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. 2023 Dec;39(3):565-577.
doi: 10.1007/s12028-023-01708-2. Epub 2023 Mar 28.

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

Ariane Lewis  1 , Michael J Young  2 , Benjamin Rohaut  3 , Ralf J Jox  4 , Jan Claassen  5 , Claire J Creutzfeldt  6   7   8 , Judy Illes  9 , Matthew Kirschen  10 , Stephen Trevick  11 , Joseph J Fins  12   13   14 ; The Curing Coma Campaign and its Contributing Members
Affiliations

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

Ariane Lewis et al. Neurocrit Care. 2023 Dec.

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.

Keywords: Coma; Disorders of consciousness; Ethics; Research.

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Conflict of interest statement

Researchers may have a variety of relationships with companies that develop medications and devices related to the care of, or research involving persons with DoC, which could lead to COI (a conflict between their private interests and official responsibilities). Because the population of persons with DoC is rather small and the number of researchers as well as companies that produce specific tools for this population are also limited, the likelihood for COI may be higher than in other areas of medicine. There are many forms of COI including personal or surrogate financial compensation, stock ownership, research support, institutional financial support, gifts, or promise of personal success. Although data on COI for research involving persons with DoC are not available, industry-related COI are prevalent among authors based in the United States in high-impact neurology journals [89].

These COI can bias researchers in study design, participant selection, recruitment and enrollment, consent, formulation of results, dissemination of findings, and translation of research into practice. In fact, both the rhetoric to describe results and the conclusions themselves of industry and pharmaceutical company funded neurology research may differ from nonfunded research [90]. This cannot be addressed through dissociation between researchers and industry and pharmaceutical companies because this would severely limit discovery [91]. Rather, all members of the team performing research involving persons with DoC must adhere to the guidance written by relevant professional organizations (e.g., the American Academy of Neurology and American Academy of Neurological Surgery) on management of COI [92, 93]. Researchers must self-identify and disclose all forms of COI to funding organizations, IRBs, persons with DoC and/or their surrogates, and peer review journals [94]. Further, they are responsible for determining ways to prevent, or at least mitigate, the effect of COI on research [95]. COI may be mitigated via self-recusal or required removal of individuals with identified COI from certain activities or decision-making tasks or staged involvement by investigators with step-back roles as the work evolves [96]. A more extreme way to address COI is through restriction, or prohibition, of participation in a research study whereby participation in the study requires termination of any conflicting financial relationships or roles.

Conflict of interest

The authors have no conflicts of interest.

References

    1. Mainali S, Aiyagari V, Alexander S, et al. Proceedings of the Second Curing Coma Campaign NIH Symposium: Challenging the Future of Research for Coma and Disorders of Consciousness. Neurocritical Care. 2022:1–25. - PMC - PubMed
    1. Young MJ, Bodien YG, Edlow BL. Ethical considerations in clinical trials for disorders of consciousness. Brain Sci. 2022;12(2):211. - PMC - PubMed
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