Informed Consent Practices in Research Involving Persons with Disorders of Consciousness

Introduction: The Curing Coma Campaign Ethics Working Group sought to understand informed consent practices for research involving persons with disorders of consciousness (DoC) to establish an empirical foundation to formulate common consent elements for research regarding this vulnerable population. Methods: Consent forms for research involving persons with DoC were collected from the Curing Coma Campaign members and Clinicaltrials.gov in the fall of 2024. We abstracted data about study specifics, the consent process, and unique considerations related to persons with DoC and then reviewed and collated them using descriptive statistics. Results: The collection process yielded 58 consent forms: 40 (69%) from member submissions and 18 (31%) from Clinicaltrials.gov. After excluding duplicates and studies that did not pertain to persons with DoC, there were 43 forms, which included 62 unique terms to describe acute brain injury/consciousness/DoC. Of 41 studies that enrolled persons with DoC, there were 4 (10%) that mentioned an evaluation for covert consciousness. Although only 3 (7%) forms mentioned an evaluation for capacity of the person with DoC/recovered from DoC, 16 (39%) referenced first-person consent if the person with DoC regained capacity. Most studies that involved study-specific medications/interventions/tests included some mention of experiential risks (26/32, 81%), but only 2 (6%) specifically addressed the challenges associated with these risks in a person with DoC. Conclusions: Consent forms for research involving persons with DoC include inconsistent terminology to describe acute brain injury/consciousness/DoC, the capacity to consent, and the potential experiential risks of study participation in the context of a DoC. There are opportunities to improve transparency and consistency of communication about research involving persons with DoC via creation of common consent elements to ensure the informed consent process protects individual autonomy.