The Ethics of Quality Improvement: Practitioners’ Perspectives

Introduction: Innovation is an essential component of quality improvement (QI) activities that aim to improve the provision of health care. These projects, however, engender ethical and regulatory issues around human subjects’ protections. A literature search was conducted to identify issues in the ethical conduct of QI. Findings from the literature search were used to develop questions for semistructured interviews with actual QI practitioners regarding the ethical conduct of QI projects. Methods and Participants: This exploratory project reviewed electronic databases to collect 125 relevant articles and develop semistructured interview questions. Using a snowball sampling method, the author conducted guided interviews with QI practitioners until a broad perspective and recurrent themes emerged. The 23 interviewees had significant experience directing QI projects and represented clinically and academically oriented practice settings across the United States. The author compared findings from the literature review with interviewees’ perspectives. Results: Participants’ perspectives differed most from the literature in beliefs about the risk/harm potential for patients, an ethical obligation to conduct QI activities, the requirement for an opt-out rather than opt-in informed consent approach, and the value of an administrative review rather than IRB review of QI projects. Participants outlined essential characteristics of QI including an institutional focus, timely results, requirements that study results feed into changes in care, and emphasis on easily measured but not statistically significant results. Conclusion: Unlike the literature, QI practitioners believe in a low harm potential for most QI activities and an ethical obligation to conduct QI. The ethical practice of QI can be enhanced through administrative review of QI projects and informing patients in the care setting about QI projects. Introduction Quality improvement (QI) is a technique for encouraging innovation in many fields. In health care, QI projects vary widely with respect to project size, design, method, health care setting, and resource use, but all have the goal of improving the health care system’s ability to provide high-quality, high-value health care(Huycke and All, 2000). These projects, however, may not adequately protect patient and clinician participants from harm (Casarett, Karlawish, and Sugarman, 2000). Human subjects’ involvement in federally funded or supported biomedical research in the United States is regulated by the “Common Rule”(Pritchard, 2001), which defines what research is, directs what Institutional Review Boards (IRBs) should examine, and outlines the role of informed