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Common Consent Elements for Research Involving Persons with Disorders of Consciousness (CCE-DOC)

  • Ethical Matters
  • Published:

Abstract

Persons with disorders of consciousness (DoC) occupy an ethically charged space in modern medicine and biomedical research. Their decisional capacity is characteristically absent or limited or unpredictably fluctuates, requiring clinicians and investigators to rely on surrogates. Although there is general guidance for informed consent (IC) for research studies, there is no specific guidance for research involving persons with DoC. There are inconsistencies in IC forms for these studies related to explanation of a DoC, evaluation of capacity, description of risks/benefits, and sharing investigational results. This is problematic for persons with DoC, their surrogates, researchers, and institutional review boards (IRBs)/research ethics boards (REBs). To address these issues, the Curing Coma Campaign (CCC) Ethics Workgroup developed the Common Consent Elements for Research Involving Persons with Disorders of Consciousness (CCE-DoC). This practical framework aims to clarify and standardize consent processes in this complex and ethically sensitive research area. Through this structured, adaptable approach, CCE-DoC may have the potential to enhance participant protections, strengthen trust, help families and decision-makers understand studies, reduce duplicative efforts across research groups, and guide investigators and IRBs/REBs in navigating the complex ethical terrain of consent in DoC research. In so doing, CCE-DoC seeks to extend respect for autonomy and trust and promote responsible research urgently needed to advance paradigms of diagnosis, prognosis, and treatment for individuals with disorders of consciousness. The framework offers example language to encourage standardization, while allowing teams flexibility to customize to local needs.

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Acknowledgements

We are grateful for valuable input provided by representatives of the Curing Coma Campaign Patient Family Advisory Committee (PFAC) on the example CCE language presented in section IV, in particular feedback from Nicholas Onofrey, Meaghan Onofrey, and Cynthia Cook.

Funding

No direct funding was received for this study.

Author information

Authors and Affiliations

  1. Massachusetts General Hospital, Harvard Medical School, 55 Fruit Street, Boston, MA, 02116, USA

    Michael J. Young

  2. Departments of Paediatrics and Clinical Neurological Sciences, Schulich School of Medicine & Dentistry, Western University, London, ON, Canada

    Saptharishi Lalgudi Ganesan

  3. Children’s Hospital—London Health Sciences Center, London, ON, Canada

    Saptharishi Lalgudi Ganesan

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

    Ralf J. Jox

  5. Department of Human Pathology, Anesthesia and Intensive Care, University of Messina, Messina, Italy

    Anna Teresa Mazzeo

  6. University of Texas Southwestern Medical School, Dallas, TX, USA

    Michael A. Rubin

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

    Jennifer K. Walter

  8. NYU Langone Medical Center, New York, NY, USA

    Ariane Lewis

Authors
  1. Michael J. Young
  2. Saptharishi Lalgudi Ganesan
  3. Ralf J. Jox
  4. Anna Teresa Mazzeo
  5. Michael A. Rubin
  6. Jennifer K. Walter
  7. Ariane Lewis

Consortia

The Curing Coma Campaign, its contributing members

Contributions

M.J.Y. and A.L. were responsible for conception and design, drafting of the manuscript, and final approval of the manuscript. S.L.G., R.J.J., A.M., M.R., and J.W. were responsible for critical revision of the manuscript and final approval of the manuscript. The Curing Coma Campaign and its contributing members had final approval of the manuscript. The manuscript requirements have been met, and the manuscript has been approved by all authors. This manuscript has not been published elsewhere and is not under review elsewhere. No checklists are applicable. The Curing Coma Campaign and its contributing members had final approval of the manuscript.

Corresponding author

Correspondence to Michael J. Young.

Ethics declarations

Conflict of interest

M.J.Y. has received support from the National Institutes of Health (NIH) BRAIN Initiative (F32MH123001), the NIH National Institute of Neurological Disorders and Stroke (1K23NS140495), NIH Common Fund’s Bridge2AI (OT2OD0327), US Department of Defense [Congressionally Directed Medical Research Programs (CDMRP) HT9425-1-1081], and the Chen Institute Mass General Neuroscience Transformative Scholar Award. S.L.G. has received research funding from the Brain Canada, the Azrieli Foundation, the Academic Medical Organizations of Southwestern Ontario, and the Canadian Institutes of Health Research.

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This commentary is related to the original paper available at 10.1007/s12028-026-02499-y.

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Young, M.J., Lalgudi Ganesan, S., Jox, R.J. et al. Common Consent Elements for Research Involving Persons with Disorders of Consciousness (CCE-DOC). Neurocrit Care (2026). https://doi.org/10.1007/s12028-026-02498-z

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