How do 66 European institutional review boards approve one protocol for an international prospective observational study on traumatic brain injury? Experiences from the CENTER-TBI study

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

doi:10.1186/s12910-020-00480-8

How do 66 European institutional review boards approve one protocol for an international prospective observational study on traumatic brain injury? Experiences from the CENTER-TBI study

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

School of Medicine

Research output: Contribution to journal › Article › peer-review

1 Scopus citations

Abstract

Background: The European Union (EU) aims to optimize patient protection and efficiency of health-care research by harmonizing procedures across Member States. Nonetheless, further improvements are required to increase multicenter research efficiency. We investigated IRB procedures in a large prospective European multicenter study on traumatic brain injury (TBI), aiming to inform and stimulate initiatives to improve efficiency. Methods: We reviewed relevant documents regarding IRB submission and IRB approval from European neurotrauma centers participating in the Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI). Documents included detailed information on IRB procedures and the duration from IRB submission until approval(s). They were translated and analyzed to determine the level of harmonization of IRB procedures within Europe. Results: From 18 countries, 66 centers provided the requested documents. The primary IRB review was conducted centrally (N = 11, 61%) or locally (N = 7, 39%) and primary IRB approval was obtained after one (N = 8, 44%), two (N = 6, 33%) or three (N = 4, 23%) review rounds with a median duration of respectively 50 and 98 days until primary IRB approval. Additional IRB approval was required in 55% of countries and could increase duration to 535 days. Total duration from submission until required IRB approval was obtained was 114 days (IQR 75-224) and appeared to be shorter after submission to local IRBs compared to central IRBs (50 vs. 138 days, p = 0.0074). Conclusion: We found variation in IRB procedures between and within European countries. There were differences in submission and approval requirements, number of review rounds and total duration. Research collaborations could benefit from the implementation of more uniform legislation and regulation while acknowledging local cultural habits and moral values between countries.

Original language	English (US)
Article number	36
Journal	BMC Medical Ethics
Volume	21
Issue number	1
DOIs	https://doi.org/10.1186/s12910-020-00480-8
State	Published - May 12 2020

Keywords

CENTER-TBI
European Union
Harmonization
Health-care research
Research ethic committees

ASJC Scopus subject areas

Issues, ethics and legal aspects
Health(social science)
Health Policy

Access to Document

10.1186/s12910-020-00480-8

Cite this

Timmers, M., Van Dijck, J. T. J. M., Van Wijk, R. P. J., Legrand, V., Van Veen, E., Maas, A. I. R., Menon, D. K., Citerio, G., Stocchetti, N., Kompanje, E. J. O., Åkerlund, C., Amrein, K., Andelic, N., Andreassen, L., Anke, A., Antoni, A., Audibert, G., Azouvi, P., Azzolini, M. L., ... Zoerle, T. (2020). How do 66 European institutional review boards approve one protocol for an international prospective observational study on traumatic brain injury? Experiences from the CENTER-TBI study. BMC Medical Ethics, 21(1), Article 36. https://doi.org/10.1186/s12910-020-00480-8

How do 66 European institutional review boards approve one protocol for an international prospective observational study on traumatic brain injury? Experiences from the CENTER-TBI study. / Timmers, Marjolein; Van Dijck, Jeroen T.J.M.; Van Wijk, Roel P.J. et al.
In: BMC Medical Ethics, Vol. 21, No. 1, 36, 12.05.2020.

Research output: Contribution to journal › Article › peer-review

Timmers, M, Van Dijck, JTJM, Van Wijk, RPJ, Legrand, V, Van Veen, E, Maas, AIR, Menon, DK, Citerio, G, Stocchetti, N, Kompanje, EJO, Åkerlund, C, Amrein, K, Andelic, N, Andreassen, L, Anke, A, Antoni, A, Audibert, G, Azouvi, P, Azzolini, ML, Bartels, R, Barzó, 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, Čović, A, Curry, N, Czeiter, E, Czosnyka, M, Dahyot-Fizelier, C, Dark, P, Dawes, H, De Keyser, V, Degos, V, Corte, FD, Den Boogert, H, Depreitere, B, Crossed Signilvesi, S, Dixit, A, Donoghue, E, Dreier, J, Dulière, 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, Kondziella, D, Koraropoulos, E, Koskinen, LO, Kovács, N, Kowark, A, Lagares, A, Lanyon, L, Laureys, S, Lecky, F, Ledoux, D, Lefering, R, Lejeune, A, Levi, L, Lightfoot, R, Lingsma, H, Castanõ-León, AM, 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, PM, Payen de la Garanderie, J-F, 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, JV, 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, RF, Schwendenwein, E, Sewalt, C, Skandsen, T, Smielewski, P, Sorinola, A, Stamatakis, E, Stanworth, S, Stevens, R, Stewart, W, Steyerberg, EW, Sundström, N, Synnot, A, Takala, R, Tamás, V, Tamosuitis, T, Taylor, MS, Ao, BT, Tenovuo, O, Theadom, A, Thomas, M, Tibboel, D, Tolias, C, Trapani, T, Tudora, CM, Vajkoczy, P, Vallance, S, Valeinis, E, Vámos, Z, Van Der Steen, G, Van Der Naalt, J, Van Essen, TA, Van Hecke, W, Van Heugten, C, Van Praag, D, Vyvere, TV, Vargiolu, A, Vega, E, Velt, K, Verheyden, J, Vespa, PM, Vik, A, Vilcinis, R, Volovici, V, Von Steinbüchel, N, Voormolen, D, Vulekovic, P, Wang, KKW, Wiegers, E, Williams, G, Wilson, L, Winzeck, S, Wolf, S, Yang, Z, Ylén, P, Younsi, A, Zeiler, FA, Zelinkova, V, Ziverte, A & Zoerle, T 2020, 'How do 66 European institutional review boards approve one protocol for an international prospective observational study on traumatic brain injury? Experiences from the CENTER-TBI study', BMC Medical Ethics, vol. 21, no. 1, 36. https://doi.org/10.1186/s12910-020-00480-8

@article{6921ac6b5a224f7597ef27da5d0c9f6a,

title = "How do 66 European institutional review boards approve one protocol for an international prospective observational study on traumatic brain injury? Experiences from the CENTER-TBI study",

abstract = "Background: The European Union (EU) aims to optimize patient protection and efficiency of health-care research by harmonizing procedures across Member States. Nonetheless, further improvements are required to increase multicenter research efficiency. We investigated IRB procedures in a large prospective European multicenter study on traumatic brain injury (TBI), aiming to inform and stimulate initiatives to improve efficiency. Methods: We reviewed relevant documents regarding IRB submission and IRB approval from European neurotrauma centers participating in the Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI). Documents included detailed information on IRB procedures and the duration from IRB submission until approval(s). They were translated and analyzed to determine the level of harmonization of IRB procedures within Europe. Results: From 18 countries, 66 centers provided the requested documents. The primary IRB review was conducted centrally (N = 11, 61%) or locally (N = 7, 39%) and primary IRB approval was obtained after one (N = 8, 44%), two (N = 6, 33%) or three (N = 4, 23%) review rounds with a median duration of respectively 50 and 98 days until primary IRB approval. Additional IRB approval was required in 55% of countries and could increase duration to 535 days. Total duration from submission until required IRB approval was obtained was 114 days (IQR 75-224) and appeared to be shorter after submission to local IRBs compared to central IRBs (50 vs. 138 days, p = 0.0074). Conclusion: We found variation in IRB procedures between and within European countries. There were differences in submission and approval requirements, number of review rounds and total duration. Research collaborations could benefit from the implementation of more uniform legislation and regulation while acknowledging local cultural habits and moral values between countries.",

keywords = "CENTER-TBI, European Union, Harmonization, Health-care research, Research ethic committees",

author = "Marjolein Timmers and {Van Dijck}, {Jeroen T.J.M.} and {Van Wijk}, {Roel P.J.} and Valerie Legrand and {Van Veen}, Ernest and Maas, {Andrew I.R.} and Menon, {David K.} and Giuseppe Citerio and Nino Stocchetti and Kompanje, {Erwin J.O.} 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 {Crossed Signilvesi}, Signula 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 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 Aurelie Lejeune and Leon Levi and Roger Lightfoot and Hester Lingsma and Castan{\~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 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 de la Garanderie}, Jean-Francois 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",

note = "Publisher Copyright: {\textcopyright} 2020 The Author(s).",

year = "2020",

month = may,

day = "12",

doi = "10.1186/s12910-020-00480-8",

language = "English (US)",

volume = "21",

journal = "BMC Medical Ethics",

issn = "1472-6939",

publisher = "BioMed Central",

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TY - JOUR

T1 - How do 66 European institutional review boards approve one protocol for an international prospective observational study on traumatic brain injury? Experiences from the CENTER-TBI study

AU - Timmers, Marjolein

AU - Van Dijck, Jeroen T.J.M.

AU - Van Wijk, Roel P.J.

AU - Legrand, Valerie

AU - Van Veen, Ernest

AU - Maas, Andrew I.R.

AU - Menon, David K.

AU - Citerio, Giuseppe

AU - Stocchetti, Nino

AU - Kompanje, Erwin J.O.

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 - Crossed Signilvesi, Signula

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

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AU - Foks, Kelly

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AU - Van Der Steen, Gregory

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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 - 2020/5/12

Y1 - 2020/5/12

N2 - Background: The European Union (EU) aims to optimize patient protection and efficiency of health-care research by harmonizing procedures across Member States. Nonetheless, further improvements are required to increase multicenter research efficiency. We investigated IRB procedures in a large prospective European multicenter study on traumatic brain injury (TBI), aiming to inform and stimulate initiatives to improve efficiency. Methods: We reviewed relevant documents regarding IRB submission and IRB approval from European neurotrauma centers participating in the Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI). Documents included detailed information on IRB procedures and the duration from IRB submission until approval(s). They were translated and analyzed to determine the level of harmonization of IRB procedures within Europe. Results: From 18 countries, 66 centers provided the requested documents. The primary IRB review was conducted centrally (N = 11, 61%) or locally (N = 7, 39%) and primary IRB approval was obtained after one (N = 8, 44%), two (N = 6, 33%) or three (N = 4, 23%) review rounds with a median duration of respectively 50 and 98 days until primary IRB approval. Additional IRB approval was required in 55% of countries and could increase duration to 535 days. Total duration from submission until required IRB approval was obtained was 114 days (IQR 75-224) and appeared to be shorter after submission to local IRBs compared to central IRBs (50 vs. 138 days, p = 0.0074). Conclusion: We found variation in IRB procedures between and within European countries. There were differences in submission and approval requirements, number of review rounds and total duration. Research collaborations could benefit from the implementation of more uniform legislation and regulation while acknowledging local cultural habits and moral values between countries.

AB - Background: The European Union (EU) aims to optimize patient protection and efficiency of health-care research by harmonizing procedures across Member States. Nonetheless, further improvements are required to increase multicenter research efficiency. We investigated IRB procedures in a large prospective European multicenter study on traumatic brain injury (TBI), aiming to inform and stimulate initiatives to improve efficiency. Methods: We reviewed relevant documents regarding IRB submission and IRB approval from European neurotrauma centers participating in the Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI). Documents included detailed information on IRB procedures and the duration from IRB submission until approval(s). They were translated and analyzed to determine the level of harmonization of IRB procedures within Europe. Results: From 18 countries, 66 centers provided the requested documents. The primary IRB review was conducted centrally (N = 11, 61%) or locally (N = 7, 39%) and primary IRB approval was obtained after one (N = 8, 44%), two (N = 6, 33%) or three (N = 4, 23%) review rounds with a median duration of respectively 50 and 98 days until primary IRB approval. Additional IRB approval was required in 55% of countries and could increase duration to 535 days. Total duration from submission until required IRB approval was obtained was 114 days (IQR 75-224) and appeared to be shorter after submission to local IRBs compared to central IRBs (50 vs. 138 days, p = 0.0074). Conclusion: We found variation in IRB procedures between and within European countries. There were differences in submission and approval requirements, number of review rounds and total duration. Research collaborations could benefit from the implementation of more uniform legislation and regulation while acknowledging local cultural habits and moral values between countries.

KW - CENTER-TBI

KW - European Union

KW - Harmonization

KW - Health-care research

KW - Research ethic committees

UR - http://www.scopus.com/inward/record.url?scp=85084535573&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85084535573&partnerID=8YFLogxK

U2 - 10.1186/s12910-020-00480-8

DO - 10.1186/s12910-020-00480-8

M3 - Article

C2 - 32398066

AN - SCOPUS:85084535573

SN - 1472-6939

VL - 21

JO - BMC Medical Ethics

JF - BMC Medical Ethics

IS - 1

M1 - 36

ER -

How do 66 European institutional review boards approve one protocol for an international prospective observational study on traumatic brain injury? Experiences from the CENTER-TBI study

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