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Ethics Along the Continuum of Research Involving Persons with Disorders of Consciousness

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Abstract

Interest in disorders of consciousness (DoC) has grown substantially over the past decade and has illuminated the importance of improving understanding of DoC biology; care needs (use of monitoring, performance of interventions, and provision of emotional support); treatment options to promote recovery; and outcome prediction. Exploration of these topics requires awareness of numerous ethics considerations related to rights and resources. The Curing Coma Campaign Ethics Working Group used its expertise in neurocritical care, neuropalliative care, neuroethics, neuroscience, philosophy, and research to formulate an informal review of ethics considerations along the continuum of research involving persons with DoC related to the following: (1) study design; (2) comparison of risks versus benefits; (3) selection of inclusion and exclusion criteria; (4) screening, recruitment, and enrollment; (5) consent; (6) data protection; (7) disclosure of results to surrogates and/or legally authorized representatives; (8) translation of research into practice; (9) identification and management of conflicts of interest; (10) equity and resource availability; and (11) inclusion of minors with DoC in research. Awareness of these ethics considerations when planning and performing research involving persons with DoC will ensure that the participant rights are respected while maximizing the impact and meaningfulness of the research, interpretation of outcomes, and communication of results.

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Acknowledgements

The authors would like to thank all the collaborators of the Curing Coma Campaign (see Supplemental Table 1).

Funding

No direct funding was received for this study. JC has an RO1 supplement for studying ethics implications of disorders of consciousness (3RO1NS106014-02S1). MJY is supported by the NIH Brain Research Through Advancing Innovative Neurotechnologies® Initiative (F32MH123001) and the American Academy of Neurology (Palatucci Advocacy Award). JI is Distinguished University Scholar and University of British Columbia Distinguished Professor in Neuroethics. JJF is supported by NIH BRAIN Initiative (1UH3 NS095554; 1RF1MH12378-01) and the NIH Eunice Kennedy Shriver National Institute of Child Health (1DP2hD1010400-01). The other authors have no financial conflicts of interest.

Author information

Authors and Affiliations

  1. NYU Langone Medical Center, 530 First Avenue, Skirball-7R, New York, NY, 10016, USA

    Ariane Lewis

  2. Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA

    Michael J. Young

  3. Inserm, CNRS, APHP - Hôpital de la Pitié Salpêtrière, Paris Brain Institute - ICM, DMU Neuroscience, Sorbonne University, Paris, France

    Benjamin Rohaut

  4. Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland

    Ralf J. Jox

  5. New York Presbyterian Hospital, Columbia University, New York, NY, USA

    Jan Claassen

  6. Harborview Medical Center, Seattle, WA, USA

    Claire J. Creutzfeldt

  7. University of Washington, Seattle, WA, USA

    Claire J. Creutzfeldt

  8. Cambia Palliative Care Center of Excellence, Seattle, WA, USA

    Claire J. Creutzfeldt

  9. University of British Columbia, Vancouver, BC, Canada

    Judy Illes

  10. The Children’s Hospital of Philadelphia, Philadelphia, PA, USA

    Matthew Kirschen

  11. Northwest Neurology, Chicago, IL, USA

    Stephen Trevick

  12. Weill Cornell Medical College, New York, NY, USA

    Joseph J. Fins

  13. Yale Law School, New Haven, CT, USA

    Joseph J. Fins

  14. Rockefeller University, New York, NY, USA

    Joseph J. Fins

Authors
  1. Ariane Lewis
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  2. Michael J. Young
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  3. Benjamin Rohaut
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  4. Ralf J. Jox
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  5. Jan Claassen
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  6. Claire J. Creutzfeldt
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  7. Judy Illes
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  8. Matthew Kirschen
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  9. Stephen Trevick
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  10. Joseph J. Fins
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and The Curing Coma Campaign and its Contributing Members

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All authors were responsible for conception and design, drafting the manuscript, critical revision of the manuscript and final approval of the manuscript. The Curing Coma Campaign and its contributing members, which includes the following individuals, had final approval of the manuscript: CH, DWO, LP.

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Correspondence to Ariane Lewis.

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Lewis, A., Young, M.J., Rohaut, B. et al. Ethics Along the Continuum of Research Involving Persons with Disorders of Consciousness. Neurocrit Care 39, 565–577 (2023). https://doi.org/10.1007/s12028-023-01708-2

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