Dr Mackenzie Graham

Functional MRI shows promise as a candidate prognostication method in acutely comatose patients following severe brain injury. However, further research is needed before this technique becomes appropriate for clinical practice. Drawing on a clinical case, we investigate the process of obtaining informed consent for this kind of research and identify four ethical issues. After describing each issue, we propose potential solutions which would make a patient's participation in research compatible with her rights and interests. First, we defend the need for traditional proxy consent against two alternative approaches. Second, we examine the impact of the intensive care unit environment on the informed consent process. Third, we discuss the therapeutic misconception and its potential influence on informed consent. Finally, we deal with issues of timing in recruiting participants and related factors which may affect the risks of participation.

Robust prognostic indicators of neurological recovery are urgently needed for acutely comatose patients. Functional neuroimaging is a highly sensitive tool for uncovering covert cognition and awareness in behaviorally nonresponsive patients with prolonged disorders of consciousness, and may be applicable to acutely comatose patients. Establishing a link between early detection of covert awareness in acutely comatose patients and eventual recovery of function could have significant implications for patient prognosis, treatment, and end-of-life decisions. Because functional neuroimaging of acutely comatose patients is currently limited to the research context, ethical guidelines for disseminating a patient's individual research results to clinical teams and surrogate decision makers are needed. We propose an ethical framework composed of four conditions that can guide ethical disclosure of individual results of neuroimaging research in the acute care context.