190 found
Sort by:
  1. 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.
    Direct download (2 more)  
     
    My bibliography  
     
    Export citation  
  2. Paul B. Miller & Charles Weijer (forthcoming). Moral Solutions in Assessing Research Risk. Irb.
    No categories
    Direct download (2 more)  
     
    My bibliography  
     
    Export citation  
  3. Mark Sheehan, Claire Timlin, Ken Peach, Ariella Binik, Wilson Puthenparampil, Mark Lodge, Sean Kehoe, Michael Brada, Neil Burnet, Steve Clarke, Adrian Crellin, Michael Dunn, Piero Fossati, Steve Harris, Michael Hocken, Tony Hope, Jonathan Ives, Tadashi Kamada, Alex John London, Robert Miller, Michael Parker, Madelon Pijls-Johannesma, Julian Savulescu, Susan Short, Loane Skene, Hirohiko Tsujii, Jeffrey Tuan & Charles Weijer (forthcoming). Position Statement on Ethics, Equipoise and Research on Charged Particle Radiation Therapy. Journal of Medical Ethics:2012-101290.
    The use of charged-particle radiation therapy (CPRT) is an increasingly important development in the treatment of cancer. One of the most pressing controversies about the use of this technology is whether randomised controlled trials are required before this form of treatment can be considered to be the treatment of choice for a wide range of indications. Equipoise is the key ethical concept in determining which research studies are justified. However, there is a good deal of disagreement about how this concept (...)
    Direct download (6 more)  
     
    My bibliography  
     
    Export citation  
  4. 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 (...)
    No categories
    Direct download (2 more)  
     
    My bibliography  
     
    Export citation  
  5. 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.
    No categories
    Direct download (3 more)  
     
    My bibliography  
     
    Export citation  
  6. 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). Ethics of Neuroimaging After Serious Brain Injury. 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 (...)
    Direct download (3 more)  
     
    My bibliography  
     
    Export citation  
  7. Charles Weijer, Monica Taljaard, Jeremy M. Grimshaw, Sarah Jl Edwards & Martin P. Eccles (2014). The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials: A Short Report. Research Ethics 10 (2):77-85.
    Owing to unique features of their design, cluster randomized trials complicate the interpretation of standard ethics guidelines. The recently published Ottawa statement on the ethical design and conduct of cluster randomized trials provides researchers and research ethics committees with detailed guidance on the design, conduct and review of cluster trials. The Ottawa statement sets out 15 recommendations, including guidance on the justification of study design, the need for research ethics committee review, the identification of research participants, obtaining informed consent, the (...)
    Direct download (4 more)  
     
    My bibliography  
     
    Export citation  
  8. 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 (...)
    Direct download (8 more)  
     
    My bibliography  
     
    Export citation  
  9. Charles Weijer, Anthony Skelton & Samantha Brennan (eds.) (2013). Bioethics in Canada. Oxford University Press.
    This is the table of contents of and introduction to a textbook entitled Bioethics in Canada. It will be published by Oxford University Press in March of 2013. It is designed mainly for use in Canada. Of the 51 articles that it contains, 26 are written by Canadians. -/- For further information, see http://www.oupcanada.com/catalog/9780195440157.html and http://www.amazon.ca/Bioethics-Canada-Charles-Weijer/dp/0195440153/ref=sr_1_1?s=books&ie=UTF8&qid=13 59542985&sr=1-1.
    Translate to English
    | Direct download  
     
    My bibliography  
     
    Export citation  
  10. Carla Angelski, Conrad Fernandez, Charles Weijer & Jun Gao (2012). The Publication of Ethically Uncertain Research: Attitudes and Practices of Journal Editors. [REVIEW] BMC Medical Ethics 13 (1):4-.
    Background: Publication of ethically uncertain research occurs despite well-published guidelines set forth in documents such as the Declaration of Helsinki. Such guidelines exist to aide editorial staff in making decisions regarding ethical acceptability of manuscripts submitted for publication, yet examples of ethically suspect and uncertain publication exist. Our objective was to survey journal editors regarding practices and attitudes surrounding such dilemmas. Methods: The Editor-in-chief of each of the 103 English-language journals from the 2005 Abridged Index Medicus list publishing original research (...)
    Direct download (8 more)  
     
    My bibliography  
     
    Export citation  
  11. Ariella Binik, Charles Weijer & Mark Sheehan (2011). Minimal Risk Remains an Open Question. American Journal of Bioethics 11 (6):25 - 27.
    The American Journal of Bioethics, Volume 11, Issue 6, Page 25-27, June 2011.
    Direct download (7 more)  
     
    My bibliography  
     
    Export citation  
  12. Sue Ross, Charles Weijer, Amiram Gafni, Ariel Ducey, Carmen Thompson & Rene Lafreniere (2010). Ethics, Economics and the Regulation and Adoption of New Medical Devices: Case Studies in Pelvic Floor Surgery. BMC Medical Ethics 11 (1):14-.
    Background: Concern has been growing in the academic literature and popular media about the licensing, introduction and adoption of surgical devices before full effectiveness and safety evidence is available to inform clinical practice. Our research will seek empirical survey evidence about the roles, responsibilities, and information and policy needs of the key stakeholders in the introduction into clinical practice of new surgical devices for pelvic floor surgery, in terms of the underlying ethical principals involved in the economic decision-making process, using (...)
    Direct download (3 more)  
     
    My bibliography  
     
    Export citation  
  13. Charles Weijer (2010). Ethics in Conduct of Trials in Developing Countries. British Medical Journal 340:1373.
    No categories
    Translate to English
    | Direct download  
     
    My bibliography  
     
    Export citation  
  14. Timothy Caulfield & Charles Weijer, Minimal Risk and Large-Scale Biobank and Cohort Research.
    No categories
    Translate to English
    | Direct download  
     
    My bibliography  
     
    Export citation  
  15. Oonagh Corrigan, John McMillan & Charles Weijer, Introduction.
    This introductory chapter begins with a brief explanation of the impetus behind the book as well as its objectives. It then discusses the history of consent and the challenges for informed consent. An overview of the subsequent chapters is presented.
    No categories
    Translate to English
    | Direct download  
     
    My bibliography  
     
    Export citation  
  16. Conrad Vincent Fernandez, Jun Gao, Caron Strahlendorf, Albert Moghrabi, Rebecca Davis Pentz, Raymond Carlton Barfield, Justin Nathaniel Baker, Darcy Santor, Charles Weijer & Eric Kodish, Providing Research Results to Participants: Attitudes and Needs of Adolescents and Parents of Children with Cancer.
    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 (...)
    No categories
    Translate to English
    | Direct download  
     
    My bibliography  
     
    Export citation  
  17. Jonathan Kimmelman, Charles Weijer & Eric M. Meslin, Helsinki Discords: FDA, Ethics, and International Drug Trials.
    No categories
    Translate to English
    | Direct download  
     
    My bibliography  
     
    Export citation  
  18. Paul B. Miller & Charles Weijer, Trust and Exploitation in Clinical Research.
    This chapter attempts to derive, define, and specify norms governing the relationship between physician-researcher and patient-subject, and to explore their interconnection. It argues that rooting the relationship between physician-researcher and patient-subject in a normative theory of trust is promising. It enables the derivation, definition, and specification of norms governing the relationship and appreciation of their interconnection.
    Translate to English
    | Direct download  
     
    My bibliography  
     
    Export citation  
  19. Kate Read, Conrad Vincent Fernandez, Jun Gao, Caron Strahlendorf, Albert Moghrabi, Rebecca Davis Pentz, Raymond Carlton Barfield, Justin Nathaniel Baker, Darcy Santor, Charles Weijer & Eric Kodish, Decision-Making by Adolescents and Parents of Children with Cancer Regarding Health Research Participation.
    Background: Low rates of participation of adolescents and young adults (AYAs) in clinical oncology trials may contribute to poorer outcomes. Factors that influence the decision of AYAs to participate in health research and whether these factors are different from those that affect the participation of parents of children with cancer. Methods: This is a secondary analysis of data from validated questionnaires provided to adolescents (>12 years old) diagnosed with cancer and parents of children with cancer at 3 sites in Canada (...)
    No categories
    Translate to English
    | Direct download  
     
    My bibliography  
     
    Export citation  
  20. 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 (...)
    Direct download (7 more)  
     
    My bibliography  
     
    Export citation  
  21. Heather Sampson, Charles Weijer & Daryl Pullman (2009). Research Governance Lessons From the National Placebo Initiative. Health Law Review 17 (2-3):26-32.
    No categories
    Direct download  
     
    My bibliography  
     
    Export citation  
  22. Arthur S. Slutsky, Leonard D. Hudson, Nancy N. Dubler, Charles Weijer & Mark R. Tonelli, Care of an Unresponsive Patient with a Poor Prognosis.
    No categories
    Translate to English
    | Direct download  
     
    My bibliography  
     
    Export citation  
  23. Charles Weijer, Ethical Challenges in ICU Research.
    No categories
    Translate to English
    | Direct download  
     
    My bibliography  
     
    Export citation  
  24. Charles Weijer (2009). Evolving Ethical Issues in Selection of Subjects for Clinical Research. Cambridge Quarterly of Healthcare Ethics 5 (03):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 (...)
    Direct download (5 more)  
     
    My bibliography  
     
    Export citation  
  25. Charles Weijer, Private Religious Schools and Public Reasons.
    No categories
    Translate to English
    | Direct download  
     
    My bibliography  
     
    Export citation  
  26. Charles Weijer, When Can Physicians Say “No” to Families and Patients?
    No categories
    Translate to English
    | Direct download  
     
    My bibliography  
     
    Export citation  
  27. Andrew McRae & Charles Weijer, U.S. Federal Regulations for Emergency Research: A Practical Guide and Commentary.
    Emergency medicine research requires the enrollment of subjects with varying decision-making capacities, including capable adults, adults incapacitated by illness or injury, and children. These different categories of subjects are protected by multiple federal regulations. These include the federal Common Rule, the Department of Health and Human Services (DHHS) regulations for pediatric research, and the Food and Drug Administration's (FDA) Final Rule for the Exception from the Requirements of Informed Consent in Emergency Situations. Investigators should be familiar with the relevant federal (...)
    Translate to English
    | Direct download  
     
    My bibliography  
     
    Export citation  
  28. Paul B. Miller & Charles Weijer (2008). Beyond Consent : The Trust-Based Obligations of Physicians to Patients in Clinical Research. In Oonagh Corrigan (ed.), The Limits of Consent: A Socio-Ethical Approach to Human Subject Research in Medicine. Oxford University Press.
     
    My bibliography  
     
    Export citation  
  29. Sue Ross, Magali Robert, Marie-Andrée Harvey, Scott Farrell, Jane Schulz, David Wilkie, Danny Lovatsis, Annette Epp, Bill Easton, Barry McMillan, Joyce Schachter, Chander Gupta & Charles Weijer, Ethical Issues Associated With the Introduction of New Surgical Devices, or Just Because We Can, Doesn't Mean We Should.
    Surgical devices are often marketed before there is good evidence of their safety and effectiveness. Our paper discusses the ethical issues associated with the early marketing and use of new surgical devices from the perspectives of the six groups most concerned. Health Canada, which is responsible for licensing new surgical devices, should amend their requirements to include rigorous clinical trials that provide data on effectiveness and safety for each new product before it is marketed. Industry should comply with all Health (...)
    No categories
    Translate to English
    | Direct download  
     
    My bibliography  
     
    Export citation  
  30. A. Rudnick & Charles Weijer, Ethics and Schizophrenia.
    No categories
    Translate to English
    | Direct download  
     
    My bibliography  
     
    Export citation  
  31. F. Brunger & Charles Weijer, Politics, Risk, and Community in the Maya ICBG Case.
    No categories
    Translate to English
    | Direct download  
     
    My bibliography  
     
    Export citation  
  32. 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 (...)
    No categories
    Translate to English
    | Direct download  
     
    My bibliography  
     
    Export citation  
  33. 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 (...)
    Direct download (10 more)  
     
    My bibliography  
     
    Export citation  
  34. Paul B. Miller & Charles Weijer, Evaluating Benefits and Harms in Clinical Research.
    No categories
    Translate to English
    | Direct download  
     
    My bibliography  
     
    Export citation  
  35. Paul B. Miller & Charles Weijer (2007). Revisiting Equipoise: A Response to Gifford. Kennedy Institute of Ethics Journal 17 (3):227-246.
    : The authors respond to objections Fred Gifford has raised against their paper "Rehabilitating Equipoise." They situate this exchange in the wider context of recent debate over equipoise, highlighting substantial points of agreement between themselves and Gifford. The authors offer a brief restatement of "Rehabilitating Equipoise" in which they amplify some of its core arguments. They then assess Gifford's objections. Finding each to be unfounded, they argue that there is no justification for "pulling the plug" on clinical equipoise.
    Direct download (6 more)  
     
    My bibliography  
     
    Export citation  
  36. 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 (...)
    No categories
    Translate to English
    | Direct download  
     
    My bibliography  
     
    Export citation  
  37. Charles Weijer & Paul B. Miller, Evaluating Benefits and Harms in Intensive Care Research.
    No categories
    Translate to English
    | Direct download  
     
    My bibliography  
     
    Export citation  
  38. 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) (...)
    Direct download (8 more)  
     
    My bibliography  
     
    Export citation  
  39. Conrad V. Fernandez & Charles Weijer (2006). Obligations in Offering to Disclose Genetic Research Results. American Journal of Bioethics 6 (6):44 – 46.
    Direct download (6 more)  
     
    My bibliography  
     
    Export citation  
  40. Paul B. Miller & Charles Weijer (2006). Fiduciary Obligation in Clinical Research. 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.
    Direct download (4 more)  
     
    My bibliography  
     
    Export citation  
  41. 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 (...)
    Direct download (8 more)  
     
    My bibliography  
     
    Export citation  
  42. Charles Weijer, Terri Schiavo: Rest in Peace.
    No categories
    Translate to English
    | Direct download  
     
    My bibliography  
     
    Export citation  
  43. Charles Weijer & Guy LeBlanc, Revisiting the Ethics of HIV Prevention Research in Developing Countries.
    Issues: We present key aspects of our paper, commissioned by UNAIDS in 2005, entitled, “Revisiting the ethics of HIV prevention research in developing countries.” In 2004 and 2005 we witnessed the closure or suspension of three international clinical trials testing tenofovir in the prevention of HIV infection in high risk groups due to the failure to provide free treatment to those who seroconvert during the conduct of the study. We examine critically moral claims for the provision of treatment to those (...)
    No categories
    Translate to English
    | Direct download (2 more)  
     
    My bibliography  
     
    Export citation  
  44. 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 and 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.
    Direct download (4 more)  
     
    My bibliography  
     
    Export citation  
  45. Ezekiel J. Emanuel & Charles Weijer, Protecting Communities in Research: From a New Principle to Rational Protections.
    No categories
    Translate to English
    | Direct download  
     
    My bibliography  
     
    Export citation  
  46. Conrad Vincent Fernandez, Shaureen Taweel, Eric D. Kodish & Charles Weijer, Disclosure of Research Result to Research Participants: Needs and Attitudes of Adolescents and Parents.
    BACKGROUND: Researchers have a moral responsibility to offer to return research results to participants, but the needs and attitudes of parents and adolescents with cancer in paediatric oncology regarding the issue are relatively unknown.OBJECTIVES: To explore the needs of potential research participants or their guardians with respect to the offer of a return of research results. METHODS: A questionnaire was used in a focus group and in telephone interviews with eight adolescents and 12 parents of children with cancer. The participants (...)
    No categories
    Translate to English
    | Direct download  
     
    My bibliography  
     
    Export citation  
  47. Charles M. Heilig & Charles Weijer, A Critical History of Individual and Collective Ethics in the Lineage of Lellouch and Schwartz.
    The notions of individual and collective ethics were first explicitly defined in the biostatistical literature in 1971 to motivate a mathematical solution to a posed ethical dilemma. This paper reviews key antecedents to these concepts and traces explicit references to them over time, primarily in the biostatistical literature. Following a historical exposition of these texts, a critical thematic analysis shows the following: the normative force of these concepts has not been adequately argued. Individual and collective ethics do not solve the (...)
    No categories
    Translate to English
    | Direct download  
     
    My bibliography  
     
    Export citation  
  48. Andrew D. McRae, Stacy Ackroyd-Stolarz & Charles Weijer, Risk in Emergency Research Using a Waiver of/Exception From Consent: Implications of a Structured Approach for Institutional Review Board Review.
    OBJECTIVE: To apply component analysis, a structured approach to the ethical analysis of risks and potential benefits in research, to published emergency research using a waiver of/exception from informed consent. The hypothesis was that component analysis could be used with a high degree of interrater reliability, and that the vast majority of emergency research would comply with a minimal-risk threshold. METHODS: A Medline search and manual search were done to identify studies using a waiver of/exception from informed consent published between (...)
    Translate to English
    | Direct download  
     
    My bibliography  
     
    Export citation  
  49. Paul B. Miller & Charles Weijer, Evaluating Risks of Non-Therapeutic Research in Children.
    No categories
    Translate to English
    | Direct download  
     
    My bibliography  
     
    Export citation  
  50. Charles Weijer, A Death in the Family: Reflections on the Terri Schiavo Case.
    No categories
    Translate to English
    | Direct download  
     
    My bibliography  
     
    Export citation  
1 — 50 / 190