Abstract
PurposeThis paper seeks to describe a recent impasse resulting from failure of a federal oversight agency to distinguish between observational studies documenting the impact of quality improvement activities versus experimental clinical trials research.Design/methodology/approachThis paper provides a review of popular press accounts, regulations, and relevant correspondence; and interviews with project leaders.FindingsA controversial federal decision in the USA quickly galvanized unusually harsh criticism from a very wide range of professional associations, healthcare researchers, and patient safety advocacy groups.Originality/valueThis incident, at a time when application of quality improvement methods and public reporting networks are becoming more widespread in healthcare, illustrates the urgent need for better distinction between clinical trials research versus quality improvement research projects. Institutional review boards are ill‐advised to apply familiar ethical safeguard reviews appropriate to the former to the latter.
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