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

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...

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)

In recent years, there has been a surge of high-profile publications on applications of artificial intelligence 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 —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 ethics of medical AI. (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)

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)