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Learning health care systems and justice.

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.

If, as we think, all should contribute toward the goal of securing and maintaining a just health care system, then all of us who participate in the health care system, including patients, have an obligation to support and participate in the real-time integration of research and practice (as long as participants' quality of care or well-being is not significantly compromised). Often the integration does not require express, activity-specific consent, even when the activities would be classified as research involving human subjects.

Framing the ethics of learning health care in this way brings to the forefront the principal moral challenge confronting the integration of research and practice in the fractured health care systems typical in the United States. Duties to contribute to a just health care system provide a basic moral justification for integrating learning into practice. At the same time, we need to facilitate research-practice integration in less than just contexts in order to provide the knowledge base necessary for the system to become more just.

This observation takes us to a third point. Our overall objective is to provide a moral framework for integrating research and practice in today's health care settings. We approach this challenge through the broad category of learning activities, including clinical trials, quality improvement practices, and comparative effectiveness research. Classification schemes that bifurcate learning activities into the two crude categories of research and practice are increasingly outmoded. We should investigate models of integration and moral frameworks that reconceive the rights and duties operative in learning health care systems. In upcoming years, making this advance will be among the foremost tasks facing bioethics and health policy.

This work was supported by grant RC1RR028876 from the National Institutes of Health--National Center for Research Resources. The content is solely the responsibility of the authors and does not represent the official views of the NCRR or the NIH. We thank the other coinvestigators on this project: Steven Goodman, Peter Pronovost, and Sean Tunis.

Ruth R. Faden is the Wagley Professor and Nancy E. Kass the Berman Professor at the Johns Hopkins Berman Institute of Bioethics, and Tom L. Beauchamp is professor of philosophy and senior research scholar at Georgetown University's Kennedy Institute of Ethics.
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Title Annotation:another voice
Author:Faden, Ruth R.; Beauchamp, Tom L.; Kass, Nancy E.
Publication:The Hastings Center Report
Geographic Code:1USA
Date:Jul 1, 2011
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