•  1
    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
  •  3
    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. 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 examin…Read more
  •  7
    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.
  •  11
  •  4
    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
  •  14
    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.
  •  12
    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
  •  17
    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
  •  24
    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
  •  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
  •  8
    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
  •  13
    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.
  •  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
  •  20
    Momento mori
    with Anthony Serafini, David DeGrazia, P. W. Armstrong, and Robert S. Olick
    Hastings Center Report 24 (3): 49-50. 1994.
  •  28
    Reporting of patient consent in healthcare cluster randomised trials is associated with the type of study interventions and publication characteristics
    with Andrew McRae, Monica Taljaard, Carol Bennett, Zoe Skea, Robert Boruch, Jamie Brehaut, Martin Eccles, Jeremy Grimshaw, and Allan Donner
    Journal of Medical Ethics 39 (2): 119-124. 2013.
    Objective Cluster randomised trial (CRT) investigators face challenges in seeking informed consent from individual patients (cluster members). This study examined associations between reporting of patient consent in healthcare CRTs and characteristics of these trials. Study design Consent practices and study characteristics were abstracted from a random sample of 160 CRTs performed in primary or hospital care settings that were published from 2000 to 2008. Multivariable logistic regression was u…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
  • Ethical Issues Posed by Cluster Randomized Trials in Health Research
    with Jeremy M. Grimshaw, Monica Taljaard, Ariella Binik, Robert Boruch, Jamie C. Brehaut, Allan Donner, Martin P. Eccles, Antonio Gallo, Andrew D. McRae, and Ray Saginur
    Trials 1 (12): 100. 2011.
  • When is informed consent required in cluster randomized trials in health research?
    with Andrew D. McRae, Ariella Binik, Angela White, Jeremy M. Grimshaw, Robert Boruch, Jamie C. Brehaut, Allan Donner, Martin P. Eccles, Raphael Saginur, Merrick Zwarenstein, and Monica Taljaard
    Trials 1 (12): 202. 2011.
  • Who is the research subject in cluster randomized trials in health research?
    with Andrew D. McRae, Ariella Binik, Jeremy M. Grimshaw, Monica Taljaard, Robert Boruch, Jamie C. Brehaut, Allan Donner, Martin P. Eccles, Antonio Gallo, Ray Saginur, and Merrick Zwarenstein
    Trials 1 (12): 118. 2011.
  •  1
    Trial by ErrorThe Ethics of Biomedical Research: An International Perspective
    with Baruch A. Brody
    Hastings Center Report 31 (1): 47. 2001.
  •  8
    Thinking clearly about the FIRST trial: addressing ethical challenges in cluster randomised trials of policy interventions involving health providers
    with Austin R. Horn, Spencer Phillips Hey, Jamie Brehaut, Dean A. Fergusson, Cory E. Goldstein, Jeremy Grimshaw, and Monica Taljaard
    Journal of Medical Ethics 44 (9): 593-598. 2018.
    The ethics of the Flexibility In duty hour Requirements for Surgical Trainees trial have been vehemently debated. Views on the ethics of the FIRST trial range from it being completely unethical to wholly unproblematic. The FIRST trial illustrates the complex ethical challenges posed by cluster randomised trials of policy interventions involving healthcare professionals. In what follows, we have three objectives. First, we critically review the FIRST trial controversy, finding that commentators h…Read more
  •  1
    Trial by Error (review)
    Hastings Center Report 31 (1): 47. 2001.
  •  10
    An Ethical Analysis of the SUPPORT Trial: Addressing Challenges Posed by a Pragmatic Comparative Effectiveness Randomized Controlled Trial
    with Austin R. Horn, Jeremy Grimshaw, Jamie Brehaut, Dean Fergusson, Cory E. Goldstein, and Monica Taljaard
    Kennedy Institute of Ethics Journal 28 (1): 85-118. 2018.
    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 framewor…Read more
  •  22
    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): 14. 2018.
    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. We conducted a scoping review of articles addressing ethical aspects of pragmatic RCTs. After applying the search strategy and eligibility criteria, 36 articles were inc…Read more
  •  8
    Does Consent Form Follow Function?
    with Jamie Brehaut and Cory E. Goldstein
    American Journal of Bioethics 17 (12): 29-31. 2017.
  •  5
    Rotman Institute Opening
    with Joseph Rotman, Janice Deakin, Jane Maienschein, and Philip Kitcher
  •  12
    Assessing Decision-Making Capacity in Patients with Communication Impairments
    with Molly Cairncross, Andrew Peterson, Andrea Lazosky, and Teneille Gofton
    Cambridge Quarterly of Healthcare Ethics 25 (4): 691-699. 2016.