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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. (...) |
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In the American medical system, patients do not know the final price of treatment until long after the treatment is given, at which point it is too late to say “no.” I argue that without price disclosure many, perhaps all, tokens of consent in clinical medicine fall below the standard of valid, informed consent. This is a sweeping and broad thesis. The reason for this thesis is surprisingly simple: medical services rarely have prices attached to them that are known to (...) |
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Definition of the problem The umbrella term “explicability” refers to the reduction of opacity of artificial intelligence (AI) systems. These efforts are challenging for medical AI applications because higher accuracy often comes at the cost of increased opacity. This entails ethical tensions because physicians and patients desire to trace how results are produced without compromising the performance of AI systems. The centrality of explicability within the informed consent process for medical AI systems compels an ethical reflection on the trade-offs. Which (...) |
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BackgroundThe informed consent process in clinical trials has been extensively studied to inform the development processes which protect research participants and encourage their autonomy. However, ensuring a meaningful informed consent process is still of great concern in many research settings due to its complexity in practice and interwined socio-cultural factors.ObjectivesThis study explored the practices and meaning of the informed consent process in two clinial trials conducted by Oxford University Clinical Research Unit in collaboration with the Hospital for Tropical Diseases in (...) |
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Informed consent is at the core of the clinical relationship. With the introduction of machine learning (ML) in healthcare, the role of informed consent is challenged. This paper addresses the issue of whether patients must be informed about medical ML applications and asked for consent. It aims to expose the discrepancy between ethical and practical considerations, while arguing that this polarization is a false dichotomy: in reality, ethics is applied to specific contexts and situations. Bridging this gap and considering the (...) |
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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 (...) |
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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... |
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Valid Informed consent to medical treatment or research participation has traditionally been viewed as consisting of the following requirements: the person has t... |
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In the article “Informed Consent: What Must be Disclosed and What Must be Understood?” Joseph Millum and Danielle Bromwich argue that informed consent requires satisfaction of certain disclosure an... |
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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... |
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Some bioethicists argue that a doctor may frame treatment options in terms of effects on survival rather than on mortality in order to influence patients to choose the better option. The debate over such framing typically assumes that the survival and mortality frames convey the same numerical information. However, certain empirical findings contest this numerical equivalence assumption, demonstrating that framing effects may in fact be due to the two frames implying different information about the numerical bounds of survival and mortality (...) |
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One of the ethical principles of medical research involving human subjects is obtaining proper informed consent (IC). However, if the participants’ actual awareness of medical research terminology is lower than the researchers’ prediction of that awareness, it may cause difficulty obtaining proper IC. Therefore, this study aims to clarify the presence of “perception gaps” and then discuss IC-related issues and measures based on the insights obtained. We conducted two online surveys: a “public survey” to understand the Japanese public’s awareness of (...) |
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Moral agential neuroenhancement can transform us into better people. However, critics of MB raise four central objections to MANEs use: It destroys moral freedom; it kills one moral agent and replaces them with another, better agent; it carries significant risk of infection and illness; it benefits society but not the enhanced person; and it’s wrong to experiment on nonconsenting persons. Herein, I defend MANE’s use for prisoners of war fighting unjustly. First, the permissibility of killing unjust combatants entails that, in (...) |
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Mental health-related data generated by app users during the routine use of Consumer Mental Health Apps (CMHAs) are being increasingly leveraged for research and product improvement studies. However, it remains unclear which ethical safeguards and practices should be implemented by researchers and app developers to protect users during these studies, and concerns have been raised over their current implementation in CMHAs. To better understand which ethical safeguards and practices are implemented, why and how, 17 app developers and researchers were interviewed (...) |
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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 (...) |
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Informed Consent: What Must Be Disclosed and What Must Be Understood seeks to challenge the “standard view” of consent. It seeks to do so by segregating the “disclosure function” from the “understa... |
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In their latest contribution to a series of important joint papers on informed consent, Joseph Millum and Danielle Bromwich analyze and reject what they call the “standard view” on informed... |
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In their target article, Millum and Bromwich situate their article against a backdrop of well-documented empirical research demonstrating that many participants have variable and often poor... |
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Research regulations around the world do not impose any limits on the risks to which consenting adults may be exposed. Nonetheless, most review committees regard some risks as too high, even for consenting adults. To justify this practice, commentators have appealed to a range of considerations which are external to informed consent and the risks themselves. Most prominently, some argue that exposing consenting adults to very high risks has the potential to undermine public trust in research. This justification assumes that (...) |
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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 (...) |
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Although precision medicine cuts across a large spectrum of professions, interdisciplinary and cross-sectorial moral deliberation has yet to be widely enacted, let alone formalized in this field. In a recent research project on precision medicine, we designed a dialogical forum (i.e. ‘the Ethics Laboratory’) giving interdisciplinary and cross-sectorial stakeholders an opportunity to discuss their moral conundrums in concert. We organized and carried out four Ethics Laboratories. In this article, we use Simone de Beauvoir’s concept of moral ambiguity as a lens (...) |
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Harms and risks to groups and third-parties can be significant in the context of research, particularly in data-centric studies involving genomic, artificial intelligence, and/or machine learning technologies. This article explores whether and how United States federal regulations should be adapted to better align with current ethical thinking and protect group interests. Three aspects of the Common Rule deserve attention and reconsideration with respect to group interests: institutional review board (IRB) assessment of the risks/benefits of research; disclosure requirements in the informed (...) |
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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... |
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Millum and Bromwich’s excellent article provides both conceptual and practical rationale for reexamining the fundamentals of the informed consent process for research and clinical interventi... |
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