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  1. Should Research Ethics Encourage the Production of Cost-Effective Interventions?Govind Persad - 2016 - In Daniel Strech & Marcel Mertz (eds.), Ethics and Governance of Biomedical Research: Theory and Practice. Cham: Springer. pp. 13-28.
    This project considers whether and how research ethics can contribute to the provision of cost-effective medical interventions. Clinical research ethics represents an underexplored context for the promotion of cost-effectiveness. In particular, although scholars have recently argued that research on less-expensive, less-effective interventions can be ethical, there has been little or no discussion of whether ethical considerations justify curtailing research on more expensive, more effective interventions. Yet considering cost-effectiveness at the research stage can help ensure that scarce resources such as tissue (...)
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  • For the Common Good: Philosophical Foundations of Research Ethics.Alex John London - 2021 - New York, NY, USA: Oxford University Press.
    The foundations of research ethics are riven with fault lines emanating from a fear that if research is too closely connected to weighty social purposes an imperative to advance the common good through research will justify abrogating the rights and welfare of study participants. The result is an impoverished conception of the nature of research, an incomplete focus on actors who bear important moral responsibilities, and a system of ethics and oversight highly attuned to the dangers of research but largely (...)
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  • Against Permitted Exploitation in Developing World Research Agreements.Danielle M. Wenner - 2015 - Developing World Bioethics 16 (1):36-44.
    This paper examines the moral force of exploitation in developing world research agreements. Taking for granted that some clinical research which is conducted in the developing world but funded by developed world sponsors is exploitative, it asks whether a third party would be morally justified in enforcing limits on research agreements in order to ensure more fair and less exploitative outcomes. This question is particularly relevant when such exploitative transactions are entered into voluntarily by all relevant parties, and both research (...)
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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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  • A Non-Paternalistic Model of Research Ethics and Oversight: Assessing the Benefits of Prospective Review.Alex John London - 2012 - Journal of Law, Medicine and Ethics 40 (4):930-944.
    To judge from the rash of recent law review articles, it is a miracle that research with human subjects in the U.S. continues to draw breath under the asphyxiating heel of the rent-seeking, creativity-stifling, jack-booted bureaucrethics that is the current system of research ethics oversight and review. Institutional Review Boards, sometimes called Research Ethics Committees, have been accused of perpetrating “probably the most widespread violation of the First Amendment in our nation's history,” resulting in a “disaster, not only for academics, (...)
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  • The Risk-Escalation Model: A Principled Design Strategy for Early-Phase Trials.Spencer Phillips Hey & Jonathan Kimmelman - 2014 - Kennedy Institute of Ethics Journal 24 (2):121-139.
    Should first-in-human trials be designed to maximize the prospect of therapeutic benefit for volunteers, prioritize avoidance of unintended harms, or aim for some happy medium between the two? Perennial controversies surrounding initiation and design of early-phase trials hinge on how this question is resolved. In this paper, we build on the premise that the task of early-phase testing is to optimize various components of a potential therapy so that later, confirmatory trials have the maximal probability of informing drug development and (...)
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  • How do researchers decide early clinical trials?Hannah Grankvist & Jonathan Kimmelman - 2016 - Medicine, Health Care and Philosophy 19 (2):191-198.
    Launch of clinical investigation represents a substantial escalation in commitment to a particular clinical translation trajectory; it also exposes human subjects to poorly understood interventions. Despite these high stakes, there is little to guide decision-makers on the scientific and ethical evaluation of early phase trials. In this article, we review policies and consensus statements on human protections, drug regulation, and research design surrounding trial launch, and conclude that decision-making is largely left to the discretion of research teams and sponsors. We (...)
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  • First-in-human HIV-remission studies: reducing and justifying risk.Rebecca Dresser - 2017 - Journal of Medical Ethics 43 (2):78-81.
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  • Building an Ethical Foundation for First-in-Human Nanotrials.Rebecca Dresser - 2012 - Journal of Law, Medicine and Ethics 40 (4):802-808.
    The biomedical literature and popular media are full of upbeat reports about the health benefits we can expect from medical innovations using nanotechnology. Some particularly enthusiastic reports portray nanotechnology as one of the innovations that will lead to a significantly extended human life span. Extreme enthusiasts predict that nanotechnology “will ultimately enable us to redesign and rebuild, molecule by molecule, our bodies and brains….”Nanomaterials have special characteristics that could contribute to improved patient care. But the same characteristics that make nanotechnology (...)
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  • Alive and Well: The Research Imperative.Rebecca Dresser - 2012 - Journal of Law, Medicine and Ethics 40 (4):915-921.
    The government-sponsored Tuskegee syphilis study had a huge impact on U.S. research ethics and policy. Study investigators regarded subjects as “mere means” to their research ends, which led to a variety of ethical violations. Investigators used deception so that subjects would see participation as therapeutic — researchers promoted the therapeutic misconception because this advanced study objectives. The research would produce important information, and this justified lying to research subjects.Today we see this sort of intentional deception as unjustified no matter how (...)
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