As a recent special report in the Hastings Center Report demonstrates, many bioethicists are rethinking the way we regulate both biomedical research and clinical practice, as well as the sharp boundary that the field has assumed can and should exist between them. Such a rethinking is long overdue. There is surely a meaningful normative distinction between activities whose expected risk‐benefit profile is and is not “reasonable” for participants (to echo the language in the Common Rule—the core set of human research (...) guidelines found in many federal regulations). But neither the research‐practice distinction nor the criteria underlying it—the intention of the actor, whether the activity is “systematic,” and whether its results are “generalizable”—closely track good and bad outcomes for research participants and patients or justify either the bureaucratic, paternalistic licensing system that governs human subjects research or the comparatively lax governance of medical practice. The specious distinction between research and practice is especially ripe for dismantling in light of the embarrassing fact that evidence‐based medicine remains more aspiration than reality. (shrink)

Guidelines orient best practices in medicine, yet, in health care, many real world constraints limit their optimal realization. Since guideline implementation problems are not systematically anticipated, they will be discovered only post facto, in a learning curve period, while the already implemented guideline is tweaked, debugged and adapted. This learning process comes with costs to human health and quality of life. Despite such predictable hazard, the study and modeling of medical guideline implementation is still seldom pursued. In this article we (...) argue that to systematically identify, predict and prevent medical guideline implementation errors is both an epistemic responsibility and an ethical imperative in health care, in order to properly provide beneficence, minimize or avoid harm, show respect for persons, and administer justice. Furthermore, we suggest that implementation knowledge is best achieved technically by providing simulation modeling studies to anticipate the realization of medical guidelines, in multiple contexts, with system and scenario analysis, in its alignment with the emerging field of implementation science and in recognition of learning health systems. It follows from both claims that it is an ethical imperative and an epistemic responsibility to simulate medical guidelines in context to minimize harm in health care, before guideline implementation. (shrink)