• Roel P J van Wijk, van Dijck Jeroen T J M JTJM University Neurosurgical Center Holland, LUMC, HMC & HAGA, Leiden & The Hague, the Netherlands., Marjolein Timmers, Ernest van Veen, Giuseppe Citerio, Hester F Lingsma, Maas Andrew I R AIR Department of Neurosurgery, Antwerp University Hospital, Edegem, Belgium; University of Antwerp, Antwerp, Belgium., David K Menon, Wilco C Peul, Nino Stocchetti, Kompanje Erwin J O EJO Department of Intensive Care, Erasmus MC - University Medical Centre Rotterdam, Rotterdam, the Netherlands; Department of Medical Ethics and Philos, and CENTER-TBI investigators and participants.
• University Neurosurgical Center Holland, LUMC, HMC & HAGA, Leiden & The Hague, the Netherlands.
• J Crit Care. 2020 Oct 1; 59: 6-15.

PurposeEnrolling traumatic brain injury (TBI) patients with an inability to provide informed consent in research is challenging. Alternatives to patient consent are not sufficiently embedded in European and national legislation, which allows procedural variation and bias. We aimed to quantify variations in informed consent policy and practice.MethodsVariation was explored in the CENTER-TBI study. Policies were reported by using a questionnaire and national legislation. Data on used informed consent procedures were available for 4498 patients from 57 centres across 17 European countries.ResultsVariation in the use of informed consent procedures was found between and within EU member states. Proxy informed consent (N = 1377;64%) was the most frequently used type of consent in the ICU, followed by patient informed consent (N = 426;20%) and deferred consent (N = 334;16%). Deferred consent was only actively used in 15 centres (26%), although it was considered valid in 47 centres (82%).ConclusionsAlternatives to patient consent are essential for TBI research. While there seems to be concordance amongst national legislations, there is regional variability in institutional practices with respect to the use of different informed consent procedures. Variation could be caused by several reasons, including inconsistencies in clear legislation or knowledge of such legislation amongst researchers.Copyright © 2020. Published by Elsevier Inc.

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