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  1. Reconceptualising risk–benefit analyses: the case of HIV cure research.Robert Steel - 2020 - Journal of Medical Ethics 46 (3):212-219.
    Modern antiretroviral therapies are capable of suppressing HIV in the bloodstream to undetectable levels. Nonetheless, people living with HIV must maintain lifelong adherence to ART to avoid the re-emergence of the infection. So despite the existence and efficacy of ART, there is still substantial interest in development of a cure. But HIV cure trials can be risky, their success is as of yet unlikely, and the medical gain of being cured is limited against a baseline of ART access. The medical (...)
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  • Ethical and practical considerations for cell and gene therapy toward an HIV cure: findings from a qualitative in-depth interview study in the United States.Jane Simoni, Steven G. Deeks, Michael J. Peluso, John A. Sauceda, Boro Dropulić, Kim Anthony-Gonda, Jen Adair, Jeff Taylor, Lynda Dee, Jeff Sheehy, Laurie Sylla, Michael Louella, Hursch Patel, John Kanazawa & Karine Dubé - 2022 - BMC Medical Ethics 23 (1):1-17.
    BackgroundHIV cure research involving cell and gene therapy has intensified in recent years. There is a growing need to identify ethical standards and safeguards to ensure cell and gene therapy HIV cure research remains valued and acceptable to as many stakeholders as possible as it advances on a global scale.MethodsTo elicit preliminary ethical and practical considerations to guide CGT HIV cure research, we implemented a qualitative, in-depth interview study with three key stakeholder groups in the United States: biomedical HIV cure (...)
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  • Ethical considerations for HIV remission clinical research involving participants diagnosed during acute HIV infection.Stuart Rennie, Maartje Dijkstra, Karine Dubé, Joseph D. Tucker & Adam Gilbertson - 2021 - BMC Medical Ethics 22 (1):1-12.
    HIV remission clinical researchers are increasingly seeking study participants who are diagnosed and treated during acute HIV infection—the brief period between infection and the point when the body creates detectable HIV antibodies. This earliest stage of infection is often marked by flu-like illness and may be an especially tumultuous period of confusion, guilt, anger, and uncertainty. Such experiences may present added ethical challenges for HIV research recruitment, participation, and retention. The purpose of this paper is to identify potential ethical challenges (...)
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  • The psychology of “cure” - unique challenges to consent processes in HIV cure research in South Africa.Keymanthri Moodley, Ciara Staunton, Theresa Rossouw, Malcolm de Roubaix, Zoe Duby & Donald Skinner - 2019 - BMC Medical Ethics 20 (1):9.
    Consent processes for clinical trials involving HIV prevention research have generated considerable debate globally over the past three decades. HIV cure/eradication research is scientifically more complex and consequently, consent processes for clinical trials in this field are likely to pose a significant challenge. Given that research efforts are now moving toward HIV eradication, stakeholder engagement to inform appropriate ethics oversight of such research is timely. This study sought to establish the perspectives of a wide range of stakeholders in HIV treatment (...)
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  • Understanding, Communication, and Consent.Joseph Millum & Danielle Bromwich - 2018 - Ergo: An Open Access Journal of Philosophy 5:45-68.
    Misconceived Consent: Miguel has stage IV lung cancer. He has nearly exhausted his treatment options when his oncologist, Dr. Llewellyn, tells him about an experimental vaccine trial that may boost his immune response to kill cancer cells. Dr. Llewellyn provides Miguel with a consent form that explains why the study is being conducted, what procedures he will undergo, what the various risks and benefits are, alternative sources of treatment, and so forth. She even sits down with him, carefully talks through (...)
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  • Informed Consent: What Must Be Disclosed and What Must Be Understood?Joseph Millum & Danielle Bromwich - 2021 - American Journal of Bioethics 21 (5):46-58.
    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 (...)
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  • Bioethical reflexivity and requirements of valid consent: conceptual tools.John Barugahare - 2019 - BMC Medical Ethics 20 (1):44.
    Despite existing international, regional and national guidance on how to obtain valid consent to health-related research, valid consent remains both a practical and normative challenge. This challenge persists despite additional evidence-based guidance obtained through conceptual and empirical research in specific localities on the same subject. The purpose of this paper is to provide an account for why, despite this guidance, this challenge still persist and suggest conceptual resources that can help make sense of this problem and eventually mitigate it’. This (...)
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  • Hydroxychloroquine and COVID-19: critiquing the impact of disease public profile on policy and clinical decision-making.Yves S. J. Aquino & Nicolo Cabrera - 2020 - Journal of Medical Ethics 46 (9):574-578.
    The controversy surrounding the use of hydroxychloroquine, an antimalarial drug, for COVID-19 has raised numerous ethical and policy problems. Since the suggestion that HCQ has potential for COVID-19, there have been varying responses from clinicians and healthcare institutions, ranging from adoption of protocols using HCQ for routine care to the conduct of randomised controlled trials to an effective system-wide prohibition on its use for COVID-19. In this article, we argue that the concept of ‘disease public profile’ has become a prominent, (...)
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