Results for ' equipoise'

184 found
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  1.  38
    Equipoise and Nonmedical Risks.Brandon Boesch - 2014 - American Journal of Bioethics 14 (4):16-18.
    DeMarco and colleagues present a compelling method of dealing with medical risks for which there is equipoise which might be implicated in a given research protocol. This commentary examines how the proposed model should inform the disclosure of other, non-medical risks. Since equipoise is a fairly unclear notion for non-medical risks (since there is little sense of professional uncertainty regarding these risks), this could lead to the inclusion of nearly unlimited non-medical risks. To account for these risks more (...)
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  2. 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 (...)
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  3.  90
    Community equipoise and the architecture of clinical research.Jason H. T. Karlawish & John Lantos - 1997 - Cambridge Quarterly of Healthcare Ethics 6 (4):385-.
    Equipoise is an essential condition to justify a clinical trial. The term, describes a state of uncertainty: the data suggest but do not prove a drug's safety and efficacy The only way to resolve this uncertainty is further study In many cases, a clinical trial seems to be the most efficient way to prove safety and efficacy Equipoise is therefore not an esoteric philosophic construct applied to research ethics. Rather, since it is vital for the justification of clinical (...)
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  4. Policy Equipoise and Interventional Superiority.Douglas MacKay - forthcoming - Journal of Development Effectiveness.
    According to the norm of policy equipoise, it is permissible to randomly assign participants to two or more interventions in a public policy randomized controlled trial (RCT) when there is meaningful uncertainty among the relevant expert community regarding which intervention is superior. While this norm is gaining traction in the research ethics literature, the idea of interventional superiority remains unclear. Is one intervention superior to another if it is reasonably expected to realize one outcome of interest more effectively, even (...)
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  5. Clinical Equipoise: Actual or Hypothetical Disagreement?Scott Gelfand - 2013 - Journal of Medicine and Philosophy 38 (6):590--604.
    In his influential 1987 essay, “Equipoise and The Ethics of Randomized Clinical Research,” Benjamin Freedman argued that Charles Fried’s theoretical equipoise requirement threatened clinical research because it was overwhelmingly fragile and rendered unethical too many randomized clinical trials. Freedman, therefore, proposed an alternative requirement, the clinical equipoise requirement, which is now considered to be the fundamental or guiding principle concerning the ethics of enrolling patients in randomized clinical trials. In this essay I argue that Freedman’s clinical (...) requirement is ambiguous and can be interpreted in (at least) two different ways. I furthermore claim that, ironically, the best interpretation of the clinical equipoise requirement opens Freedman to the same objection that he leveled against Fried twenty-five years ago; namely, that it (Freedman’s clinical equipoise requirement) renders unethical too many randomized clinical trials. (shrink)
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  6. What Role Should Equipoise Play in Experimental Development Economics?Marcos Picchio - forthcoming - Economics and Philosophy.
    Unlike with randomized controlled trials (RCTs) in clinical research, little has been said about the ethical principles that should regulate the use of RCTs in experimental development economics. One well-known principle in clinical research ethics is the principle of clinical equipoise. Some recent commentators suggest that an analogue of clinical equipoise should play a role in experimental development economics. In this article, I first highlight some difficulties with importing the concept to experimental development economics. I then argue that (...)
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  7.  67
    Community-equipoise and the ethics of randomized clinical trials.Fred Gifford - 1995 - Bioethics 9 (2):127–148.
    This paper critically examines a particular strategy for resolving the central ethical dilemma associated with randomized clinical trials — the “community equipoise” strategy . The dilemma is that RCTs appear to violate a physician's duty to choose that therapy which there is most reason to believe is in the patient's best interest, randomizing patients even once evidence begins to favor one treatment. The community equipoise strategy involves the suggestion that our judgment that neither treatment is to be preferred (...)
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  8.  35
    Equipoise and the Criteria for Reasonable Action.Emily L. Evans & Alex John London - 2006 - Journal of Law, Medicine and Ethics 34 (2):441-450.
    Critics of clinical equipoise have long argued that it represents an overly permissive, and therefore morally unacceptable, mechanism for resolving the tensions inherent in clinical research. In particular, the equipoise requirement is often attacked on the grounds that it is not sufficiently responsive to the interests of individual patients. In this paper, we outline a view of equipoise that not only withstands a stronger version of this objection, which was recently articulated by Deborah Hellman, but also plays (...)
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  9. Equipoise, Knowledge and Ethics in Clinical Research and Practice.Richard Ashcroft - 1999 - Bioethics 13 (3-4):314-326.
    It is widely maintained that a clinical trial is ethical only if some form of equipoise between the treatments being compared obtains. To be in equipoise between two treatments A and B is to be cognitively indifferent between the statement ‘A is strictly more effective than B’ and its negation. It is natural to claim that equipoise regarding A and B is necessary for randomised assignment to treatments A and B to be beneficent and non‐maleficent and is (...)
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  10. Equipoise: Beyond rehabilitation?Jerry Menikoff - 2003 - Kennedy Institute of Ethics Journal 13 (4):347-351.
    : Challenging the interpretation of Charles Fried's use of "equipoise" presented by Paul Miller and Charles Weijer in a recent issue of the Kennedy Institute of Ethics Journal , this commentary argues that Fried was in no way promoting the concept of equipoise. In fact, his key point was that patients have a right to know and to make their own decisions about participation in clinical trials, regardless of equipoise, however it is defined.
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  11. Equipoise as a means of managing uncertainty: personal, communal and proxy.P. Alderson - 1996 - Journal of Medical Ethics 22 (3):135-139.
    Equipoise is advocated as a means of achieving high scientific and ethical standards in randomised trials. As used in the context of research the word describes a state of uncertainty characterised by the belief that in a trial no arm is known to offer greater harm or benefit than any other arm. Clinicians who lack personal equipoise are advised to accept clinical or communal equipoise, based on current unresolved disagreement among the medical profession. Equipoise is mainly (...)
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  12.  49
    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 (...)
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  13.  80
    Clinical Equipoise: Foundational Requirement or Fundamental Error.Alex John London - 2007 - In Bonnie Steinbock, The Oxford handbook of bioethics. New York: Oxford University Press.
    Any view of equipoise faces perhaps the most radical and far-reaching objections from moral foundations. These objections hold that the equipoise requirement conflates the ethics of medical research and the ethics of clinical medicine. Once this conflation is recognized, this position holds, research can be given a new foundation on the imperative to avoid exploiting research participants. This article argues that what is novel in this critique is not as successful as its proponents claim and that the ultimate (...)
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  14. Clinical equipoise and the incoherence of research ethics.Franklin G. Miller & Howard Brody - 2007 - Journal of Medicine and Philosophy 32 (2):151 – 165.
    The doctrine of clinical equipoise is appealing because it appears to permit physicians to maintain their therapeutic obligation to offer optimal medical care to patients while conducting randomized controlled trials (RCTs). The appearance, however, is deceptive. In this article we argue that clinical equipoise is defective and incoherent in multiple ways. First, it conflates the sound methodological principle that RCTs should begin with an honest null hypothesis with the questionable ethical norm that participants in these trials should never (...)
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  15. Educational Equipoise and the Educational Misconception; Lessons from Bioethics.Gil Hersch - 2018 - Teaching and Learning Inquirey 6 (2):3-15.
    Some advances in bioethics regarding ethical considerations that arise in the context of medical research can also be relevant when thinking about the ethical considerations that arise in the context of SoTL research. In this article, I aim to bring awareness to two potential ethical challenges SoTL researchers might face when playing a dual role of teacher and researcher that are similar to the challenges physicians face in their dual role of physician and researcher. In this article, I argue that (...)
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  16. Rehabilitating Equipoise.Paul B. Miller & Charles Weijer - 2003 - Kennedy Institute of Ethics Journal 13 (2):93-118.
    : When may a physician legitimately offer enrollment in a randomized clinical trial (RCT) to her patient? Two answers to this question have had a profound impact on the research ethics literature. Equipoise, as originated by Charles Fried, which we term Fried's equipoise (FE), stipulates that a physician may offer trial enrollment to her patient only when the physician is genuinely uncertain as to the preferred treatment. Clinical equipoise (CE), originated by Benjamin Freedman, requires that there exist (...)
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  17.  53
    Behavioral Equipoise: A Way to Resolve Ethical Stalemates in Clinical Research.Robert Silbergleit & Peter A. Ubel - 2011 - American Journal of Bioethics 11 (2):1-8.
    Randomized trials depend on clinicians feeling that they are morally justified in allowing their patients to be randomized across treatment arms. Typically such justification rides on what has been called “clinical equipoise”—when there is disagreement of opinion among the community of experts about whether one treatment is better than another, then physicians can ethically enter their patients into a clinical trial, even if individual physicians are not at equipoise. Recent debates over prominent studies, however, illustrate that controversy can (...)
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  18.  51
    Clinical Equipoise and Adaptive Clinical Trials.Nicolas Fillion - 2019 - Topoi 38 (2):457-467.
    Ethically permissible clinical trials must not expose subjects to risks that are unreasonable in relation to anticipated benefits. In the research ethics literature, this moral requirement is typically understood in one of two different ways: as requiring the existence of a state of clinical equipoise, meaning a state of honest, professional disagreement among the community of experts about the preferred treatment; or as requiring an equilibrium between individual and collective ethics. It has been maintained that this second interpretation makes (...)
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  19.  33
    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 (...)
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  20.  77
    Equipoise and the duty of care in clinical research: A philosophical response to our critics.Paul B. Miller & Charles Weijer - 2007 - Journal of Medicine and Philosophy 32 (2):117 – 133.
    Franklin G. Miller and colleagues have stimulated renewed interest in research ethics through their work criticizing clinical equipoise. Over three years and some twenty articles, they have also worked to articulate a positive alternative view on norms governing the conduct of clinical research. Shared presuppositions underlie the positive and critical dimensions of Miller and colleagues' work. However, recognizing that constructive contributions to the field ought to enjoy priority, we presently scrutinize the constructive dimension of their work. We argue that (...)
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  21.  76
    Social value, clinical equipoise, and research in a public health emergency.Alex John London - 2018 - Bioethics 33 (3):326-334.
    The 2016 CIOMS International ethical guidelines for health‐related research involving humans states that ‘health‐related research should form an integral part of disaster response’ and that, ‘widespread emergency use [of unproven interventions] with inadequate data collection about patient outcomes must therefore be avoided’ (Guideline 20). This position is defended against two lines of criticism that emerged during the 2014 Ebola outbreak. One holds that desperately ill patients have a moral right to try unvalidated medical interventions (UMIs) and that it is therefore (...)
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  22. Equipoise, standard of care and consent: responding to the authorisation of new COVID-19 treatments in randomised controlled trials.Soren Holm, Jonathan Lewis & Rafael Dal-Ré - 2023 - Journal of Medical Ethics 49 (7):465-470.
    In response to the COVID-19 pandemic, large-scale research and pharmaceutical regulatory processes have proceeded at a dramatically increased pace with new and effective, evidence-based COVID-19 interventions rapidly making their way into the clinic. However, the swift generation of high-quality evidence and the efficient processing of regulatory authorisation have given rise to more specific and complex versions of well-known research ethics issues. In this paper, we identify three such issues by focusing on the authorisation of molnupiravir, a novel antiviral medicine aimed (...)
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  23. Resituating the principle of equipoise: Justice and access to care in non-ideal conditions.Rebecca Kukla - 2007 - Kennedy Institute of Ethics Journal 17 (3):171-202.
    : The principle of equipoise traditionally is grounded in the special obligations of physician-investigators to provide research participants with optimal care. This grounding makes the principle hard to apply in contexts with limited health resources, to research that is not directed by physicians, or to non-therapeutic research. I propose a different version of the principle of equipoise that does not depend upon an appeal to the Hippocratic duties of physicians and that is designed to be applicable within a (...)
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  24.  92
    The real problem with equipoise.Winston Chiong - 2006 - American Journal of Bioethics 6 (4):37 – 47.
    The equipoise requirement in clinical research demands that, if patients are to be randomly assigned to one of two interventions in a clinical trial, there must be genuine doubt about which is better. This reflects the traditional view that physicians must never knowingly compromise the care of their patients, even for the sake of future patients. Equipoise has proven to be deeply problematic, especially in the Third World. Some recent critics have argued against equipoise on the grounds (...)
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  25. Equipoise, standard of care, and consent: Responding to the authorisation of new COVID-19 treatments in randomised controlled trials.Soren Holm, Jonathan Lewis & Rafael Dal-Ré - 2022 - Journal of Medical Ethics:1-6.
    In response to the COVID-19 pandemic, large-scale research and pharmaceutical regulatory processes have proceeded at a dramatically increased pace with new and effective, evidence-based COVID-19 interventions rapidly making their way into the clinic. However, the swift generation of high-quality evidence and the efficient processing of regulatory authorisation have given rise to more specific and complex versions of well-known research ethics issues. In this paper, we identify three such issues by focusing on the authorisation of Molnupiravir, a novel antiviral medicine aimed (...)
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  26.  18
    Clinical Equipoise and RCT Design.Charles Weijer - unknown
    This presentation addresses these questions: • “Upon what ethical grounds may the physician offer RCT enrollment to a patient?” • Which is the preferred moral basis of the RCT?
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  27.  39
    Overinterpreting Equipoise.Jerry Menikoff - 2011 - American Journal of Bioethics 11 (2):13 - 14.
    The factual premise: A clinical trial takes place, with results suggesting that a new treatment is better than standard care for a particular medical problem. One large group of physicians—call the...
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  28.  17
    Clinical equipoise and the therapeutic misconception.J. D. Moreno - 2003 - Hastings Center Report 33 (5):6-7.
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  29.  19
    Equipoise and Randomization.Steven Joffe Robert D. Truog - 2008 - In Ezekiel J. Emanuel, The Oxford textbook of clinical research ethics. New York: Oxford University Press.
  30.  28
    Behavior Equipoise: Is It Ready for Prime Time?Katherine Wasson - 2011 - American Journal of Bioethics 11 (2):14 - 16.
  31.  76
    A Critique of Clinical Equipoise: Therapeutic Misconception in the Ethics of Clinical Trials.Franklin G. Miller & Howard Brody - 2003 - Hastings Center Report 33 (3):19-28.
    A predominant ethical view holds that physician‐investigators should conduct their research with therapeutic intent. And since a physician offering a therapy wouldn't prescribe second‐rate treatments, the experimental intervention and the best proven therapy should appear equally effective. "Clinical equipoise" is necessary. But this perspective is flawed. The ethics of research and of therapy are fundamentally different, and clinical equipoise should be abandoned.
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  32.  86
    Revisiting equipoise: A response to Gifford.Paul B. Miller & Charles Weijer - 2007 - Kennedy Institute of Ethics Journal 17 (3):227-246.
    : The authors respond to objections Fred Gifford has raised against their paper "Rehabilitating Equipoise." They situate this exchange in the wider context of recent debate over equipoise, highlighting substantial points of agreement between themselves and Gifford. The authors offer a brief restatement of "Rehabilitating Equipoise" in which they amplify some of its core arguments. They then assess Gifford's objections. Finding each to be unfounded, they argue that there is no justification for "pulling the plug" on clinical (...)
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  33.  12
    Dual Uncertainties: On Equipoise, Sex Differences and Chirality in Clinical Research.Sara Dahlen - 2021 - The New Bioethics 27 (3):219-229.
    Ethical justification for clinical research may invoke equipoise, an element of scientific uncertainty regarding the superior choice if presented with different therapeutic options. Given a relativ...
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  34.  19
    What Counts as Equipoise?Henry J. Silverman & Didier Dreyfuss - 2015 - Hastings Center Report 45 (3):3-4.
    A commentary on “SUPPORT: Risks, Harms, and Equipoise,” by Robert M. Nelson; “The Controversy over SUPPORT Continues and the Hyperbole Increases,” by Alan R. Fleischman; and “SUPPORT and the Ethics of Study Implementation,” by John D. Lantos and Chris Feudtner, all in the January‐February 2015 issue.
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  35.  3
    Equipoise and Personal Experience: Maintaining Objectivity in Psychedelic Research.Katrina DeBonis, Walter Dunn & Thomas Strouse - 2025 - American Journal of Bioethics 25 (1):74-76.
    The resurgence of psychedelic research has brought with it unique ethical considerations, including the role of personal psychedelic experience among facilitators. Some have argued that personal ps...
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  36.  28
    Uncertainty, Bias, and Equipoise: A New Approach to the Ethics of Clinical Research.Michael Goldsby & William P. Kabasenche - 2014 - Theoretical and Applied Ethics 3 (1):35-59.
    The concept of equipoise is considered by many to be part of the ethical justification for using human subjects in clinical research. In general, equipoise indicates some uncertainty about the relative merits of the experimental intervention compared to existing treatments. Relieving this uncertainty gives scientific value to an experiment, thereby making the risks to human subjects in the trial acceptable, other considerations notwithstanding. But characterizing equipoise remains controversial since Freedman’s groundbreaking publication on the subject. We offer a (...)
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  37.  62
    Freedman's 'clinical equipoise' and sliding-scale all-dimensions-considered equipoise'.Fred Gifford - 2000 - Journal of Medicine and Philosophy 25 (4):399 – 426.
    It is often claimed that a clinical investigator may ethically participate (e.g., enroll patients) in a trial only if she is in equipoise (if she has no way to ground a preference for one arm of the study). But this is a serious problem, for as data accumulate, it can be expected that there will be a discernible trend favoring one of the treatments prior to the point where we achieve the trial's objective. In this paper, I critically evaluate (...)
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  38.  67
    So-called "clinical equipoise" and the argument from design.Fred Gifford - 2007 - Journal of Medicine and Philosophy 32 (2):135 – 150.
    In this article, I review and expand upon arguments showing that Freedman's so-called "clinical equipoise" criterion cannot serve as an appropriate guide and justification for the moral legitimacy of carrying out randomized clinical trials. At the same time, I try to explain why this approach has been given so much credence despite compelling arguments against it, including the fact that Freedman's original discussion framed the issues in a misleading way, making certain things invisible: Clinical equipoise is conflated with (...)
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  39.  63
    Position statement on ethics, equipoise and research on charged particle radiation therapy.Mark Sheehan, Claire Timlin, Ken Peach, Ariella Binik & Wilson Puthenparampil - 2014 - Journal of Medical Ethics 40 (8):572-575.
    The use of charged-particle radiation therapy is an increasingly important development in the treatment of cancer. One of the most pressing controversies about the use of this technology is whether randomised controlled trials are required before this form of treatment can be considered to be the treatment of choice for a wide range of indications. Equipoise is the key ethical concept in determining which research studies are justified. However, there is a good deal of disagreement about how this concept (...)
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  40. Public Policy Experiments without Equipoise: When is Randomization Fair?Douglas MacKay & Emma Cohn - 2023 - Ethics and Human Research 45 (1):15-28.
    Government agencies and nonprofit organizations have increasingly turned to randomized controlled trials (RCTs) to evaluate public policy interventions. Random assignment is widely understood to be fair when there is equipoise; however, some scholars and practitioners argue that random assignment is also permissible when an intervention is reasonably expected to be superior to other trial arms. For example, some argue that random assignment to such an intervention is fair when the intervention is scarce, for it is sometimes fair to use (...)
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  41. The ethics of public policy RCTs: The principle of policy equipoise.Douglas MacKay - 2017 - Bioethics 32 (1):59-67.
    In this article, I ask whether a principle analogous to the principle of clinical equipoise should govern the design and conduct of RCTs evaluating the effectiveness of policy interventions. I answer this question affirmatively, and introduce and defend the principle of policy equipoise. According to this principle, all arms of a policy RCT must be, at minimum, in a state of equipoise with the best proven policy that is also morally and practically attainable and sustainable. For all (...)
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  42.  42
    On the Utility and Distinctness of the Concept of Behavioral Equipoise.J. S. Swindell Blumenthal-Barby - 2011 - American Journal of Bioethics 11 (2):9-10.
    In their paper, “Behavioral Equipoise: A Way to Resolve Ethical Stalemates in Clinical Research, “ Peter Ubel and Robert Silbergleit (2011) propose that we adopt another principle, the principle of behavioral equipoise, whereby RCTs are also morally justified in cases where they are expected to address the controversy, disagreement, or behavioral resistance surrounding a particular treatment. Adopting this ethical standard would allow for research to move forward and, as a result, for the resolution of stalemates between clinicians who (...)
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  43.  30
    HEAVEN, Equipoise, and What's Best for the Patient.Scott Gelfand - 2017 - American Journal of Bioethics Neuroscience 8 (4):219-221.
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  44. Pragmatic Clinical Research, Informed Consent, and Clinical Equipoise.Lynn A. Jansen - 2024 - Social Philosophy and Policy 41 (2):306-326.
    There is a growing movement within contemporary medical ethics to blur the boundaries between clinical medicine and clinical research. Some writers now argue that the research-practice distinction is outdated and the importance of distinguishing between research and medicine is no longer as pressing as it once was or seemed to be. Instead, we are now urged to view the health-care system as a dynamic “learning health-care system” in which research components are embedded within standard clinical care. This essay defends the (...)
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  45.  40
    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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  46.  22
    Equipoise and randomization.Steven Joffe & R. Truog - 2008 - In Ezekiel J. Emanuel, The Oxford textbook of clinical research ethics. New York: Oxford University Press. pp. 245--60.
  47. Extending Clinical Equipoise to Phase 1 Trials Involving Patients: Unresolved Problems.James A. Anderson & Jonathan Kimmelman - 2010 - Kennedy Institute of Ethics Journal 20 (1):75-98.
    Notwithstanding requirements for scientific/social value and risk/benefit proportionality in major research ethics policies, there are no widely accepted standards for these judgments in Phase 1 trials. This paper examines whether the principle of clinical equipoise can be used as a standard for assessing the ratio of risk to direct-benefit presented by drugs administered in one category of Phase 1 study—first-in-human trials involving patients. On the basis of the supporting evidence for, and architecture of, Phase 1 studies, the articles offers (...)
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  48. Clinical equipoise and the therapeutic misconception-Miller and Brody reply.F. G. Miller & H. Brody - 2003 - Hastings Center Report 33 (5):7-7.
     
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  49.  63
    Clinical Equipoise and Not the Uncertainty Principle Is the Moral Underpinning of the Randomised Controlled Trial.Charles Weijer, Stanley H. Shapiro & Kathleen Cranley Glass - unknown
  50.  59
    Learning health systems, clinical equipoise and the ethics of response adaptive randomisation.Alex John London - 2018 - Journal of Medical Ethics 44 (6):409-415.
    To give substance to the rhetoric of ‘learning health systems’, a variety of novel trial designs are being explored to more seamlessly integrate research with medical practice, reduce study duration and reduce the number of participants allocated to ineffective interventions. Many of these designs rely on response adaptive randomisation. However, critics charge that RAR is unethical on the grounds that it violates the principle of equipoise. In this paper, I reconstruct critiques of RAR as holding that it is inconsistent (...)
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