Abstract
Purpose: Enrolling traumatic brain injury (731) 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. (C) 2020 Published by Elsevier Inc.
Original language | English |
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Pages (from-to) | 6-15 |
Number of pages | 10 |
Journal | Journal of Critical Care |
Volume | 59 |
DOIs | |
Publication status | Published - Oct 2020 |
Externally published | Yes |
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Informed consent procedures in patients with an acute inability to provide informed consent : Policy and practice in the CENTER-TBI study. / The CENTER-TBI investigators and participants.
In: Journal of Critical Care, Vol. 59, 10.2020, p. 6-15.Research output: Contribution to journal › Article
TY - JOUR
T1 - Informed consent procedures in patients with an acute inability to provide informed consent
T2 - Policy and practice in the CENTER-TBI study
AU - The CENTER-TBI investigators and participants
AU - van Wijk, Roel P.J.
AU - van Dijck, Jeroen T.J.M.
AU - Timmers, Marjolein
AU - van Veen, Ernest
AU - Citerio, Giuseppe
AU - Lingsma, Hester
AU - Maas, Andrew I.R.
AU - Menon, David
AU - Peul, Wilco
AU - Stocchetti, Nino
AU - Kompanje, Erwin
AU - Åkerlund, Cecilia
AU - Amrein, Krisztina
AU - Andelic, Nada
AU - Andreassen, Lasse
AU - Anke, Audny
AU - Antoni, Anna
AU - Audibert, Gérard
AU - Azouvi, Philippe
AU - Azzolini, Maria Luisa
AU - Bartels, Ronald
AU - Barzó, Pál
AU - Beauvais, Romuald
AU - Beer, Ronny
AU - Bellander, Bo Michael
AU - Belli, Antonio
AU - Benali, Habib
AU - Berardino, Maurizio
AU - Beretta, Luigi
AU - Blaabjerg, Morten
AU - Bragge, Peter
AU - Brazinova, Alexandra
AU - Brinck, Vibeke
AU - Brooker, Joanne
AU - Brorsson, Camilla
AU - Buki, Andras
AU - Bullinger, Monika
AU - Cabeleira, Manuel
AU - Caccioppola, Alessio
AU - Calappi, Emiliana
AU - Calvi, Maria Rosa
AU - Cameron, Peter
AU - Lozano, Guillermo Carbayo
AU - Carbonara, Marco
AU - Cavallo, Simona
AU - Chevallard, Giorgio
AU - Chieregato, Arturo
AU - Ceyisakar, Iris
AU - Coburn, Mark
AU - Coles, Jonathan
AU - Cooper, Jamie D.
AU - Correia, Marta
AU - Čović, Amra
AU - Curry, Nicola
AU - Czeiter, Endre
AU - Czosnyka, Marek
AU - Dahyot-Fizelier, Claire
AU - Dark, Paul
AU - Dawes, Helen
AU - De Keyser, Véronique
AU - Degos, Vincent
AU - Corte, Francesco Della
AU - den Boogert, Hugo
AU - Depreitere, Bart
AU - Đilvesi, Đula
AU - Dixit, Abhishek
AU - Donoghue, Emma
AU - Dreier, Jens
AU - Dulière, Guy Loup
AU - Ercole, Ari
AU - Esser, Patrick
AU - Ezer, Erzsébet
AU - Fabricius, Martin
AU - Feigin, Valery L.
AU - Foks, Kelly
AU - Frisvold, Shirin
AU - Furmanov, Alex
AU - Gagliardo, Pablo
AU - Galanaud, Damien
AU - Gantner, Dashiell
AU - Gao, Guoyi
AU - George, Pradeep
AU - Ghuysen, Alexandre
AU - Giga, Lelde
AU - Glocker, Ben
AU - Golubovic, Jagoš
AU - Gomez, Pedro A.
AU - Gratz, Johannes
AU - Gravesteijn, Benjamin
AU - Grossi, Francesca
AU - Gruen, Russell L.
AU - Gupta, Deepak
AU - Haagsma, Juanita A.
AU - Haitsma, Iain
AU - Helbok, Raimund
AU - Helseth, Eirik
AU - Horton, Lindsay
AU - Huijben, Jilske
AU - Hutchinson, Peter J.
AU - Jacobs, Bram
AU - Jankowski, Stefan
AU - Jarrett, Mike
AU - Jiang, Ji Yao
AU - Johnson, Faye
AU - Jones, Kelly
AU - Karan, Mladen
AU - Kolias, Angelos G.
AU - Kompanje, Erwin
AU - Kondziella, Daniel
AU - Koraropoulos, Evgenios
AU - Koskinen, Lars Owe
AU - Kovács, Noémi
AU - Kowark, Ana
AU - Lagares, Alfonso
AU - Lanyon, Linda
AU - Laureys, Steven
AU - Lecky, Fiona
AU - Ledoux, Didier
AU - Lefering, Rolf
AU - Legrand, Valerie
AU - Lejeune, Aurelie
AU - Levi, Leon
AU - Lightfoot, Roger
AU - Lingsma, Hester
AU - Castaño-León, Ana M.
AU - Maegele, Marc
AU - Majdan, Marek
AU - Manara, Alex
AU - Manley, Geoffrey
AU - Martino, Costanza
AU - Maréchal, Hugues
AU - Mattern, Julia
AU - McMahon, Catherine
AU - Melegh, Béla
AU - Menon, David
AU - Menovsky, Tomas
AU - Misset, Benoit
AU - Mulazzi, Davide
AU - Muraleedharan, Visakh
AU - Murray, Lynnette
AU - Negru, Ancuta
AU - Nelson, David
AU - Newcombe, Virginia
AU - Nieboer, Daan
AU - Nyirádi, József
AU - Olubukola, Otesile
AU - Oresic, Matej
AU - Ortolano, Fabrizio
AU - Palotie, Aarno
AU - Parizel, Paul M.
AU - Payen, Jean François
AU - Perera, Natascha
AU - Perlbarg, Vincent
AU - Persona, Paolo
AU - Peul, Wilco
AU - Piippo-Karjalainen, Anna
AU - Pirinen, Matti
AU - Ples, Horia
AU - Polinder, Suzanne
AU - Pomposo, Inigo
AU - Posti, Jussi P.
AU - Puybasset, Louis
AU - Radoi, Andreea
AU - Ragauskas, Arminas
AU - Raj, Rahul
AU - Rambadagalla, Malinka
AU - Rhodes, Jonathan
AU - Richardson, Sylvia
AU - Richter, Sophie
AU - Ripatti, Samuli
AU - Rocka, Saulius
AU - Roe, Cecilie
AU - Roise, Olav
AU - Rosand, Jonathan
AU - Rosenfeld, Jeffrey V.
AU - Rosenlund, Christina
AU - Rosenthal, Guy
AU - Rossaint, Rolf
AU - Rossi, Sandra
AU - Rueckert, Daniel
AU - Rusnák, Martin
AU - Sahuquillo, Juan
AU - Sakowitz, Oliver
AU - Sanchez-Porras, Renan
AU - Sandor, Janos
AU - Schäfer, Nadine
AU - Schmidt, Silke
AU - Schoechl, Herbert
AU - Schoonman, Guus
AU - Schou, Rico Frederik
AU - Schwendenwein, Elisabeth
AU - Sewalt, Charlie
AU - Skandsen, Toril
AU - Smielewski, Peter
AU - Sorinola, Abayomi
AU - Stamatakis, Emmanuel
AU - Stanworth, Simon
AU - Stevens, Robert
AU - Stewart, William
AU - Steyerberg, Ewout W.
AU - Sundström, Nina
AU - Synnot, Anneliese
AU - Takala, Riikka
AU - Tamás, Viktória
AU - Tamosuitis, Tomas
AU - Taylor, Mark Steven
AU - Ao, Braden Te
AU - Tenovuo, Olli
AU - Theadom, Alice
AU - Thomas, Matt
AU - Tibboel, Dick
AU - Tolias, Christos
AU - Trapani, Tony
AU - Tudora, Cristina Maria
AU - Vajkoczy, Peter
AU - Vallance, Shirley
AU - Valeinis, Egils
AU - Vámos, Zoltán
AU - Van der Steen, Gregory
AU - van der Naalt, Joukje
AU - van Essen, Thomas A.
AU - Van Hecke, Wim
AU - van Heugten, Caroline
AU - Van Praag, Dominique
AU - Vyvere, Thijs Vande
AU - Vargiolu, Alessia
AU - Vega, Emmanuel
AU - Velt, Kimberley
AU - Verheyden, Jan
AU - Vespa, Paul M.
AU - Vik, Anne
AU - Vilcinis, Rimantas
AU - Volovici, Victor
AU - von Steinbüchel, Nicole
AU - Voormolen, Daphne
AU - Vulekovic, Petar
AU - Wang, Kevin K.W.
AU - Wiegers, Eveline
AU - Williams, Guy
AU - Wilson, Lindsay
AU - Winzeck, Stefan
AU - Wolf, Stefan
AU - Yang, Zhihui
AU - Ylén, Peter
AU - Younsi, Alexander
AU - Zeiler, Frederick A.
AU - Zelinkova, Veronika
AU - Ziverte, Agate
AU - Zoerle, Tommaso
PY - 2020/10
Y1 - 2020/10
N2 - Purpose: Enrolling traumatic brain injury (731) 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. (C) 2020 Published by Elsevier Inc.
AB - Purpose: Enrolling traumatic brain injury (731) 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. (C) 2020 Published by Elsevier Inc.
KW - Ethics
KW - European Union
KW - Informed consent
KW - Traumatic brain injury
UR - http://www.scopus.com/inward/record.url?scp=85085505275&partnerID=8YFLogxK
U2 - 10.1016/j.jcrc.2020.05.004
DO - 10.1016/j.jcrc.2020.05.004
M3 - Article
C2 - 32485440
VL - 59
SP - 6
EP - 15
JO - Journal of Critical Care
JF - Journal of Critical Care
SN - 0883-9441
ER -