An ethics framework for a learning health care system: a departure from traditional research ethics and clinical ethics.

January-February 2013/ HASTINGS CENTER REPORT Calls are increasing for American health care to be organized as a learning health care system, defined by the Institute of Medicine as a health care system “in which knowledge generation is so embedded into the core of the practice of medicine that it is a natural outgrowth and product of the healthcare delivery process and leads to continual improvement in care.” We applaud this conception, and in this paper, we put forward a new ethics framework for it. No such framework has previously been articulated. The goals of our framework are twofold: to support the transformation to a learning health care system and to help ensure that learning activities carried out within such a system are conducted in an ethically acceptable fashion. A moral framework for a learning health care system will depart in important respects from contemporary conceptions of clinical and research ethics. The dominant paradigm in research ethics and in federal regulations has relied on a sharp distinction between research and practice—a segregation model that dates to the influential publications of the National Commission for the Protection of Human Subjects in the 1970s. The learning health care system, by contrast, proposes that it is acceptable and indeed essential to integrate research and practice. From this perspective, the dominant ethical paradigm from the 1970s to the present time is antithetical to and problematic for the learning health care system, at a time when clinical practice is far from optimal and learning to improve care is sorely needed. Several hundred thousand people die needlessly each year from medical mistakes. There is reason to believe that adult patients receive only approximately 50 percent of recommended therapies, and that up to 30 percent of health care spending is wasted. The need to improve health care is urgent, yet the current ethics paradigm may hinder improvement. For example, the expansion of one of the most successful quality improvement interventions ever—saving thousands of lives by preventing central line-associated bloodstream infections in intensive care units—was almost halted due to concerns about research ethics oversight. But few have come forward to express concerns and oversight for the thirty thousand or so people who will die unnecessarily each year in the United States from this type of infection. Quality improvement and comparative effectiveness research are emblematic of the kinds of ongoing learning activities that a learning health care system is designed to promote. As we argue in the first article in this supplement to the Hastings Center Report, quality improvement and comparative effectiveness research bring into sharp relief the problems with the criteria traditionally used to distinguish research and practice. The fuzziness of the distinction, coupled with the oversight burdens that are required of research but not of practice, creates dubious incentives to redesign quality improvement and comparative effectiveness activities in ways that minimize the likelihood that they will be classified as reAn Ethics Framework for a Learning Health Care System: A Departure from Traditional Research Ethics and Clinical Ethics