Journal of health care law & policy最新文献

In this article, we examine the legality and ethics of a controversial but widespread practice in clinical research: choice-masking nudges. A choice-masking nudge (CMN) exists when a research team explicitly obscures a meaningful choice from participants by presenting a default decision as the standard way forward. Even though an easy-to-use opt-out mechanism is available for participants who independently express concerns with the standard default, the fact that a default has been pre-selected is not made obvious to research participants. To opt out of the nudge, a participant must overtly request non-standard treatment. We argue that use of such nudges in medical research can be justified by their individual, collective, and social benefits, provided that they respect autonomy and satisfy our four further acceptability conditions. The structure of this Article is as follows. In Part II, we describe three controversial cases of CMNs in medical research. In Part III, we provide background on nudging and explain how our proposed CMNs fit into the existing literature on nudging and libertarian paternalism. In Part IV, we explain how the reasonable person standard as employed by United States research regulations can be used to support CMNs. In Part IV, we anticipate some of the strongest objections to CMNs by explaining how CMNs are compatible with a wide range of plausible accounts of autonomy. Finally, in Part VI, we discuss four additional core considerations an acceptable CMN must meet: legitimate policy goals; benefits outweighing harms; burdens distributed fairly; and absence of ethically superior feasible alternatives. We also analyze the three existing controversies explored in Part II and show how each would benefit from the conceptual clarity offered by our analytic framework. Medical research is complicated and can be difficult for participants to understand; thoughtfully designed CMNs can play an important role in gently guiding large numbers of research participants toward decision outcomes that really are best for them and their communities.

While promising to eventually revolutionize medicine, the capacity to cheaply and quickly generate an individual's entire genome has not been without controversy. Producing information on this scale seems to violate some of the accepted norms governing the practice of medicine, norms that evolved during the early years of genetic testing when a targeted paradigm dominated. One of these widely accepted norms was that an individual had a right not to know genetic information about him or herself. Prompted by evolving professional practice guidelines, the right not to know has become a highly controversial topic. The medical community and bioethicists are actively engaged in a contentious debate about the extent to which individual choice should play a role (if at all) in determining which clinically significant findings are returned. This paper explores the extent to which it is legally and ethically necessary to respect the so-called right not to know genetic information about oneself. Challenging the majority view that the right not to know is sacrosanct, I push back against that vigorously held (although not always rigorously defended) position, in defense of the idea that we should abandon the notion of a strong right not to know. Drawing on the fields of law, philosophy and social science, I provide an extended argument in support of a default for returning high value genetic information without asking about a preference not to know. I conclude by offering some recommendations about how best to balance individual autonomy and professional beneficence as the field of genomic medicine continues to evolve.