Results for 'standard of care'

978 found
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  1.  87
    The 'Standard of Care' Debate and Global Justice in Research.Sapfo Lignou - 2011 - Research Ethics 7 (1):5-12.
    In this essay the ethical issues related to the ‘standard of care’ are discussed together with the implications for the treatment of the control group in transnational clinical trials. It is argued that the human right to health and the duty of justice formulate the moral basis on which this case should be debated.
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  2.  20
    (1 other version)Standard of Care, Institutional Obligations, and Distributive Justice.Douglas MacKay - 2013 - Bioethics 29 (4):262-273.
    The problem of standard of care in clinical research concerns the level of treatment that investigators must provide to subjects in clinical trials. Commentators often formulate answers to this problem by appealing to two distinct types of obligations: professional obligations and natural duties. In this article, I investigate whether investigators also possess institutional obligations that are directly relevant to the problem of standard of care, that is, those obligations a person has because she occupies a particular (...)
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  3.  50
    The standard of care debate: against the myth of an "international consensus opinion".U. Schuklenk - 2004 - Journal of Medical Ethics 30 (2):194-197.
    It is argued by Lie et al in the current issue of the Journal of Medical Ethics that an international consensus opinion has formed on the issue of standards of care in clinical trials undertaken in developing countries. This opinion, so they argue, rejects the Declaration of Helsinki’s traditional view on this matter. They propose furthermore that the Declaration of Helsinki has lost its moral authority in the controversy in research ethics. Although the latter conclusion is supported by this (...)
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  4.  59
    The standard of care debate: the Declaration of Helsinki versus the international consensus opinion.R. K. Lie - 2004 - Journal of Medical Ethics 30 (2):190-193.
    The World Medical Association’s revised Declaration of Helsinki endorses the view that all trial participants in every country are entitled to the worldwide best standard of care. In this paper the authors show that this requirement has been rejected by every national and international committee that has examined this issue. They argue that the consensus view now holds that it is ethically permissible, in some circumstances, to provide research participants less than the worldwide best care. Finally, the (...)
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  5.  9
    Standard of Care: The Law of American Bioethics.George J. Annas - 1993 - Oxford University Press USA.
    The law has therefore had two conflicting impacts on medical ethics: the positive effect of eroding paternalism and replacing it with a patient-centered ethic; and the negative effect of encouraging physicians to be more concerned with avoiding litigation than doing the "right" thing.
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  6. The Standard of Care in Medical Negligence—Moving on from Bolam?Harvey Teff - 1998 - Oxford Journal of Legal Studies 18 (3):473-484.
    Historically, the standard of care in medical negligence provided considerable scope for external evaluation of clinical judgment. Under the Bolam test, however, determining the standard was seen by the courts as essentially a matter for the medical profession, to be resolved by expert testimony with minimal court scrutiny. In recent years, courts have become more willing to probe such testimony and challenge the credibility of medical experts, although they would very rarely override clinical judgment. The House of (...)
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  7.  81
    Defining standard of care in the developing world: The intersection of international research ethics and health systems analysis.Adnan A. Hyder & Liza Dawson - 2005 - Developing World Bioethics 5 (2):142–152.
    ABSTRACT In recent years there has been intense debate regarding the level of medical care provided to ‘standard care’ control groups in clinical trials in developing countries, particularly when the research sponsors come from wealthier countries. The debate revolves around the issue of how to define a standard of medical care in a country in which many people are not receiving the best methods of medical care available in other settings. In this paper, we (...)
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  8.  29
    Introducing Standards of Care in the Commercialization of Nanotechnology.Vivian Weil - 2006 - International Journal of Applied Philosophy 20 (2):205-213.
    While the entire “wish-list” of expected benefits from nanotechnology has received little scrutiny in the U.S. with regard to issues of social justice, ethics specialists and social scientists are beginning to focus on the responsible conduct of actual nano research and development (R&D) in government, commercial, and academic institutions. In view of the current rush to commercialization, the rush by universities to “get aboard,” and the importance of public trust, it is essential to investigate strategies to promote responsible conduct in (...)
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  9.  27
    Standards of Care in Global Health: Identifying the Right Question.Paul Ndebele - 2017 - Hastings Center Report 47 (5):28-29.
    Govind Persad and Ezekiel Emanuel's article “The Case for Resource Sensitivity: Why It Is Ethical to Provide Cheaper, Less Effective Treatments in Global Health,” in this issue of the Hastings Center Report, is a reminder of the debates around resources for health care that raged during the years immediately preceding and following the fifth revision of the Declaration of Helsinki, in 2000. In global health, it is a common expectation for rich countries to assist poor countries in resolving health (...)
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  10.  11
    Standards of Care.Alvin Novik - 1989 - Hastings Center Report 19 (4):40-41.
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  11. Standards of care-reply.G. Annas - 1989 - Hastings Center Report 19 (4):41-41.
     
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  12. Standard of Care.George J. Annas & Peter J. M. MacFarlane - 1995 - Bioethics 9 (1):80-82.
     
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  13.  28
    Stemming the Standard‐of‐Care Sprawl.Kayte Spector-Bagdady, Raymond De Vries, Lisa Hope Harris & Lisa Kane Low - 2017 - Hastings Center Report 47 (6):16-24.
    The “best interests of the patient” standard—a complex balance between the principles of beneficence and autonomy—is the driving force of ethical clinical care. Clinicians’ fear of litigation is a challenge to that ethical paradigm. But is it ever ethically appropriate for clinicians to undertake a procedure with the primary goal of protecting themselves from potential legal action? Complicating that question is the fact that tort liability is adjudicated based on what most clinicians are doing, not the scientific basis (...)
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  14.  49
    Stemming the Standard‐of‐Care Sprawl.Kayte Spector-Bagdady, Raymond Vries, Lisa Hope Harris & Lisa Kane Low - 2017 - Hastings Center Report 47 (6):16-24.
    The “best interests of the patient” standard—a complex balance between the principles of beneficence and autonomy—is the driving force of ethical clinical care. Clinicians’ fear of litigation is a challenge to that ethical paradigm. But is it ever ethically appropriate for clinicians to undertake a procedure with the primary goal of protecting themselves from potential legal action? Complicating that question is the fact that tort liability is adjudicated based on what most clinicians are doing, not the scientific basis (...)
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  15.  27
    Standard-of-care propositions should permit informative comparisons.Howard Mann - 2009 - American Journal of Bioethics 9 (3):46 – 47.
  16.  60
    Reporting of informed consent, standard of care and post-trial obligations in global randomized intervention trials: A systematic survey of registered trials.Emma R. M. Cohen, Jennifer M. O'neill, Michel Joffres, Ross E. G. Upshur & Edward Mills - 2008 - Developing World Bioethics 9 (2):74-80.
    Objective: Ethical guidelines are designed to ensure benefits, protection and respect of participants in clinical research. Clinical trials must now be registered on open-access databases and provide details on ethical considerations. This systematic survey aimed to determine the extent to which recently registered clinical trials report the use of standard of care and post-trial obligations in trial registries, and whether trial characteristics vary according to setting. Methods: We selected global randomized trials registered on http://www.clinicaltrials.gov and http://www.controlled-trials.com. We searched (...)
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  17.  42
    Standard of care in clinical research with human tissue engineered products (hteps).Leen Trommelmans & Kris Dierickx - 2009 - American Journal of Bioethics 9 (3):44 – 45.
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  18.  23
    Standard of care for social harms in HIV prevention trials: A South African perspective.Takshita Sookan, Ganzamungu Zihindula & Douglas Wassenaar - 2020 - Developing World Bioethics 20 (4):194-199.
    BackgroundThe prevention of HIV remains an ongoing global concern. The safety and welfare of participants in these trials are imperative. Research Ethics Committees (RECs) review all reports of serious adverse events, adverse events and social harms arising in the course of such trials. There is little guidance for RECs on how to respond appropriately to social harm reports.MethodologyThis paper reviews the literature on social harms in HIV prevention trials and offers suggestions for RECs on how to respond appropriately to such (...)
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  19.  44
    Can China’s ‘standard of care’ for COVID-19 be replicated in Europe?Vera Lucia Raposo - 2020 - Journal of Medical Ethics 46 (7):451-454.
    The Director-General of the WHO has suggested that China’s approach to the COVID-19 crisis could be the standard of care for global epidemics. However, as remarkable as the Chinese strategy might be, it cannot be replicated in other countries and certainly not in Europe. In Europe, there is a distribution of power between the European Union and its member states. In contrast, China’s political power is concentrated in the central government. This enables it to take immediate measures that (...)
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  20.  25
    Customary Standard of Care: A Challenge for Regulation and Practice.Sandra H. Johnson - 2013 - Hastings Center Report 43 (6):9-10.
    Law wrangles with setting and applying standards for the practice of medicine in many different arenas. One of the most prominent is medical malpractice litigation in which the trial process examines a physician's performance and measures it against the standard of care. The profession's prevailing custom, with some substantial tolerance for “respectable minority” views, has been the gold standard for scrutinizing physician practice and treatment decisions in the malpractice context. Using the profession's custom as the measure against (...)
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  21.  12
    Upholding standards of care for difficult patients.Anna Ojascastro - 1999 - Bioethics Forum 16 (3):17-21.
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  22.  78
    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. 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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  24.  34
    The Sticky Standard of Care.Michelle Oberman - 2017 - Hastings Center Report 47 (6):25-26.
    The problem at the heart of “Stemming the Standard-of-Care Sprawl: Clinician Self-Interest and the Case of Electronic Fetal Monitoring,” an article by Kayte Spector-Bagdady and colleagues in the November-December 2017 issue of the Hastings Center Report, is the persistence of a suboptimal standard of care long after evidence-driven approaches would dictate a change. That problem is not simply defensive medicine, or what the authors call “standard-of-care sprawl.” Instead, it is that, in some cases, the (...)
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  25.  22
    Defining Research Risk in Standard of Care Trials: Lessons from SUPPORT.Joel K. Press & Caryn J. Rogers - 2017 - Journal of Medicine and Philosophy 42 (2):184-198.
    Recent controversy surrounding the Surfactant Positive Airway Pressure and Pulse Oximetry Trial and the Office for Human Resource Protection’s judgment that its informed consent procedures were inadequate has unmasked considerable confusion about OHRP’s definition of research risks. The controversy concerns application of that definition to trials comparing multiple treatments within the existing standard of care. Some have argued that it is impossible for such trials to pose research risks on the grounds that all risks associated with a (...)-of-care treatment should instead be considered risks of treatment. However, analysis of OHRP’s definition demonstrates that some risks in such trials can be research risks. (shrink)
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  26.  36
    Practical, Ethical, and Legal Challenges Underlying Crisis Standards of Care.James G. Hodge, Dan Hanfling & Tia P. Powell - 2013 - Journal of Law, Medicine and Ethics 41 (s1):50-55.
    Public health emergencies invariably entail difficult decisions among medical and emergency first responders about how to allocate essential, scarce resources. To the extent that these critical choices can profoundly impact community and individual health outcomes, achieving consistency in how these decisions are executed is valuable. Since the terrorist attacks on September 11, 2001, however, public and private sector allocation plans and decisions have followed uncertain paths. Lacking empirical evidence and national input, various entities and actors have proffered multifarious approaches on (...)
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  27.  17
    Clinical standards of care and the Declaration of Helsinki: The battle is over, or is it?Udo Schuklenk - 2001 - Monash Bioethics Review 20 (1):S63-S66.
    This article briefly reviews the discussion over changes to the Declaration of Helsinki. It suggests that the final product the World Medical Association has adopted as its guiding research ethics document is superior to the version it has replaced, but falls short of what would be ethically desirable.
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  28.  74
    The Ethical Standard of Care.Rosamond Rhodes - 2006 - American Journal of Bioethics 6 (2):76-78.
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  29.  56
    What is the best standard for the standard of care in clinical research?Rieke van der Graaf & Johannes J. M. van Delden - 2009 - American Journal of Bioethics 9 (3):35 – 43.
    During the past decennium, one of the main issues discussed in research ethics has been focused on the care that should be provided to the control group in a clinical trial. This discussion is also called the standard of care debate . Current international research ethics guidelines contain a wide variety of standards for the standard of care—including the provision of the highest attainable, the best available, the best current, a proven , and an established (...)
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  30.  59
    Respecting Disability Rights — Toward Improved Crisis Standards of Care.Michelle M. Mello, Govind Persad & Douglas B. White - 2020 - New England Journal of Medicine (5):DOI: 10.1056/NEJMp2011997.
    We propose six guideposts that states and hospitals should follow to respect disability rights when designing policies for the allocation of scarce, lifesaving medical treatments. Four relate to criteria for decisions. First, do not use categorical exclusions, especially ones based on disability or diagnosis. Second, do not use perceived quality of life. Third, use hospital survival and near-term prognosis (e.g., death expected within a few years despite treatment) but not long-term life expectancy. Fourth, when patients who use ventilators in their (...)
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  31.  30
    Standard of care - the law of American bioethics.R. J. Neuberger - 1994 - Journal of Medical Ethics 20 (4):265-265.
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  32.  35
    Guide to published "standards of care".Elliot L. Sagall - 1976 - Journal of Law, Medicine and Ethics 4 (1):1-1.
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  33.  22
    Standard of Care.Sheldon F. Kurtz - 1995 - Ethics and Behavior 5 (2):185-188.
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  34.  44
    Informed Consent and Standard of Care: What Must Be Disclosed.Ruth Macklin & Lois Shepherd - 2013 - American Journal of Bioethics 13 (12):9-13.
    The Office for Human Research Protections was correct in determining that the consent forms for the National Institutes of Health -sponsored SUPPORT study were seriously flawed. Several articles defended the consent forms and criticized the OHRP's actions. Disagreement focuses on three central issues: how risks and benefits should be described in informed consent documents; the meaning and application of the concept of “standard of care” in the context of research; and the proper role of OHRP. Examination of the (...)
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  35.  32
    Maximizing Resources: Ensuring Standard of Care for a Transgender Child in a Rural Setting.Jacqueline J. Glover & Daniel H. Reirden - 2019 - American Journal of Bioethics 19 (7):66-67.
    Volume 19, Issue 7, July 2019, Page 66-67.
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  36.  21
    Psychedelics as Standard of Care? Many Questions Remain.Kurt Rasmussen & David E. Olson - 2022 - Cambridge Quarterly of Healthcare Ethics 31 (4):477-481.
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  37.  51
    Module four: Standards of care and clinical trials.Michael J. Selgelid - 2005 - Developing World Bioethics 5 (1):55–72.
    ABSTRACTThis module examines ethical debates about the level of care that should be provided to human research participants. Particular attention is placed on the question of what should be considered an ethically acceptable control arm. You will also learn what relevant international and domestic regulatory documents say about standards of care.
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  38.  8
    Conscience, Disobedience, and Standard of Care.Stephen R. Latham - 2024 - Hastings Center Report 54 (4):10-12.
    In the article “Principled Conscientious Provision: Referral Symmetry and Its Implications for Protecting Secular Conscience,” Abram L. Brummett, Tanner Hafen, and Mark C. Navin reject what they call the “referral asymmetry” in U.S. conscientious objection law in medicine, which recognizes rights of conscientiously objecting physicians to withhold referrals for medical interventions but does not (yet) recognize rights of physicians to make referrals for medical interventions to which they are morally committed but to which their health care institutions are morally (...)
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  39.  60
    Placebo orthodoxy and the double standard of care in multinational clinical research.Maya J. Goldenberg - 2015 - Theoretical Medicine and Bioethics 36 (1):7-23.
    It has been almost 20 years since the field of bioethics was galvanized by a controversial series of multinational AZT trials employing placebo controls on pregnant HIV-positive women in the developing world even though a standard of care existed in the sponsor countries. The trove of ethical investigations that followed was thoughtful and challenging, yet an important and problematic methodological assumption was left unexplored. In this article, I revisit the famous “double standard of care” case study (...)
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  40.  44
    Eliminating Categorical Exclusion Criteria in Crisis Standards of Care Frameworks.Catherine L. Auriemma, Ashli M. Molinero, Amy J. Houtrow, Govind Persad, Douglas B. White & Scott D. Halpern - 2020 - American Journal of Bioethics 20 (7):28-36.
    During public health crises including the COVID-19 pandemic, resource scarcity and contagion risks may require health systems to shift—to some degree—from a usual clinical ethic, focused on the well-being of individual patients, to a public health ethic, focused on population health. Many triage policies exist that fall under the legal protections afforded by “crisis standards of care,” but they have key differences. We critically appraise one of the most fundamental differences among policies, namely the use of criteria to categorically (...)
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  41. What is the standard of care in experimental development economics?Marcos Picchio - 2024 - Politics, Philosophy and Economics 23 (2):205-226.
    A central feature of experimental development economics is the use of randomized controlled trials (RCTs) to evaluate the effectiveness of prospective socioeconomic interventions. The use of RCTs in development economics raises a host of ethical issues which are just beginning to be explored. In this article, I address one ethical issue in particular: the routine use of the status quo as a control when designing and conducting a development RCT. Drawing on the literature on the principle of standard (...) in medical research ethics, as well as considerations of distributive justice in non-ideal circumstances, I argue that the practice of using the status quo as a control is ethically justifiable. However, I add an important qualification based on the natural duty of rescue to address the concern that my account is overly permissive. (shrink)
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  42.  37
    Stratified Scarcity: Redefining the Standard of Care.E. Haavi Morreim - 1989 - Journal of Law, Medicine and Ethics 17 (4):356-367.
    Professor Hall is to be congratulated on his thoughtful analysis of an issue that, as he rightly suggests, “is one of the most important issues that will confront health care tort law throughout the remainder of the century.”’ He argues that malpractice law currently can accommodate considerable latitude both for a conservative streamlining of medical practices in general and for a cost-sensitivity in individual treatment decisions. And he further argues that existing tort principles, such as the locality rule, can (...)
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  43.  15
    Egalitarianism as Justification: Why and How Should Egalitarian Considerations Reshape the Standard of Care in Negligence Law?Tsachi Keren-Paz - 2003 - Theoretical Inquiries in Law 4 (1).
    The two leading theoretical approaches to tort law — economic analysis and corrective justice — are blind to distributive considerations. Moreover, even the main distributive approaches to tort law — loss-spreading and fairness — fail to emphasize egalitarianism as a distributive consideration. This article argues that egalitarianism should influence the normative evaluation of one’s conduct as negligent or not. It first explains why normatively negligence law should be sensitive to the egalitarian concern, suggesting three different accounts for this claim, based (...)
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  44.  30
    Legal Briefing: Crisis Standards of Care and Legal Protections during Disasters and Emergencies.Thaddeus M. Pope & Mitchell F. Palazzo - 2010 - Journal of Clinical Ethics 21 (4):358-367.
    This article outlines current safe harbors in the law for healthcare practitioners who work in a disaster setting. It reviews available legal protection in crisis situations with respect to the Emergency Medical Treatment and Labor Act (EMTALA), criminal liability, and licensure.
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  45.  50
    In Defense of (Some) Altered Standards of Care for Ebola Infections in Developed Countries.Philip M. Rosoff - 2015 - HEC Forum 27 (1):1-9.
    The current outbreak of Ebola virus infection in West Africa continues to spread. Several patients have now been treated in the United States and preparations are being made for more. Because of the strict isolation required for their care, questions have been raised about what diagnostic and therapeutic interventions should be available. I discuss the ethical challenges associated with caring for patients in strict isolation and personnel wearing bulky protective gear with reduced dexterity and flexibility, the limitations this may (...)
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  46.  91
    The ambiguity and the exigency: Clarifying 'standard of care' arguments in international research.Alex John London - 2000 - Journal of Medicine and Philosophy 25 (4):379 – 397.
    This paper examines the concept of a 'standard of care' as it has been used in recent arguments over the ethics of international human-subjects research. It argues that this concept is ambiguous along two different axes, with the result that there are at least four possible standard of care arguments that have not always been clearly distinguished. As a result, it has been difficult to assess the implications of opposing standard of care arguments, to (...)
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  47.  31
    Rationing Crisis: Bogus Standards of Care Unmasked by Covid-19.George J. Annas - 2020 - American Journal of Bioethics 20 (7):167-169.
    Volume 20, Issue 7, July 2020, Page 167-169.
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  48.  21
    Ethically Navigating the Murky Waters of “Contingency Standards of Care”.Matthew K. Wynia & Jason Persoff - 2021 - American Journal of Bioethics 21 (8):20-21.
    Reading Alfandre and colleagues’ compelling paper in this issue of the Journal—in which the authors outline a useful process for navigating the ethics of “contingency” standards of care—brou...
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  49.  48
    Medical malpractice and the legal standard of care.Gary E. Jones - 1989 - Journal of Medical Humanities 10 (1):45-54.
    In this essay, I examine the relationship between lawsuits for medical malpractice and the legal standard of care. I suggest that there is an insidious, dynamic relationship between physicians' reactions to the recent increase in malpractice litigation and an artificial elevation of the legal standard of care. Since, that is, the legal standard for proper medical care is based upon the community standard of care rather than the reasonable person standard, to (...)
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  50. Sham Surgery and Genuine Standards of Care: Can the Two be Reconciled?Alex John London & Joseph B. Kadane - 2003 - American Journal of Bioethics 3 (4):61-64.
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