Outcome-adaptive randomization has been proposed as a corrective to certain ethical difficulties inherent in the traditional randomized clinical trial using fixed-ratio randomization. In particular, it has been suggested that OAR redresses the balance between individual and collective ethics in favour of the former. In this paper, I examine issues of welfare and autonomy arising in relation to OAR. A central issue in discussions of welfare in OAR is equipoise, and the moral status of OAR is crucially influenced by the way (...) in which this concept is construed. If OAR is based on a model of equipoise that demands strict indifference between competing interventions throughout the trial, such equipoise is disturbed by accruing data favouring one treatment over another; OAR seeks to redress this by weighting randomization to the seemingly superior treatment. However, this is a partial response, as patients continue to be allocated to the inferior therapy. Moreover, it rests upon considerations of aggregate harms and benefits, and does not therefore uphold individual ethics. Issues of fairness also arise, as early and late enrollees are randomized on a different basis. Fixed-ratio randomization represents a fuller and more consistent response to a loss of equipoise, as so construed. With regard to consent, the complexity of OAR poses challenges to adequate disclosure and comprehension. Additionally, OAR does not offer a remedy to the therapeutic misconception—participants’ tendency to attribute treatment allocation in an RCT to individual clinical judgments, rather than to scientific considerations—and, if anything, accentuates rather than alleviates this misconception. In relation to these issues, OAR fails to offer ethical advantages over fixed-ratio randomization. More broadly, the ethical basis of OAR can be seen to lie more in collective than in individual ethics, and overall it fares worse in this territory than fixed-ratio randomization. (shrink)

Choice architecture is heralded as a policy approach that does not coercively reduce freedom of choice. Still we might worry that this approach fails to respect individual choice because it subversively manipulates individuals, thus contravening their personal autonomy. In this article I address two arguments to this effect. First, I deny that choice architecture is necessarily heteronomous. I explain the reasons we have for avoiding heteronomous policy-making and offer a set of four conditions for non-heteronomy. I then provide examples of (...) nudges that meet these conditions. I argue that these policies are capable of respecting and promoting personal autonomy, and show this claim to be true across contrasting conceptions of autonomy. Second, I deny that choice architecture is disrespectful because it is epistemically paternalistic. This critique appears to loom large even against non-heteronomous nudges. However, I argue that while some of these policies may exhibit epistemically paternalistic tendencies, these tendencies do not necessarily undermine personal autonomy. Thus, if we are to find such policies objectionable, we cannot do so on the grounds of respect for autonomy. (shrink)

Most anti-paternalists claim that informed and competent self-regarding choices are protected by autonomy, while ill-informed or impaired self-regarding choices are not. Joel Feinberg, among many others, argues that we can in this way distinguish impermissible “hard” paternalism from permissible “soft” paternalism. I argue that this view confronts two related problems in its treatment of ill-informed decision-makers. First, it faces a dilemma when applied to decision-makers who are responsible for their ignorance: it either permits too much, or else too little, intervention (...) to satisfy its proponents. Second, the most promising rationales in favor of the view ignore the distinction between an agent’s voluntarily bringing about some state of affairs, on the one hand, and an agent’s voluntarily assuming a risk, on the other. I conclude that a decision-maker’s ignorance is irrelevant to the permissibility of intervention on her behalf. If it is permissible to intervene in a given ill-informed choice, it would be permissible to intervene in an otherwise similar but informed choice, at least provided that intervention would produce similar benefits in both cases. This shows that we should sometimes accept straightforwardly paternalistic rationales. (shrink)

In recent years, there has been a surge of high-profile publications on applications of artificial intelligence (AI) systems for medical diagnosis and prognosis. While AI provides various opportunities for medical practice, there is an emerging consensus that the existing studies show considerable deficits and are unable to establish the clinical benefit of AI systems. Hence, the view that the clinical benefit of AI systems needs to be studied in clinical trials—particularly randomised controlled trials (RCTs)—is gaining ground. However, an issue that (...) has been overlooked so far in the debate is that, compared with drug RCTs, AI RCTs require methodological adjustments, which entail ethical challenges. This paper sets out to develop a systematic account of the ethics of AI RCTs by focusing on the moral principles of clinical equipoise, informed consent and fairness. This way, the objective is to animate further debate on the (research) ethics of medical AI. (shrink)

The shift away from paternalistic decision-making and toward patient-centered, shared decision-making has stemmed from the recognition that in order to practice medicine ethically, health care professionals must take seriously the values and preferences of their patients. At the same time, there is growing recognition that minor and seemingly irrelevant features of how choices are presented can substantially influence the decisions people make. Behavioral economists have identified striking ways in which trivial differences in the presentation of options can powerfully and predictably (...) affect people's choices. Choice-affecting features of the decision environment that do not restrict the range of choices or significantly alter the incentives have come to be known as “nudges.” Although some have criticized conscious efforts to influence choice, we believe that clinical nudges may often be morally justified. The most straightforward justification for nudge interventions is that they help people bypass their cognitive limitations—for example, the tendency to choose the first option presented even when that option is not the best for them—thereby allowing people to make choices that best align with their rational preferences or deeply held values. However, we argue that this justification is problematic. We argue that, if physicians wish to use nudges to shape their patients’ choices, the justification for doing so must appeal to an ethical and professional standard, not to patients’ preferences. We demonstrate how a standard with which clinicians and bioethicists already are quite familiar—the best-interest standard—offers a robust justification for the use of nudges. (shrink)

Recently Jason Hanna has argued that a particular type of susceptibility to framing effects—namely, the tendency to reverse one’s choice between certain logically equivalent frames—invalidates actual tokens of consent. Here I argue that this claim is false: proneness to choice-reversal per se between the relevant types of frames does not invalidate consent.

Drunken sex is common. Despite how common drunken sex is, we think very uncritically about it. In this paper, I want to examine whether drunk individuals can consent to sex. Specifically, I answer this question: suppose that an individual, D, who is drunk but can still engage in reasoning and communication, agrees to have sex with a sober individual, S; is D’s consent to sex with S morally valid? I will argue that, within a certain range of intoxication, an individual (...) who is drunk can give valid consent to have sex with an individual who is sober. (shrink)

Suppose that a patient is receiving treatment options from her doctor. In one case, the doctor says, “the surgery has a 90% survival rate.” Now, suppose the doctor instead said, “the procedure has a 10% mortality rate.” Predictably, the patient is more likely to consent on the first description and more likely to dissent on the second. This is an example of a framing effect. A framing effect occurs when “the description of [logically-equivalent] options in terms of gains (positive frame) (...) rather than losses (negative frame) elicits systematically different choices.” Framing effects are ubiquitous, but they are particularly troublesome in medicine. Many worry that there is tension between valuing informed consent and using framing effects in clinical settings. In this paper, I answer this question: if an individual is subject to a framing effect when she gives her consent, does this undermine the validity of her consent? I argue that framing effects do not undermine consent in general. (shrink)

Cognitive scientists have identified a wide range of biases and heuristics in human decision making over the past few decades. Only recently have bioethicists begun to think seriously about the implications of these findings for topics such as agency, autonomy, and consent. This article aims to provide an overview of biases and heuristics that have been identified and a framework in which to think comprehensively about the impact of them on the exercise of autonomous decision making. I analyze the impact (...) that these biases and heuristics have on the following dimensions of autonomy: understanding, intentionality, absence of alienating or controlling influence, and match between formally autonomous preferences or decisions and actual choices or actions. (shrink)

The dominant legal and regulatory approach to protecting information privacy is a form of mandated disclosure commonly known as “notice-and-consent.” Many have criticized this approach, arguing that privacy decisions are too complicated, and privacy disclosures too convoluted, for individuals to make meaningful consent decisions about privacy choices—decisions that often require us to waive important rights. While I agree with these criticisms, I argue that they only meaningfully call into question the “consent” part of notice-and-consent, and that they say little about (...) the value of notice. We ought to decouple notice from consent, and imagine notice serving other normative ends besides readying people to make informed consent decisions. (shrink)