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
