Special Report: The Ethics of Using QI Methods to Improve Health Care Quality and Safety

Abstract

PREFACE Powerful forces of change are at work within the American health care system. The public debate concerning health care financing and access to insurance coverage is intensifying. But below the surface of the media and policy debate about cost and access, a quieter but perhaps more significant process of change is under way: the transformation of health care management and delivery--indeed, health professional work itself-through health care quality improvement. The innovative, interdisciplinary quality improvement (QI) movement has begun to significantly upgrade delivery of health care in the United States. Taking its cue from reform approaches in other industries, and driven especially by studies indicating a shockingly widespread incidence of medical errors and a striking lack of consistency in the standard of care patients receive in different facilities and from different practitioners, the QI movement has arrived in health care. Using knowledge gained from the disciplines of medicine, nursing, health care management, and medical and health services research, it attempts to mobilize people within the health care system to work together in a systematic way to improve the care they provide. In this work, discipline-specific knowledge is combined with experiential learning and discovery to make improvements. Ethical issues arise in QI because attempts to improve the quality of care for some patients may sometimes inadvertently cause harm, or may benefit some at the expense of others, or may waste scarce health care resources. Ethical issues also arise because some activities aimed at improvement have been interpreted as a form of medical research in which patients are used as subjects. If this interpretation is correct, QI would come under the same complex review and regulatory requirements that have been set up to govern biomedical and other types of research. But is this type of regulation necessary, given what QI involves? Is it the most effective and reasonable way to regulate QI to ensure that it is carried out in an ethical fashion? These are important questions, both conceptually and practically. Thus far, however, relatively few attempts have been made to address QI from an ethical perspective, and the interface between research and quality improvement has not been adequately explored or defined. Federal agencies with responsibilities in this area have disagreed on where the interface between medical research and QI lies and how it should be handled. (See Box 1 for a particularly dramatic example of such a conflict.) The strict ethical rules of oversight, regulation, and patient consent for human subjects research, including the requirement for institutional review board (IRB) approval, have significant implications for the feasibility and cost of pursuing QI activities. More specifically, the mechanism developed to govern ethical conduct in one important area--human subjects research--could have the perverse, if unintended, consequence of interfering directly with an equally important ethical imperative in another area-that is, unceasing efforts by health care professionals to make clinical care safer and more effective. The current state of uncertainty about what is ethically and legally required to safeguard participants in QI activities has already become a disincentive to engage in QI, making it more difficult to bring about the system transformation urgently needed if health care is to be made better and safer for patients. 1. The Pittsburgh ESRD Case In October 2000, a nephrologist coauthored an article about a project to improve the dialysis care delivered to patients in Medicare's End Stage Renal Disease (ESRD) program. (1) Some time after the article appeared, the university at which he held a faculty appointment notified him that an audit of faculty publications had identified this project as a quality improvement effort that met the definition of human subjects research but had not undergone IRB review. …