•  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
  •  33
    Does benefit justify research with children?
    Bioethics 32 (1): 27-35. 2018.
    The inclusion of children in research gives rise to a difficult ethical question: What justifies children's research participation and exposure to research risks when they cannot provide informed consent? This question arises out of the tension between the moral requirement to obtain a subject's informed consent for research participation, on the one hand, and the limited capacity of most children to provide informed consent, on the other. Most agree that children's participation in clinical res…Read more
  •  23
    Position statement on ethics, equipoise and research on charged particle radiation therapy
    with Mark Sheehan, Claire Timlin, Ken Peach, and Wilson Puthenparampil
    Journal of Medical Ethics 40 (8): 572-575. 2014.
    The use of charged-particle radiation therapy 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 thi…Read more
  •  23
    Rethinking Risk in Pediatric Research
    with Kathleen Cranley Glass
    Journal of Law, Medicine and Ethics 36 (3): 567-576. 2008.
    This article reviews four areas of pediatric research in which we have identified questionable levels of allowable risk, exceeding those foreseen by the Commission. They are the following: the categorization of increasingly risky interventions as minimal risk in a variety of protocols; the increasing number of applications for federal panel review of research not otherwise approvable because of higher projected risk levels; research on asymptomatic at risk children; and the inclusion of children…Read more
  •  19
    On the Minimal Risk Threshold in Research With Children
    American Journal of Bioethics 14 (9): 3-12. 2014.
    To protect children in research, procedures that are not administered in the medical interests of a child must be restricted. The risk threshold for these procedures is generally measured according to the concept of minimal risk. Minimal risk is often defined according to the risks of “daily life.” But it is not clear whose daily life should serve as the baseline; that is, it is not clear to whom minimal risk should refer. Commentators in research ethics often argue that “minimal risk” should re…Read more
  •  19
    Minimal Risk Remains an Open Question
    with Charles Weijer and Mark Sheehan
    American Journal of Bioethics 11 (6). 2011.
    The American Journal of Bioethics, Volume 11, Issue 6, Page 25-27, June 2011
  •  17
  •  15
    This thesis is a contribution to the ethical justification for clinical research with children. A research subject’s participation in a trial is usually justified, in part, by informed consent. Informed consent helps to uphold the moral principle of respect for persons. But children’s limited ability to make informed choices gives rise to a problem. It is unclear what, if anything, justifies their participation in research. Some research ethicists propose to resolve this problem by appealing to …Read more
  •  10
    Minority report: can minor parents refuse treatment for their child?
    with Helen Lynne Turnham and Dominic Wilkinson
    Journal of Medical Ethics 46 (6): 355-359. 2020.
    Infants are unable to make their own decisions or express their own wishes about medical procedures and treatments. They rely on surrogates to make decisions for them. Who should be the decision-maker when an infant’s biological parents are also minors? In this paper, we analyse a case in which the biological mother is a child. The central questions raised by the case are whether minor parents should make medical decisions on behalf of an infant, and if so, what are the limits to this decision-m…Read more
  •  9
    Delaying and withholding interventions: ethics and the stepped wedge trial
    Journal of Medical Ethics 45 (10): 662-667. 2019.
    Ethics has been identified as a central reason for choosing the stepped wedge trial over other kinds of trial designs. The potential advantage of the stepped wedge design is that it provides all arms of the trial with the active intervention over the course of the study. Some groups receive it later than others, but the study intervention is not withheld from any group. This feature of the stepped wedge design seems particularly ethically advantageous in two instances: when the study interventio…Read more
  •  9
    Randomization Should Be Disclosed to Potential Research Subjects
    with Mark Sheehan
    American Journal of Bioethics 13 (12): 35-37. 2013.
    No abstract
  •  6
    A Defense of The-Risks-of-Daily-Life
    Kennedy Institute of Ethics Journal 27 (3): 413-442. 2017.
    Most agree that clinical research offers one of the best prospects of improving pediatric medicine. Most also agree that children may be exposed to some degree of risk while participating in clinical trials. But the degree of risk that should be permitted and the reasons for which it should be permitted remain controversial. In this paper, I examine a central risk threshold in research with children—the threshold constraining risks that do not offer research subjects the prospect of direct medic…Read more
  •  5
    SARS-CoV-2 challenge studies: ethics and risk minimisation
    with Susan Bull, Euzebiusz Jamrozik, and Michael J. Parker
    Journal of Medical Ethics 47 (12): 79-79. 2021.
    COVID-19 poses an exceptional threat to global public health and well-being. Recognition of the need to develop effective vaccines at unprecedented speed has led to calls to accelerate research pathways ethically, including by conducting challenge studies ) with SARS-CoV-2. Such research is controversial, with concerns being raised about the social, legal, ethical and clinical implications of infecting healthy volunteers with SARS-CoV-2 for research purposes. Systematic risk evaluations are crit…Read more
  •  1
    Ethics guidelines and commentary suggest that a central function of research ethics committees is to assess the scientific merit of the protocols they review. However, some commentators object to this role, and evidence suggests that the assessment of scientific merit is a significant source of confusion and animosity between ethics committees and clinical investigators. In this essay, we argue that ethics committees should assess the scientific value and validity of research protocols and that …Read more
  • Logistic, Ethical, and political dimensions of stepped wedge trials: critical review and case studies
    with Audrey Prost, Abubakar Ibrahim, Anjana Roy, Manuela de Allegri, Christelle Mouchoux, Tobias Dreischulte, Helen Ayles, James J. Lewis, and David Osrin
    Trials 1 (16): 351. 2015.
  • Does clinical equipoise apply to cluster randomized trials in health research?
    with Charles Weijer, Andrew McRae, Jeremy Grimshaw, Monica Taljaard, Robert Boruch, Jamie Brehaut, Allan Donner, Martin Eccles, Antonio Gallo, Raphael Saginur, and Merrick Zwarenstein
    Trials 12. 2011.
  • Who is the research subject in cluster randomized trials in health research?
    with Andrew D. McRae, Charles Weijer, 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.
  • When is informed consent required in cluster randomized trials in health research?
    with Andrew D. McRae, Charles Weijer, 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.