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Semin Neurol 2018; 38(05): 539-547
DOI: 10.1055/s-0038-1668077
Review Article
Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Informed Consent for the Human Research Subject with a Neurologic Disorder

Neil H. Vaishnav
1   San Francisco School of Medicine, University of California, San Francisco, California
,
Winston Chiong
2   San Francisco Weill Institute for Neurosciences, University of California, San Francisco, California
› Author Affiliations
Further Information

Publication History

Publication Date:
15 October 2018 (online)

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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.

Keywords

consent - capacity - law - ethics - neurologic
 

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