(2013). Can Informed Consent Go Too Far? Balancing Consent and Public Benefit in Research. The American Journal of Bioethics: Vol. 13, No. 4, pp. 1-2. doi: 10.1080/15265161.2013.778645.

A commentary on “Were There ‘Additional Foreseeable Risks’ in the SUPPORT Study?,” by Henry J. Silverman and Didier Dreyfuss; “SUPPORT: Risks, Harms, and Equipoise,” by Robert M. Nelson; “The Controversy over SUPPORT Continues and the Hyperbole Increases,” by Alan R. Fleischman; and “SUPPORT and Comparative Effectiveness Trials: What's at Stake?,” by Lois Shepherd, all in the January‐February 2015 issue.

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. (shrink)