• 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 …Read more
  •  46
    Assessing Decision-Making Capacity in the Behaviorally Nonresponsive Patient With Residual Covert Awareness
    with Andrew Peterson, Lorina Naci, Damian Cruse, Davinia Fernández-Espejo, Mackenzie Graham, and Adrian M. Owen
    American Journal of Bioethics Neuroscience 4 (4): 3-14. 2013.
  •  13
    [Demarcating Research and Treatment Interventions: A Case Illustration]: Commentary
    with Benjamin Freedman
    IRB: Ethics & Human Research 14 (4): 5. 1992.
  •  37
    An Ethics of Welfare for Patients Diagnosed as Vegetative With Covert Awareness
    with Mackenzie Graham, Damian Cruse, Davinia Fernandez-Espejo, Teneille Gofton, Laura E. Gonzalez-Lara, Andrea Lazosky, Lorina Naci, Loretta Norton, Andrew Peterson, Kathy N. Speechley, Bryan Young, and Adrian M. Owen
    American Journal of Bioethics Neuroscience 6 (2): 31-41. 2015.
  •  37
    Ethical issues in pragmatic randomized controlled trials: a review of the recent literature identifies gaps in ethical argumentation (review)
    with Cory E. Goldstein, Jamie C. Brehaut, Dean A. Fergusson, Jeremy M. Grimshaw, Austin R. Horn, and Monica Taljaard
    BMC Medical Ethics 19 (1): 1-10. 2018.
    Background Pragmatic randomized controlled trials are designed to evaluate the effectiveness of interventions in real-world clinical conditions. However, these studies raise ethical issues for researchers and regulators. Our objective is to identify a list of key ethical issues in pragmatic RCTs and highlight gaps in the ethics literature. Methods We conducted a scoping review of articles addressing ethical aspects of pragmatic RCTs. After applying the search strategy and eligibility criteria, 3…Read more
  •  5
    Controlled Donation After Circulatory Determination of Death: A Scoping Review of Ethical Issues, Key Concepts, and Arguments
    with Nicholas Murphy, Maxwell Smith, Jennifer Chandler, Erika Chamberlain, Teneille Gofton, and Marat Slessarev
    Journal of Law, Medicine and Ethics 49 (3): 418-440. 2021.
    Controlled donation after circulatory determination of death (cDCDD) is an important strategy for increasing the pool of eligible organ donors.
  •  23
    Introduction
    with Corrigan Oonagh and McMillan John
    Journal for Peace and Justice Studies 18 (1-2): 86-86. 2009.
    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.
  •  11
    Informed consent in pragmatic trials: results from a survey of trials published 2014–2019
    with Jennifer Zhe Zhang, Stuart G. Nicholls, Kelly Carroll, Hayden Peter Nix, Cory E. Goldstein, Spencer Phillips Hey, Jamie C. Brehaut, Paul C. McLean, Dean A. Fergusson, and Monica Taljaard
    Journal of Medical Ethics 49 (1): 34-40. 2022.
    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 inc…Read more
  •  4
    Ethics of non-therapeutic research on imminently dying patients in the intensive care unit
    with Nicholas Murphy, Derek Debicki, Geoffrey Laforge, Loretta Norton, Teneille Gofton, and Marat Slessarev
    Journal of Medical Ethics 49 (5): 311-318. 2023.
    Non-therapeutic research with imminently dying patients in intensive care presents complex ethical issues. The vulnerabilities of the imminently dying, together with societal disquiet around death and dying, contribute to an intuition that such research is beyond the legitimate scope of scientific inquiry. Yet excluding imminently dying patients from research hinders the advancement of medical science to the detriment of future patients. Building on existing ethical guidelines for research, we p…Read more
  •  4
    Family experiences with non-therapeutic research on dying patients in the intensive care unit
    with Amanda van Beinum, Nick Murphy, Vanessa Gruben, Aimee Sarti, Laura Hornby, Sonny Dhanani, and Jennifer Chandler
    Journal of Medical Ethics 48 (11): 845-851. 2022.
    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 …Read more
  •  25
    Research participants are afforded protections to ensure their rights and welfare are not unduly jeopardized by research activities. Yet people who do not meet the criteria for research participant status may likewise be impacted by research activities, and ethicists argue that protections should be afforded these “research bystanders.” The standard rationale for extending protections to research bystanders contends that they are sufficiently like research participants that the ethical principle…Read more
  •  8
    Research ethics for emerging trial designs: does equipoise need to adapt?
    with Spencer Phillips Hey, Monica Taljaard, and Aaron S. Kesselheim
    Bmj 360. 2018.
    Key messages The research environment has changed since clinical equipoise was first proposed 30 years ago New trial designs—such as umbrella and basket trials, adaptive platform trials, and cluster randomised trials—raise new ethical challenges for evaluating the state of scientific uncertainty and communicating about risks with patients and participants Clinical equipoise needs to evolve We propose the design of specific guidelines to provide ethics committees and trialists with instructions f…Read more
  •  10
    BackgroundEarly in the COVID-19 pandemic, the urgent need to discover effective therapies for COVID-19 prompted questions about the ethical problem of randomization along with its widely accepted solution: equipoise. In this scoping review, uses of equipoise in discussions of randomized controlled trials of COVID-19 therapies are evaluated to answer three questions. First, how has equipoise been applied to COVID-19 research? Second, has equipoise been employed accurately? And third, do concerns …Read more
  •  12
    Caregiver reactions to neuroimaging evidence of covert consciousness in patients with severe brain injury: a qualitative interview study
    with Adrian M. Owen, Sarah Munce, Laura Elizabeth Gonzalez-Lara, Fiona Webster, and Andrew Peterson
    BMC Medical Ethics 22 (1): 1-13. 2021.
    BackgroundSevere brain injury is a leading cause of death and disability. Diagnosis and prognostication are difficult, and errors occur often. Novel neuroimaging methods can improve diagnostic and prognostic accuracy, especially in patients with prolonged disorders of consciousness (PDoC). Yet it is currently unknown how family caregivers understand this information, raising ethical concerns that disclosure of neuroimaging results could result in therapeutic misconception or false hope.MethodsTo…Read more
  •  8
    Rules of the Road for Patient-Driven Consent Processes
    with Hayden P. Nix
    American Journal of Bioethics 20 (5): 36-37. 2020.
    Volume 20, Issue 5, June 2020, Page 36-37.
  • Accommodating quality and service improvement research within existing ethical principles
    with Cory E. Goldstein, Jamie Brehaut, Marion Campbell, Dean A. Fergusson, Jeremy M. Grimshaw, Karla Hemming, Austin R. Horn, and Monica Taljaard
    Trials 19 (1): 334. 2018.
    Quality and service improvement (QSI) research employs a broad range of methods to enhance the efficiency of healthcare delivery. QSI research differs from traditional healthcare research and poses unique ethical questions. Since QSI research aims to generate knowledge to enhance quality improvement efforts, should it be considered research for regulatory purposes? Is review by a research ethics committee required? Should healthcare providers be considered research participants? If participation…Read more
  • Stepped-wedge trials should be classified as research for the purpose of ethical review
    with Karla Hemming, Monica Taljaard, Tom Marshall, and Cory E. Goldstein
    Clinical Trials 16 (6): 580-588. 2019.
  •  15
  •  6
    Ottawa Statement does not impede randomised evaluation of government health programmes
    with Monica Taljaard
    Journal of Medical Ethics 46 (1): 31-33. 2020.
    In this issue of JME, Watson et al call 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, Watson et al argue that the health programme per se is not within the researcher’s control or responsibility and, thus, is out of scope for ethics …Read more
  •  18
    Working for the Weekend Is Not Meaningful Work
    American Journal of Bioethics 19 (9): 48-50. 2019.
    Volume 19, Issue 9, September 2019, Page 48-50.
  •  19
    Ethical issues raised by cluster randomised trials conducted in low-resource settings: identifying gaps in the Ottawa Statement through an analysis of the PURE Malawi trial
    with Tiwonge K. Mtande, Mina C. Hosseinipour, Monica Taljaard, Mitch Matoga, Cory E. Goldstein, Billy Nyambalo, and Nora E. Rosenberg
    Journal of Medical Ethics 45 (6): 388-393. 2019.
    The increasing use of cluster randomised trials in low-resource settings raises unique ethical issues. The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomised Trials is the first international ethical guidance document specific to cluster trials, but it is unknown if it adequately addresses issues in low-resource settings. In this paper, we seek to identify any gaps in the Ottawa Statement relevant to cluster trials conducted in low-resource settings. Our method is to analys…Read more
  •  23
    Functional MRI shows promise as a candidate prognostication method in acutely comatose patients following severe brain injury. However, further research is needed before this technique becomes appropriate for clinical practice. Drawing on a clinical case, we investigate the process of obtaining informed consent for this kind of research and identify four ethical issues. After describing each issue, we propose potential solutions which would make a patient’s participation in research compatible w…Read more
  •  28
    The Forum
    with Fern Brunger, Simon Shimshon Rubin, Ruth Macklin, Michael A. Grodin, Sondra Crosby, and Susan Douglas Kelley
    Ethics and Behavior 12 (4): 371-387. 2002.
    This Article does not have an abstract
  •  49
    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
  •  10
    What questions can a placebo answer?
    Monash Bioethics Review 34 (1): 23-36. 2016.
    The concept of clinical equipoise restricts the use of placebo controls in clinical trials when there already exists a proven effective treatment. Several critics of clinical equipoise have put forward alleged counter-examples to this restriction—describing instances of ethical placebo-controlled trials that apparently violate clinical equipoise. In this essay, we respond to these examples and show that clinical equipoise is not as restrictive of placebos as these authors assume. We argue that a…Read more
  •  21
    A Principled Argument, But Not a Practical One
    with Andrew Peterson, Lorina Naci, and Adrian M. Owen
    American Journal of Bioethics Neuroscience 4 (1): 52-53. 2013.
  •  54
    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
  •  26
    Momento mori
    with Anthony Serafini, David DeGrazia, P. W. Armstrong, and Robert S. Olick
    Hastings Center Report 24 (3): 49-50. 1994.