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.

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.