•  29
    In her article, Pascale Hess raises the issue of whether her proposed model may be extrapolated and applied to clinical research fields other than stem cell-based interventions in the brain (SCBI-B) (Hess 2012). Broadly summarized, Hess’s model suggests prioritizing efficacy over safety in phase 1 trials involving irreversible interventions in the brain, when clinical criteria meet the appropriate population suffering from “degenerative brain diseases” (Hess 2012). Although there is a need to re…Read more
  •  25
    Is a ‘Last Chance’ Treatment Possible After an Irreversible Brain Intervention?
    with Frederic Gilbert, Susan Dodds, and Robert M. I. Kapsa
    American Journal of Bioethics Neuroscience 6 (2). 2015.
  •  24
    Controlling Brain Cells With Light: Ethical Considerations for Optogenetic Clinical Trials
    with Frederic Gilbert and Robert M. I. Kapsa
    American Journal of Bioethics Neuroscience 5 (3): 3-11. 2014.
  •  11
    This paper examines potential ethical and legal issues arising during the research, develop- ment and clinical use of a proposed strategy in personalized medicine (PM): using human induced pluripotent stem cell (iPSC)-derived tissue cultures as predictive models of individ- ual patients to inform treatment decisions. We focus on epilepsy treatment as a likely early application of this strategy, for which early-stage stage research is underway. In relation to the research process, we examine issu…Read more
  •  7
    In their article, Sankary et al. (2022) provided important preliminary findings on how research participants exiting from clinical trials engage in decisions related to the removal or post-trial us...
  •  5
    Clinical trials aim to minimise participant risk and generate new clinical knowledge for the wider population. Many military agencies are now investing efforts in pushing towards developing new treatments involving Brain-Computer Interfaces, Gene Therapy and Stem Cells interventions. These trials are targeting smaller disease groups, as such they give rise to novel participant risks of harms that are largely not accommodated by existing practice. This is of most concern with irreversible harms a…Read more