Centre.

F.  What if I want to compare the outcomes of a new method of patient care/treatment vs the old method? A comparative intervention study examining two evidence-based methods, with people prospectively randomized between the two methods to determine which is better, is regarded as research involving humans.

For more Information
The QI vs Research Self Screening Tool may be of further assistance in determining whether a proposed activity is a QI project or does not meet the definition of research involving humans.
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