Ethical Approval

The CENTER-TBI study (EC grant 602150) has been conducted in accordance with all relevant laws of the EU if directly applicable or of direct effect and all relevant laws of the country where the Recruiting sites were located, including but not limited to, the relevant privacy and data protection laws and regulations (the “Privacy Law”), the relevant laws and regulations on the use of human materials, and all relevant guidance relating to clinical studies from time to time in force including, but not limited to, the ICH Harmonised Tripartite Guideline for Good Clinical Practice (CPMP/ICH/135/95) (“ICH GCP”) and the World Medical Association Declaration of Helsinki entitled “Ethical Principles for Medical Research Involving Human Subjects”. Informed Consent by the patients and/or the legal representative/next of kin was obtained, accordingly to the local legislations, for all patients recruited in the Core Dataset of CENTER-TBI and documented in the e-CRF.

Ethical approval was obtained for each recruiting sites. The list of sites, Ethical Committees, approval numbers and approval dates can be found below:

Country City Insitute Ethical Commitee Number Approval Date Approval
AU Austria Vienna Medizinische Universität Wien - Universitätsklinik für Unfallchirurgie Ethikkommission der Medizinischen Universität Wien 1646/2014 03-MAY-2016
AU Austria Innsbruck Medizinische Universität Innsbruck

Universitätsklinik für Neurologie

Ethikkommission der Medizinischen Universität Innsbruck AN2014-0336   343/4.22 01-DEC-2014
BE Belgium Antwerp Antwerp University Hospital Centraal Ethisch Comité - Ethisch Comité Universitair Ziekenhuis Antwerpen en de Universiteit Antwerpen B300201422714 17-NOV-2014
BE Belgium Liège CHR Citadelle Centraal Ethisch Comité - Ethisch Comité Universitair Ziekenhuis Antwerpen en de Universiteit Antwerpen B300201422714 17-NOV-2014
Comité d'Ethique 412 1427 25-NOV-2014
BE Belgium Liège CHU Centraal Ethisch Comité - Ethisch Comité Universitair Ziekenhuis Antwerpen en de Universiteit Antwerpen B300201422714 17-NOV-2014
Comité d'Ethique hospitalo-facultaire niversitaire de Liège (707) B707201422102 / 2014-244 07-OCT-2014
BE Belgium Leuven UZ Leuven Centraal Ethisch Comité - Ethisch Comité Universitair Ziekenhuis Antwerpen en de Universiteit Antwerpen B300201422714 13-JUN-2015
Comissie Medische Ethiek UZ KU Leuven / Onderzoek B322201523981 / S57019 (ML11365) 10-JUL-2014
DK Denmark Odense Odense Universiteitshospital - Neurokirurgisk afdeling De Videnskabsetiske Komitéer for Region Syddanmark S-20140215 16-MAR-2015
DK Denmark Copenhagen Region Hovedstaden Rigshopitalet De Videnskabsetiske Komitéer for Region Syddanmark S-20140215 16-MAR-2015
FI Finland Turku Turku University Hospital Varsinais suomen sairaanhoitopiirin kuntayhtyma - Eettinen Toimikunta 95/1801/2014 24-OCT-2014
FI Finland Helsinki Helsinki University Central Hospital Varsinais suomen sairaanhoitopiirin kuntayhtyma - Eettinen Toimikunta 95/1801/2014 24-OCT-2014
FR France Paris APHP Agence Nationale de Sécurité du Médicament et des Produits de Santé ANSM 141421B-31 19-DEC-2014
FR France Besançon CHRU de Besançon Agence Nationale de Sécurité du Médicament et des Produits de Santé ANSM 141421B-31 19-DEC-2014
FR France Lille Lille University Hospital Agence Nationale de Sécurité du Médicament et des Produits de Santé ANSM 141421B-31 19-DEC-2014
FR France Grenoble University Hospital of Grenoble Agence Nationale de Sécurité du Médicament et des Produits de Santé ANSM 141421B-31 19-DEC-2014
FR France Nancy University Hospital Nancy Agence Nationale de Sécurité du Médicament et des Produits de Santé ANSM 141421B-31 19-DEC-2014
FR France Poitiers CHU Poitiers Agence Nationale de Sécurité du Médicament et des Produits de Santé ANSM 141421B-31 19-DEC-2014
DE Germany Heidelberg Universitätsklinikum Heidelberg

Neurochirurgische Kliniki

Ethikkommission Medizinsche Fakultät Heidelberg S-435/2014 27-MAY-2015
DE Germany Berlin Charité | Campus Virchow Klinikum Ethikkommission an der Medizinsche Fakultät

Der rheinsch-Westfälischen Technischen Hocgschule Aachen

1098/15 26-FEB-2016
DE Germany Aachen Uniklinik RWTH Aachen Ethikkommission an der Medizinsche Fakultät

Der rheinsch-Westfälischen Technischen Hocgschule Aachen

EK 174/15 02-JUL-2015
DE Germany Ludwigsburg Klinikum Ludwigsburg Ethikkommission Medizinsche Fakultät Heidelberg S-435/2014 29-JAN-2016
HU Hungary Pecs Pecsi Tudomanyegyetem Klinikai Kozpont ETT TUKEB Egészségügyi Tudományos Tanács 42558-3/2014/EKU 02-OCT-2014
Pécsi Tudományegyetem 5421 28-MAR-2015
HU Hungary Szeged zegedi tudományegyetem orvostudományi kar

Szent Györgyi Albert Klinikai Központ

ETT TUKEB Egészségügyi Tudományos Tanács 42558-3/2014/EKU 2-OCT-2014
Szegedi Tudományegyetem 3803 23-MAY-2016
IR Israel Haifa Rambam Medical Center Helsinki Committee, Rambam Health Care Campus RMB 373-14 22-JUL-2015
IR Israel Jeruzalem Hadassah-hebrew University Medical Center Hadassah Medical Organization IRB 0590-16 HMO 06-DEC-2016
IT Italy Milan Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Direzione Scientifica Comitato Etico 542/2014 20-OCT-2014
IT Italy Milan Ospedale San Raffaele Comitato Etico - Ospedale San Raffaele 217/2014 10-APR-2015
IT Italy Torino AOU Città della Salute e della Scienza di Torino Comitato Etico Interaziendale A.O.U. Città della Salute e della Scienza di Torino - A.O. Ordine Mauriziano - A.S.L. 0015269 15-FEB-2016
IT Italy Cesena Bufalini Hospital Comitato Etico IRST IRCCS AVR 1675/2015 I.5/207 18-MAR-2015
IT Italy Padova Azienda Ospedaliera Università di Padova Comitato Etico - Ospedale San Raffaele 217/2014 10-APR-2015
IT Italy Monza San Gerardo Hospital/ASST Comitato Etico Della Provincia Monza Brianza NA 22-DEC-2014
IT Italy Novara Maggiore Della Carità Hospital Comitato Etico Interaziendale A.O.U. 'Maggiore della Carità' CE 46/15 03-JUL-2015
IT Italy Milan Niguarda Hospital Comitato Etico - Ospedale Niguarda Ca' Granda 636-122015 23-DEC-2015
LV Latvia Riga Pauls Stradins Clinical University Hospital Ethics Commiitee for Clinical Research at Pauls Stradins Clinical University Hospital Development Society 171215-1E 17-DEC-2015
LV Latvia Riga Riga Eastern Clinical University Hospital Ethics Commiitee for Clinical Research at Pauls Stradins Clinical University Hospital Development Society 171215-1E 17-DEC-2015
LV Latvia Rezekne Rezekne Hospital Ethics Commiitee for Clinical Research at Pauls Stradins Clinical University Hospital Development Society 171215-1E 17-DEC-2015
LI Lithuania Vilnius Vilniaus Universiteto Ligonine VILNIAUS REGIONINIS BIOMEDICININIŲ TYRIMŲ ETIKOS KOMITETAS 158200-15-801-323 06-OCT-2015
LI Lithuania Kaunas LSMUL Kauno klinikos Skubio pagalbos skyrius KAUNO  REGIONINIS BIOMEDICININIŲ TYRIMŲ ETIKOS KOMITETAS BE-2-6 06-JAN-2015
NL Netherlands Leiden Het Leids Universitair Medisch Centrum te Leiden Leids Universitair Centrum - Commissie Medische Ethiek P14.222/NV/nv 03-DEC-2014
NL Netherlands Rotterdam Erasmus MC Leids Universitair Centrum - Commissie Medische Ethiek P14.222/NV/nv 03-DEC-2014
NL Netherlands The Hague Medisch Centrum Haaglanden Leids Universitair Centrum - Commissie Medische Ethiek P14.222/NV/nv 03-DEC-2014
NL Netherlands The Hague Het Haga Hospital Leids Universitair Centrum - Commissie Medische Ethiek P14.222/NV/nv 25-NOV-2015
NL Netherlands Nijmegen Radboud UMC Leids Universitair Centrum - Commissie Medische Ethiek P14.222/NV/nv 02-JUL-2015
NL Netherlands Tilburg St. Elisabeth Ziekenhuis Leids Universitair Centrum - Commissie Medische Ethiek P14.222/NV/nv 02-JUL-2015
NL Netherlands Groningen UMC Groningen Leids Universitair Centrum - Commissie Medische Ethiek P14.222/NV/nv 03-DEC-2014
NO Norway Tromso Universitetssykehuset Nord-Norge Regional komité for medisinsk og helsefaglig

forskningsetikk REK midt-Norge (REK midt)

2014/1454 23-MAR-2015
NO Norway Trondheim St.Olavs Hospital Regional komité for medisinsk og helsefaglig

forskningsetikk REK midt-Norge (REK midt)

2014/1454 23-MAR-2015
NO Norway Oslo Oslo Universitetssykehus Regional komité for medisinsk og helsefaglig

forskningsetikk REK midt-Norge (REK midt)

2014/1454 23-MAR-2015
RO Romania Timisoara Clinica de Neurochirurgie

Universitatea de Medicina si Farmacie "Victor Babes" Timisoara

Comitetului de Etica a Spitalului Clinic Judeteam de Urgenta Timisoara N/A 16-OCT-2014
RS Serbia Novi Sad Klinidkog centra Vojvodine Etidkog odbora Klinidkog centra Vojvodine 00-08/332 11-JUL-2014
ES Spain Madrid Hospital Universitario 12 de Octubre Comité Etico de Investigacion Clinica del Hospital Universitario 12 de Octubre 14/262 03-NOV-2014
ES Spain Barcelona Vall d'Hebron University Hospital Comité ético de investigación clínica y comisión de proyectos de investigación del hospital universitari Vall d'Hebron ID-RTF080 13-NOV-2014
ES Spain Bilbao Clínico Universitario de Cruces Comité Etico de Investigacion Clinica de Euskadi PI2014158 24-FEB-2015
ES Spain Valencia Clínico Universitario de Valencia Comité Etico de Investigacion Clinica del Clínico Universitario de Valencia F-CE-GEva-15 23-APR-2015
SE Sweden Stockholm Karolinksa University Hospital EPN (Regionala Etikprövningsnämnden i Stockholm) 2014/1473-31/4 24-SEP-2014
SE Sweden Umea Umea University Hosptital EPN (Regionala Etikprövningsnämnden i Stockholm) 2014/1473-31/4 24-SEP-2014
SU Switzerland Lausanne Centre hospitalier universitaire Vaudois La Commission cantonale (VD) d'éthique de la recherche sur l'être humain (CER-VD) 473/11 09-DEC-2014
UK UK Birmingham Queen Elizabeth Hospital NHS HRA 14/SC/1370 22-DEC-2014
UHB Research Governance Office - Queen Elizabeth Hospital RRK5224 24-FEB-2016
UK UK Cambridge Cambridge University Hospital NHS Foundation Trust NHS HRA 14/SC/1370 22-DEC-2014
Research and Development Department - Cambridge University Hospital NHS Foundation Trust AO93184 30-JAN-2015
UK UK Southampton University Hospitals Southhampton NHS Trust NHS HRA 14/SC/1370 22-DEC-2014
Research Governance Office - University Hospitals Southhampton NHS Trust RHM CRI0294 13-MAR-2015
UK UK Sheffield Sheffield Teaching Hospitals NHS Foundation Trust NHS HRA 14/SC/1370 22-DEC-2014
Research and Development Department - Sheffield Teaching Hospitals NHS Foundation Trust STH18187 25-MAR-2015
UK UK London Kings college London NHS HRA 14/SC/1370 22-DEC-2014
Research & Innovation Office - Kings college London NHS Foundation Trust KCH15-204 30-DEC-2015
UK UK Salford Salford Royal Hospital NHS HRA 14/SC/1370 22-DEC-2014
Research and Development Department - Salford Royal Hospital NHS Foundation Trust 2015/025ET 27-JUL-2015
UK UK Liverpool The Walton centre NHS Foundation Trust NHS HRA 14/SC/1370 22-DEC-2014
Research & Innovation Office - The Walton centre NHS Foundation Trust RG154-15 11-MAY-2015
UK UK Bristol Southmead Hospital Bristol NHS HRA 14/SC/1370 22-DEC-2014
Research & Innovation - North Bristol NHS Trust 3427 23-DEC-2014
UK/SC UK/Scotland Edinburgh Lothian Health Board NHS Scotland 14/SS/1086 23-DEC-2014
Research and Development Department - University Hospitals Division NHS Lothian 2015/0171 19-JUN-2015