The Institute of Medicine has called on health care leaders to transform their health systems into “learning health care systems,” capable of studying and continuously improving their practices. Learning health care systems commit to carrying out numerous kinds of investigations, ranging from clinical effectiveness studies to quality improvement research and implementation science. One challenge in realizing the IOM’s vision has been lingering uncertainty about whether the data collection and monitoring central to learning health care systems is actually research and if so, what kind of ethical oversight it should have. This is not a new question. Yet so far, there has been no foundational analysis of the fit between the existing human subjects protection framework in use in the United States and the new kinds of data collection activities that are being, and increasingly will be, undertaken by learning health care systems.

A special report from the Hastings Center Report, published as a supplement to the January-February 2013 issue, fills this void. The special report leads off with two feature articles from a group of scholars led by Nancy Kass and Ruth Faden at Johns Hopkins University. In the first, the team argues that conceptual, moral, and empirical problems surround the received view that there is a sharp distinction between the ethical oversight of clinical research and that of clinical practice. In the second, it proposes a new ethics framework for the integrated approach of a learning health care system. Following these two articles are seven commentaries by leading figures in the ethics and regulatory oversight of health care research.