Abstract

The papers by Nancy Kass, Ruth Faden, and colleagues describe an ethical imperative to study clinical care as it is being delivered. The goal of learning from each patient is attractive, but integrating research and clinical practice is not easy. The authors suggest that the bioethical framework in use for the past forty years to oversee clinical research may be as much an impediment to the development of a learning health care system as a means of protecting the interests of patients. This framework draws a bright line between clinical research and clinical care activities, subjecting clinical research to institutional review and ongoing oversight while assuming that clinical care is conducted primarily in the interests of patients and not in need of additional ethical oversight. The authors identify five characteristics that have been used to distinguish the two activities, and they conclude that none succeed. The practical implications of this conclusion are left unspecified, however. Should ethical oversight simply be eliminated for these kinds of research activities on the grounds that oversight is not mandated for clinical care and the two cannot be distinguished?