Should Quality Improvement Projects Require IRB Approval?

Quality improvement and evidence-based practice change projects and the institutional review board: is approval necessary?

T here is often confusion in determining whether quality improvement (QI) projects and evidence-based practice (EBP) change projects require Institutional Review Board (IRB) approval. The distinction between research and QI-EBP change projects begins with an understanding of their distinct definitions. Research is defined in the U.S. Department of Health and Human Services Federal Regulations (...

How quality improvement projects influence organizational culture.

QUALITY IMPROVEMENT RESEARCH Methods for evaluation of small scale quality improvement projects

Evaluation is an integral component of quality improvement and there is much to be learned from the evaluation of small scale quality improvement initiatives at a local level. This type of evaluation is useful for a number of different reasons including monitoring the impact of local projects, identifying and dealing with issues as they arise within a project, comparing local projects to draw l...

Hypothesis Generation in Quality Improvement Projects: Approaches for Exploratory Studies

In quality improvement projects—such as Six Sigma projects—an exploratory phase can be discerned, during which possible causes, influence factors or variation sources are identified. In a subsequent confirmatory phase the effects of these possible causes are experimentally verified. Whereas the confirmatory phase is well understood, in both the statistical sciences and philosophy of science, th...

Methods for evaluation of small scale quality improvement projects.

Evaluation is an integral component of quality improvement and there is much to be learned from the evaluation of small scale quality improvement initiatives at a local level. This type of evaluation is useful for a number of different reasons including monitoring the impact of local projects, identifying and dealing with issues as they arise within a project, comparing local projects to draw l...