Informed consent procedures in patients with an acute inability to provide informed consent: Policy and practice in the CENTER-TBI study.
Brain Injuries, Traumatic
/ blood
Europe
/ epidemiology
Follow-Up Studies
Human Experimentation
/ legislation & jurisprudence
Humans
Informed Consent
/ legislation & jurisprudence
Intensive Care Units
Israel
/ epidemiology
Patient Admission
Policy
Prospective Studies
Proxy
/ legislation & jurisprudence
Research Personnel
/ psychology
Surveys and Questionnaires
Ethics
European Union
Informed consent
Traumatic brain injury
Journal
Journal of critical care
ISSN: 1557-8615
Titre abrégé: J Crit Care
Pays: United States
ID NLM: 8610642
Informations de publication
Date de publication:
10 2020
10 2020
Historique:
received:
11
12
2019
revised:
13
05
2020
accepted:
14
05
2020
pubmed:
3
6
2020
medline:
21
5
2021
entrez:
3
6
2020
Statut:
ppublish
Résumé
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. We aimed to quantify variations in informed consent policy and practice. 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. 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%). 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.
Identifiants
pubmed: 32485440
pii: S0883-9441(20)30563-3
doi: 10.1016/j.jcrc.2020.05.004
pii:
doi:
Types de publication
Journal Article
Multicenter Study
Observational Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
6-15Subventions
Organisme : Department of Health
Pays : United Kingdom
Investigateurs
Cecilia Åkerlund
(C)
Krisztina Amrein
(K)
Nada Andelic
(N)
Lasse Andreassen
(L)
Audny Anke
(A)
Anna Antoni
(A)
Gérard Audibert
(G)
Philippe Azouvi
(P)
Maria Luisa Azzolini
(ML)
Ronald Bartels
(R)
Pál Barzó
(P)
Romuald Beauvais
(R)
Ronny Beer
(R)
Bo-Michael Bellander
(BM)
Antonio Belli
(A)
Habib Benali
(H)
Maurizio Berardino
(M)
Luigi Beretta
(L)
Morten Blaabjerg
(M)
Peter Bragge
(P)
Alexandra Brazinova
(A)
Vibeke Brinck
(V)
Joanne Brooker
(J)
Camilla Brorsson
(C)
Andras Buki
(A)
Monika Bullinger
(M)
Manuel Cabeleira
(M)
Alessio Caccioppola
(A)
Emiliana Calappi
(E)
Maria Rosa Calvi
(MR)
Peter Cameron
(P)
Guillermo Carbayo Lozano
(GC)
Marco Carbonara
(M)
Simona Cavallo
(S)
Giorgio Chevallard
(G)
Arturo Chieregato
(A)
Giuseppe Citerio
(G)
Iris Ceyisakar
(I)
Mark Coburn
(M)
Jonathan Coles
(J)
Jamie D Cooper
(JD)
Marta Correia
(M)
Amra Čović
(A)
Nicola Curry
(N)
Endre Czeiter
(E)
Marek Czosnyka
(M)
Claire Dahyot-Fizelier
(C)
Paul Dark
(P)
Helen Dawes
(H)
Véronique De Keyser
(V)
Vincent Degos
(V)
Francesco Della Corte
(FD)
Hugo den Boogert
(H)
Bart Depreitere
(B)
Đula Đilvesi
(Đ)
Abhishek Dixit
(A)
Emma Donoghue
(E)
Jens Dreier
(J)
Guy-Loup Dulière
(GL)
Ari Ercole
(A)
Patrick Esser
(P)
Erzsébet Ezer
(E)
Martin Fabricius
(M)
Valery L Feigin
(VL)
Kelly Foks
(K)
Shirin Frisvold
(S)
Alex Furmanov
(A)
Pablo Gagliardo
(P)
Damien Galanaud
(D)
Dashiell Gantner
(D)
Guoyi Gao
(G)
Pradeep George
(P)
Alexandre Ghuysen
(A)
Lelde Giga
(L)
Ben Glocker
(B)
Jagoš Golubovic
(J)
Pedro A Gomez
(PA)
Johannes Gratz
(J)
Benjamin Gravesteijn
(B)
Francesca Grossi
(F)
Russell L Gruen
(RL)
Deepak Gupta
(D)
Juanita A Haagsma
(JA)
Iain Haitsma
(I)
Raimund Helbok
(R)
Eirik Helseth
(E)
Lindsay Horton
(L)
Jilske Huijben
(J)
Peter J Hutchinson
(PJ)
Bram Jacobs
(B)
Stefan Jankowski
(S)
Mike Jarrett
(M)
Ji-Yao Jiang
(JY)
Faye Johnson
(F)
Kelly Jones
(K)
Mladen Karan
(M)
Angelos G Kolias
(AG)
Erwin Kompanje
(E)
Daniel Kondziella
(D)
Evgenios Koraropoulos
(E)
Lars-Owe Koskinen
(LO)
Noémi Kovács
(N)
Ana Kowark
(A)
Alfonso Lagares
(A)
Linda Lanyon
(L)
Steven Laureys
(S)
Fiona Lecky
(F)
Didier Ledoux
(D)
Rolf Lefering
(R)
Valerie Legrand
(V)
Aurelie Lejeune
(A)
Leon Levi
(L)
Roger Lightfoot
(R)
Hester Lingsma
(H)
Andrew I R Maas
(AIR)
Ana M Castaño-León
(AM)
Marc Maegele
(M)
Marek Majdan
(M)
Alex Manara
(A)
Geoffrey Manley
(G)
Costanza Martino
(C)
Hugues Maréchal
(H)
Julia Mattern
(J)
Catherine McMahon
(C)
Béla Melegh
(B)
David Menon
(D)
Tomas Menovsky
(T)
Benoit Misset
(B)
Davide Mulazzi
(D)
Visakh Muraleedharan
(V)
Lynnette Murray
(L)
Ancuta Negru
(A)
David Nelson
(D)
Virginia Newcombe
(V)
Daan Nieboer
(D)
József Nyirádi
(J)
Otesile Olubukola
(O)
Matej Oresic
(M)
Fabrizio Ortolano
(F)
Aarno Palotie
(A)
Paul M Parizel
(PM)
Jean-François Payen
(JF)
Natascha Perera
(N)
Vincent Perlbarg
(V)
Paolo Persona
(P)
Wilco Peul
(W)
Anna Piippo-Karjalainen
(A)
Matti Pirinen
(M)
Horia Ples
(H)
Suzanne Polinder
(S)
Inigo Pomposo
(I)
Jussi P Posti
(JP)
Louis Puybasset
(L)
Andreea Radoi
(A)
Arminas Ragauskas
(A)
Rahul Raj
(R)
Malinka Rambadagalla
(M)
Jonathan Rhodes
(J)
Sylvia Richardson
(S)
Sophie Richter
(S)
Samuli Ripatti
(S)
Saulius Rocka
(S)
Cecilie Roe
(C)
Olav Roise
(O)
Jonathan Rosand
(J)
Jeffrey V Rosenfeld
(JV)
Christina Rosenlund
(C)
Guy Rosenthal
(G)
Rolf Rossaint
(R)
Sandra Rossi
(S)
Daniel Rueckert
(D)
Martin Rusnák
(M)
Juan Sahuquillo
(J)
Oliver Sakowitz
(O)
Renan Sanchez-Porras
(R)
Janos Sandor
(J)
Nadine Schäfer
(N)
Silke Schmidt
(S)
Herbert Schoechl
(H)
Guus Schoonman
(G)
Rico Frederik Schou
(RF)
Elisabeth Schwendenwein
(E)
Charlie Sewalt
(C)
Toril Skandsen
(T)
Peter Smielewski
(P)
Abayomi Sorinola
(A)
Emmanuel Stamatakis
(E)
Simon Stanworth
(S)
Robert Stevens
(R)
William Stewart
(W)
Ewout W Steyerberg
(EW)
Nino Stocchetti
(N)
Nina Sundström
(N)
Anneliese Synnot
(A)
Riikka Takala
(R)
Viktória Tamás
(V)
Tomas Tamosuitis
(T)
Mark Steven Taylor
(MS)
Braden Te Ao
(BT)
Olli Tenovuo
(O)
Alice Theadom
(A)
Matt Thomas
(M)
Dick Tibboel
(D)
Marjolein Timmers
(M)
Christos Tolias
(C)
Tony Trapani
(T)
Cristina Maria Tudora
(CM)
Peter Vajkoczy
(P)
Shirley Vallance
(S)
Egils Valeinis
(E)
Zoltán Vámos
(Z)
Gregory Van der Steen
(G)
Joukje van der Naalt
(J)
Jeroen T J M van Dijck
(JTJM)
Thomas A van Essen
(TA)
Wim Van Hecke
(W)
Caroline van Heugten
(C)
Dominique Van Praag
(D)
Thijs Vande Vyvere
(TV)
Roel P J van Wijk
(RPJ)
Alessia Vargiolu
(A)
Emmanuel Vega
(E)
Kimberley Velt
(K)
Jan Verheyden
(J)
Paul M Vespa
(PM)
Anne Vik
(A)
Rimantas Vilcinis
(R)
Victor Volovici
(V)
Nicole von Steinbüchel
(N)
Daphne Voormolen
(D)
Petar Vulekovic
(P)
Kevin K W Wang
(KKW)
Eveline Wiegers
(E)
Guy Williams
(G)
Lindsay Wilson
(L)
Stefan Winzeck
(S)
Stefan Wolf
(S)
Zhihui Yang
(Z)
Peter Ylén
(P)
Alexander Younsi
(A)
Frederick A Zeiler
(FA)
Veronika Zelinkova
(V)
Agate Ziverte
(A)
Tommaso Zoerle
(T)
Informations de copyright
Copyright © 2020. Published by Elsevier Inc.
Déclaration de conflit d'intérêts
Declaration of Competing Interest The authors declare that they have no competing interests.