Controversy and Quality Improvement: Lingering Questions About Ethics, Oversight, and Patient Safety Research

摘要

A collaborative project between Johns Hopkins quality improvement (QI) and patient safety experts and the Michigan Health & Hospital Association (MHA)'s Keystone Center for Patient Safety and Quality evaluated the use of a safety program and checklist to reduce the rate of central line-associated bloodstream infections (CLABSI) in 103 intensive care units (ICUs) in Michigan. Results published in the New England Journal of Medicine documented a dramatic reduction in the rate of infections. The project subsequently prompted a flurry of questions related to whether evaluating the patient safety intervention constituted human subjects research and, if so, whether any additional protections were necessary for the patients or clinicians involved. This article summarizes the project and discusses six ethical and regulatory issues relevant not only to this case but, more broadly, to evidence-based patient safety initiatives.