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

doi:10.1016/j.jcrc.2020.05.004

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

Research output: Contribution to journal › Article

1 Citation (Scopus)

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
Pages (from-to)	6-15
Number of pages	10
Journal	Journal of Critical Care
Volume	59
DOIs	https://doi.org/10.1016/j.jcrc.2020.05.004
Publication status	Published - Oct 2020
Externally published	Yes

Access to Document

10.1016/j.jcrc.2020.05.004

Link to publication in Scopus

Cite this

@article{61d470a04ba7467e843c4bb873f8c556,

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

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.",

keywords = "Ethics, European Union, Informed consent, Traumatic brain injury",

author = "{The CENTER-TBI investigators and participants} and {van Wijk}, {Roel P.J.} and {van Dijck}, {Jeroen T.J.M.} and Marjolein Timmers and {van Veen}, Ernest and Giuseppe Citerio and Hester Lingsma and Maas, {Andrew I.R.} and David Menon and Wilco Peul and Nino Stocchetti and Erwin Kompanje and Cecilia {\AA}kerlund and Krisztina Amrein and Nada Andelic and Lasse Andreassen and Audny Anke and Anna Antoni and G{\'e}rard Audibert and Philippe Azouvi and Azzolini, {Maria Luisa} and Ronald Bartels and P{\'a}l Barz{\'o} and Romuald Beauvais and Ronny Beer and Bellander, {Bo Michael} and Antonio Belli and Habib Benali and Maurizio Berardino and Luigi Beretta and Morten Blaabjerg and Peter Bragge and Alexandra Brazinova and Vibeke Brinck and Joanne Brooker and Camilla Brorsson and Andras Buki and Monika Bullinger and Manuel Cabeleira and Alessio Caccioppola and Emiliana Calappi and Calvi, {Maria Rosa} and Peter Cameron and Lozano, {Guillermo Carbayo} and Marco Carbonara and Simona Cavallo and Giorgio Chevallard and Arturo Chieregato and Iris Ceyisakar and Mark Coburn and Jonathan Coles and Cooper, {Jamie D.} and Marta Correia and Amra {\v C}ovi{\'c} and Nicola Curry and Endre Czeiter and Marek Czosnyka and Claire Dahyot-Fizelier and Paul Dark and Helen Dawes and {De Keyser}, V{\'e}ronique and Vincent Degos and Corte, {Francesco Della} and {den Boogert}, Hugo and Bart Depreitere and {\D}ula {\D}ilvesi and Abhishek Dixit and Emma Donoghue and Jens Dreier and Duli{\`e}re, {Guy Loup} and Ari Ercole and Patrick Esser and Erzs{\'e}bet Ezer and Martin Fabricius and Feigin, {Valery L.} and Kelly Foks and Shirin Frisvold and Alex Furmanov and Pablo Gagliardo and Damien Galanaud and Dashiell Gantner and Guoyi Gao and Pradeep George and Alexandre Ghuysen and Lelde Giga and Ben Glocker and Jago{\v s} Golubovic and Gomez, {Pedro A.} and Johannes Gratz and Benjamin Gravesteijn and Francesca Grossi and Gruen, {Russell L.} and Deepak Gupta and Haagsma, {Juanita A.} and Iain Haitsma and Raimund Helbok and Eirik Helseth and Lindsay Horton and Jilske Huijben and Hutchinson, {Peter J.} and Bram Jacobs and Stefan Jankowski and Mike Jarrett and Jiang, {Ji Yao} and Faye Johnson and Kelly Jones and Mladen Karan and Kolias, {Angelos G.} and Erwin Kompanje and Daniel Kondziella and Evgenios Koraropoulos and Koskinen, {Lars Owe} and No{\'e}mi Kov{\'a}cs and Ana Kowark and Alfonso Lagares and Linda Lanyon and Steven Laureys and Fiona Lecky and Didier Ledoux and Rolf Lefering and Valerie Legrand and Aurelie Lejeune and Leon Levi and Roger Lightfoot and Hester Lingsma and Casta{\~n}o-Le{\'o}n, {Ana M.} and Marc Maegele and Marek Majdan and Alex Manara and Geoffrey Manley and Costanza Martino and Hugues Mar{\'e}chal and Julia Mattern and Catherine McMahon and B{\'e}la Melegh and David Menon and Tomas Menovsky and Benoit Misset and Davide Mulazzi and Visakh Muraleedharan and Lynnette Murray and Ancuta Negru and David Nelson and Virginia Newcombe and Daan Nieboer and J{\'o}zsef Nyir{\'a}di and Otesile Olubukola and Matej Oresic and Fabrizio Ortolano and Aarno Palotie and Parizel, {Paul M.} and Payen, {Jean Fran{\c c}ois} and Natascha Perera and Vincent Perlbarg and Paolo Persona and Wilco Peul and Anna Piippo-Karjalainen and Matti Pirinen and Horia Ples and Suzanne Polinder and Inigo Pomposo and Posti, {Jussi P.} and Louis Puybasset and Andreea Radoi and Arminas Ragauskas and Rahul Raj and Malinka Rambadagalla and Jonathan Rhodes and Sylvia Richardson and Sophie Richter and Samuli Ripatti and Saulius Rocka and Cecilie Roe and Olav Roise and Jonathan Rosand and Rosenfeld, {Jeffrey V.} and Christina Rosenlund and Guy Rosenthal and Rolf Rossaint and Sandra Rossi and Daniel Rueckert and Martin Rusn{\'a}k and Juan Sahuquillo and Oliver Sakowitz and Renan Sanchez-Porras and Janos Sandor and Nadine Sch{\"a}fer and Silke Schmidt and Herbert Schoechl and Guus Schoonman and Schou, {Rico Frederik} and Elisabeth Schwendenwein and Charlie Sewalt and Toril Skandsen and Peter Smielewski and Abayomi Sorinola and Emmanuel Stamatakis and Simon Stanworth and Robert Stevens and William Stewart and Steyerberg, {Ewout W.} and Nina Sundstr{\"o}m and Anneliese Synnot and Riikka Takala and Vikt{\'o}ria Tam{\'a}s and Tomas Tamosuitis and Taylor, {Mark Steven} and Ao, {Braden Te} and Olli Tenovuo and Alice Theadom and Matt Thomas and Dick Tibboel and Christos Tolias and Tony Trapani and Tudora, {Cristina Maria} and Peter Vajkoczy and Shirley Vallance and Egils Valeinis and Zolt{\'a}n V{\'a}mos and {Van der Steen}, Gregory and {van der Naalt}, Joukje and {van Essen}, {Thomas A.} and {Van Hecke}, Wim and {van Heugten}, Caroline and {Van Praag}, Dominique and Vyvere, {Thijs Vande} and Alessia Vargiolu and Emmanuel Vega and Kimberley Velt and Jan Verheyden and Vespa, {Paul M.} and Anne Vik and Rimantas Vilcinis and Victor Volovici and {von Steinb{\"u}chel}, Nicole and Daphne Voormolen and Petar Vulekovic and Wang, {Kevin K.W.} and Eveline Wiegers and Guy Williams and Lindsay Wilson and Stefan Winzeck and Stefan Wolf and Zhihui Yang and Peter Yl{\'e}n and Alexander Younsi and Zeiler, {Frederick A.} and Veronika Zelinkova and Agate Ziverte and Tommaso Zoerle",

year = "2020",

month = oct,

doi = "10.1016/j.jcrc.2020.05.004",

language = "English",

volume = "59",

pages = "6--15",

journal = "Journal of Critical Care",

issn = "0883-9441",

publisher = "Saunders",

}

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 -