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  1. Consideration and Disclosure of Group Risks in Genomics and Other Data-Centric Research: Does the Common Rule Need Revision?Carolyn Riley Chapman, Gwendolyn P. Quinn, Heini M. Natri, Courtney Berrios, Patrick Dwyer, Kellie Owens, Síofra Heraty & Arthur L. Caplan - forthcoming - American Journal of Bioethics:1-14.
    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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  • Informed Consent Under Ignorance.Daniel Villiger - forthcoming - American Journal of Bioethics:1-13.
    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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  • Response to Open Peer Commentaries on “Informed Consent: What Must Be Disclosed and What Must Be Understood?”.Danielle Bromwich & Joseph Millum - 2021 - American Journal of Bioethics 21 (7):1-5.
    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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  • Safeguarding Users of Consumer Mental Health Apps in Research and Product Improvement Studies: an Interview Study.Kamiel Verbeke, Charu Jain, Ambra Shpendi & Pascal Borry - 2024 - Neuroethics 17 (1):1-20.
    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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  • When Does Nudging Represent Fraudulent Disclosure?Jennifer Blumenthal-Barby, Neal W. Dickert & Derek Soled - 2021 - American Journal of Bioethics 21 (5):63-66.
    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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  • Fragmented understanding: exploring the practice and meaning of informed consent in clinical trials in Ho Chi Minh City, Vietnam.Jennifer Ilo Van Nuil, Evelyne Kestelyn, Susan Bull, Phu Hoan Nguyen, Phuong Thanh Le, Ngoc Bao Hong Lam, Thuan Trong Dang & Yen Hong Thi Nguyen - 2023 - BMC Medical Ethics 24 (1):1-13.
    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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  • Levels of explicability for medical artificial intelligence: What do we normatively need and what can we technically reach?Frank Ursin, Felix Lindner, Timo Ropinski, Sabine Salloch & Cristian Timmermann - 2023 - Ethik in der Medizin 35 (2):173-199.
    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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  • Utilizing Community Research Committees to Improve the Informed Consent Process.Marc Tunzi, Robert P. Lennon, David Satin & Philip G. Day - 2021 - American Journal of Bioethics 21 (5):73-75.
    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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  • Varieties of Minimalism about Informed Consent.Gopal Sreenivasan - 2021 - American Journal of Bioethics 21 (5):66-68.
    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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  • Informed Consent, Understanding, and Trust.David B. Resnik - 2021 - American Journal of Bioethics 21 (5):61-63.
    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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  • Why Have Uniform Informed Consent Documents When the Research Volunteers Are So Diverse?Ross E. McKinney - 2021 - American Journal of Bioethics 21 (5):59-60.
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  • More than Conveying Information: Informed Consent as Speech Act.David C. Magnus, Jacob A. Blythe, Jason N. Batten & Bonnie O. Wong - 2021 - American Journal of Bioethics 21 (5):1-3.
    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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  • Machine learning applications in healthcare and the role of informed consent: Ethical and practical considerations.Giorgia Lorenzini, David Martin Shaw, Laura Arbelaez Ossa & Bernice Simone Elger - forthcoming - Clinical Ethics:147775092210944.
    Informed consent is at the core of the clinical relationship. With the introduction of machine learning 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 whole (...)
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  • Promoting Disclosure and Understanding in Informed Consent: Optimizing the Impact of the Common Rule “Key Information” Requirement.Stephanie A. Kraft, Elliott M. Weiss & Kathryn M. Porter - 2021 - American Journal of Bioethics 21 (5):70-72.
    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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  • The fertility of moral ambiguity in precision medicine.Jeanette Bresson Ladegaard Knox & Mette Nordahl Svendsen - 2023 - Medicine, Health Care and Philosophy 26 (3):465-476.
    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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  • Informed Consent, Error and Suspending Ignorance: Providing Knowledge or Preventing Error?Arnon Keren & Ori Lev - 2022 - Ethical Theory and Moral Practice 25 (2):351-368.
    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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  • Public Awareness of Medical Research Terminology in Japan, and the Accuracy of Physicians’ Predictions regarding that Awareness.Ayako Kamisato, Hyunsoo Hong & Suguru Okubo - 2023 - Asian Bioethics Review 15 (4):397-416.
    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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  • Informed Consent Conversations: Neither the Beginning nor the End.Liza-Marie Johnson & Barclay R. Rogers - 2021 - American Journal of Bioethics 21 (5):76-78.
    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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  • Moral Neuroenhancement for Prisoners of War.Blake Hereth - 2022 - Neuroethics 15 (1):1-20.
    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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  • The Grounds of the Disclosure Requirement for Informed Consent.Tom Dougherty - 2021 - American Journal of Bioethics 21 (5):68-70.
    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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