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It is almost universally acknowledged that risks have to be weighed against benefits, but there are different ways to perform the weighing. In conventional risk analysis, collectivist risk-weighing is the standard. This means that an option is accepted if the sum of all individual benefits outweighs the sum of all individual risks. In practices originating in clinical medicine, such as ethical appraisals of clinical trials, individualist risk-weighing is the standard. This implies a much stricter criterion for risk acceptance, namely that (...) |
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: Despite its mandate on minimizing harms in clinical trials, the Common Rule provides little guidance as to how IRBs should evaluate risk. The Common Rule and derivative commentaries tend to conceptualize risk review as an expert-based endeavor aimed at an objective and universal evaluation of possible harm; they also have tended to locate risk in the research activity itself rather than in the context of the research. These views of risk conflict with scholarship showing that risk evaluations are socially (...) |
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Clinical equipoise has been proposed as an ethical principle relating uncertainty and moral leeway in clinical research. Although CE has traditionally been indicated as a necessary condition for a morally justified introduction of a new RCT, questions related to the interpretation of this principle remain woefully open. Recent proposals to rehabilitate CE have divided the bioethical community on its ethical merits. This paper presents a new argument that brings out the epistemological difficulties we encounter in justifying CE as a principle (...) |
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A probabilistic explication is offered of equipoise and uncertainty in clinical trials. In order to be useful in the justification of clinical trials, equipoise has to be interpreted in terms of overlapping probability distributions of possible treatment outcomes, rather than point estimates representing expectation values. Uncertainty about treatment outcomes is shown to be a necessary but insufficient condition for the ethical defensibility of clinical trials. Additional requirements are proposed for the nature of that uncertainty. The indecisiveness of our criteria for (...) |
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In this essay, Paul Lauritzen examines Richard B. Miller's liberal account of pediatric ethics by asking if the duty to promote a child's basic interests is substantial enough to secure the well-being of children. This question is raised in light of two case studies: daytime TV talk shows that broadcast interviews with sexually active children, and a medical study conducted to test the effect of growth hormone treatment on adult height in peripubertal children. In both cases, Lauritzen argues, children are (...) |
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When surgery is performed on pregnant women forthe sake of the fetus (MFS or maternal fetalsurgery), it is often discussed in terms of thefetus alone. This usage exemplifies whatphilosophers call the fallacy of abstraction: considering a concept as if it were separablefrom another concept whose meaning isessentially related to it. In light of theirpotential separability, research on pregnantwomen raises the possibility of conflictsbetween the interests of the woman and those ofthe fetus. Such research should meet therequirement of equipoise, i.e., a (...) |
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Despite its several variations, the central position of equipoise is that subjects in clinical experiments should not be randomized to conditions when others believe that better alternatives exist. This position has been challenged over issues of which group in the medical or research community is authorized to make that determination, and it has been argued that informed consent provides sufficient ethical protection for participants independent of equipoise. In this paper I frame ethical participation in clinical research as a two-party decision (...) |
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Morain and colleagues (Morain et al. 2019) propose two conditions for avoiding role conflicts: if “(A) research participation would not substantially disadvantage the patient as compared with usual... |
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