Skip to search
Skip to main content
Back to Search
Start Over
Informed consent procedures in patients with an acute inability to provide informed consent: Policy and practice in the CENTER-TBI study
Authors :
van Wijk, R van Dijck, J Timmers, M van Veen, E Citerio, G Lingsma, H Maas, A Menon, D Peul, W Stocchetti, N Kompanje, E Åkerlund, C Amrein, K Andelic, N Andreassen, L Anke, A Antoni, A Audibert, G Azouvi, P Azzolini, M Bartels, R Barzó, P Beauvais, R Beer, R Bellander, B 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, M Cameron, P Lozano, G Carbonara, M Cavallo, S Chevallard, G Chieregato, A Ceyisakar, I Coburn, M Coles, J Cooper, J Correia, M Čović, A Curry, N Czeiter, E Czosnyka, M Dahyot-Fizelier, C Dark, P Dawes, H De Keyser, V Degos, V Corte, F den Boogert, H Depreitere, B Đilvesi, Đ Dixit, A Donoghue, E Dreier, J Dulière, G Ercole, A Esser, P Ezer, E Fabricius, M Feigin, V 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, P Gratz, J Gravesteijn, B Grossi, F Gruen, R Gupta, D Haagsma, J Haitsma, I Helbok, R Helseth, E Horton, L Huijben, J Hutchinson, P Jacobs, B Jankowski, S Jarrett, M Jiang, J Johnson, F Jones, K Karan, M Kolias, A Kondziella, D Koraropoulos, E Koskinen, L Kovács, N Kowark, A Lagares, A Lanyon, L Laureys, S Lecky, F Ledoux, D Lefering, R Legrand, V Lejeune, A Levi, L Lightfoot, R Castaño-León, A Maegele, M Majdan, M Manara, A Manley, G Martino, C Maréchal, H Mattern, J Mcmahon, C Melegh, B Menovsky, T Misset, B Mulazzi, D Muraleedharan, V Murray, L Negru, A Nelson, D Newcombe, V Nieboer, D Nyirádi, J Olubukola, O Oresic, M Ortolano, F Palotie, A Parizel, P Payen, J Perera, N Perlbarg, V Persona, P Piippo-Karjalainen, A Pirinen, M Ples, H Polinder, S Pomposo, I Posti, J 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 Rusnák, M Sahuquillo, J Sakowitz, O Sanchez-Porras, R Sandor, J Schäfer, N Schmidt, S Schoechl, H Schoonman, G Schou, R Schwendenwein, E Sewalt, C Skandsen, T Smielewski, P Sorinola, A Stamatakis, E Stanworth, S Stevens, R Stewart, W Steyerberg, E Sundström, N Synnot, A Takala, R Tamás, V Tamosuitis, T Taylor, M Ao, B Tenovuo, O Theadom, A Thomas, M Tibboel, D Tolias, C Trapani, T Tudora, C Vajkoczy, P Vallance, S Valeinis, E Vámos, Z Van der Steen, G van der Naalt, J van Essen, T Van Hecke, W van Heugten, C Van Praag, D Vyvere, T Vargiolu, A Vega, E Velt, K Verheyden, J Vespa, P Vik, A Vilcinis, R Volovici, V von Steinbüchel, N Voormolen, D Vulekovic, P Wang, K Wiegers, E Williams, G Wilson, L Winzeck, S Wolf, S Yang, Z Ylén, P Younsi, A Zeiler, F Zelinkova, V Ziverte, A Zoerle, T van Wijk, Roel P. J. van Dijck, Jeroen T. J. M. Timmers, Marjolein van Veen, Ernest Citerio, Giuseppe Lingsma, Hester F. Maas, Andrew I. R. Menon, David K. Peul, Wilco C. Stocchetti, Nino Kompanje, Erwin J. O. Åkerlund, Cecilia Amrein, Krisztina Andelic, Nada Andreassen, Lasse Anke, Audny Antoni, Anna Audibert, Gérard Azouvi, Philippe Azzolini, Maria Luisa Bartels, Ronald Barzó, Pál Beauvais, Romuald Beer, Ronny Bellander, Bo-Michael Belli, Antonio Benali, Habib Berardino, Maurizio Beretta, Luigi Blaabjerg, Morten Bragge, Peter Brazinova, Alexandra Brinck, Vibeke Brooker, Joanne Brorsson, Camilla Buki, Andras Bullinger, Monika Cabeleira, Manuel Caccioppola, Alessio Calappi, Emiliana Calvi, Maria Rosa Cameron, Peter Lozano, Guillermo Carbayo Carbonara, Marco Cavallo, Simona Chevallard, Giorgio Chieregato, Arturo Ceyisakar, Iris Coburn, Mark Coles, Jonathan Cooper, Jamie D. Correia, Marta Čović, Amra Curry, Nicola Czeiter, Endre Czosnyka, Marek Dahyot-Fizelier, Claire Dark, Paul Dawes, Helen De Keyser, Véronique Degos, Vincent Corte, Francesco Della den Boogert, Hugo Depreitere, Bart Đilvesi, Đula Dixit, Abhishek Donoghue, Emma Dreier, Jens Dulière, Guy-Loup Ercole, Ari Esser, Patrick Ezer, Erzsébet Fabricius, Martin Feigin, Valery L. Foks, Kelly Frisvold, Shirin Furmanov, Alex Gagliardo, Pablo Galanaud, Damien Gantner, Dashiell Gao, Guoyi George, Pradeep Ghuysen, Alexandre Giga, Lelde Glocker, Ben Golubovic, Jagoš Gomez, Pedro A. Gratz, Johannes Gravesteijn, Benjamin Grossi, Francesca Gruen, Russell L. Gupta, Deepak Haagsma, Juanita A. Haitsma, Iain Helbok, Raimund Helseth, Eirik Horton, Lindsay Huijben, Jilske Hutchinson, Peter J. Jacobs, Bram Jankowski, Stefan Jarrett, Mike Jiang, Ji-Yao Johnson, Faye Jones, Kelly Karan, Mladen Kolias, Angelos G. Kompanje, Erwin Kondziella, Daniel Koraropoulos, Evgenios Koskinen, Lars-Owe Kovács, Noémi Kowark, Ana Lagares, Alfonso Lanyon, Linda Laureys, Steven Lecky, Fiona Ledoux, Didier Lefering, Rolf Legrand, Valerie Lejeune, Aurelie Levi, Leon Lightfoot, Roger Lingsma, Hester Castaño-León, Ana M. Maegele, Marc Majdan, Marek Manara, Alex Manley, Geoffrey Martino, Costanza Maréchal, Hugues Mattern, Julia McMahon, Catherine Melegh, Béla Menon, David Menovsky, Tomas Misset, Benoit Mulazzi, Davide Muraleedharan, Visakh Murray, Lynnette Negru, Ancuta Nelson, David Newcombe, Virginia Nieboer, Daan Nyirádi, József Olubukola, Otesile Oresic, Matej Ortolano, Fabrizio Palotie, Aarno Parizel, Paul M. Payen, Jean-François Perera, Natascha Perlbarg, Vincent Persona, Paolo Peul, Wilco Piippo-Karjalainen, Anna Pirinen, Matti Ples, Horia Polinder, Suzanne Pomposo, Inigo Posti, Jussi P. Puybasset, Louis Radoi, Andreea Ragauskas, Arminas Raj, Rahul Rambadagalla, Malinka Rhodes, Jonathan Richardson, Sylvia Richter, Sophie Ripatti, Samuli Rocka, Saulius Roe, Cecilie Roise, Olav Rosand, Jonathan Rosenfeld, Jeffrey V. Rosenlund, Christina Rosenthal, Guy Rossaint, Rolf Rossi, Sandra Rueckert, Daniel Rusnák, Martin Sahuquillo, Juan Sakowitz, Oliver Sanchez-Porras, Renan Sandor, Janos Schäfer, Nadine Schmidt, Silke Schoechl, Herbert Schoonman, Guus Schou, Rico Frederik Schwendenwein, Elisabeth Sewalt, Charlie Skandsen, Toril Smielewski, Peter Sorinola, Abayomi Stamatakis, Emmanuel Stanworth, Simon Stevens, Robert Stewart, William Steyerberg, Ewout W. Sundström, Nina Synnot, Anneliese Takala, Riikka Tamás, Viktória Tamosuitis, Tomas Taylor, Mark Steven Ao, Braden Te Tenovuo, Olli Theadom, Alice Thomas, Matt Tibboel, Dick Tolias, Christos Trapani, Tony Tudora, Cristina Maria Vajkoczy, Peter Vallance, Shirley Valeinis, Egils Vámos, Zoltán Van der Steen, Gregory van der Naalt, Joukje van Essen, Thomas A. Van Hecke, Wim van Heugten, Caroline Van Praag, Dominique Vyvere, Thijs Vande Vargiolu, Alessia Vega, Emmanuel Velt, Kimberley Verheyden, Jan Vespa, Paul M. Vik, Anne Vilcinis, Rimantas Volovici, Victor von Steinbüchel, Nicole Voormolen, Daphne Vulekovic, Petar Wang, Kevin K. W. Wiegers, Eveline Williams, Guy Wilson, Lindsay Winzeck, Stefan Wolf, Stefan Yang, Zhihui Ylén, Peter Younsi, Alexander Zeiler, Frederick A. Zelinkova, Veronika Ziverte, Agate Zoerle, Tommaso van Wijk, R van Dijck, J Timmers, M van Veen, E Citerio, G Lingsma, H Maas, A Menon, D Peul, W Stocchetti, N Kompanje, E Åkerlund, C Amrein, K Andelic, N Andreassen, L Anke, A Antoni, A Audibert, G Azouvi, P Azzolini, M Bartels, R Barzó, P Beauvais, R Beer, R Bellander, B 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, M Cameron, P Lozano, G Carbonara, M Cavallo, S Chevallard, G Chieregato, A Ceyisakar, I Coburn, M Coles, J Cooper, J Correia, M Čović, A Curry, N Czeiter, E Czosnyka, M Dahyot-Fizelier, C Dark, P Dawes, H De Keyser, V Degos, V Corte, F den Boogert, H Depreitere, B Đilvesi, Đ Dixit, A Donoghue, E Dreier, J Dulière, G Ercole, A Esser, P Ezer, E Fabricius, M Feigin, V 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, P Gratz, J Gravesteijn, B Grossi, F Gruen, R Gupta, D Haagsma, J Haitsma, I Helbok, R Helseth, E Horton, L Huijben, J Hutchinson, P Jacobs, B Jankowski, S Jarrett, M Jiang, J Johnson, F Jones, K Karan, M Kolias, A Kondziella, D Koraropoulos, E Koskinen, L Kovács, N Kowark, A Lagares, A Lanyon, L Laureys, S Lecky, F Ledoux, D Lefering, R Legrand, V Lejeune, A Levi, L Lightfoot, R Castaño-León, A Maegele, M Majdan, M Manara, A Manley, G Martino, C Maréchal, H Mattern, J Mcmahon, C Melegh, B Menovsky, T Misset, B Mulazzi, D Muraleedharan, V Murray, L Negru, A Nelson, D Newcombe, V Nieboer, D Nyirádi, J Olubukola, O Oresic, M Ortolano, F Palotie, A Parizel, P Payen, J Perera, N Perlbarg, V Persona, P Piippo-Karjalainen, A Pirinen, M Ples, H Polinder, S Pomposo, I Posti, J 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 Rusnák, M Sahuquillo, J Sakowitz, O Sanchez-Porras, R Sandor, J Schäfer, N Schmidt, S Schoechl, H Schoonman, G Schou, R Schwendenwein, E Sewalt, C Skandsen, T Smielewski, P Sorinola, A Stamatakis, E Stanworth, S Stevens, R Stewart, W Steyerberg, E Sundström, N Synnot, A Takala, R Tamás, V Tamosuitis, T Taylor, M Ao, B Tenovuo, O Theadom, A Thomas, M Tibboel, D Tolias, C Trapani, T Tudora, C Vajkoczy, P Vallance, S Valeinis, E Vámos, Z Van der Steen, G van der Naalt, J van Essen, T Van Hecke, W van Heugten, C Van Praag, D Vyvere, T Vargiolu, A Vega, E Velt, K Verheyden, J Vespa, P Vik, A Vilcinis, R Volovici, V von Steinbüchel, N Voormolen, D Vulekovic, P Wang, K Wiegers, E Williams, G Wilson, L Winzeck, S Wolf, S Yang, Z Ylén, P Younsi, A Zeiler, F Zelinkova, V Ziverte, A Zoerle, T van Wijk, Roel P. J. van Dijck, Jeroen T. J. M. Timmers, Marjolein van Veen, Ernest Citerio, Giuseppe Lingsma, Hester F. Maas, Andrew I. R. Menon, David K. Peul, Wilco C. Stocchetti, Nino Kompanje, Erwin J. O. Åkerlund, Cecilia Amrein, Krisztina Andelic, Nada Andreassen, Lasse Anke, Audny Antoni, Anna Audibert, Gérard Azouvi, Philippe Azzolini, Maria Luisa Bartels, Ronald Barzó, Pál Beauvais, Romuald Beer, Ronny Bellander, Bo-Michael Belli, Antonio Benali, Habib Berardino, Maurizio Beretta, Luigi Blaabjerg, Morten Bragge, Peter Brazinova, Alexandra Brinck, Vibeke Brooker, Joanne Brorsson, Camilla Buki, Andras Bullinger, Monika Cabeleira, Manuel Caccioppola, Alessio Calappi, Emiliana Calvi, Maria Rosa Cameron, Peter Lozano, Guillermo Carbayo Carbonara, Marco Cavallo, Simona Chevallard, Giorgio Chieregato, Arturo Ceyisakar, Iris Coburn, Mark Coles, Jonathan Cooper, Jamie D. Correia, Marta Čović, Amra Curry, Nicola Czeiter, Endre Czosnyka, Marek Dahyot-Fizelier, Claire Dark, Paul Dawes, Helen De Keyser, Véronique Degos, Vincent Corte, Francesco Della den Boogert, Hugo Depreitere, Bart Đilvesi, Đula Dixit, Abhishek Donoghue, Emma Dreier, Jens Dulière, Guy-Loup Ercole, Ari Esser, Patrick Ezer, Erzsébet Fabricius, Martin Feigin, Valery L. Foks, Kelly Frisvold, Shirin Furmanov, Alex Gagliardo, Pablo Galanaud, Damien Gantner, Dashiell Gao, Guoyi George, Pradeep Ghuysen, Alexandre Giga, Lelde Glocker, Ben Golubovic, Jagoš Gomez, Pedro A. Gratz, Johannes Gravesteijn, Benjamin Grossi, Francesca Gruen, Russell L. Gupta, Deepak Haagsma, Juanita A. Haitsma, Iain Helbok, Raimund Helseth, Eirik Horton, Lindsay Huijben, Jilske Hutchinson, Peter J. Jacobs, Bram Jankowski, Stefan Jarrett, Mike Jiang, Ji-Yao Johnson, Faye Jones, Kelly Karan, Mladen Kolias, Angelos G. Kompanje, Erwin Kondziella, Daniel Koraropoulos, Evgenios Koskinen, Lars-Owe Kovács, Noémi Kowark, Ana Lagares, Alfonso Lanyon, Linda Laureys, Steven Lecky, Fiona Ledoux, Didier Lefering, Rolf Legrand, Valerie Lejeune, Aurelie Levi, Leon Lightfoot, Roger Lingsma, Hester Castaño-León, Ana M. Maegele, Marc Majdan, Marek Manara, Alex Manley, Geoffrey Martino, Costanza Maréchal, Hugues Mattern, Julia McMahon, Catherine Melegh, Béla Menon, David Menovsky, Tomas Misset, Benoit Mulazzi, Davide Muraleedharan, Visakh Murray, Lynnette Negru, Ancuta Nelson, David Newcombe, Virginia Nieboer, Daan Nyirádi, József Olubukola, Otesile Oresic, Matej Ortolano, Fabrizio Palotie, Aarno Parizel, Paul M. Payen, Jean-François Perera, Natascha Perlbarg, Vincent Persona, Paolo Peul, Wilco Piippo-Karjalainen, Anna Pirinen, Matti Ples, Horia Polinder, Suzanne Pomposo, Inigo Posti, Jussi P. Puybasset, Louis Radoi, Andreea Ragauskas, Arminas Raj, Rahul Rambadagalla, Malinka Rhodes, Jonathan Richardson, Sylvia Richter, Sophie Ripatti, Samuli Rocka, Saulius Roe, Cecilie Roise, Olav Rosand, Jonathan Rosenfeld, Jeffrey V. Rosenlund, Christina Rosenthal, Guy Rossaint, Rolf Rossi, Sandra Rueckert, Daniel Rusnák, Martin Sahuquillo, Juan Sakowitz, Oliver Sanchez-Porras, Renan Sandor, Janos Schäfer, Nadine Schmidt, Silke Schoechl, Herbert Schoonman, Guus Schou, Rico Frederik Schwendenwein, Elisabeth Sewalt, Charlie Skandsen, Toril Smielewski, Peter Sorinola, Abayomi Stamatakis, Emmanuel Stanworth, Simon Stevens, Robert Stewart, William Steyerberg, Ewout W. Sundström, Nina Synnot, Anneliese Takala, Riikka Tamás, Viktória Tamosuitis, Tomas Taylor, Mark Steven Ao, Braden Te Tenovuo, Olli Theadom, Alice Thomas, Matt Tibboel, Dick Tolias, Christos Trapani, Tony Tudora, Cristina Maria Vajkoczy, Peter Vallance, Shirley Valeinis, Egils Vámos, Zoltán Van der Steen, Gregory van der Naalt, Joukje van Essen, Thomas A. Van Hecke, Wim van Heugten, Caroline Van Praag, Dominique Vyvere, Thijs Vande Vargiolu, Alessia Vega, Emmanuel Velt, Kimberley Verheyden, Jan Vespa, Paul M. Vik, Anne Vilcinis, Rimantas Volovici, Victor von Steinbüchel, Nicole Voormolen, Daphne Vulekovic, Petar Wang, Kevin K. W. Wiegers, Eveline Williams, Guy Wilson, Lindsay Winzeck, Stefan Wolf, Stefan Yang, Zhihui Ylén, Peter Younsi, Alexander Zeiler, Frederick A. Zelinkova, Veronika Ziverte, Agate Zoerle, Tommaso
Publication Year :
2020
Abstract
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.Weaimed 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 from57 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.
Details
Database :
OAIster
Notes :
English
Publication Type :
Electronic Resource
Accession number :
edsoai.on1308934193
Document Type :
Electronic Resource