The Office for Human Research Protections was correct in determining that the consent forms for the National Institutes of Health -sponsored SUPPORT study were seriously flawed. Several articles defended the consent forms and criticized the OHRP's actions. Disagreement focuses on three central issues: how risks and benefits should be described in informed consent documents; the meaning and application of the concept of “standard of care” in the context of research; and the proper role of OHRP. Examination of the consent forms (...) reveals that they failed to disclose the reasonably foreseeable risks of the experimental interventions in the study, as well as the potential for differences in the degree of risk between these interventions. Although the concept of “standard of care” may be helpful in determining the ethical acceptability of other aspects of research, such as clinical equipoise, it is not helpful in discussing consent requirements. (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)