Overzealous oversight of healthcare quality improvement projects

Abstract

Purpose

This 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/approach

This paper provides a review of popular press accounts, regulations, and relevant correspondence; and interviews with project leaders.

Findings

A 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/value

This 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.

Citation

Birnbaum, D. and Ratcliffe, R.L. (2008), "Overzealous oversight of healthcare quality improvement projects", Clinical Governance: An International Journal, Vol. 13 No. 4, pp. 290-295. https://doi.org/10.1108/14777270810912987