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  1. Voluntariness of Consent to Research: A Conceptual Model.Paul S. Appelbaum, Charles W. Lidz & Robert Klitzman - 2009 - Hastings Center Report 39 (1):30-39.
    Voluntariness of consent to research has not been sufficiently explored through empirical research. The aims of this study were to develop a more comprehensive approach to assessing voluntariness and to generate preliminary data on the extent and correlates of limitations on voluntariness. We developed a questionnaire to evaluate subjects’ reported motivations and constraints on voluntariness. 88 subjects in five different areas of clinical research—substance abuse, cancer, HIV, interventional cardiology, and depression—were assessed. Subjects reported a variety of motivations for participation. Offers (...)
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  • Reflective Equilibrium and Empirical Data: Third Person Moral Experiences in Empirical Medical Ethics.Martine de Vries & Evert van Leeuwen - 2009 - Bioethics 24 (9):490-498.
    ABSTRACT In ethics, the use of empirical data has become more and more popular, leading to a distinct form of applied ethics, namely empirical ethics. This ‘empirical turn’ is especially visible in bioethics. There are various ways of combining empirical research and ethical reflection. In this paper we discuss the use of empirical data in a special form of Reflective Equilibrium (RE), namely the Network Model with Third Person Moral Experiences. In this model, the empirical data consist of the moral (...)
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  • (1 other version)Convention for protection of human rights and dignity of the human being with regard to the application of biology and biomedicine: Convention on human rights and biomedicine.Council of Europe - 1997 - Kennedy Institute of Ethics Journal 7 (3):277-290.
    In lieu of an abstract, here is a brief excerpt of the content:Convention for Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Biomedicine: Convention on Human Rights and BiomedicineCouncil of EuropePreambleThe Member States of the Council of Europe, the other States and the European Community signatories hereto,Bearing in mind the Universal Declaration of Human Rights proclaimed by the General Assembly of the United Nations on 10 December 1948;Bearing in mind the (...)
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  • The birth of the empirical turn in bioethics.Pascal Borry, Paul Schotsmans & Kris Dierickx - 2005 - Bioethics 19 (1):49–71.
    Since its origin, bioethics has attracted the collaboration of few social scientists, and social scientific methods of gathering empirical data have remained unfamiliar to ethicists. Recently, however, the clouded relations between the empirical and normative perspectives on bioethics appear to be changing. Three reasons explain why there was no easy and consistent input of empirical evidence into bioethics. Firstly, interdisciplinary dialogue runs the risk of communication problems and divergent objectives. Secondly, the social sciences were absent partners since the beginning of (...)
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  • Clarifying the ethics of clinical research: A path toward avoiding the therapeutic misconception.Paul S. Appelbaum - 2002 - American Journal of Bioethics 2 (2):22 – 23.
    (2002). Clarifying the Ethics of Clinical Research: A Path toward Avoiding the Therapeutic Misconception. The American Journal of Bioethics: Vol. 2, No. 2, pp. 22-23.
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  • Clinical Equipoise: Foundational Requirement or Fundamental Error.Alex John London - 2007 - In Bonnie Steinbock (ed.), 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 success of (...)
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  • Including qualitative research in systematic reviews: opportunities and problems.Mary Dixon-Woods, Ray Fitzpatrick & Karen Roberts - 2001 - Journal of Evaluation in Clinical Practice 7 (2):125-133.
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  • Indifference of subjects: An alternative to equipoise in randomized clinical trials.Robert M. Veatch - 2002 - Social Philosophy and Policy 19 (2):295-323.
    The physician who upholds the Hippocratic oath is supposed to be loyal to his or her patients. This requires choosing only the therapy that the physician believes is best for the patient. However, knowing what is best requires randomized clinical trials. Thus, clinicians must be willing to recruit their patients to be assigned at random to one of two therapies in order to determine which is best based on the highest standards of pharmacological science.
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  • Indifference Of Subjects: An Alternative To Equipoise In Randomized Clinical Trials.Robert Veatch - 2002 - Social Philosophy and Policy 19 (2):295-323.
    The physician who upholds the Hippocratic oath is supposed to be loyal to his or her patients. This requires choosing only the therapy that the physician believes is best for the patient. However, knowing what is best requires randomized clinical trials. Thus, clinicians must be willing to recruit their patients to be assigned at random to one of two therapies in order to determine which is best based on the highest standards of pharmacological science.
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  • How do parents experience being asked to enter a child in a randomised controlled trial?Valerie Shilling & Bridget Young - 2009 - BMC Medical Ethics 10 (1):1-.
    BackgroundAs the number of randomised controlled trials of medicines for children increases, it becomes progressively more important to understand the experiences of parents who are asked to enrol their child in a trial. This paper presents a narrative review of research evidence on parents' experiences of trial recruitment focussing on qualitative research, which allows them to articulate their views in their own words.DiscussionParents want to do their best for their children, and socially and legally their role is to care for (...)
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  • What is the role of empirical research in bioethical reflection and decision-making? An ethical analysis.Pascal Borry, Paul Schotsmans & Kris Dierickx - 2004 - Medicine, Health Care and Philosophy 7 (1):41-53.
    The field of bioethics is increasingly coming into contact with empirical research findings. In this article, we ask what role empirical research can play in the process of ethical clarification and decision-making. Ethical reflection almost always proceeds in three steps: the description of the moral question,the assessment of the moral question and the evaluation of the decision-making. Empirical research can contribute to each step of this process. In the description of the moral object, first of all, empirical research has a (...)
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  • 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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  • What is the role of empirical research in bioethical reflection and decision-making? An ethical analysis.Pascal Borry, Paul Schotsmans & Kris Dierickx - 2004 - Medicine, Health Care and Philosophy 7 (1):41-53.
    The field of bioethics is increasingly coming into contact with empirical research findings. In this article, we ask what role empirical research can play in the process of ethical clarification and decision-making. Ethical reflection almost always proceeds in three steps: the description of the moral question,the assessment of the moral question and the evaluation of the decision-making. Empirical research can contribute to each step of this process. In the description of the moral object, first of all, empirical research has a (...)
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  • Bench to bedside: Mapping the moral terrain of clinical research.Steven Joffe & Franklin G. Miller - 2008 - Hastings Center Report 38 (2):30-42.
    : Medical research is widely thought to have a fundamentally therapeutic orientation, in spite of the fact that clinical research is thought to be ethically distinct from medical care. We need an entirely new conception of clinical research ethics—one that looks to science instead of the doctor-patient relationship.
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  • Reflective Equilibrium and Empirical Data: Third Person Moral Experiences in Empirical Medical Ethics.Evert Van Leeuwen Martine De Vries - 2010 - Bioethics 24 (9):490-498.
    In ethics, the use of empirical data has become more and more popular, leading to a distinct form of applied ethics, namely empirical ethics. This ‘empirical turn’ is especially visible in bioethics. There are various ways of combining empirical research and ethical reflection. In this paper we discuss the use of empirical data in a special form of Reflective Equilibrium (RE), namely the Network Model with Third Person Moral Experiences. In this model, the empirical data consist of the moral experiences (...)
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  • Mapping the Moral Terrain of Clinical Research.Steven Joffe & Franklin G. Miller - 2012 - Hastings Center Report 38 (2):30-42.
    Medical research is widely thought to have a fundamentally therapeutic orientation, in spite of the fact that clinical research is thought to be ethically distinct from medical care. We need an entirely new conception of clinical research ethics—one that looks to science instead of the doctor‐patient relationship.
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  • Therapeutic Discourse Among Nurses and Physicians in Controlled Clinical Trials.Susan L. Instone, Mary-Rose Mueller & Tari L. Gilbert - 2008 - Nursing Ethics 15 (6):803-812.
    An ethnographic field study about the informed consent process in investigational drug trials for seriously ill persons with hepatitis C suggests that nurses and physicians referred to these trials as giving treatment, even though they involved placebos. Interview data and informed consent documents contained frequent references to the term `treatment trial' or `treatment'. Although these findings were unexpected and not the original focus of our study, we consider them in the light of an extensive literature on the `therapeutic misconception' that (...)
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  • Therapeutic Misconception in Clinical Research: Frequency and Risk Factors.Paul S. Appelbaum, Charles W. Lidz & Thomas Grisso - 2004 - IRB: Ethics & Human Research 26 (2):1.
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  • False Hopes and Best Data: Consent to Research and the Therapeutic Misconception.Paul S. Appelbaum, Loren H. Roth, Charles W. Lidz, Paul Benson & William Winslade - 1987 - Hastings Center Report 17 (2):20-24.
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