Personal Care in Learning Health Care Systems

The idea of a "learning health care system"--one that systematically integrates clinical research with medical care--has received considerable attention recently. Some commentators argue that under certain conditions pragmatic comparative effectiveness randomized trials can be conducted ethically within the context of a learning health care system without the informed consent of patients for research participation. In this article, we challenge this perspective and contend that conducting randomized trials of individual treatment options without consent is neither necessary nor desirable to promote and sustain learning health care systems. Our argument draws on the normative conception of personal care developed by Charles Fried in a landmark 1974 book on the ethics of randomized controlled trials.