Informed consent procedures for emergency interventional research in patients with traumatic brain injury and ischaemic stroke

Informed consent procedures for emergency interventional research in patients with traumatic brain injury and ischaemic stroke
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Erwin J O Kompanje, Jeroen T J M van Dijck, Vicky Chalos, Sophie A van den Berg, Paula M Janssen, Paul J Nederkoorn, Mathie uvan der Jagt, Giuseppe Citerio, Nino Stocchetti, Diederik W J Dippel, Wilco C Peul
The Lancet Neurology, 21 October 2020
Summary
Health-care professionals and researchers have a legal and ethical responsibility to inform patients before carrying out diagnostic tests or treatment interventions as part of a clinical study. Interventional research in emergency situations can involve patients with some degree of acute cognitive impairment, as is regularly the case in traumatic brain injury and ischaemic stroke. These patients or their proxies are often unable to provide informed consent within narrow therapeutic time windows. International regulations and national laws are criticised for being inconclusive or restrictive in providing solutions. Currently accepted consent alternatives are deferred consent, exception from consent, or waiver of consent. However, these alternatives appear under-utilised despite being ethically permissible, socially acceptable, and regulatorily compliant. We anticipate that, when the requirements for medical urgency are properly balanced with legal and ethical conduct, the increased use of these alternatives has the potential to improve the efficiency and quality of future emergency interventional studies in patients with an inability to provide informed consent.

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