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  1. Risk, benefit, and social value in Covid-19 human challenge studies: pandemic decision making in historical context.Mabel Rosenheck - 2022 - Monash Bioethics Review 40 (2):188-213.
    AbstractDuring the Covid-19 pandemic, ethicists and researchers proposed human challenge studies as a way to speed development of a vaccine that could prevent disease and end the global public health crisis. The risks to healthy volunteers of being deliberately infected with a deadly and novel pathogen were not low, but the benefits could have been immense. This essay is a history of the three major efforts to set up a challenge model and run challenge studies in 2020 and 2021. The (...)
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  • The ethical anatomy of payment for research participants.Joanna Różyńska - 2022 - Medicine, Health Care and Philosophy 25 (3):449-464.
    In contrast to most publications on the ethics of paying research subjects, which start by identifying and analyzing major ethical concerns raised by the practice (in particular, risks of undue inducement and exploitation) and end with a set of—more or less well-justified—ethical recommendations for using payment schemes immune to these problems, this paper offers a systematic, principle-based ethical analysis of the practice. It argues that researchers have aprima faciemoral obligation to offer payment to research subjects, which stems from the principle (...)
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  • Ethical considerations around volunteer payments in a malaria human infection study in Kenya: an embedded empirical ethics study.Dorcas Kamuya, Vicki Marsh, Melissa Kapulu, Philip Bejon, Irene Jao, Esther Awuor Owino & Primus Che Chi - 2022 - BMC Medical Ethics 23 (1):1-13.
    Human Infection Studies have emerged as an important research approach with the potential to fast track the global development of vaccines and treatments for infectious diseases, including in low resource settings. Given the high level of burdens involved in many HIS, particularly prolonged residency and biological sampling requirements, it can be challenging to identify levels of study payments that provide adequate compensation but avoid ‘undue’ levels of inducement to participate. Through this embedded ethics study, involving 97 healthy volunteers and other (...)
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  • Incentive Payments and Research Related Risks—No Reason to Change.Søren Holm - 2021 - American Journal of Bioethics 21 (3):43-45.
    The paper by Lynch et al. argues that payments to research participants in biomedical research can be divided into three different categories, reimbursement, compensation, and incentive and...
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  • Paying for Fairness? Incentives and Fair Subject Selection.Douglas MacKay & Rebecca L. Walker - 2021 - American Journal of Bioethics 21 (3):35-37.
    In their Target Article, “Promoting Ethical Payment in Human Infection Challenge Studies,” Lynch et al. propose a framework for ethical payment to research participants and apply it to the c...
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  • Which Benefits Can Justify Risks in Research?Tessa I. van Rijssel, Ghislaine J. M. W. van Thiel, Helga Gardarsdottir, Johannes J. M. van Delden & on Behalf of the Trials@Home Consortium - forthcoming - American Journal of Bioethics:1-11.
    Research ethics committees (RECs) evaluate whether the risk-benefit ratio of a study is acceptable. Decentralized clinical trials (DCTs) are a novel approach for conducting clinical trials that potentially bring important benefits for research, including several collateral benefits. The position of collateral benefits in risk-benefit assessments is currently unclear. DCTs raise therefore questions about how these benefits should be assessed. This paper aims to reconsider the different types of research benefits, and their position in risk-benefit assessments. We first propose a categorization (...)
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  • Promoting Ethical Payments in Human Challenge Studies Conducted in LMICs: Are We Asking the Right Questions?Paul Ndebele & Adnan A. Hyder - 2021 - American Journal of Bioethics 21 (3):51-53.
    The paper by Lynch et al. raises interesting ethical questions regarding whether and how much SARS-CoV-2 Human Challenge Studies participants should be paid. We appreciate the timely e...
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  • Paying the Right Amount to Challenge Trial Participants – We Need to Use Behavioral Science Insights to Sell What’s Right.Peter A. Ubel & J. S. Blumenthal-Barby - 2021 - American Journal of Bioethics 21 (3):38-39.
    Sometimes doing what’s right depends on anticipating how people will react when you do the right thing. Consider two aspects of challenge trial payments discussed by Lynch and colleagues. Th...
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  • Plumbing the Depths of Ethical Payment for Research Participation.Holly Fernandez Lynch, Thomas C. Darton, Jae Levy, Frank McCormick, Ubaka Ogbogu, Ruth O. Payne, Alvin E. Roth, Akilah Jefferson Shah, Thomas Smiley & Emily A. Largent - 2021 - American Journal of Bioethics 21 (5):W8-W11.
    The peer commentaries on our Target Article, “Promoting Ethical Payment in Human Infection Challenge Studies,” offer a number of insights that will help advance the co...
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  • What Can We Learn from COVID-19 Drug Development and Access for Non-Pandemic Diseases? A Chinese Perspective.Hui Zhang, Zhiping Guo, Lijun Shen, Yongguang Yang, Zhenxiang Zhang & Yuming Wang - 2021 - American Journal of Bioethics 21 (12):42-45.
    The target article by Lynch et al. offers approaches for improving trial availability and Expanded Access for non-pandemic diseases based on the analysis of the COVID-19 experience in the US...
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  • Risky first-in-human clinical trials on medically fragile persons: owning the moral cost.Christopher Bobier - 2024 - Theoretical Medicine and Bioethics 45 (6):447-459.
    The purpose of a first-in-human (FIH) clinical trial is to gather information about how the drug or device affects and interacts with the human body: its safety, side effects, and (potential) dosage. As such, the primary goal of a FIH trial is not participant benefit but to gain knowledge of drug or device efficacy, i.e., baseline human safety knowledge. Some FIH clinical trials carry _significant_ foreseeable risk to participants with little to no foreseeable participant benefit. Participation in such trials would (...)
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  • Ethical and practical considerations arising from community consultation on implementing controlled human infection studies using Schistosoma mansoni in Uganda.Moses Egesa, Agnes Ssali, Edward Tumwesige, Moses Kizza, Emmanuella Driciru, Fiona Luboga, Meta Roestenberg, Janet Seeley & Alison M. Elliott - 2022 - Global Bioethics 33 (1):78-102.
    Issues related to controlled human infection studies using Schistosoma mansoni (CHI-S) were explored to ensure the ethical and voluntary participation of potential CHI-S volunteers in an endemic setting in Uganda. We invited volunteers from a fishing community and a tertiary education community to guide the development of informed consent procedures. Consultative group discussions were held to modify educational materials on schistosomiasis, vaccines and the CHI-S model and similar discussions were held with a test group. With both groups, a mock consent (...)
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  • A Call for Radical Transparency regarding Research Payments.Emily E. Anderson & Brandon Brown - 2021 - American Journal of Bioethics 21 (3):45-47.
    In the target article “Promoting Ethical Payment in Human Infection Challenge Studies,” Fernandez Lynch et al. call for more information sharing about research payment amounts to study parti...
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  • Considering the Importance of Context for Ethical Practice on Reimbursement, Compensation and Incentives for Volunteers in Human Infection Controlled Studies.Primus Che Chi, Esther Owino, Irene Jao, Vicki Marsh & Dorcas Kamuya - 2021 - American Journal of Bioethics 21 (3):40-42.
    The proposed framework by Lynch et al. (2021) for promoting ethical forms of payment in Human Infection Controlled Studies (HICS) in general and SARS-Cov-2 HICS in particular is an important contri...
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  • Research Participants Should Be Rewarded Rather than “Compensated for Time and Burdens”.Joanna Różyńska - 2021 - American Journal of Bioethics 21 (3):53-55.
    Paying research subjects for their participation in biomedical studies is an increasingly common and acceptable practice. Nevertheless, it continues to raise numerous conceptual, ethical, and pract...
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  • (1 other version)Exploring the ethics of tuberculosis human challenge models.Abie Rohrig, Josh Morrison, Gavriel Kleinwaks, Jonathan Pugh, Helen McShane & Julian Savulescu - forthcoming - Journal of Medical Ethics.
    We extend recent conversation about the ethics of human challenge trials to tuberculosis (TB). TB challenge studies could accelerate vaccine development, but ethical concerns regarding risks to trial participants and third parties have been a limiting factor. We analyse the expected social value and risks of different challenge models, concluding that if a TB challenge trial has between a 10% and a 50% chance of leading to the authorisation and near-universal delivery of a more effective vaccine 3–5 years earlier, then (...)
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  • Time to Professionalize Service to Research? Pay Nothing or Full Wage for Labor.Julian Savulescu - 2021 - American Journal of Bioethics 21 (3):32-34.
    There is asbestos under the eaves of my house, outside my bedroom and bathroom. Imagine I want to remove it. I know there is a danger with asbestos removal causing asbestosis and mesothelioma. I do...
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  • What Fairness Demands: How We Can Promote Fair Compensation in Human Infection Challenge Studies and Beyond.Seán O’Neill McPartlin & Josh Morrison - 2021 - American Journal of Bioethics 21 (3):48-50.
    This commentary shall focus on the central claim made in Lynch et al.’s paper “Promoting Ethical Payment in Human Infection Challenge Studies.” According to their paper, there is a threefold...
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