Intended for healthcare professionals


Consent for research in hyperacute stroke

BMJ 2006; 332 doi: (Published 15 June 2006) Cite this as: BMJ 2006;332:1405
  1. Lynne Stobbart, Department of Health research capacity development research fellow (,
  2. Madeleine J Murtagh, lecturer in social sciences and public health,
  3. Stephen J Louw, chair, Newcastle upon Tyne Hospitals NHS Trust Clinical Ethics Advisory Group,
  4. Gary A Ford, consultant stroke physician,
  5. Helen Rodgers, reader in stroke medicine
  1. School of Population and Health Sciences, Faculty of Medicine, University of Newcastle upon Tyne, Newcastle upon Tyne NE2 4HH
  2. Department of General Internal Medicine, Freeman Hospital, Newcastle upon Tyne NE7 7DN
  3. Stroke Research Group, Institute for Ageing and Health, Clinical Research Facility, Royal Victoria Infirmary, Newcastle upon Tyne NE1 4LP

    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 …

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