In recent years, an old challenge to informed consent has been rediscovered: the challenge of ignorance. Several authors argue that due to the presence of irreducible ignorance in certain treatments, giving informed consent to these treatments is not possible. The present paper examines in what ways ignorance is believed to prevent informed consent and which treatments are affected by that. At this, it becomes clear that if the challenge of ignorance truly holds, it poses a major problem to informed consent. (...) The paper argues, however, that from both an empirical and a theoretical point of view, it is not convincing that ignorance prevents informed consent. Still, it seems important that the presence of irreducible ignorance is openly discussed during the informed consent process. (shrink)

Disclosure in clinical practice is aimed at promoting patient autonomy, usually culminating in patient choice (e.g., to consent to an operation or not, or between different medications). In medical ethics, there is an implicit background assumption that knowing more about (X) automatically translates to greater, or more genuine, autonomy with respect to one's choices involving (X). I challenge this assumption by arguing that in rare cases, withholding information can promote a patient's autonomy (understood as the capacity for rational choice in (...) alignment with one's values and goals). (shrink)

Philosophy and Phenomenological Research, Volume 103, Issue 2, Page 441-461, September 2021.

During the COVID-19 pandemic, there were many vaccine trials which had significant purposes which participants needed to understand to validly consent. For example, participants needed to understand that the purpose of dose-escalation vaccine trials was to give incremental doses of vaccine until participants became ill. Likewise, participants needed to understand that if they received placebos, they could no later take a genuine vaccine to preserve the integrity of the trials. Yet, these intuitive judgements about what participants need to understand to (...) validly consent are rejected by recent accounts of consent. According to these accounts, as long as participants were given a good opportunity to learn these purposes, they do not need to actually understand them to consent. In this paper, I reject this consensus, and I argue that participants who failed to understand these aims associated with vaccine trials failed to provide legitimate consent. I defend this claim by developing and defending a new understanding condition for valid consent. According to this understanding condition, a participant must understand when a consent transaction has features which violate the norms which govern the medical practice with which they are acquainted. I argue that this condition is independently plausible and best explains why participants needed to understand these aims associated with vaccine trials to validly consent. (shrink)

For several decades, Kant scholars, inspired by the Groundwork false-promising example, have constructed consent-based criteria for using another merely as a means. Unfortunately, these consent-based accounts produce assessments that are both counter-intuitive and un-Kantian in relatively simple cases. This article investigates why these consent-based accounts fail and offers an alternative. The Groundwork false-promising example has encouraged a problematically narrow understanding of the conditions for using another merely as a means in virtue of the fact that the example involves a consent-sensitive (...) duty. This article demonstrates that the scope of the prohibition on using another merely as a means includes both consent-sensitive and consent-insensitive duties and offers a duty-based account that reflects this. (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 standard account of informed consent has recently met serious criticism, focused on the mismatch between its implications and widespread intuitions about the permissibility of conducting research and providing treatment under conditions of partial knowledge. Unlike other critics of the standard account, we suggest an account of the relations between autonomy, ignorance, and valid consent that avoids these implausible implications while maintaining the standard core idea, namely, that the primary purpose of the disclosure requirement of informed consent is to prevent (...) autonomy-undermining ignorance. The problem with the standard account, we argue, is that it fails to distinguish between different forms of ignorance–in particular, error and suspending ignorance–that have very different effects on individuals’ ability to provide valid consent. While error often undermines our ability to provide valid consent, suspending ignorance, we argue, does not. Once the moral weight of this distinction is appreciated, it becomes apparent that valid informed consent requires far less knowledge than suggested by the standard account. (shrink)

In their important and insightful article, Joseph Millum and Danielle Bromwich distinguish two informational requirements for valid consent—the disclosure requirement and the understanding requirem...

Millum and Bromwich provide a thorough and thoughtful analysis of what is required for sufficient informed consent, offering distinct conceptualizations of the ethical requirements of disclo...

It is commonly claimed that when X coerces Y into consenting to Z φ-ing, Y’s consent is invalid, and Z is only permitted to φ if this reduces harm or increases optionality for Y. This article demonstrates that Y’s consent in such cases is valid if Y is choosing between options that include all those Z has a duty to offer Y and no autonomy-reducing options Z has a duty to not offer Y. When these conditions are met, Z acts (...) permissibly in φ-ing even if φ-ing does not reduce harm for Y or increase Y’s optionality. (shrink)

Social Networking Services provide services in return for rights to commercialize users’ personal data. We argue that what makes this transaction permissible is not users’ autonomous consent but the provision of sufficiently valuable opportunities to exchange data for services. We argue that the value of these opportunities should be assessed for both (a) a range of users with different decision-making abilities and (b) third parties. We conclude that regulation should shift from aiming to ensure autonomous consent towards ensuring that users (...) face options that they will use to advance individual and common interests. (shrink)

Studies of patient decision‐making use many different measures to evaluate the quality of decisions and the decision‐making process, partly to determine whether the ethical goals of informed consent, patient autonomy, and shared decision‐making have been achieved. We describe these measures, grouped under three main approaches, and review their limitations, leading to three conclusions. First, no measure or combination of measures can provide a complete assessment of decision quality. Second, the quality of a decision is best characterized vaguely, for instance as (...) “good,” “satisfactory,” or “poor,” and these categorizations depend on qualitative judgments that go beyond quantitative measures. Third, bioethicists should focus on identifying and addressing poor or problematic decisions, rather than trying to incrementally increase decision quality, quantified by a measure. Decision‐quality measures can be useful in research and in advancing important goals of bioethics, as long as the challenges of defining and measuring decision quality are recognized. (shrink)

In recent years, the principle of informed consent has come under significant pressure with the rise of biobanks and data infrastructures for medical research. Study-specific consent is unfeasible in the context of biobank and data infrastructure research; and while broad consent facilitates research, it has been criticised as being insufficient to secure a truly informed consent. Dynamic consent has been promoted as a promising alternative approach that could help patients and research participants regain control over the use of their biospecimen (...) and health data in medical research. Critical voices have focused mainly on concerns around its implementation; but little has been said about the argument that dynamic consent is morally superior to broad consent as a way to respect people’s individual autonomy. In this paper, we identify two versions of this argument—an information-focused version and a control-focused version—and then argue that both fail to establish the moral superiority of dynamic over broad consent. In particular, we argue that since autonomous choices are a certain species of choices, it is neither obvious that dynamic consent would meaningfully enhance people’s autonomy, nor that it is morally justifiable to act on every kind of consent choice enabled by dynamic consent. (shrink)