Consent for research in hyperacute stroke

Essential studies in the first six hours are hampered by rules on consent

Stroke accounts for 11% of deaths in England and Wales each year.1 Without improvements in strategies for prevention or treatment in an increasingly ageing society the incidence of vascular events, particularly stroke, will increase by 33% by 2020.2 Yet, according to the National Audit Office, “An emergency response to stroke with efficient and effective acute care is generally lacking.”1

Increased research capacity will be essential to developing such a response, and the recently established Stroke Research Network aims to develop this capacity to improve prevention, treatment, and rehabilitation in stroke. But recent European legislation may curtail participation by patients with stroke in such clinical trials.

The Medicines for Human Use (Clinical Trials) Regulations 20043 implement the European Union Clinical Trials Directive (2001/20/EC),4 potentially restricting research with incapacitated adults. A considerable proportion of patients with stroke are unable to give informed consent owing to their neurological impairment. Most interventions in acute stroke have short therapeutic time windows, hence the maxim “Time is …