200 found
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  1.  18
    Charles Weijer, Tommaso Bruni, Teneille Gofton, G. Bryan Young, Loretta Norton, Andrew Peterson & Adrian M. Owen (2015). Ethical Considerations in Functional Magnetic Resonance Imaging Research in Acutely Comatose Patients. 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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  2.  64
    Ariella Binik & Charles Weijer (2014). Why the Debate Over Minimal Risk Needs to Be Reconsidered. 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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  3.  24
    Paul B. Miller & Charles Weijer (2003). Rehabilitating Equipoise. 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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  4.  10
    Charles Weijer & E. J. Emanuel, Protecting Communities in Biomedical Research.
    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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  5.  2
    Tommaso Bruni & Charles Weijer (2015). A Misunderstanding Concerning Futility. 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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  6.  11
    Charles Weijer (1999). Protecting Communities in Research: Philosophical and Pragmatic Challenges. 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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  7.  5
    Charles Weijer & Paul B. Miller, When Are Research Risks Reasonable in Relation to Anticipated Benefits?
    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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  8.  11
    Paul B. Miller & Charles Weijer (2006). Fiduciary Obligation in Clinical Research. Journal of Law, Medicine & 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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  9.  20
    Benjamin Freedman, Abraham Fuks & Charles Weijer (1993). In Loco Parentis: Minimal Risk as an Ethical Threshold for Research Upon Children. Hastings Center Report 23 (2):13-19.
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  10. Conrad V. Fernandez & Charles Weijer (2006). Obligations in Offering to Disclose Genetic Research Results. American Journal of Bioethics 6 (6):44 – 46.
  11.  8
    Charles Weijer (2000). The Ethical Analysis of Risk. Journal of Law, Medicine & Ethics 28 (4):344-361.
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  12.  2
    Conrad V. Fernandez, Eric Kodish & Charles Weijer, Informing Study Participants of Research Results: An Ethical Imperative.
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  13.  11
    Anne Rowan-Legg, Charles Weijer, J. Gao & C. Fernandez (2009). A Comparison of Journal Instructions Regarding Institutional Review Board Approval and Conflict-of-Interest Disclosure Between 1995 and 2005. 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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  14.  4
    Andrew Peterson, Loretta Norton, Lorina Naci, Adrian M. Owen & Charles Weijer (2014). Toward a Science of Brain Death. American Journal of Bioethics 14 (8):29-31.
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  15.  11
    Jonathan Kimmelman, Charles Weijer & Eric M. Meslin, Helsinki Discords: FDA, Ethics, and International Drug Trials.
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  16.  10
    Benjamin Freedman, Kathleen Cranley Glass & Charles Weijer (1996). Placebo Orthodoxy in Clinical Research II: Ethical, Legal, and Regulatory Myths. Journal of Law, Medicine & Ethics 24 (3):252-259.
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  17.  25
    Charles Weijer, Stanley H. Shapiro & Kathleen Cranley Glass, Clinical Equipoise and Not the Uncertainty Principle Is the Moral Underpinning of the Randomised Controlled Trial.
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  18.  16
    Paul B. Miller & Charles Weijer (2003). Will the Real Charles Fried Please Stand Up? Kennedy Institute of Ethics Journal 13 (4):353-357.
    : In response to the preceding commentary by Jerry Menikoff in this issue of the Journal , the authors argue that Fried's central concern is not that randomized clinical trials (RCTs) are conducted without consent, but rather that various aspects of the design and conduct of RCTs are in tension with physicians' duties of personal care to their patients. Although Fried does argue that the existence of equipoise cannot justify failure to obtain consent from research subjects, informed consent by itself (...)
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  19.  3
    Conrad V. Fernandez, Darcy Santor, Charles Weijer, Caron Strahlendorf, Albert Moghrabi, Rebecca Pentz, Jun Gao & Eric Kodish, The Return of Research Results to Participants: Pilot Questionnaire of Adolescents and Parents of Children with Cancer.
    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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  20.  9
    Paul B. Miller & Charles Weijer (2006). Trust Based Obligations of the State and Physician-Researchers to Patient-Subjects. 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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  21.  12
    Charles Weijer (2009). Evolving Ethical Issues in Selection of Subjects for Clinical Research. Cambridge Quarterly of Healthcare Ethics 5 (3):334.
    Wittgenstein, in his famous critique of philosophy, noted that the influence of an idea can be such that it alters the way that we see the world. “It is like a pair of glasses on our nose through which we see whatever we look at,” he said. “It never occurs to us to take them off.” This view of the power of an idea suggests that the interpretation of an event, and what response this event calls for, can depend upon (...)
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  22.  7
    Benjamin Freedman, Charles Weijer & Kathleen Cranley Glass (1996). Placebo Orthodoxy in Clinical Research I: Empirical and Methodological Myths. Journal of Law, Medicine & Ethics 24 (3):243-251.
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  23.  7
    James A. Anderson & Charles Weijer (2002). The Research Subject as Wage Earner. 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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  24.  4
    Charles Weijer (2002). When Argument Fails. American Journal of Bioethics 2 (2):10 – 11.
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  25.  8
    Charles Weijer & R. A. Crouch (1999). Why Should We Include Women and Minorities in Randomized Controlled Trials? Journal of Clinical Ethics 10 (2):100.
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  26.  12
    Charles Weijer & Paul B. Miller (2007). Refuting the Net Risks Test: A Response to Wendler and Miller's "Assessing Research Risks Systematically". Journal of Medical Ethics 33 (8):487-490.
    Earlier in the pages of this journal (p 481), Wendler and Miller offered the "net risks test" as an alternative approach to the ethical analysis of benefits and harms in research. They have been vocal critics of the dominant view of benefit-harm analysis in research ethics, which encompasses core concepts of duty of care, clinical equipoise and component analysis. They had been challenged to come up with a viable alternative to component analysis which meets five criteria. The alternative must (1) (...)
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  27.  7
    Charles Weijer, Gary Goldsand & Ezekiel J. Emanuel, Protecting Communities in Research: Current Guidelines and Limits of Extrapolation.
    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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  28.  5
    Charles Weijer & Paul B. Miller, Therapeutic Obligation in Clinical Research.
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  29.  7
    Charles Weijer & Guy J. Leblanc (2006). The Balm of Gilead: Is the Provision of Treatment to Those Who Seroconvert in HIV Prevention Trials a Matter of Moral Obligation or Moral Negotiation? Journal of Law, Medicine & Ethics 34 (4):793-808.
    Must treatment be provided to subjects who acquire HIV during the course of a prevention study? An analysis of ethical foundation, regulation, and recent argumentation provides no basis for the obligation. We outline an alternative approach to the problem based on moral negotiation.
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  30.  14
    Charles Weijer, Research Involving the Vulnerable Sick.
    Research involving the vulnerable sick raises difficult challenges for investigators and Institutional Review Boards. Exactly who among the ill counts as vulnerable is a matter of judgement, and involves consideration of susceptibility to harm and capacity to provide free and informed consent. A balanced approach is required when protections are considered, and the benefits as well as the risks of research participation must be carefully weighed. A variety of protections for the vulnerable sick in research are available, including enrolling subjects (...)
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  31.  7
    Charles Weijer & James A. Anderson (2001). The Ethics Wars: Disputes Over International Research. Hastings Center Report 31 (3):18-20.
    The effort to revise the Declaration of Helsinki and the CIOMS Guidelines has sparked a sometimes vitriolic debate centering on the use of placebo controls.
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  32.  2
    Kathleen Cranley Glass, Charles Weijer, Trudo Lemmens, Roberta M. Palmour & Stanley H. Shapiro (forthcoming). Structuring the Review of Human Genetics Protocols Part II: Diagnostic and Screening Studies. IRB: Ethics & Human Research.
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  33.  10
    Benjamin Freedman, Charles Weijer & Eugene Bereza (1993). Case Notes and Charting of Bioethical Case Consultations. HEC Forum 5 (3):176-195.
    In summary, the usual elements of a typical health care ethics consultation note might reasonably accommodate the needs and expectations of relevant parties, and would therefore include: 1. identification of the relevant ethical issues, questions, or dilemmas; 2. reference to any relevant facts--medical, nursing, social, psychological, spiritual, legal, political, etc.; 3. a prioritized list of recommendations to improve coordinated care; 4. a clear and concise articulation of relevant arguments, wtih specific reference to the list of recommendations as well as to (...)
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  34. Conrad V. Fernandez, Chris Skedgel & Charles Weijer, Considerations and Costs of Disclosing Study Findings to Research Participants.
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  35.  4
    Charles Weijer, Stanley Shapiro, Abraham Fuks, Kathleen Cranley Glass & Myriam Skrutkowska, Monitoring Clinical Research: An Obligation Unfulfilled.
    The revelation that data obtained for the US-based National Surgical Adjuvant Breast and Bowel Project (NSABP) from subjects enrolled at Hôpital Saint-Luc in Montreal was falsified has eroded public trust in research. Institutions can educate researchers and help prevent unethical research practices by establishing procedures to monitor research involving human subjects. Research monitoring encompasses four categories of activity: annual reviews of continuing research, monitoring of informed consent, monitoring of adherence to approved protocols and monitoring of the integrity of data. The (...)
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  36.  25
    Benjamin Freedman, Abraham Fuks & Charles Weijer, Demarcating Research and Treatment: A Systematic Approach for the Analysis of the Ethics of Clinical Research.
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  37.  20
    Paul B. Miller & Charles Weijer (2007). Equipoise and the Duty of Care in Clinical Research: A Philosophical Response to Our Critics. 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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  38.  1
    Charles Weijer, The Ethics of Placebo-Controlled Trials.
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  39.  9
    Charles Weijer, Placebo-Controlled Trials in Schizophrenia: Are They Ethical? Are They Necessary?
    The current controversy as to the proper role of the placebo control in the evaluation of new treatments for schizophrenia requires an analysis that is sensitive to both ethical and scientific issues. Clinical equipoise, widely regarded as the moral foundation of the randomized controlled trial (RCT), requires the use of best available treatment as the control in RCT. Scientific criticisms of the use of an active control are examined and none present an insuperable barrier to the use of an active (...)
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  40.  4
    Kevin M. Ramsey & Charles Weijer, Ethics of Surgical Training in Developing Countries.
    The practice of surgical trainees operating in developing countries is gaining interest in the medical community. Although there has been little analysis about the ethical impact of these electives, there has been some concerns raised over the possible exploitation of trainees and their patients. An ethical review of this practice shows that care needs to be taken to prevent harm. Inexperienced surgeons learning surgical skills in developing countries engender greater risk of violating basic ethical principles. Advanced surgical trainees who have (...)
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  41.  7
    Charles Weijer & Carl Elliott, Pulling the Plug on Futility.
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  42.  16
    Spencer Phillips Hey & Charles Weijer (2013). Assay Sensitivity and the Epistemic Contexts of Clinical Trials. 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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  43. Paul B. Miller & Charles Weijer (2006). Fiduciary Obligation in Clinical Research. Journal of Law, Medicine and Ethics 34 (2):424-440.
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  44.  5
    Anonymous M. D./PhD Student, Charles Weijer & Akira Akabayashi (2003). Unethical Author Attribution. Cambridge Quarterly of Healthcare Ethics 12 (1):124-130.
    I am an M.D/Ph.D. student and work as a research assistant for the director of a division of the school of medicine who is an M.D. He assigned me to research a certain topic and gave me no guidelines or guidance as to how to do it. Nevertheless, I did the research and wrote it up. My supervisor liked the report and said that he thought it was so good that “I would like to offer you the opportunity to publish (...)
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  45.  3
    Charles Weijer & Akira Akabayashi (2003). Unethical Author Attribution. Cambridge Quarterly of Healthcare Ethics 12 (1):124-130.
    I am an M.D/Ph.D. student and work as a research assistant for the director of a division of the school of medicine who is an M.D. He assigned me to research a certain topic and gave me no guidelines or guidance as to how to do it. Nevertheless, I did the research and wrote it up. My supervisor liked the report and said that he thought it was so good that “I would like to offer you the opportunity to publish (...)
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  46.  26
    Carl Elliott & Charles Weijer, Cruel and Unusual Treatment.
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  47.  3
    Kathleen Cranley Glass, Charles Weijer, Denis Cournoyer, Trudo Lemmens, Roberta M. Palmour, Stanley H. Shapiro & Benjamin Freedman (1999). Structuring the Review of Human Genetics Protocols. IRB: Ethics & Human Research 21.
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  48.  1
    Charles Weijer (2002). I Need a Placebo Like I Need a Hole in the Head. Journal of Law, Medicine & Ethics 30 (1):69-72.
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  49.  1
    Charles Weijer, Should Physicians Accept Gifts From Their Patients? No: Gifts Debase the True Value of Care.
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  50.  23
    Charles Weijer, Queer Science: The Use and Abuse of Research Into Homosexuality.
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