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  1. Should the use of adaptive machine learning systems in medicine be classified as research?Robert Sparrow, Joshua Hatherley, Justin Oakley & Chris Bain - 2024 - American Journal of Bioethics 24 (10):58-69.
    A novel advantage of the use of machine learning (ML) systems in medicine is their potential to continue learning from new data after implementation in clinical practice. To date, considerations of the ethical questions raised by the design and use of adaptive machine learning systems in medicine have, for the most part, been confined to discussion of the so-called “update problem,” which concerns how regulators should approach systems whose performance and parameters continue to change even after they have received regulatory (...)
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  • Clinical equipoise: Why still the gold standard for randomized clinical trials?Charlemagne Asonganyi Folefac & Hugh Desmond - 2024 - Clinical Ethics 19 (1):1-11.
    The principle of clinical equipoise has been variously characterized by ethicists and clinicians as fundamentally flawed, a myth, and even a moral balm. Yet, the principle continues to be treated as the de facto gold standard for conducting randomized control trials in an ethical manner. Why do we hold on to clinical equipoise, despite its shortcomings being widely known and well-advertised? This paper reviews the most important arguments criticizing clinical equipoise as well as what the most prominent proposed alternatives are. (...)
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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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  • Taking the principle of the primacy of the human being seriously.Joanna Różyńska - 2021 - Medicine, Health Care and Philosophy 24 (4):547-562.
    This paper targets an orphan topic in research ethics, namely the so called principle of the primacy of the human being, which states that the interests of the human subject should always take precedence over the interests of science and society. Although the principle occupies the central position in the majority of international ethical and legal standards for biomedical research, it has been commented in the literature mainly in passing. With a few notable exceptions, there is little in-depth discussion about (...)
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  • Can and should the research–therapy distinction be maintained? Reflections in the light of innovative last-resort treatment.Gert Helgesson - 2019 - Research Ethics 15 (2):1-14.
    It has been debated for quite some time among bioethicists and others whether or not the distinction between therapy and research in healthcare can and should be maintained. This paper tries to clarify what the disagreement is about, and argues that the distinction can be maintained in most, if not all, situations. However, even if it can be maintained, it does not necessarily follow that it should. It is argued here that there are good reasons to maintain the distinction both (...)
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  • A framework for risk-benefit evaluations in biomedical research.Annette Rid & David Wendler - 2011 - Kennedy Institute of Ethics Journal 21 (2):141-179.
    One of the key ethical requirements for biomedical research is that it have an acceptable risk-benefit profile (Emanuel, Wendler, and Grady 2000). The International Conference of Harmonization guidelines mandate that clinical trials should be initiated and continued only if “the anticipated benefits justify the risks” (1996). Guidelines from the Council for International Organizations of Medical Sciences state that biomedical research is acceptable only if the “potential benefits and risks are reasonably balanced” (2002). U.S. federal regulations require that the “risks to (...)
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  • A capacity-based approach for addressing ancillary care needs: implications for research in resource limited settings.Patricia L. Bright & Robert M. Nelson - 2012 - Journal of Medical Ethics 38 (11):672-676.
    A paediatric clinical trial conducted in a developing country is likely to encounter conditions or illnesses in participants unrelated to the study. Since local healthcare resources may be inadequate to meet these needs, research clinicians may face the dilemma of deciding when to provide ancillary care and to what extent. The authors propose a model for identifying ancillary care obligations that draws on assessments of urgency, the capacity of the local healthcare infrastructure and the capacity of the research infrastructure. The (...)
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  • Rethinking the Regulatory Triggers for Prospective Ethics Review.Carl H. Coleman - 2019 - Journal of Law, Medicine and Ethics 47 (2):247-253.
    Under the Common Rule, federally-supported activities involving human participants are presumptively required to undergo prospective ethics review if they are “designed to develop or contribute to generalizable knowledge.” However, the “generalizable knowledge” standard is inherently ambiguous; moreover, it is both over- and under-inclusive of the type of activities that warrant prospective ethical oversight. Rather than conditioning prospective ethics review on an ethically irrelevant criterion like the generalizable knowledge standard, this article proposes that prior ethics review should be required when some (...)
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  • Spheres of Morality: The Ethical Codes of the Medical Profession.Samuel Doernberg & Robert Truog - 2023 - American Journal of Bioethics 23 (12):8-22.
    The medical profession contains five “spheres of morality”: clinical care, clinical research, scientific knowledge, population health, and the market. These distinct sets of normative commitments require physicians to act in different ways depending on the ends of the activity in question. For example, a physician-scientist emphasizes patients’ well-being in clinic, prioritizes the scientific method in lab, and seeks to maximize shareholder returns as a board member of a pharmaceutical firm. Physicians increasingly occupy multiple roles in healthcare and move between them (...)
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  • Clinical Equipoise and Moral Leeway: An Epistemological Stance.Daniele Chiffi & Ahti-Veikko Pietarinen - 2019 - Topoi 38 (2):447-456.
    Clinical equipoise has been proposed as an ethical principle relating uncertainty and moral leeway in clinical research. Although CE has traditionally been indicated as a necessary condition for a morally justified introduction of a new RCT, questions related to the interpretation of this principle remain woefully open. Recent proposals to rehabilitate CE have divided the bioethical community on its ethical merits. This paper presents a new argument that brings out the epistemological difficulties we encounter in justifying CE as a principle (...)
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  • Confusions in the equipoise concept and the alternative of fully informed overlapping rational decisions.David W. Chambers - 2011 - Medicine, Health Care and Philosophy 14 (2):133-142.
    Despite its several variations, the central position of equipoise is that subjects in clinical experiments should not be randomized to conditions when others believe that better alternatives exist. This position has been challenged over issues of which group in the medical or research community is authorized to make that determination, and it has been argued that informed consent provides sufficient ethical protection for participants independent of equipoise. In this paper I frame ethical participation in clinical research as a two-party decision (...)
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  • The clinical investigator-subject relationship: a contextual approach.David B. Resnik - 2009 - Philosophy, Ethics, and Humanities in Medicine 4:16-.
    BackgroundThe nature of the relationship between a clinical investigator and a research subject has generated considerable debate because the investigator occupies two distinct roles: clinician and scientist. As a clinician, the investigator has duties to provide the patient with optimal care and undivided loyalty. As a scientist, the investigator has duties to follow the rules, procedures and methods described in the protocol.Results and conclusionIn this article, I present a contextual approach to the investigator-subject relationship. The extent of the investigator's duty (...)
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  • In Plain Sight: A Solution to a Fundamental Challenge in Human Research.Lois Shepherd & Margaret Foster Riley - 2012 - Journal of Law, Medicine and Ethics 40 (4):970-989.
    The physician-researcher conflict of interest, a long-standing and widely recognized ethical challenge of clinical research, has thus far eluded satisfactory solution. The conflict is fairly straightforward. Medical research and medical therapy are distinct pursuits; the former is aimed at producing generalizable knowledge for the benefit of future patients, whereas the latter is aimed at addressing the individualized medical needs of a particular patient. When the physician-researcher combines these pursuits, he or she serves two masters and cannot — no matter how (...)
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  • Outcome-adaptive randomization in clinical trials: issues of participant welfare and autonomy.Julius Sim - 2019 - Theoretical Medicine and Bioethics 40 (2):83-101.
    Outcome-adaptive randomization (OAR) has been proposed as a corrective to certain ethical difficulties inherent in the traditional randomized clinical trial (RCT) using fixed-ratio randomization. In particular, it has been suggested that OAR redresses the balance between individual and collective ethics in favour of the former. In this paper, I examine issues of welfare and autonomy arising in relation to OAR. A central issue in discussions of welfare in OAR is equipoise, and the moral status of OAR is crucially influenced by (...)
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  • The Ethics of Clinical Care and the Ethics of Clinical Research: Yin and Yang.Charles J. Kowalski, Raymond J. Hutchinson & Adam J. Mrdjenovich - 2017 - Journal of Medicine and Philosophy 42 (1):7-32.
    The Belmont Report’s distinction between research and the practice of accepted therapy has led various authors to suggest that these purportedly distinct activities should be governed by different ethical principles. We consider some of the ethical consequences of attempts to separate the two and conclude that separation fails along ontological, ethical, and epistemological dimensions. Clinical practice and clinical research, as with yin and yang, can be thought of as complementary forces interacting to form a dynamic system in which the whole (...)
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  • Ethics of medical care and clinical research: a qualitative study of principal investigators in biomedical HIV prevention research.Bridget G. Haire - 2013 - Journal of Medical Ethics 39 (4):231-235.
    In clinical research there is a tension between the role of a doctor, who must serve the best interests of the patient, and the role of the researcher, who must produce knowledge that may not have any immediate benefits for the research participant. This tension is exacerbated in HIV research in low and middle income countries, which frequently uncovers comorbidities other than the condition under study. Some bioethicists argue that as the goals of medicine and those of research are distinct, (...)
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  • A partial defense of clinical equipoise.Scott D. Gelfand - 2019 - Research Ethics 15 (2):1-17.
    In this essay, I suggest that a slightly modified version of Freedman’s formulation of the clinical equipoise requirement is justified. I begin this essay with a brief discussion of the equipoise r...
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