Ethical oversight in quality improvement and quality improvement research: New approaches to promote a learning health care system Ethics in Biomedical Research

Kevin Fiscella, Jonathan N. Tobin, Jennifer K. Carroll, Hua He, Gbenga Ogedegbe

Research output: Contribution to journalArticle

Abstract

Background: Institutional review boards (IRBs) distinguish health care quality improvement (QI) and health care quality improvement research (QIR) based primarily on the rigor of the methods used and the purported generalizability of the knowledge gained. Neither of these criteria holds up upon scrutiny. Rather, this apparently false dichotomy may foster under-protection of participants in QI projects and over-protection of participants within QIR. Discussion: Minimal risk projects should entail minimal oversight including waivers for informed consent for both QI and QIR projects. Minimizing the burdens of conducting QIR, while ensuring minimal safeguards for QI projects, is needed to restore this imbalance in oversight. Potentially, such ethical oversight could be provided by the integration of Institutional Review Boards and Clinical Ethical Committees, using a more integrated and streamlined approach such as a two-step process involving a screening review, followed by a review by committee trained in QIR. Standards for such ethical review and training in these standards, coupled with rapid review cycles, could facilitate an appropriate level of oversight within the context of creating and sustaining learning health care systems. Summary: We argue that QI and QIR are not reliably distinguishable. We advocate for approaches that improve protections for QI participants while minimizing over-protection for participants in QIR through reasonable ethical oversight that aligns risk to participants in both QI and QIR with the needs of a learning health care system.

Original languageEnglish (US)
Article number63
JournalBMC Medical Ethics
Volume16
Issue number1
DOIs
StatePublished - Sep 17 2015

Keywords

  • Ethics, Research
  • Ethics, clinical
  • Ethics, committees research
  • Health services research
  • Informed consent
  • Learning health care systems
  • Quality improvement
  • Quality improvement research
  • Research subjects
  • Waiver of informed consent

ASJC Scopus subject areas

  • Issues, ethics and legal aspects
  • Health(social science)
  • Health Policy

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