Van Wijk RPJ, Van Dijck JTJM, Timmers M, Van Veen E, Citerio G, Lingsma HF, Maas AIR, Menon DK, Peul WC, Stocchetti N, Kompanje EJO, Akerlund C, Amrein K, Andelic N, Andreassen L, Anke A, Antoni A, Audibert G, Azouvi P, Azzolini ML, Bartels R, Barzo P, Beauvais R, Beer R, Bellander BM, Belli A, Benali H, Berardino M, Beretta L, Blaabjerg M, Bragge P, Brazinova A, Brinck V, Brooker J, Brorsson C, Buki A, Bullinger M, Cabeleira M, Caccioppola A, Calappi E, Calvi MR, Cameron P, Lozano GC, Carbonara M, Cavallo S, Chevallard G, Chieregato A, Ceyisakar I, Coburn M, Coles J, Cooper JD, Correia M, Covic A, Curry N, Czeiter E, Czosnyka M, Dahyot-Fizelier C, Dark P, Dawes H, De Keyser V, Degos V, Della Corte F, Den Boogert H, Depreitere B, Dilvesi D, Dixit A, Donoghue E, Dreier J, Duliere GL, Ercole A, Esser P, Ezer E, Fabricius M, Feigin VL, Foks K, Frisvold S, Furmanov A, Gagliardo P, Galanaud D, Gantner D, Gao G, George P, Ghuysen A, Giga L, Glocker B, Golubovic J, Gomez PA, Gratz J, Gravesteijn B, Grossi F, Gruen RL, Gupta D, Haagsma JA, Haitsma I, Helbok R, Helseth E, Horton L, Huijben J, Hutchinson PJ, Jacobs B, Jankowski S, Jarrett M, Jiang JY, Johnson F, Jones K, Karan M, Kolias AG, Kompanje E, Kondziella D, Koraropoulos E, Koskinen LO, Kovacs N, Kowark A, Lagares A, Lanyon L, Laureys S, Lecky F, Ledoux D, Lefering R, Legrand V, Lejeune A, Levi L, Lightfoot R, Lingsma H, Castano-Leon AM, Maegele M, Majdan M, Manara A, Manley G, Martino C, Marechal H, Mattern J, Mcmahon C, Melegh B, Menon D, Menovsky T, Misset B, Mulazzi D, Muraleedharan V, Murray L, Negru A, Nelson D, Newcombe V, Nieboer D, Nyiradi J, Olubukola O, Oresic M, Ortolano F, Palotie A, Parizel PM, Payen JF, Perera N, Perlbarg V, Persona P, Peul W, Piippo-Karjalainen A, Pirinen M, Ples H, Polinder S, Pomposo I, Posti JP, Puybasset L, Radoi A, Ragauskas A, Raj R, Rambadagalla M, Rhodes J, Richardson S, Richter S, Ripatti S, Rocka S, Roe C, Roise O, Rosand J, Rosenfeld J, Rosenlund C, Rosenthal G, Rossaint R, Rossi S, Rueckert D, Rusnak M, Sahuquillo J, Sakowitz O, Sanchez-Porras R, Sandor J, Schaefer N, Schmidt S, Schoechl H, Schoonman G, Schou RF, Schwendenwein E, Sewalt C, Skandsen T, Smielewski P, Sorinola A, Stamatakis E, Stanworth S, Stevens R, Stewart W, Steyerberg EW, Sundstrom N, Synnot A, Takala R, Tamas V, Tamosuitis T, Taylor MS, Te Ao B, Tenovuo O, Theadom A, Thomas M, Tibboel D, Tolias C, Trapani T, Tudora CM, Vajkoczy P, Vallance S, Valeinis E, Vamos Z, Van Der Steen G, Van Der Naalt J, Van Essen TA, Van Hecke W, Van Heugten C, Van Praag D, Vande Vyvere T, Vargiolu A, Vega E, Velt K, Verheyden J, Vespa PM, Vik A, Vilcinis R, Volovici V, Von Steinbuchel N, Voormolen D, Vulekovic P, Wang KKW, Wiegers E, Williams G, Wilson L, Winzeck S, Wolf S, Yang Z, Ylen P, Younsi A, Zeiler FA, Zelinkova V, Ziverte A, Zoerle T (2020)
Publication Type: Journal article
Publication year: 2020
Book Volume: 59
Pages Range: 6-15
DOI: 10.1016/j.jcrc.2020.05.004
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.
APA:
Van Wijk, R.P.J., Van Dijck, J.T.J.M., Timmers, M., Van Veen, E., Citerio, G., Lingsma, H.F.,... Zoerle, T. (2020). Informed consent procedures in patients with an acute inability to provide informed consent: Policy and practice in the CENTER-TBI study. Journal of Critical Care, 59, 6-15. https://dx.doi.org/10.1016/j.jcrc.2020.05.004
MLA:
Van Wijk, Roel P. J., et al. "Informed consent procedures in patients with an acute inability to provide informed consent: Policy and practice in the CENTER-TBI study." Journal of Critical Care 59 (2020): 6-15.
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