•  361
    Ethical considerations in functional magnetic resonance imaging research in acutely comatose patients
    with Tommaso Bruni, Teneille Gofton, G. Bryan Young, Loretta Norton, Andrew Peterson, and Adrian M. Owen
    Brain 0-0. 2015.
    After severe brain injury, one of the key challenges for medical doctors is to determine the patient’s prognosis. Who will do well? Who will not do well? Physicians need to know this, and families need to do this too, to address choices regarding the continuation of life supporting therapies. However, current prognostication methods are insufficient to provide a reliable prognosis. Functional Magnetic Resonance Imaging (MRI) holds considerable promise for improving the accuracy of prognosis in …Read more
  •  137
    In Loco Parentis Minimal Risk as an Ethical Threshold for Research upon Children
    with Benjamin Freedman and Abraham Fuks
    Hastings Center Report 23 (2): 13-19. 1993.
  •  118
    Structuring the Review of Human Genetics Protocols
    with Kathleen Cranley Glass, Denis Cournoyer, Trudo Lemmens, Roberta M. Palmour, Stanley H. Shapiro, and Benjamin Freedman
    IRB: Ethics & Human Research 21. 1999.
  •  89
    Unethical Author Attribution
    with Anonymous M. D./PhD Student and Akira Akabayashi
    Cambridge Quarterly of Healthcare Ethics 12 (1): 124-130. 2003.
    I am an M.D/Ph.D. student and work as a research assistant for the director of a division of the school of medicine who is an M.D. He assigned me to research a certain topic and gave me no guidelines or guidance as to how to do it. Nevertheless, I did the research and wrote it up. My supervisor liked the report and said that he thought it was so good that “I would like to offer you the opportunity to publish it and list you as the primary author.” Some bells went off when he so grandly offered t…Read more
  •  79
    Meaningful work as due inducement
    Theoretical Medicine and Bioethics 26 (5): 431-435. 2005.
  •  79
    Why the Debate over Minimal Risk Needs to be Reconsidered
    Journal of Medicine and Philosophy 39 (4): 387-405. 2014.
    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 disagreement b…Read more
  •  75
    Protecting Communities in Research: Philosophical and Pragmatic Challenges
    Cambridge Quarterly of Healthcare Ethics 8 (4): 501-513. 1999.
    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?
  •  75
    The research subject as wage earner
    with James A. Anderson
    Theoretical Medicine and Bioethics 23 (4-5): 359-376. 2002.
    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 minimu…Read more
  •  69
    The publication of ethically uncertain research: attitudes and practices of journal editors
    with Carla Angelski, Conrad V. Fernandez, and Jun Gao
    BMC Medical Ethics 13 (1): 4. 2012.
    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…Read more
  •  63
    Rehabilitating Equipoise
    with Paul B. Miller
    Kennedy Institute of Ethics Journal 13 (2): 93-118. 2003.
    : 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 th…Read more
  •  62
    Ethical Criteria for Human Challenge Studies in Infectious Diseases: Table 1
    with Ben Bambery, Michael Selgelid, Julian Savulescu, and Andrew J. Pollard
    Public Health Ethics 9 (1): 92-103. 2016.
    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 currentl…Read more
  •  54
    Refuting the net risks test: a response to Wendler and Miller's "Assessing research risks systematically"
    with Paul B. Miller
    Journal of Medical Ethics 33 (8): 487-490. 2007.
    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 (…Read more
  •  47
    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?
  •  47
    Assay Sensitivity and the Epistemic Contexts of Clinical Trials
    Perspectives in Biology and Medicine 56 (1): 1-17. 2013.
    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 scienc…Read more
  •  45
    Ethics, economics and the regulation and adoption of new medical devices: case studies in pelvic floor surgery
    with Sue Ross, Amiram Gafni, Ariel Ducey, Carmen Thompson, and Rene Lafreniere
    BMC Medical Ethics 11 (1): 14-. 2010.
    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 et…Read more
  •  45
    Ethics of neuroimaging after serious brain injury
    with 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, and Adrian M. Owen
    BMC Medical Ethics 15 (1): 41. 2014.
    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 min…Read more
  •  44
    Fiduciary Obligation in Clinical Research
    with Paul B. Miller
    Journal of Law, Medicine and Ethics 34 (2): 424-440. 2006.
    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
  •  43
    Trust based obligations of the state and physician-researchers to patient-subjects
    with Paul B. Miller
    Journal of Medical Ethics 32 (9): 542-547. 2006.
    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 on…Read more
  •  42
    The Return of Research Results to Participants: Pilot Questionnaire of Adolescents and Parents of Children with Cancer
    with Conrad V. Fernandez, Darcy Santor, Caron Strahlendorf, Albert Moghrabi, Rebecca Pentz, Jun Gao, and Eric Kodish
    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 revi…Read more
  •  41
    Equipoise and the duty of care in clinical research: A philosophical response to our critics
    with Paul B. Miller
    Journal of Medicine and Philosophy 32 (2). 2007.
    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 presentl…Read more
  •  40
    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 jour…Read more
  •  39
  •  38
    Will the real Charles Fried please stand up?
    with Paul B. Miller
    Kennedy Institute of Ethics Journal 13 (4): 353-357. 2003.
    : 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 i…Read more
  •  36
    Toward a Science of Brain Death
    with Andrew Peterson, Loretta Norton, Lorina Naci, and Adrian M. Owen
    American Journal of Bioethics 14 (8): 29-31. 2014.
    No abstract
  •  35
    Stakeholder views regarding ethical issues in the design and conduct of pragmatic trials: study protocol
    with Stuart G. Nicholls, Kelly Carroll, Jamie Brehaut, Spencer Phillips Hey, Cory E. Goldstein, Merrick Zwarenstein, Ian D. Graham, Joanne E. McKenzie, Lauralyn McIntyre, Vipul Jairath, Marion K. Campbell, Jeremy M. Grimshaw, Dean A. Fergusson, and Monica Taljaard
    BMC Medical Ethics 19 (1): 90. 2018.
    Randomized controlled trial trial designs exist on an explanatory-pragmatic spectrum, depending on the degree to which a study aims to address a question of efficacy or effectiveness. As conceptualized by Schwartz and Lellouch in 1967, an explanatory approach to trial design emphasizes hypothesis testing about the mechanisms of action of treatments under ideal conditions, whereas a pragmatic approach emphasizes testing effectiveness of two or more available treatments in real-world conditions. I…Read more
  •  34
    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
  •  33
    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,…Read more
  •  33
    Revisiting equipoise: A response to Gifford
    with Paul B. Miller
    Kennedy Institute of Ethics Journal 17 (3): 227-246. 2007.
    : 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 "…Read more