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Quality improvement projects and research review

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Seeking to improve service by audit or quality improvement projects is a continuous obligation for health care professionals. Putting obstacles in the way of such activities might lead to perpetuation of poor practices. Some quality improvement projects, however, may be fairly complex and the changes made may entail a possibility of harm to some patients. Such projects may be regarded as research and for the protection of patients they may be required to submit to formal review by research review boards and ethics committees. Such a requirement would, however, inhibit many improvement projects and overburden hospital ethical committees. So when does an improvement project become research and how do we distinguish between the two?

In 2000, workers in Pittsburgh, Pennsylvania published a paper describing a quality improvement project involving all renal dialysis centres in the state. In some centres dialysis was often performed for shorter times than prescribed and physicians had therefore prescribed longer times than needed in order to achieve the times they wanted. By regular review and by comparing poorer performing centres with better performing centres improvements were achieved over several months. When the paper was reported to the local Institutional Review Board it ruled that the project was research and should have been submitted for review. Two other professional bodies gave conflicting opinions as to whether the project was or was not research. As a result quality improvement projects in End Stage Renal Disease networks have been impeded.

Various features that make projects research have been put forward, such as anticipated generalisability of results, lack of direct benefit to patients, use of new procedures, or use of a control group. The author of this paper adds to the list substantial funding, non-therapeutic aims, and individual patients rather than care systems or providers as subjects. Quality improvement, as opposed to research, provides rapid feedback to the care system generating the data with the aim of changing practice within that system.

In view of the lack of consensus on the issue a series of meetings and papers is to be led by the Hastings Centre in New York. (To sign on for a working online conference go to and to “online conference”. Information from