Informed consent procedures in patients with an acute inability to provide informed consent: Policy and practice in the CENTER-TBI study.

Autor: van Wijk RPJ; University Neurosurgical Center Holland, LUMC, HMC & HAGA, Leiden & The Hague, the Netherlands., van Dijck JTJM; University Neurosurgical Center Holland, LUMC, HMC & HAGA, Leiden & The Hague, the Netherlands., Timmers M; Department of Intensive Care, Erasmus MC - University Medical Centre Rotterdam, Rotterdam, the Netherlands., van Veen E; Department of Intensive Care, Erasmus MC - University Medical Centre Rotterdam, Rotterdam, the Netherlands; Centre for Medical Decision Making, Department of Public Health, Erasmus MC - University Medical Centre Rotterdam, Rotterdam, the Netherlands., Citerio G; School of Medicine and Surgery, University of Milan-Bicocca, Milan, Italy; San Gerardo Hospital, ASST, Monza, Italy., Lingsma HF; Centre for Medical Decision Making, Department of Public Health, Erasmus MC - University Medical Centre Rotterdam, Rotterdam, the Netherlands., Maas AIR; Department of Neurosurgery, Antwerp University Hospital, Edegem, Belgium; University of Antwerp, Antwerp, Belgium., Menon DK; Department of Anaesthesia, University of Cambridge, Cambridge, United Kingdom., Peul WC; University Neurosurgical Center Holland, LUMC, HMC & HAGA, Leiden & The Hague, the Netherlands., Stocchetti N; Department of Physiopathology and Transplantation, Milan University, Milan, Italy; Neuro ICU Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milano, Milan, Italy., Kompanje EJO; Department of Intensive Care, Erasmus MC - University Medical Centre Rotterdam, Rotterdam, the Netherlands; Department of Medical Ethics and Philosophy of Medicine, Erasmus MC - University Medical Centre Rotterdam, Rotterdam, the Netherlands. Electronic address: e.j.o.kompanje@erasmusmc.nl.
Jazyk: angličtina
Zdroj: Journal of critical care [J Crit Care] 2020 Oct; Vol. 59, pp. 6-15. Date of Electronic Publication: 2020 May 25.
DOI: 10.1016/j.jcrc.2020.05.004
Abstrakt: Purpose: Enrolling 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.
Methods: Variation 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.
Results: Variation 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%).
Conclusions: Alternatives 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.
Competing Interests: Declaration of Competing Interest The authors declare that they have no competing interests.
(Copyright © 2020. Published by Elsevier Inc.)
Databáze: MEDLINE
Externí odkaz: