Learning Health Care Systems and Justice

Abstract

Emily Largent, Steven Joffe, and Franklin Miller offer a stimulating contribution to the literature on integrating medical research and practice. We agree on both the need to move toward what the Institute of Medicine has called a learning health care system and the need for new conceptions for integrating research and practice within it. We also agree with the authors' view, first advanced by Robert Truog and colleagues in 1999, that it can be ethically acceptable to randomize patients without express consent in trials comparing widely used, approved interventions that pose no additional risk. With appropriate oversight, learning health care systems ought to conduct such trials on a regular basis. Our approach to the ethical integration of research and practice differs from that of Largent, Joffe, and Miller in several respects, three of which we address here. First, we do not concentrate on research per se, but instead on what we take to be the broader category of learning. Learning includes what is now conventionally classified as research (with or without human subjects) and various other activities that often are not formally classified as research, such as quality improvement efforts and various segments of public health practice. These activities share the goal of obtaining information that can help improve health care services and systems. Second, we focus on providing a justification for learning in health care as a morally essential, not morally optional, feature of a health care system. The justification is grounded in the critical role that learning plays in achieving and sustaining a just health care system, by which we mean a system in which present and future generations have guaranteed access to adequate and high-quality health care services without generating undue financial burdens on patients and families. The required justification rests on two empirical assumptions: 1) a just health care system cannot be secured without continuous commitment to improving the quality and efficiency of health services, and 2) honoring this commitment depends on efficiently integrating into clinical service delivery a wide range of learning activities, including those conventionally classified as research. Nations cannot afford to provide everyone with every available medical intervention without regard to the magnitude of benefits and costs. In the face of this ineliminable constraint on resources, continuously gathering information about what works best for whom--and what does not--is vital. …