IRB: Ethics & Human Research

An Instrument to Differentiate between Clinical Research and Quality Improvement

What mechanism should be used to conduct the review of quality improvement activities to ensure their ethical integrity?

One important step toward an appropriate ethical review of quality improvement (QI) is to distinguish it from clinical research. We developed an instrument grounded in the regulatory definition of research, the Standards for Quality Improvement Reporting Excellence (SQUIRE) publication guidelines, and an ethical framework to differentiate between QI and clinical research activities. An expert panel worked through face-to-face and asynchronous deliberation to refine the focus, content, and design of the draft instrument. We established content validity of the instrument by testing it on prior proposals to the Dartmouth College institutional review board (IRB) and on new proposals. It provides an important and appropriate starting point to differentiate between QI and clinical research, and to recognize when overlap occurs. The instrument is not intended as an absolute adjudicator, but as a tool to enhance reflection upon and discussions regarding the difference between QI and research.

Greg Ogrinc, William A. Nelson, Susan M. Adams, and Ann E. O’Hara, “An Instrument to Differentiate between Clinical Research and Quality Improvement,” IRB: Ethics & Human Research 35, no. 5 (2013): 1-8.

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