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Health Care in Contexts of Risk, Uncertainty, and Hybridity pp 253–273Cite as

Military Medicine Research: Incorporation of High Risk of Irreversible Harms into a Stratified Risk Framework for Clinical Trials

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Part of the book series: Military and Humanitarian Health Ethics ((MHHE))

Abstract

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 at early trial stages, where participants may forfeit any future therapy, and in personalised medicine, where the individual participant assumes all of the trial risk. Given these new experimental interventions involve high risk of irreversible harms, how much risk should patients be exposed to when participating in experimental testing of innovative technologies? Designing clinical trials which better balance risk/benefit ratios for participants is crucial. The aim of this book chapter is to suggest a new stratified risk framework aimed at minimising the risk-benefit ratio to participants in clinical trials associated with high risk of irrevocable harms. We will argue (a) it demands a higher-level of clinical data capture at earlier trial stages than predicated by current trial doctrine; (b) it also requires publication of all trial data to minimise risk to participants of any future trial.

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Acknowledgements

Funding from the Australian Research Council Discovery Early Career Researcher Award (project number DE150101390) and from Centre of Excellence Scheme (Project Number CE140100012) are gratefully acknowledged.

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Authors and Affiliations

  1. University of Melbourne, Melbourne, Australia

    Alexander R. Harris

  2. University of Tasmania, Hobart, Australia

    Frederic Gilbert

Authors
  1. Alexander R. Harris
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  2. Frederic Gilbert
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Editors and Affiliations

  1. Zurich Center for Military Medical Ethics, Center for Ethics, University of Zürich, Zürich, Switzerland

    Daniel Messelken

  2. Center of Reference for Education on IHL & Ethics, International Committee of Military Medicine, Bern, Switzerland

    David Winkler

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Harris, A.R., Gilbert, F. (2022). Military Medicine Research: Incorporation of High Risk of Irreversible Harms into a Stratified Risk Framework for Clinical Trials. In: Messelken, D., Winkler, D. (eds) Health Care in Contexts of Risk, Uncertainty, and Hybridity. Military and Humanitarian Health Ethics. Springer, Cham. https://doi.org/10.1007/978-3-030-80443-5_16

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