Ethical oversight in quality improvement and quality improvement research: new approaches to promote a learning health care system.

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

doi:10.1186/s12910-015-0056-2

Abstract

BackgroundInstitutional 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.DiscussionMinimal 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.SummaryWe 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.

Highlights

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
We focus on the interface between quality improvement research (QIR) and quality improvement (QI)
We argue that QIR and QI are indistinguishable; that they are sufficiently distinct from other types of clinical research that they warrant their own distinct processes and committees for ethical oversight and that the level of oversight should balance risk to participants with an ethical imperative to improve care

Summary

Discussion

Key topics would include: 1) Purposes and appropriate methods of QI/QIR; 2) Specific examples of ethical concerns; 4) Issues related to consent and conditions required for a waiver of informed consent; 5) Process for balancing competing ethical concerns, including potential benefits, risks, and burdens to potential participants, i.e. patients, staff and/or administration) and to the health care system and patients at large. Most notably, such training would aim to establish shared understanding among committee members regarding how to balance competing ethical concerns in ways that would facilitate rather than hinder the development of learning health care systems. This passive approach to informed consent may minimize response bias that occurs with active, opt-in consent [36]

Background

Conclusion