Philosophy &Public Affairs, Volume 52, Issue 1, Page 69-100, Winter 2024.

This essay is about the timing of research consent, a process that involves participants being given information about, among other things, upcoming research interventions and then being invited to waive their claims against those interventions being undertaken. The standard practice, as regards timing, is as follows: participants are invited to waive all their claims at a single moment in time, and that point in time immediately follows the information-provision. I argue that there we’re not justified in keeping to this practice. (...) What we ought to do is disaggregate the claim-waiving part of the process and move it later, such that the participant is invited to waive her claim against the undertaking of any given intervention only the immediate moment before that intervention is to be undertaken. (shrink)

The way in which consent to sexual interactions is understood in the US is undergoing a transformation. Many universities, sometimes at the behest of lawmakers, are moving to adopt ‘affirmative consent’ policies, which define consent in terms of affirmative behavior that goes beyond mere silence or lack of resistance. Although these policies are a move in the right direction, I argue that their content has not been properly understood. In particular, the circumstances in which nonverbal behavior may communicate consent are (...) more limited than might be apparent. And even though these circumstances can be abstractly identified, it is difficult to give people adequate guidance about when some of them obtain. Moreover, I argue that no matter how the allowance for nonverbal behavior is construed, affirmative consent policies unnecessarily prohibit interactions that people may have reason to engage in. I propose an alternative policy that remedies these problems with the affirmative consent policies that are currently being implemented. And I note that the justification for this alternative policy does not turn on any special features of the university setting. Instead, the account I give suggests grounds for reforming the law as well. (shrink)

Over the last few decades, multiple studies have examined the understanding of participants in clinical research. They show variable and often poor understanding of key elements of disclosure, such as expected risks and the experimental nature of treatments. Did the participants in these studies give valid consent? According to the standard view of informed consent they did not. The standard view holds that the recipient of consent has a duty to disclose certain information to the profferer of consent because valid (...) consent requires that information to be understood. The contents of the understanding and disclosure requirements are therefore conceptually linked. In this paper, we argue that the standard view is mistaken. The disclosure and understanding requirements have distinct grounds tied to two different ways in which a token of consent can be rendered invalid. Analysis of these grounds allows us to derive the contents of the two requirements. It also implies that it is sometimes permissible to enroll willing participants who have not understood everything that they ought to be told about their clinical trials. (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 light of recent advances in machine learning for medical applications, the automation of medical diagnostics is imminent. That said, before machine learning algorithms find their way into clinical practice, various problems at the epistemic level need to be overcome. In this paper, we discuss different sources of uncertainty arising for clinicians trying to evaluate the trustworthiness of algorithmic evidence when making diagnostic judgments. Thereby, we examine many of the limitations of current machine learning algorithms (with deep learning in particular) (...) and highlight their relevance for medical diagnostics. Among the problems we inspect are the theoretical foundations of deep learning (which are not yet adequately understood), the opacity of algorithmic decisions, and the vulnerabilities of machine learning models, as well as concerns regarding the quality of medical data used to train the models. Building on this, we discuss different desiderata for an uncertainty amelioration strategy that ensures that the integration of machine learning into clinical settings proves to be medically beneficial in a meaningful way. (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)

Background Achieving meaningful consent can be challenging, particularly in contexts of diminished literacy, yet is a vital part of participant protection in global health research. Method We explored the challenges and potential solutions of achieving meaningful consent through a qualitative study in a predominantly hill tribe ethnic minority population in northern Thailand, a culturally distinctive population with low literacy. Semi-structured interviews were conducted with 37 respondents who had participated in scrub typhus clinical research, their family members, researchers and other key (...) informants. A thematic analysis was conducted. Results Our analysis identified four interrelated themes surrounding participants’ ability to give consent: varying degrees of research understanding, limitations of using informal translators, issues impacting decisions to join research, and voluntariness of consent. Suggestions for achieving more meaningful consent included the use of formal translators and community engagement with research populations. Conclusions Participant’s agency in decision making to join research should be supported, but research information needs to be communicated to potential participants in a way that they can understand. We found that improved understanding about the study and its potential benefits and harms goes beyond literacy or translation and requires attention to social and cultural factors. (shrink)

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

In this paper, I answer the following question: suppose that two individuals, C and D, have been in a long-term committed relationship, and D now has dementia, while C is competent; if D agrees to have sex with C, is it permissible for C to have sex with D? Ultimately, I defend the view that, under certain conditions, D can give valid consent to sex with C, rendering sex between them permissible. Specifically, I argue there is compelling reason to endorse (...) the following thesis: -/- Prior Consent Thesis: D, when competent, can give valid prior consent to sex with her competent partner (C) that will take place after she has dementia, assuming that D is the same person as she was when she gave prior consent, meaning that, if D, when competent, gave prior consent to sex with C, then C may permissibly have sex with D. In section I, I explain both the background and the existing literature on this issue. In section II, I outline relevant stipulations about the kinds of cases I will be examining. In section III, I defend the Prior Consent Thesis. And, in section IV, I address objections to the Prior Consent Thesis. (shrink)

In “Informed Consent: What Must be Disclosed and What Must be Understood?”, we reject a dogma at the heart of research ethics. We demonstrate that the constitutive claim...

In this paper, we illustrate some serious difficulties involved in conveying information about uncertain risks and securing informed consent for risky interventions in a clinical setting. We argue that in order to secure informed consent for a medical intervention, physicians often need to do more than report a bare, numerical probability value. When probabilities are given, securing informed consent generally requires communicating how probability expressions are to be interpreted and communicating something about the quality and quantity of the evidence for (...) the probabilities reported. Patients may also require guidance on how probability claims may or may not be relevant to their decisions, and physicians should be ready to help patients understand these issues. (shrink)