224 found
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  1.  52
    Informing Study Participants of Research Results: An Ethical Imperative.Conrad V. Fernandez, Eric Kodish & Charles Weijer - 2003 - IRB: Ethics & Human Research 25 (3):12.
  2.  31
    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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  3. 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.
    To what risks may children participating in research be subjected? Institutional review boards can stand surrogate for parents by filtering out studies whose risk is unacceptably high.
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  4.  58
    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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  5.  93
    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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  6.  92
    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.  39
    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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  8.  88
    Fiduciary Obligation in Clinical Research.Paul B. Miller & Charles Weijer - 2006 - Journal of Law, Medicine and Ethics 34 (2):424-440.
    Bioethics is currently witnessing unprecedented debate over the moral and legal norms governing the conduct of clinical research. At the center of this debate is the duty of care in clinical research, and its most widely accepted specification, clinical equipoise. In recent work, we have argued that equipoise and cognate concepts central to the ethics of clinical research have been left unnecessarily vulnerable to criticism. We have suggested that the vulnerability lies in the conspicuous absence of an articulated foundation in (...)
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  9.  73
    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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  10. 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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  11.  73
    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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  12. 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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  13.  55
    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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  14.  30
    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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  15. 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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  16.  44
    (1 other version)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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  17.  21
    Considerations and Costs of Disclosing Study Findings to Research Participants.Conrad V. Fernandez, Chris Skedgel & Charles Weijer - unknown
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  18. 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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  19.  40
    Helsinki Discords: FDA, Ethics, and International Drug Trials.Jonathan Kimmelman, Charles Weijer & Eric M. Meslin - unknown
  20.  79
    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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  21.  19
    Controlled Donation After Circulatory Determination of Death: A Scoping Review of Ethical Issues, Key Concepts, and Arguments.Nicholas Murphy, Charles Weijer, Maxwell Smith, Jennifer Chandler, Erika Chamberlain, Teneille Gofton & Marat Slessarev - 2021 - Journal of Law, Medicine and Ethics 49 (3):418-440.
    Controlled donation after circulatory determination of death (cDCDD) is an important strategy for increasing the pool of eligible organ donors.
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  22.  15
    Thinking Clearly about Research Risk: Implications of the Work of Benjamin Freedman.Charles Weijer - 1999 - IRB: Ethics & Human Research 21 (6):1.
  23.  25
    Informed consent in pragmatic trials: results from a survey of trials published 2014–2019.Jennifer Zhe Zhang, Stuart G. Nicholls, Kelly Carroll, Hayden Peter Nix, Cory E. Goldstein, Spencer Phillips Hey, Jamie C. Brehaut, Paul C. McLean, Charles Weijer, Dean A. Fergusson & Monica Taljaard - 2022 - Journal of Medical Ethics 49 (1):34-40.
    ObjectivesTo describe reporting of informed consent in pragmatic trials, justifications for waivers of consent and reporting of alternative approaches to standard written consent. To identify factors associated with (1) not reporting and (2) not obtaining consent.MethodsSurvey of primary trial reports, published 2014–2019, identified using an electronic search filter for pragmatic trials implemented in MEDLINE, and registered in ClinicalTrials.gov.ResultsAmong 1988 trials, 132 (6.6%) did not include a statement about participant consent, 1691 (85.0%) reported consent had been obtained, 139 (7.0%) reported a (...)
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  24.  37
    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.
    Abstract:The ethical principle of autonomy requires physicians to respect patient autonomy when present, and to protect the patient who lacks autonomy. Fulfilling this ethical obligation when a patient has a communication impairment presents considerable challenges. Standard methods for evaluating decision-making capacity require a semistructured interview. Some patients with communication impairments are unable to engage in a semistructured interview and are at risk of the wrongful loss of autonomy. In this article, we present a general strategy for assessing decision-making capacity in (...)
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  25.  77
    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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  26. 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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  27.  29
    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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  28.  75
    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.
  29.  72
    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.  36
    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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  31.  46
    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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  32.  34
    Moral Solutions in Assessing Research Risk.Paul B. Miller & Charles Weijer - 2000 - IRB: Ethics & Human Research 22 (5):6.
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  33.  42
    I Need a Placebo like I Need a Hole in the Head.Charles Weijer - 2002 - Journal of Law, Medicine and Ethics 30 (1):69-72.
    In this issue of the Journal of Law, Medicine & Ethics Peter Clark provides a comprehensive and sound ethical analysis of clinical trials examining the treatment of advanced Parkinson's disease with fetal tissue transplantation. These studies raise profound questions about how clinical trials of surgical interventions ought to be conducted. At stake is not only the ethical basis of such trials, but differing views as to the proper role of science in medicine and its limitations.Experience with the broader debate on (...)
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  34.  81
    Ethics of neuroimaging after serious brain injury.Charles Weijer, Andrew Peterson, Fiona Webster, Mackenzie Graham, Damian Cruse, Davinia Fernández-Espejo, Teneille Gofton, Laura E. Gonzalez-Lara, Andrea Lazosky, Lorina Naci, Loretta Norton, Kathy Speechley, Bryan Young & Adrian M. Owen - 2014 - BMC Medical Ethics 15 (1):41.
    Patient outcome after serious brain injury is highly variable. Following a period of coma, some patients recover while others progress into a vegetative state (unresponsive wakefulness syndrome) or minimally conscious state. In both cases, assessment is difficult and misdiagnosis may be as high as 43%. Recent advances in neuroimaging suggest a solution. Both functional magnetic resonance imaging and electroencephalography have been used to detect residual cognitive function in vegetative and minimally conscious patients. Neuroimaging may improve diagnosis and prognostication. These techniques (...)
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  35.  51
    Obligations in offering to disclose genetic research results.Conrad V. Fernandez & Charles Weijer - 2006 - American Journal of Bioethics 6 (6):44 – 46.
  36.  7
    COVID-19 human challenge trials and randomized controlled trials: lessons for the next pandemic.Charles Weijer - 2024 - Research Ethics 20 (4):636-649.
    The COVID-19 pandemic touched off an unprecedented search for vaccines and treatments. Without question, the development of vaccines to prevent COVID-19 was an enormous scientific accomplishment. Further, the RECOVERY and Solidarity trials identified effective treatments for COVID-19. But all was not success. The urgent need for COVID-19 prevention and treatment fueled an embrace of risks—to research participants and to the reliability of the science itself—as allegedly necessary costs to speed scientific progress. Scientists and (even) ethicists supported overturning longstanding norms protecting (...)
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  37.  59
    Demarcating Research and Treatment: A Systematic Approach for the Analysis of the Ethics of Clinical Research.Benjamin Freedman, Abraham Fuks & Charles Weijer - unknown
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  38.  63
    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
  39.  35
    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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  40.  58
    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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  41.  78
    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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  42.  23
    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 ofJME, Watsonet alcall 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 (RECs), Watsonet alargue that the health programme per se is not within the researcher’s control or responsibility and, thus, is out of scope for ethics review. We argue that this (...)
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  43.  18
    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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  44.  23
    Pulling the Plug on Futility.Charles Weijer & Carl Elliott - unknown
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  45.  29
    The Ethics Wars Disputes over International Research.Charles Weijer & James A. Anderson - 2001 - 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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  46.  35
    Therapeutic Obligation in Clinical Research.Charles Weijer & Paul B. Miller - unknown
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  47.  26
    When argument fails.Charles Weijer - 2002 - American Journal of Bioethics 2 (2):10 – 11.
  48.  52
    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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  49.  28
    Family experiences with non-therapeutic research on dying patients in the intensive care unit.Amanda van Beinum, Nick Murphy, Charles Weijer, Vanessa Gruben, Aimee Sarti, Laura Hornby, Sonny Dhanani & Jennifer Chandler - 2022 - Journal of Medical Ethics 48 (11):845-851.
    Experiences of substitute decision-makers with requests for consent to non-therapeutic research participation during the dying process, including to what degree such requests are perceived as burdensome, have not been well described. In this study, we explored the lived experiences of family members who consented to non-therapeutic research participation on behalf of an imminently dying patient. We interviewed 33 family members involved in surrogate research consent decisions for dying patients in intensive care. Non-therapeutic research involved continuous physiological monitoring of dying patients (...)
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  50.  80
    Evolving Ethical Issues in Selection of Subjects for Clinical Research.Charles Weijer - 1996 - Cambridge Quarterly of Healthcare Ethics 5 (3):334-345.
    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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