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Review
. 2018 Oct;38(5):539-547.
doi: 10.1055/s-0038-1668077. Epub 2018 Oct 15.

Informed Consent for the Human Research Subject With a Neurologic Disorder

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Review

Informed Consent for the Human Research Subject With a Neurologic Disorder

Neil H Vaishnav et al. Semin Neurol. .

Abstract

The doctrine of informed consent sits at the intersection of law, ethics, and neuroscience, posing unique challenges for human subject research involving neurological patients. These challenges are compounded by the variegated nature of both neurological injury and the law governing research consent. This article provides a framework for investigators likely to encounter subjects with some degree of neurological impairment, whose capacity to consent requires scrupulous assessment prior to enrollment in research trials. We consider several researches and disease contexts-from emergency epilepsy research to long-term dementia research-and clarify the ethical and legal principles governing consent for participation in each. We additionally explore empirical research on consent capacity and survey several areas of emerging ethical import that will require the attention of investigators in decades to come.

Conflict of interest statement

Disclosure The authors report no conflicts of interest in this work.

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