The American journal of bioethics : AJOB
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The Office of Human Research Protections was not justified in issuing findings against the SUPPORT Institutions. Our community can learn from the evolving healthcare transformation into learning health systems by thinking about the novel ethical issues about standard of care research raised by the SUPPORT with the same spirit of quality improvement. ⋯ This article uses the example of the Wisconsin cystic fibrosis randomized clinical trial for newborn screening trial to explore the distinctions between risks of research and clinical care and waivers of informed consent for randomization. Collaborative exploration of these complex policy issues is needed and further deliberation, community engagement, and social science research will be critical to advance novel approaches for informed consent.
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Libertarian paternalism's notion of "nudging" refers to steering individual decision making so as to make choosers better off without breaching their free choice. If successful, this may offer an ideal synthesis between the duty to respect patient autonomy and that of beneficence, which at times favors paternalistic influence. A growing body of literature attempts to assess the merits of nudging in health care. ⋯ This article focuses on this question. While it concedes that nudging could amount to improper exploitation of cognitive weaknesses, it defends the practice of nudging in a wide range of other conditions. The conclusion is that, when ethically legitimate, nudging offers an important new paradigm for informed consent, with a special potential to overcome the classical dilemma between paternalistic beneficence and respect for autonomy.
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End-of-life decision making is fraught with ethical challenges. Withholding or withdrawing life support therapy is widely considered ethical in patients with high treatment burden, poor premorbid status, or significant projected disability even when such treatment is not "futile." Whether such withdrawal of therapy in the aftermath of attempted suicide is ethical is not well established in the literature. ⋯ We suggest that it is appropriate to withdraw life support, regardless of the cause of the critical illness or disability, when the following criteria are met: (1) Surrogates request withdrawal of care and the adequacy of surrogates is confirmed, (2) an external reasonability standard is met, (3) passage of time, perhaps 72 hours, to allow certainty regarding the patient's wishes, and (4) psychiatric morbidity should be considered as grounds for withdrawal only in truly treatment-refractory cases. Fundamentally, we believe the question to ask is, "If this were not an attempted suicide, would a request to withdraw care be reasonable?" We believe that under these circumstances, such withdrawal of life support, even in an individual who has attempted suicide, does not constitute physician assistance with suicide and is distinct from physician aid-in-dying in several important respects.