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Charles Weijer
University of Western Ontario
  1.  26
    Assessing Decision-Making Capacity in the Behaviorally Nonresponsive Patient With Residual Covert Awareness.Andrew Peterson, Lorina Naci, Charles Weijer, Damian Cruse, Davinia Fernández-Espejo, Mackenzie Graham & Adrian M. Owen - 2013 - American Journal of Bioethics Neuroscience 4 (4):3-14.
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  2.  27
    Informing Study Participants of Research Results: An Ethical Imperative.Conrad V. Fernandez, Eric Kodish & Charles Weijer - unknown
  3.  18
    When Are Research Risks Reasonable in Relation to Anticipated Benefits?Charles Weijer & Paul B. Miller - unknown
    The question "When are research risks reasonable in relation to anticipated benefits?" is at the heart of disputes in the ethics of clinical research. Institutional review boards are often criticized for inconsistent decision-making, a problem that is compounded by a number of contemporary controversies, including the ethics of research involving placebo controls, developing countries, incapable adults and emergency rooms. If this pressing ethical question is to be addressed in a principled way, then a systematic approach to the ethics of risk (...)
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  4.  1
    Ottawa Statement Does Not Impede Randomised Evaluation of Government Health Programmes.Charles Weijer & Monica Taljaard - 2020 - Journal of Medical Ethics 46 (1):31-33.
    In this issue of JME, Watson et al call for research evaluation of government health programmes and identify ethical guidance, including the Ottawa Statement on the ethical design and conduct of cluster randomised trials, as a hindrance. While cluster randomised trials of health programmes as a whole should be evaluated by research ethics committees, Watson et al argue that the health programme per se is not within the researcher’s control or responsibility and, thus, is out of scope for ethics review. (...)
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  5.  20
    An Ethics of Welfare for Patients Diagnosed as Vegetative With Covert Awareness.Mackenzie Graham, Charles Weijer, Damian Cruse, Davinia Fernandez-Espejo, Teneille Gofton, Laura E. Gonzalez-Lara, Andrea Lazosky, Lorina Naci, Loretta Norton, Andrew Peterson, Kathy N. Speechley, Bryan Young & Adrian M. Owen - 2015 - American Journal of Bioethics Neuroscience 6 (2):31-41.
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  6.  63
    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 a state of (...)
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  7. Does Clinical Equipoise Apply to Cluster Randomized Trials in Health Research?Ariella Binik, Charles Weijer, Andrew McRae, Jeremy Grimshaw, Monica Taljaard, Robert Boruch, Jamie Brehaut, Allan Donner, Martin Eccles, Antonio Gallo, Raphael Saginur & Merrick Zwarenstein - 2011 - Trials 12.
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  8.  27
    Protecting Communities in Biomedical Research.Charles Weijer & E. J. Emanuel - unknown
    Although for the last 50 years, ethicists dealing with human experimentation have focused primarily on the need to protect individual research subjects and vulnerable groups, biomedical research, especially in genetics, now requires the establishment of standards for the protection of communities. We have developed such a strategy, based on five steps. (i) Identification of community characteristics relevant to the biomedical research setting, (ii) delineation of a typology of different types of communities using these characteristics, (iii) determination of the range of (...)
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  9.  22
    The Ethical Analysis of Risk.Charles Weijer - 2000 - Journal of Law, Medicine and Ethics 28 (4):344-361.
  10.  37
    Fiduciary Obligation in Clinical Research.Paul B. Miller & Charles Weijer - 2006 - Journal of Law, Medicine and Ethics 34 (2):424-440.
    Heated debate surrounds the question whether the relationship between physician-researcher and patient-subject is governed by a duty of care. Miller and Weijer argue that fiduciary law provides a strong legal foundation for this duty, and for articulating the terms of the relationship between physician-researcher and patient-subject.
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  11.  8
    Fiduciary Obligation in Clinical Research.Paul B. Miller & Charles Weijer - 2006 - Journal of Law, Medicine and Ethics 34 (2):424-440.
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  12. In Loco Parentis Minimal Risk as an Ethical Threshold for Research Upon Children.Benjamin Freedman, Abraham Fuks & Charles Weijer - 1993 - Hastings Center Report 23 (2):13-19.
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  13.  7
    An Ethical Analysis of the SUPPORT Trial: Addressing Challenges Posed by a Pragmatic Comparative Effectiveness Randomized Controlled Trial.Austin R. Horn, Charles Weijer, Jeremy Grimshaw, Jamie Brehaut, Dean Fergusson, Cory E. Goldstein & Monica Taljaard - 2018 - Kennedy Institute of Ethics Journal 28 (1):85-118.
    Pragmatic comparative effectiveness randomized controlled trials evaluate the effectiveness of one interventions under real-world clinical conditions. The results of ceRCTs are often directly generalizable to everyday clinical practice, providing information critical to decision-making by patients, clinicians, and healthcare policymakers. The PRECIS-2 framework identifies nine domains that serve to score a trial on a continuum between very explanatory to very pragmatic. According to the framework, pragmatic trials may have one or more of the following features: there are fewer eligibility criteria for (...)
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  14.  4
    It Does Not Matter Whether Research Interventions Are Usual Care.Cory E. Goldstein & Charles Weijer - 2020 - American Journal of Bioethics 20 (1):47-48.
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  15.  70
    Protecting Communities in Research: Philosophical and Pragmatic Challenges.Charles Weijer - 1999 - Cambridge Quarterly of Healthcare Ethics 8 (4):501-513.
    The issue of the protection of communities in clinical research first arose 10 years ago in studies conducted in technologically developing countries by scientists from technologically developed nations. The question was, which ethical standards ought to apply, those of the Western investigators or local standards?
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  16.  8
    The Ethical Analysis of Risk.Charles Weijer - 2000 - Journal of Law, Medicine and Ethics 28 (4):344-361.
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  17.  8
    Considerations and Costs of Disclosing Study Findings to Research Participants.Conrad V. Fernandez, Chris Skedgel & Charles Weijer - unknown
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  18.  10
    Working for the Weekend Is Not Meaningful Work.Charles Weijer & Mackenzie Graham - 2019 - American Journal of Bioethics 19 (9):48-50.
    Volume 19, Issue 9, September 2019, Page 48-50.
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  19. Ethical Issues Posed by Cluster Randomized Trials in Health Research.Charles Weijer, Jeremy M. Grimshaw, Monica Taljaard, Ariella Binik, Robert Boruch, Jamie C. Brehaut, Allan Donner, Martin P. Eccles, Antonio Gallo, Andrew D. McRae & Ray Saginur - 2011 - Trials 1 (12):100.
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  20. Ethical Considerations in Functional Magnetic Resonance Imaging Research in Acutely Comatose Patients.Charles Weijer, Tommaso Bruni, Teneille Gofton, G. Bryan Young, Loretta Norton, Andrew Peterson & Adrian M. Owen - 2015 - Brain:0-0.
    After severe brain injury, one of the key challenges for medical doctors is to determine the patient’s prognosis. Who will do well? Who will not do well? Physicians need to know this, and families need to do this too, to address choices regarding the continuation of life supporting therapies. However, current prognostication methods are insufficient to provide a reliable prognosis. -/- Functional Magnetic Resonance Imaging (MRI) holds considerable promise for improving the accuracy of prognosis in acute brain injury patients. Nonetheless, (...)
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  21.  72
    The Research Subject as Wage Earner.James A. Anderson & Charles Weijer - 2002 - Theoretical Medicine and Bioethics 23 (4-5):359-376.
    The practice of paying research subjects for participating inclinical trials has yet to receive an adequate moral analysis.Dickert and Grady argue for a wage payment model in whichresearch subjects are paid an hourly wage based on that ofunskilled laborers. If we accept this approach, what follows?Norms for just working conditions emerge from workplacelegislation and political theory. All workers, includingpaid research subjects under Dickert and Grady''s analysis,have a right to at least minimum wage, a standard work week,extra pay for overtime hours, (...)
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  22.  24
    Helsinki Discords: FDA, Ethics, and International Drug Trials.Jonathan Kimmelman, Charles Weijer & Eric M. Meslin - unknown
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  23.  47
    Ethical Criteria for Human Challenge Studies in Infectious Diseases: Table 1.Ben Bambery, Michael Selgelid, Charles Weijer, Julian Savulescu & Andrew J. Pollard - 2016 - Public Health Ethics 9 (1):92-103.
    Purposeful infection of healthy volunteers with a microbial pathogen seems at odds with acceptable ethical standards, but is an important contemporary research avenue used to study infectious diseases and their treatments. Generally termed ‘controlled human infection studies’, this research is particularly useful for fast tracking the development of candidate vaccines and may provide unique insight into disease pathogenesis otherwise unavailable. However, scarce bioethical literature is currently available to assist researchers and research ethics committees in negotiating the distinct issues raised by (...)
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  24. When is Informed Consent Required in Cluster Randomized Trials in Health Research?Andrew D. McRae, Ariella Binik, Charles Weijer, Angela White, Jeremy M. Grimshaw, Robert Boruch, Jamie C. Brehaut, Allan Donner, Martin P. Eccles, Raphael Saginur, Merrick Zwarenstein & Monica Taljaard - 2011 - Trials 1 (12):202.
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  25.  19
    Placebo Orthodoxy in Clinical Research I: Empirical and Methodological Myths.Benjamin Freedman, Charles Weijer & Kathleen Cranley Glass - 1996 - Journal of Law, Medicine and Ethics 24 (3):243-251.
  26.  39
    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 it (...)
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  27.  4
    Placebo Orthodoxy in Clinical Research I: Empirical and Methodological Myths.Benjamin Freedman, Charles Weijer & Kathleen Cranley Glass - 1996 - Journal of Law, Medicine and Ethics 24 (3):243-251.
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  28.  14
    Informed Consent for Functional MRI Research on Comatose Patients Following Severe Brain Injury: Balancing the Social Benefits of Research Against Patient Autonomy.Tommaso Bruni, Mackenzie Graham, Loretta Norton, Teneille Gofton, Adrian M. Owen & Charles Weijer - 2019 - Journal of Medical Ethics 45 (5):299-303.
    Functional MRI shows promise as a candidate prognostication method in acutely comatose patients following severe brain injury. However, further research is needed before this technique becomes appropriate for clinical practice. Drawing on a clinical case, we investigate the process of obtaining informed consent for this kind of research and identify four ethical issues. After describing each issue, we propose potential solutions which would make a patient’s participation in research compatible with her rights and interests. First, we defend the need for (...)
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  29.  42
    Assay Sensitivity and the Epistemic Contexts of Clinical Trials.Spencer Phillips Hey & Charles Weijer - 2013 - Perspectives in Biology and Medicine 56 (1):1-17.
    In February 2010, the World Medical Association hosted an international symposium on the ethics of placebo controls in clinical trials (WMA 2010). Despite years of debate, ethicists, clinical trialists, and policy makers remain divided over the ethical acceptability of using placebos in research when a proven, effective treatment is available. The protracted nature of this problem is due, at least in part, to a perceived conflict between the opposing demands placed on clinical research by science and ethics. A good, scientifically (...)
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  30.  24
    Placebo Orthodoxy in Clinical Research II: Ethical, Legal, and Regulatory Myths.Benjamin Freedman, Kathleen Cranley Glass & Charles Weijer - 1996 - Journal of Law, Medicine and Ethics 24 (3):252-259.
  31.  14
    Obligations in Offering to Disclose Genetic Research Results.Conrad V. Fernandez & Charles Weijer - 2006 - American Journal of Bioethics 6 (6):44 – 46.
  32.  9
    Placebo Orthodoxy in Clinical Research II: Ethical, Legal, and Regulatory Myths.Benjamin Freedman, Kathleen Cranley Glass & Charles Weijer - 1996 - Journal of Law, Medicine and Ethics 24 (3):252-259.
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  33.  36
    A Comparison of Journal Instructions Regarding Institutional Review Board Approval and Conflict-of-Interest Disclosure Between 1995 and 2005.Anne Rowan-Legg, Charles Weijer, J. Gao & C. Fernandez - 2009 - Journal of Medical Ethics 35 (1):74-78.
    OBJECTIVES: To compare 2005 and 1995 ethics guidelines from journal editors to authors regarding requirements for institutional review board (IRB) approval and conflict-of-interest (COI) disclosure. DESIGN: A descriptive study of the ethics guidelines published in 103 English-language biomedical journals listed in the Abridged Index Medicus in 1995 and 2005. Each journal was reviewed by the principal author and one of four independent reviewers. RESULTS: During the period, the proportion of journals requiring IRB approval increased from 42% (95% CI 32.2% to (...)
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  34.  23
    Providing Research Results to Participants: Attitudes and Needs of Adolescents and Parents of Children with Cancer.Conrad Vincent Fernandez, Jun Gao, Caron Strahlendorf, Albert Moghrabi, Rebecca Davis Pentz, Raymond Carlton Barfield, Justin Nathaniel Baker, Darcy Santor, Charles Weijer & Eric Kodish - unknown
    PURPOSE: There is an increasing demand for researchers to provide research results to participants. Our aim was to define an appropriate process for this, based on needs and attitudes of participants. METHODS: A multicenter survey in five sites in the United States and Canada was offered to parents of children with cancer and adolescents with cancer. Respondents indicated their preferred mode of communication of research results with respect to implications; timing, provider, and content of the results; reasons for and against (...)
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  35.  27
    Acknowledging Awareness: Informing Families of Individual Research Results for Patients in the Vegetative State.Mackenzie Graham, Charles Weijer, Andrew Peterson, Lorina Naci, Damian Cruse, Davinia Fernández-Espejo, Laura Gonzalez-Lara & Adrian M. Owen - 2015 - Journal of Medical Ethics 41 (7):534-538.
  36.  79
    Why the Debate Over Minimal Risk Needs to Be Reconsidered.Ariella Binik & Charles Weijer - 2014 - Journal of Medicine and Philosophy 39 (4):387-405.
    Minimal risk is a central concept in the ethical analysis of research with children. It is defined as the risks “. . . ordinarily encountered in daily life . . . .” But the question arises: who is the referent for minimal risk? Commentators in the research ethics literature often answer this question by endorsing one of two possible interpretations: the uniform interpretation or the relative interpretation of minimal risk. We argue that describing the debate over minimal risk as a (...)
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  37.  37
    The Return of Research Results to Participants: Pilot Questionnaire of Adolescents and Parents of Children with Cancer.Conrad V. Fernandez, Darcy Santor, Charles Weijer, Caron Strahlendorf, Albert Moghrabi, Rebecca Pentz, Jun Gao & Eric Kodish - unknown
    PURPOSE: The offer to return research results to participants is increasingly recognized as an ethical obligation, although few researchers routinely return results. We examined the needs and attitudes of parents of children with cancer and of adolescents with cancer to the return of research results. METHODS: Seven experts in research ethics scored content validity on parent and adolescent questionnaires previously developed through focus group and phone interviews. The questionnaires were revised and provided to 30 parents and 10 adolescents in a (...)
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  38.  11
    Moral Solutions in Assessing Research Risk.Paul B. Miller & Charles Weijer - forthcoming - IRB: Ethics & Human Research.
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  39.  9
    A Principled Argument, But Not a Practical One.Andrew Peterson, Lorina Naci, Charles Weijer & Adrian M. Owen - 2013 - American Journal of Bioethics Neuroscience 4 (1):52-53.
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  40.  37
    Trust Based Obligations of the State and Physician-Researchers to Patient-Subjects.Paul B. Miller & Charles Weijer - 2006 - Journal of Medical Ethics 32 (9):542-547.
    When may a physician enroll a patient in clinical research? An adequate answer to this question requires clarification of trust-based obligations of the state and the physician-researcher respectively to the patient-subject. The state relies on the voluntarism of patient-subjects to advance the public interest in science. Accordingly, it is obligated to protect the agent-neutral interests of patient-subjects through promulgating standards that secure these interests. Component analysis is the only comprehensive and systematic specification of regulatory standards for benefit-harm evaluation by research (...)
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  41.  30
    Protecting Communities in Research: Current Guidelines and Limits of Extrapolation.Charles Weijer, Gary Goldsand & Ezekiel J. Emanuel - unknown
    As genetic research increasingly focuses on communities, there have been calls for extending research protections to them. We critically examine guidelines developed to protect aboriginal communities and consider their applicability to other communities. These guidelines are based on a model of researcher-community partnership and span the phases of a research project, from protocol development to publication. The complete list of 23 protections may apply to those few non-aboriginal communities, such as the Amish, that are highly cohesive. Although some protections may (...)
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  42.  32
    Toward a Science of Brain Death.Andrew Peterson, Loretta Norton, Lorina Naci, Adrian M. Owen & Charles Weijer - 2014 - American Journal of Bioethics 14 (8):29-31.
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  43.  20
    Ethical issues in pragmatic randomized controlled trials: a review of the recent literature identifies gaps in ethical argumentation. [REVIEW]Cory E. Goldstein, Charles Weijer, Jamie C. Brehaut, Dean A. Fergusson, Jeremy M. Grimshaw, Austin R. Horn & Monica Taljaard - 2018 - BMC Medical Ethics 19 (1):14.
    Pragmatic randomized controlled trials are designed to evaluate the effectiveness of interventions in real-world clinical conditions. However, these studies raise ethical issues for researchers and regulators. Our objective is to identify a list of key ethical issues in pragmatic RCTs and highlight gaps in the ethics literature. We conducted a scoping review of articles addressing ethical aspects of pragmatic RCTs. After applying the search strategy and eligibility criteria, 36 articles were included and reviewed using content analysis. Our review identified four (...)
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  44.  19
    Ethical Issues in Pragmatic Randomized Controlled Trials: A Review of the Recent Literature Identifies Gaps in Ethical Argumentation. [REVIEW]Cory E. Goldstein, Charles Weijer, Jamie C. Brehaut, Dean A. Fergusson, Jeremy M. Grimshaw, Austin R. Horn & Monica Taljaard - 2018 - BMC Medical Ethics 19 (1):1-10.
    Background Pragmatic randomized controlled trials are designed to evaluate the effectiveness of interventions in real-world clinical conditions. However, these studies raise ethical issues for researchers and regulators. Our objective is to identify a list of key ethical issues in pragmatic RCTs and highlight gaps in the ethics literature. Methods We conducted a scoping review of articles addressing ethical aspects of pragmatic RCTs. After applying the search strategy and eligibility criteria, 36 articles were included and reviewed using content analysis. Results Our (...)
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  45.  11
    Assessing Decision-Making Capacity in Patients with Communication Impairments.Molly Cairncross, Andrew Peterson, Andrea Lazosky, Teneille Gofton & Charles Weijer - 2016 - Cambridge Quarterly of Healthcare Ethics 25 (4):691-699.
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  46.  10
    Protecting Communities in Pharmacogenetic and Pharmacogenomic Research.Charles Weijer & P. B. Miller - unknown
    The existing EELS literature has usefully identified the scope of ethical issues posed by pharmacogenetic and pharmacogenomic research. The time has come for in-depth examination of particular ethical issues. The involvement of racial and ethnic communities in pharmacogenetic and pharmacogenomic research is contentious precisely because it touches upon the science and politics of studying racial and ethnic difference. To date, the ethics literature has not seriously taken account of the fact that such research impinges upon the interests of communities, and (...)
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  47.  19
    Therapeutic Obligation in Clinical Research.Charles Weijer & Paul B. Miller - unknown
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  48.  46
    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
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  49. Structuring the Review of Human Genetics Protocols.Kathleen Cranley Glass, Charles Weijer, Denis Cournoyer, Trudo Lemmens, Roberta M. Palmour, Stanley H. Shapiro & Benjamin Freedman - 1999 - IRB: Ethics & Human Research 21.
     
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  50.  21
    A Misunderstanding Concerning Futility.Tommaso Bruni & Charles Weijer - 2015 - American Journal of Bioethics 15 (7):59-60.
    It is a comment on Geppert about the concept of futility in cases of treatment-resistant anorexia nervosa.
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