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Related Concept Videos

Ethics in Research01:56

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Today, scientists agree that good research is ethical in nature and is guided by a basic respect for human dignity and safety. However, this has not always been the case. Modern researchers must demonstrate that the research they perform is ethically sound.
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Transauricular Vagus Nerve Stimulation and Electroencephalographic Assessment in Disorders of Consciousness
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Informed Consent Practices in Research Involving Persons with Disorders of Consciousness.

Ariane Lewis1, Saptharishi Lalgudi Ganesan2,3, Ralf J Jox4

  • 1NYU Langone Health, New York, NY, USA. ariane.kansas.lewis@gmail.com.

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|November 6, 2025
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Summary

Informed consent for research on disorders of consciousness (DoC) lacks consistent terminology and clear communication regarding risks. Developing common consent elements is crucial for protecting autonomy in this vulnerable population.

Keywords:
ComaDisorders of consciousnessEthicsResearch

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Area of Science:

  • Neuroscience
  • Bioethics
  • Clinical Research

Background:

  • The Curing Coma Campaign investigated informed consent for research involving individuals with disorders of consciousness (DoC).
  • Understanding current consent practices is essential for developing standardized consent elements for this vulnerable group.

Purpose of the Study:

  • To analyze informed consent forms used in research with individuals experiencing disorders of consciousness.
  • To identify inconsistencies in terminology and risk communication within these consent forms.

Main Methods:

  • Collected 58 consent forms from Curing Coma Campaign members and ClinicalTrials.gov in Fall 2024.
  • Abstracted data on study specifics, consent processes, and DoC-related considerations.
  • Utilized descriptive statistics to review and collate the abstracted data.

Main Results:

  • Analyzed 43 unique consent forms for research involving individuals with DoC.
  • Found inconsistent terminology (62 terms) for brain injury/consciousness/DoC.
  • Few forms (10%) mentioned covert consciousness evaluation, and even fewer (7%) addressed capacity to consent.
  • While 81% mentioned experiential risks, only 6% detailed challenges for individuals with DoC.

Conclusions:

  • Consent forms for DoC research exhibit significant inconsistencies in terminology, capacity assessment, and risk communication.
  • There is a clear need for common consent elements to enhance transparency and consistency.
  • Standardized elements will better protect the autonomy of individuals with disorders of consciousness during research participation.