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  1.  563 DLs
    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.
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  2.  64 DLs
    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.  25 DLs
    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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  4.  23 DLs
    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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  5.  22 DLs
    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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  6.  22 DLs
    Charles Weijer, The Ethical Analysis of Risks and Potential Benefits in Human Subjects Research: History, Theory, and Implications for U.S. Regulation.
    This paper addresses three questions central to the ethical analysis of risks and potential benefits in human subjects research: 1. How was the ethical analysis of risk understood by the members of the U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (National Commission)? 2. What conceptual framework should guide the ethical analysis of risk? 3. What changes to U.S. regulations would the implementation of such a framework require?
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  7.  21 DLs
    Charles Weijer, Queer Science: The Use and Abuse of Research Into Homosexuality.
  8.  20 DLs
    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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  9.  19 DLs
    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.
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  10.  16 DLs
    Carl Elliott & Charles Weijer, Cruel and Unusual Treatment.
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  11.  15 DLs
    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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  12.  15 DLs
    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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  13.  15 DLs
    Charles Weijer, Characterizing the Population in Clinical Trials: Barriers, Comparability, and Implications for Review.
    The definition of the study population for a clinical trial via the criteria for trial eligibility has implications for the validity of the study and its applicability to clinical practice. Though issues of equity regarding the selection of subjects for research have long been a concern of ethicists, issues regarding the impact of subject selection on a trial's generalizability have only recently attracted ethical scrutiny. After a review of the history of the ethics of subject selection, I focus on three (...)
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  14.  14 DLs
    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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  15.  13 DLs
    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 (...)
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  16.  12 DLs
    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 (...)
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  17.  12 DLs
    Andrew D. McRae & Charles Weijer, Lessons From Everyday Lives: A Moral Justification for Acute Care Research.
    Progress in emergency and critical care requires that clinical research be performed on patients who are incapable of granting consent for research participation. Analyses of the ethics of such research have left some questions incompletely answered. Why should we be permitted to expose vulnerable patients to research risks without their consent? In particular, how do we justify research interventions that have no potential benefit for participants (nontherapeutic interventions)? This article presents a moral justification for nontherapeutic interventions in emergency research. By (...)
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  18.  12 DLs
    Charles Weijer (2005). Meaningful Work as Due Inducement. Theoretical Medicine and Bioethics 26 (5):431-435.
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  19.  12 DLs
    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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  20.  12 DLs
    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.
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  21.  11 DLs
    Jonathan Kimmelman, Charles Weijer & Eric M. Meslin, Helsinki Discords: FDA, Ethics, and International Drug Trials.
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  22.  10 DLs
    Ezekiel J. Emanuel & Charles Weijer, Protecting Communities in Research: From a New Principle to Rational Protections.
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  23.  10 DLs
    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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  24.  10 DLs
    Charles Weijer, The Ethical Analysis of Risk in Intensive Care Unit Research.
    Research in the intensive care unit (ICU) is commonly thought to pose 'serious risk' to study participants. This perception may be at the root of a variety of impediments to the conduct of clinical trials in the ICU setting. Component analysis offers a promising approach to the ethical analysis of ICU research. Because clinical trials commonly involve a mixture of study interventions, therapeutic and nontherapeutic procedures must be analyzed separately. Therapeutic procedures must meet the requirement of clinical equipoise. Risks associated (...)
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  25.  10 DLs
    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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  26.  9 DLs
    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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  27.  9 DLs
    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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  28.  9 DLs
    Charles Weijer, Benjamin Freedman, Stanley Shapiro, Abraham Fuks, Myriam Skrutkowska & Maria Sigurjonsdottir, Assessing the Interpretation of Criteria for Clinical Trial Eligibility: A Survey of Oncology Investigators.
    OBJECTIVE: To investigate whether eligibility criteria that exclude the elderly, persons with psychiatric disease, and persons with substance abuse problems from participation in randomized controlled trials (RCTs) are subjective and hence a source of variability in enrolment decisions and investigator uncertainty. DESIGN: Survey questionnaire. PARTICIPANTS: Cancer investigators from the United States and Canada. INTERVENTIONS: Investigators were presented with clinical vignettes from 3 patient categories--eligible, ineligible and uncertain--for each of 5 eligibility criteria--3 subjective and 2 objective--and were asked whether they would (...)
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  29.  9 DLs
    Charles Weijer (1999). Protecting Communities in Research: Philosophical and Pragmatic Challenges. Cambridge Quarterly of Healthcare Ethics 8 (04):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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  30.  9 DLs
    Charles Weijer & Claudio F. Lanata, Ethical Considerations in the Conduct of Vaccine Trials in Developing Countries.
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  31.  9 DLs
    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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  32.  8 DLs
    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.
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  33.  8 DLs
    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 (...)
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  34.  8 DLs
    Charles Weijer (2000). The Ethical Analysis of Risk. Journal of Law, Medicine & Ethics 28 (4):344-361.
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  35.  8 DLs
    Charles Weijer, Film and Narrative in Bioethics: Akira Kurosawa's Ikiru.
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  36.  8 DLs
    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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  37.  8 DLs
    Charles Weijer & James A. Anderson, A Critical Appraisal of Protections for Aboriginal Communities in Biomedical Research.
    As scientists target communities for research into the etiology, especially the genetic determinants of common diseases, there have been calls for the protection of communities. This paper identifies the distinct characteristics of aboriginal communities and their implications for research in these communities. It also contends that the framework in the Belmont Report is inadequate in this context and suggests a fourth principle of respect for communities. To explore how such a principle might be specified and operationalized, it reviews existing guidelines (...)
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  38.  8 DLs
    F. Brunger & Charles Weijer, Politics, Risk, and Community in the Maya ICBG Case.
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  39.  7 DLs
    Charles Weijer, Bernard Dickens & Eric M. Meslin, Bioethics for Clinicians: 10. Research Ethics.
    Medical research involving human subjects raises complex ethical, legal and social issues. Investigators sometimes find that their obligations with respect to a research project come into conflict with their obligations to individual patients. The ethical conduct of research rests on 3 guiding principles: respect for persons, beneficience, and justice. Respect for persons underlies the duty to obtain informed consent from study participants. Beneficence demands a favourable balance between the potential benefits and harms of participation. Justice requires that vulnerable people not (...)
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  40.  7 DLs
    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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  41.  7 DLs
    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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  42.  7 DLs
    Wim Dekkers, Charles Weijer & Norbert Paul (1995). Book Reviews. [REVIEW] Theoretical Medicine and Bioethics 16 (2).
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  43.  7 DLs
    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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  44.  7 DLs
    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 (...)
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  45.  7 DLs
    Charles Weijer, Selecting Subjects for Participation in Clinical Research: An Empirical Inquiry and Ethical Analysis.
    Procedures for the selection of subjects for participation in randomized clinical trials--usually formalized as eligibility criteria in the study protocol--have both scientific and ethical implications. In this thesis, I undertake an examination of eligibility criteria at three stages in the genesis and dissemination of medical knowledge: clinical trial protocol, interpretation by investigators, and reporting of study results.In the first chapter, ethical issues in subject selection are reviewed and the main study questions are presented. In the second chapter, the results of (...)
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  46.  7 DLs
    Susan Douglas Kelley, Sondra Crosby, Michael A. Grodin, Ruth Macklin, Simon Shimshon Rubin, Fern Brunger & Charles Weijer (2002). The Forum. Ethics and Behavior 12 (4):371 – 387.
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  47.  7 DLs
    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 (...)
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  48.  7 DLs
    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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  49.  6 DLs
    Françoise Baylis, A. Ireland, David Kaufman & Charles Weijer, Protecting Human Research Subjects: Case-Based Learning for Canadian Research Ethics Boards and Researchers.
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  50.  6 DLs
    Arthur S. Slutsky, Leonard D. Hudson, Nancy N. Dubler, Charles Weijer & Mark R. Tonelli, Care of an Unresponsive Patient with a Poor Prognosis.
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