We conducted focus groups to assess patient attitudes toward research on medical practices in the context of usual care. We found that patients focus on the implications of this research for their relationship with and trust in their physicians. Patients view research on medical practices as separate from usual care, demanding dissemination of information and in most cases, individual consent. Patients expect information about this research to come through their physician, whom they rely on to identify and filter associated risks. (...) In general, patients support this research, but worry that participation in research involving randomization may undermine individualized care that acknowledges their unique medical histories. These findings suggest the need for public education on variation in practice among physicians and the need for a collaborative approach to the governance of research on medical practices that addresses core values of trust, transparency, and partnership. (shrink)

: Medical research is widely thought to have a fundamentally therapeutic orientation, in spite of the fact that clinical research is thought to be ethically distinct from medical care. We need an entirely new conception of clinical research ethics—one that looks to science instead of the doctor-patient relationship.

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)

A special report of The Hastings Center and the Association of American Medical Colleges addressed the ethical oversight of learning health systems, which seek to combine high‐quality patient care with routine data collection aimed at improving patient outcomes. The report contained two position papers, authored by a number of distinguished bioethicists, and several commentaries. The position papers urged two changes. First, they urged a rethinking of our approach to the regulation of human subjects research, so as to make it easier (...) in the future for learning health systems to function well. Second, they argued that the rethinking required dispensing with a strict distinction between research and therapy, which has been a major tenet of bioethics since the Belmont Report, which explicated basic ethical principles governing human subjects research. We fully support the objectives of the authors, and we agree that the learning health system is an important advance that serves patients well. Unnecessary regulatory burden ought not impede this progress. We disagree, however, that the best way to bring about these needed changes in the regulatory environment is to reject the basic distinction between research and treatment. Unfortunately, we find the arguments in favor of that strategy to be, in places, reminiscent of what we take to be basic conceptual errors that hampered the ethical understanding of human subjects research prior to adoption of the Belmont Report. To see why one need not reject the research‐treatment distinction in order to promote learning health systems, we first investigate in some detail the arguments offered for eliminating the distinction. We next turn to an issue not addressed by those authors, namely, the relationship between the physician or investigator and the patient or subject, to illustrate why the distinction is important and what is lost if it is jettisoned. (shrink)