26 found
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  1.  46
    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.
    Placebo-controlled trials are held by many, including regulators at agencies like the United States Food and Drug Administration, to be the gold standard in the assessment of new medical interventions. Yet the use of placebo controls in clinical trials has been the focus of considerable controversy. In this two-part article, we challenge a number of common beliefs concerning the value of placebo controls. Part I critiques statistical and other scientific justifications for the use of placebo controls in clinical research. The (...)
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  2.  22
    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.
    The use of statistics in medical research has been compared to a religion: it has its high priests, supplicants, and orthodoxy. Although the comparison may be more unfair to religion than to research, a useful lesson can nonetheless be drawn: the practice of clinical research may benefit—as does the spirit—from critical self-examination. Arguably, no aspect of the conduct of clinical trials is currently more controversial—and thus in as dire need of critical examination—than the use of placebo controls. The ethical and (...)
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  3.  10
    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.
    The use of statistics in medical research has been compared to a religion: it has its high priests, supplicants, and orthodoxy. Although the comparison may be more unfair to religion than to research, a useful lesson can nonetheless be drawn: the practice of clinical research may benefit—as does the spirit—from critical self-examination. Arguably, no aspect of the conduct of clinical trials is currently more controversial—and thus in as dire need of critical examination—than the use of placebo controls. The ethical and (...)
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  4.  48
    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
  5.  20
    Monitoring Clinical Research: An Obligation Unfulfilled.Charles Weijer, Stanley Shapiro, Abraham Fuks, Kathleen Cranley Glass & Myriam Skrutkowska - unknown
    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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  6.  28
    Incompetent Persons as Research Subjects and the Ethics of Minimal Risk.Kathleen Cranley Glass & Marc Speyer-Ofenberg - 1996 - Cambridge Quarterly of Healthcare Ethics 5 (3):362.
    The voluntary and informed consent of subjects has been the central focus of concern in research reviews, overshadowing the importance of all other considerations. The Nuremberg Code, with its rights-based protection of the subject's autonomy above all else, made it difficult to justify research with no intended benefit when subjects are incompetent to make a valid informed choice to participate. Subsequent codes providing for research with incompetent subjects followed the lead of Nuremberg, substituting the informed authorization of a proxy for (...)
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  7.  53
    The Research Imperative Revisited: Considerations for Advancing the Debate Surrounding Medical Research as Moral Imperative.Katherine Wayne & Kathleen Cranley Glass - 2010 - Perspectives in Biology and Medicine 53 (3):373-387.
    The continuous pursuit and support of medical research on both a societal and individual level is frequently presupposed as laudable, or even obligatory. However, some critics have challenged the assumption that medical research ought to be conducted. These critics reject claims that there is a moral obligation to pursue research, and that medical research may always be justifiable given adequate safeguards and regulations. We align ourselves with critics of the research imperative to the extent that we believe that medical research (...)
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  8.  5
    The Physician/Investigator's Obligation to Patients Participating in Research: The Case of Placebo Controlled Trials.Kathleen Cranley Glass & Duff Waring - 2005 - Journal of Law, Medicine and Ethics 33 (3):575-585.
    Some authors argue that the ethics of medical care and the ethics of research differ, and that it is a mistake to conflate the two. They propose “that medical research and medical treatment are two distinct forms of activities, governed by different ethical principles.” This raises the question of whether physicians who are also clinical investigators may separate their role as physician from that of researcher when they are involved in clinical trials, thereby avoiding the obligations required in the physician-patient (...)
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  9.  12
    The Physician/Investigator's Obligation to Patients Participating in Research: The Case of Placebo Controlled Trials.Kathleen Cranley Glass & Duff Waring - 2005 - Journal of Law, Medicine and Ethics 33 (3):575-585.
    Some authors argue that the ethics of medical care and the ethics of research differ, and that it is a mistake to conflate the two. They propose “that medical research and medical treatment are two distinct forms of activities, governed by different ethical principles.” This raises the question of whether physicians who are also clinical investigators may separate their role as physician from that of researcher when they are involved in clinical trials, thereby avoiding the obligations required in the physician-patient (...)
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  10. 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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  11.  23
    Rethinking Risk in Pediatric Research.Kathleen Cranley Glass & Ariella Binik - 2008 - Journal of Law, Medicine and Ethics 36 (3):567-576.
    This article reviews four areas of pediatric research in which we have identified questionable levels of allowable risk, exceeding those foreseen by the Commission. They are the following: the categorization of increasingly risky interventions as minimal risk in a variety of protocols; the increasing number of applications for federal panel review of research not otherwise approvable because of higher projected risk levels; research on asymptomatic at risk children; and the inclusion of children and adolescents in placebo-controlled trials for participants of (...)
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  12.  32
    Stem Cell Trials: Lessons From Gene Transfer Research.Jonathan Kimmelman, Francoise Baylis & Kathleen Cranley Glass - 2006 - Hastings Center Report 36 (1):23-26.
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  13.  28
    Decisional Challenges for Children Requiring Assisted Ventilation at Home.Kathleen Cranley Glass & Franco A. Carnevale - 2006 - HEC Forum 18 (3):207-221.
  14.  21
    Toward a Duty to Report Clinical Trials Accurately: The Clinical Alert and Beyond.Kathleen Cranley Glass - 1994 - Journal of Law, Medicine and Ethics 22 (4):327-338.
    Advances in medicine depend not only on the generation of information but also on its dissemination. Clinically relevant data must be transmitted to the practitioners who will use it. Health care professionals in North America are aware of their ethical and legal obligations to inform patients adequately concerning interventions and treatments so that they may make informed choices about medical care. This obligation has been well described and defined by the courts and in the literature of medicine, ethics, and law. (...)
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  15.  16
    Structuring the Review of Human Genetics Protocols Part II: Diagnostic and Screening Studies.Kathleen Cranley Glass, Charles Weijer, Trudo Lemmens, Roberta M. Palmour & Stanley H. Shapiro - 1997 - IRB: Ethics & Human Research 19 (3/4):1.
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  16.  11
    Toward a Duty to Report Clinical Trials Accurately: The Clinical Alert and Beyond.Kathleen Cranley Glass - 1994 - Journal of Law, Medicine and Ethics 22 (4):327-338.
    Advances in medicine depend not only on the generation of information but also on its dissemination. Clinically relevant data must be transmitted to the practitioners who will use it. Health care professionals in North America are aware of their ethical and legal obligations to inform patients adequately concerning interventions and treatments so that they may make informed choices about medical care. This obligation has been well described and defined by the courts and in the literature of medicine, ethics, and law. (...)
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  17.  68
    LeRoy Walters and Julie Gage Palmer, the Ethics of Human Gene Therapy.Kathleen Cranley Glass - 1999 - Theoretical Medicine and Bioethics 20 (5):489-490.
  18.  14
    Effective Trial Design Need Not Conflict with Good Patient Care.Kathleen Cranley Glass & Duff Waring - 2002 - American Journal of Bioethics 2 (2):25 – 26.
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  19.  51
    Protection of Human Subjects and Scientific Progress: Can the Two Be Reconciled?Kathleen Cranley Glass, David B. Resnik, Stephen Olufemi Sodeke, Halley S. Faust, Rebecca Dresser, Nancy M. P. King, C. D. Herrera, David Orentlicher & Lynn A. Jansen - 2006 - Hastings Center Report 36 (1):4-9.
  20.  8
    Structuring the Review of Human Genetics Protocols Part-III: Gene Therapy Studies.Kathleen Cranley Glass, Charles Weijer, Denis Cournoyer, Trudo Lemmens, Reberta M. Palmour, Stanley H. Shapiro & Benjamin Freedman - 1999 - IRB: Ethics & Human Research 21 (2):1.
  21.  12
    Weiss V. Solomon: A Case Study in Institutional Responsibility for Clinical Research.Benjamin Freedman & Kathleen Cranley Glass - 1990 - Journal of Law, Medicine and Ethics 18 (4):395-403.
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  22.  12
    Weiss V. Solomon: A Case Study in Institutional Responsibility for Clinical Research.Benjamin Freedman & Kathleen Cranley Glass - 1990 - Journal of Law, Medicine and Ethics 18 (4):395-403.
  23.  36
    Describing Our “Humanness”: Can Genetic Science Alter What It Means to Be “Human”?Angela Campbell, Kathleen Cranley Glass & Louis C. Charland - 1998 - Science and Engineering Ethics 4 (4):413-426.
    Over the past several decades, geneticists have succeeded in identifying the genetic mutations associated with disease. New strategies for treatment, including gene transfer and gene therapy, are under development. Although genetic science has been welcomed for its potential to predict and treat disease, interventions may become ethically objectionable if they threaten to alter characteristics that are distinctively human. Before we can determine whether or not a genetic technique carries this risk, we must clarify what it means to be “human”. This (...)
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  24.  4
    Reply to Dr. Ellen Burgess.Kathleen Cranley Glass - 1995 - Journal of Law, Medicine and Ethics 23 (2):212-212.
  25.  2
    Reply to Dr. Ellen Burgess.Kathleen Cranley Glass - 1995 - Journal of Law, Medicine and Ethics 23 (2):212-212.
  26.  8
    Structuring the Review of Human Genetics Protocols: Gene Localization and Identification Studies.Kathleen Cranley Glass, Charles Weijer, Roberta M. Palmour, Stanley H. Shapiro, Trudo M. Lemmens & Karen Lebacqz - 1996 - IRB: Ethics & Human Research 18 (4):1.