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

Affiliations

• ¹ University Neurosurgical Center Holland, LUMC, HMC & HAGA, Leiden & The Hague, the Netherlands.
• ² Department of Intensive Care, Erasmus MC - University Medical Centre Rotterdam, Rotterdam, the Netherlands.
• ³ Department of Intensive Care, Erasmus MC - University Medical Centre Rotterdam, Rotterdam, the Netherlands; Centre for Medical Decision Making, Department of Public Health, Erasmus MC - University Medical Centre Rotterdam, Rotterdam, the Netherlands.
• ⁴ School of Medicine and Surgery, University of Milan-Bicocca, Milan, Italy; San Gerardo Hospital, ASST, Monza, Italy.
• ⁵ Centre for Medical Decision Making, Department of Public Health, Erasmus MC - University Medical Centre Rotterdam, Rotterdam, the Netherlands.
• ⁶ Department of Neurosurgery, Antwerp University Hospital, Edegem, Belgium; University of Antwerp, Antwerp, Belgium.
• ⁷ Department of Anaesthesia, University of Cambridge, Cambridge, United Kingdom.
• ⁸ Department of Physiopathology and Transplantation, Milan University, Milan, Italy; Neuro ICU Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milano, Milan, Italy.
• ⁹ Department of Intensive Care, Erasmus MC - University Medical Centre Rotterdam, Rotterdam, the Netherlands; Department of Medical Ethics and Philosophy of Medicine, Erasmus MC - University Medical Centre Rotterdam, Rotterdam, the Netherlands. Electronic address: [email protected].
• ¹⁰ Department of Physiology and Pharmacology, Section of Perioperative Medicine and Intensive Care, Karolinska Institutet, Stockholm, Sweden.
• ¹¹ János Szentágothai Research Centre, University of Pécs, Pécs, Hungary.
• ¹² Division of Surgery and Clinical Neuroscience, Department of Physical Medicine and Rehabilitation, Oslo University Hospital and University of Oslo, Oslo, Norway.
• ¹³ Department of Neurosurgery, University Hospital Northern Norway, Tromso, Norway.
• ¹⁴ Department of Physical Medicine and Rehabilitation, University Hospital Northern Norway, Tromso, Norway.
• ¹⁵ Trauma Surgery, Medical University Vienna, Vienna, Austria.
• ¹⁶ Department of Anesthesiology & Intensive Care, University Hospital Nancy, Nancy, France.
• ¹⁷ Raymond Poincare hospital, Hopitaux de Paris, Paris, France.
• ¹⁸ Department of Anesthesiology & Intensive Care, S Raffaele University Hospital, Milan, Italy.
• ¹⁹ Department of Neurosurgery, Radboud University Medical Center, Nijmegen, the Netherlands.
• ²⁰ Department of Neurosurgery, University of Szeged, Szeged, Hungary.
• ²¹ International Projects Management, ARTTIC, Munchen, Germany.
• ²² Department of Neurology, Neurological Intensive Care Unit, Medical University of Innsbruck, Innsbruck, Austria.
• ²³ Department of Neurosurgery & Anesthesia & intensive care medicine, Karolinska University Hospital, Stockholm, Sweden.
• ²⁴ NIHR Surgical Reconstruction and Microbiology Research Centre, Birmingham, UK.
• ²⁵ Anesthesie-Réanimation, Hopitaux de Paris, Paris, France.
• ²⁶ Department of Anesthesia & ICU, AOU Città della Salute e della Scienza di Torino - Orthopedic and Trauma Center, Torino, Italy.
• ²⁷ Department of Neurology, Odense University Hospital, Odense, Denmark.
• ²⁸ BehaviourWorks Australia, Monash Sustainability Institute, Monash University, Victoria, Australia.
• ²⁹ Department of Public Health, Faculty of Health Sciences and Social Work, Trnava University, Trnava, Slovakia.
• ³⁰ Quesgen Systems Inc, Burlingame, CA, USA.
• ³¹ Australian & New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.
• ³² Department of Surgery and Perioperative Science, Umeå University, Umeå, Sweden.
• ³³ Department of Neurosurgery, Medical School, Hungary and Neurotrauma Research Group, János Szentágothai Research Centre, University of Pécs, Hungary.
• ³⁴ Department of Medical Psychology, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany.
• ³⁵ Brain Physics Lab, Division of Neurosurgery, Dept of Clinical Neurosciences, University of Cambridge, Addenbrooke's Hospital, Cambridge, UK.
• ³⁶ Neuro ICU, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan, Italy.
• ³⁷ ANZIC Research Centre, Monash University, Department of Epidemiology and Preventive Medicine, Melbourne, Victoria, Australia.
• ³⁸ Department of Neurosurgery, Hospital of Cruces, Bilbao, Spain.
• ³⁹ NeuroIntensive Care, Niguarda Hospital, Milan, Italy.
• ⁴⁰ School of Medicine and Surgery, Università Milano Bicocca, Milano, Italy; NeuroIntensive Care, ASST di Monza, Monza, Italy.
• ⁴¹ Department of Public Health, Erasmus Medical Center, University Medical Center, Rotterdam, the Netherlands.
• ⁴² Department of Anaesthesiology, University Hospital of Aachen, Aachen, Germany.
• ⁴³ Department of Anesthesia & Neurointensive Care, Cambridge University Hospital NHS Foundation Trust, Cambridge, UK.
• ⁴⁴ School of Public Health & PM, Monash University and The Alfred Hospital, Melbourne, Victoria, Australia.
• ⁴⁵ Radiology/MRI department, MRC Cognition and Brain Sciences Unit, Cambridge, UK.
• ⁴⁶ Institute of Medical Psychology and Medical Sociology, Universitätsmedizin Göttingen, Göttingen, Germany.
• ⁴⁷ Oxford University Hospitals NHS Trust, Oxford, UK.
• ⁴⁸ Intensive Care Unit, CHU Poitiers, Potiers, France.
• ⁴⁹ University of Manchester NIHR Biomedical Research Centre, Critical Care Directorate, Salford Royal Hospital NHS Foundation Trust, Salford, UK.
• ⁵⁰ Movement Science Group, Faculty of Health and Life Sciences, Oxford Brookes University, Oxford, UK.
• ⁵¹ Department of Neurosurgery, Antwerp University Hospital and University of Antwerp, Edegem, Belgium.
• ⁵² Department of Anesthesia & Intensive Care, Maggiore Della Carità Hospital, Novara, Italy.
• ⁵³ Department of Neurosurgery, University Hospitals Leuven, Leuven, Belgium.
• ⁵⁴ Department of Neurosurgery, Clinical centre of Vojvodina, Faculty of Medicine, University of Novi Sad, Novi Sad, Serbia.
• ⁵⁵ Division of Anaesthesia, University of Cambridge, Addenbrooke's Hospital, Cambridge, UK.
• ⁵⁶ Center for Stroke Research Berlin, Charité, Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Berlin, Germany.
• ⁵⁷ Intensive Care Unit, CHR Citadelle, Liège, Belgium.
• ⁵⁸ Department of Anaesthesiology and Intensive Therapy, University of Pécs, Pécs, Hungary.
• ⁵⁹ Departments of Neurology, Clinical Neurophysiology and Neuroanesthesiology, Region Hovedstaden Rigshospitalet, Copenhagen, Denmark.
• ⁶⁰ National Institute for Stroke and Applied Neurosciences, Faculty of Health and Environmental Studies, Auckland University of Technology, Auckland, New Zealand.
• ⁶¹ Department of Neurology, Erasmus MC, Rotterdam, the Netherlands.
• ⁶² Department of Anesthesiology and Intensive care, University Hospital Northern Norway, Tromso, Norway.
• ⁶³ Department of Neurosurgery, Hadassah-hebrew University Medical center, Jerusalem, Israel.
• ⁶⁴ Fundación Instituto Valenciano de Neurorrehabilitación (FIVAN), Valencia, Spain.
• ⁶⁵ Department of Neurosurgery, Shanghai Renji hospital, Shanghai Jiaotong University/school of medicine, Shanghai, China.
• ⁶⁶ Karolinska Institutet, INCF International Neuroinformatics Coordinating Facility, Stockholm, Sweden.
• ⁶⁷ Emergency Department, CHU, Liège, Belgium.
• ⁶⁸ Neurosurgery clinic, Pauls Stradins Clinical University Hospital, Riga, Latvia.
• ⁶⁹ Department of Computing, Imperial College London, London, UK.
• ⁷⁰ Department of Neurosurgery, Hospital Universitario 12 de Octubre, Madrid, Spain.
• ⁷¹ Department of Anesthesia, Critical Care and Pain Medicine, Medical University of Vienna, Austria.
• ⁷² College of Health and Medicine, Australian National University, Canberra, Australia.
• ⁷³ Department of Neurosurgery, Neurosciences Centre & JPN Apex trauma centre, All India Institute of Medical Sciences, New Delhi 110029, India.
• ⁷⁴ Department of Neurosurgery, Erasmus MC, Rotterdam, the Netherlands.
• ⁷⁵ Department of Neurosurgery, Oslo University Hospital, Oslo, Norway.
• ⁷⁶ Division of Psychology, University of Stirling, Stirling, UK.
• ⁷⁷ Division of Neurosurgery, Department of Clinical Neurosciences, Addenbrooke's Hospital & University of Cambridge, Cambridge, UK.
• ⁷⁸ Department of Neurology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.
• ⁷⁹ Neurointensive Care, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.
• ⁸⁰ Salford Royal Hospital NHS Foundation Trust Acute Research Delivery Team, Salford, UK.
• ⁸¹ Department of Intensive Care, Department of Ethics and Philosophy of Medicine, Erasmus Medical Center, Rotterdam, the Netherlands.
• ⁸² Department of Clinical Neuroscience, Neurosurgery, Umeå University, Umeå, Sweden.
• ⁸³ Hungarian Brain Research Program - Grant No. KTIA_13_NAP-A-II/8, University of Pécs, Pécs, Hungary.
• ⁸⁴ Cyclotron Research Center, University of Liège, Liège, Belgium.
• ⁸⁵ Centre for Urgent and Emergency Care Research (CURE), Health Services Research Section, School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK; Emergency Department, Salford Royal Hospital, Salford, UK.
• ⁸⁶ Institute of Research in Operative Medicine (IFOM), Witten/Herdecke University, Cologne, Germany.
• ⁸⁷ VP Global Project Management CNS, ICON, Paris, France.
• ⁸⁸ Department of Anesthesiology-Intensive Care, Lille University Hospital, Lille, France.
• ⁸⁹ Department of Neurosurgery, Rambam Medical Center, Haifa, Israel.
• ⁹⁰ Department of Anesthesiology & Intensive Care, University Hospitals Southhampton NHS Trust, Southhampton, UK.
• ⁹¹ Cologne-Merheim Medical Center (CMMC), Department of Traumatology, Orthopedic Surgery and Sportmedicine, Witten/Herdecke University, Cologne, Germany.
• ⁹² Intensive Care Unit, Southmead Hospital, Bristol, Bristol, UK.
• ⁹³ Department of Neurological Surgery, University of California, San Francisco, CA, USA.
• ⁹⁴ Department of Anesthesia & Intensive Care, M. Bufalini Hospital, Cesena, Italy.
• ⁹⁵ Department of Neurosurgery, University Hospital Heidelberg, Heidelberg, Germany.
• ⁹⁶ Department of Neurosurgery, The Walton centre NHS Foundation Trust, Liverpool, UK.
• ⁹⁷ Department of Medical Genetics, University of Pécs, Pécs, Hungary.
• ⁹⁸ Department of Neurosurgery, Emergency County Hospital Timisoara, Timisoara, Romania.
• ⁹⁹ Centre for Urgent and Emergency Care Research (CURE), Health Services Research Section, School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK.
• ¹⁰⁰ School of Medical Sciences, Örebro University, Örebro, Sweden.
• ¹⁰¹ Institute for Molecular Medicine Finland, University of Helsinki, Helsinki, Finland; Analytic and Translational Genetics Unit, Department of Medicine; Psychiatric & Neurodevelopmental Genetics Unit, Department of Psychiatry, Department of Neurology, Massachusetts General Hospital, Boston, MA, USA; Program in Medical and Population Genetics, The Stanley Center for Psychiatric Research, The Broad Institute of MIT and Harvard, Cambridge, MA, USA.
• ¹⁰² Department of Radiology, University of Antwerp, Edegem, Belgium.
• ¹⁰³ Department of Anesthesiology & Intensive Care, University Hospital of Grenoble, Grenoble, France.
• ¹⁰⁴ Department of Anesthesia & Intensive Care, Azienda Ospedaliera Università di Padova, Padova, Italy.
• ¹⁰⁵ Dept. of Neurosurgery, Leiden University Medical Center, Leiden, the Netherlands; Dept. of Neurosurgery, Medical Center Haaglanden, The Hague, the Netherlands.
• ¹⁰⁶ Department of Neurosurgery, Helsinki University Central Hospital, Finland.
• ¹⁰⁷ Institute for Molecular Medicine Finland, University of Helsinki, Helsinki, Finland.
• ¹⁰⁸ Division of Clinical Neurosciences, Department of Neurosurgery and Turku Brain Injury Centre, Turku University Hospital and University of Turku, Turku, Finland.
• ¹⁰⁹ Department of Anesthesiology and Critical Care, Pitié -Salpêtrière Teaching Hospital, Hôpitaux de Paris and University Pierre et Marie Curie, Paris, France.
• ¹¹⁰ Neurotraumatology and Neurosurgery Research Unit (UNINN), Vall d'Hebron Research Institute, Barcelona, Spain.
• ¹¹¹ Department of Neurosurgery, Kaunas University of technology and Vilnius University, Vilnius, Lithuania.
• ¹¹² Department of Neurosurgery, Rezekne Hospital, Latvia.
• ¹¹³ Department of Anaesthesia, Critical Care & Pain Medicine NHS Lothian, University of Edinburg, Edinburgh, UK.
• ¹¹⁴ MRC Biostatistics Unit, Cambridge Institute of Public Health, Cambridge, UK.
• ¹¹⁵ Department of Physical Medicine and Rehabilitation, Oslo University Hospital/University of Oslo, Oslo, Norway.
• ¹¹⁶ Division of Orthopedics, Oslo University Hospital, Oslo, Norway; Institue of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.
• ¹¹⁷ Broad Institute, Cambridge MA, Harvard Medical School, Boston MA, Massachusetts General Hospital, Boston, MA, USA.
• ¹¹⁸ National Trauma Research Institute, The Alfred Hospital, Monash University, Melbourne, Victoria, Australia.
• ¹¹⁹ Department of Neurosurgery, Odense University Hospital, Odense, Denmark.
• ¹²⁰ International Neurotrauma Research Organisation, Vienna, Austria.
• ¹²¹ Department of Neurosurgery, University Hospital Heidelberg, Heidelberg, Germany; Klinik für Neurochirurgie, Klinikum Ludwigsburg, Ludwigsburg, Germany.
• ¹²² Klinik für Neurochirurgie, Klinikum Ludwigsburg, Ludwigsburg, Germany.
• ¹²³ Division of Biostatistics and Epidemiology, Department of Preventive Medicine, University of Debrecen, Debrecen, Hungary.
• ¹²⁴ Department Health and Prevention, University Greifswald, Greifswald, Germany.
• ¹²⁵ Department of Anaesthesiology and Intensive Care, AUVA Trauma Hospital, Salzburg, Austria.
• ¹²⁶ Department of Neurology, Elisabeth-TweeSteden Ziekenhuis, Tilburg, the Netherlands.
• ¹²⁷ Department of Neuroanesthesia and Neurointensive Care, Odense University Hospital, Odense, Denmark.
• ¹²⁸ Department of Neuromedicine and Movement Science, Norwegian University of Science and Technology, NTNU, Trondheim, Norway; Department of Physical Medicine and Rehabilitation, St.Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.
• ¹²⁹ Department of Neurosurgery, University of Pécs, Pécs, Hungary.
• ¹³⁰ Division of Neuroscience Critical Care, John Hopkins University School of Medicine, Baltimore, USA.
• ¹³¹ Department of Neuropathology, Queen Elizabeth University Hospital, University of Glasgow, Glasgow, UK.
• ¹³² Department of Public Health, Erasmus Medical Center, University Medical Center, Rotterdam, the Netherlands; Dept. of Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, the Netherlands.
• ¹³³ Department of Pathophysiology and Transplantation, Milan University, Neuroscience ICU, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milano, Italy.
• ¹³⁴ Department of Radiation Sciences, Biomedical Engineering, Umeå University, Umeå, Sweden.
• ¹³⁵ Australian & New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia; Cochrane Consumers and Communication Review Group, Centre for Health Communication and Participation, School of Psychology and Public Health, La Trobe University, Melbourne, Australia.
• ¹³⁶ Perioperative Services, Intensive Care Medicine and Pain Management, Turku University Hospital and University of Turku, Turku, Finland.
• ¹³⁷ Department of Neurosurgery, Kaunas University of Health Sciences, Kaunas, Lithuania.
• ¹³⁸ Intensive Care and Department of Pediatric Surgery, Erasmus Medical Center, Sophia Children's Hospital, Rotterdam, the Netherlands.
• ¹³⁹ Department of Neurosurgery, Kings college London, London, UK.
• ¹⁴⁰ Neurologie, Neurochirurgie und Psychiatrie, Charité - Universitätsmedizin Berlin, Berlin, Germany.
• ¹⁴¹ icoMetrix NV, Leuven, Belgium.
• ¹⁴² Psychology Department, Antwerp University Hospital, Edegem, Belgium.
• ¹⁴³ NeuroIntensive Care, ASST di Monza, Monza, Italy.
• ¹⁴⁴ Director of Neurocritical Care, University of California, Los Angeles, USA.
• ¹⁴⁵ Department of Neuroanesthesia and Neurointensive Care, Odense University Hospital, Odense, Denmark; Department of Neurosurgery, St.Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.
• ¹⁴⁶ Department of Emergency Medicine, University of Florida, Gainesville, FL, USA.
• ¹⁴⁷ Department of Neurosurgery, Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Berlin, Germany.
• ¹⁴⁸ VTT Technical Research Centre, Tampere, Finland.
• ¹⁴⁹ Division of Anaesthesia, University of Cambridge, Addenbrooke's Hospital, Cambridge, UK; Section of Neurosurgery, Department of Surgery, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, MB, Canada.