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.
- informed consent
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Contributor TB and CW conceptualized the paper. TB wrote the first draft of the paper, and MG and CW edited and rewrote sections of the next draft of the paper. All other team members provided comments on subsequent drafts of the paper. All authors approved the final paper.
Funding This study was funded by the Canadian Institutes of Health Research (grant numbers: 201110GSD-277640-183782 and MOP133705).
Competing interests TG reports grants from the Lawson Health Research Institute, the Academic Medical Organization of Southwestern Ontario and St Joseph’s Health Care Foundation; she receives other funding from Medtronic for being an examining neurologist in the SURTAVI trial and from SAGE Therapeutics for being a site principal investigator in a clinical trial. CW receives consulting income from Eli Lilly and Company Canada. All other authors report no competing interests.
Patient consent Not required.
Ethics approval Western University’s Health Sciences Research Ethics Board approved the protocol of the functional MRI study.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement This article is argument-based, so that there are no unpublished data to be shared.
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