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

Research output: Contribution to journal › Journal article › Research › peer-review

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Informed consent procedures in patients with an acute inability to provide informed consent : Policy and practice in the CENTER-TBI study. / 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; Fabricius, Martin; Kondziella, Daniel; Nelson, David; The CENTER-TBI investigators and participants.

In: Journal of Critical Care, Vol. 59, 2020, p. 6-15.

Research output: Contribution to journal › Journal article › Research › peer-review

Harvard

van Wijk, RPJ, van Dijck, JTJM, Timmers, M, van Veen, E, Citerio, G, Lingsma, HF, Maas, AIR, Menon, DK, Peul, WC, 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, Fabricius, M, Kondziella, D, Nelson, D & The CENTER-TBI investigators and participants 2020, 'Informed consent procedures in patients with an acute inability to provide informed consent: Policy and practice in the CENTER-TBI study', Journal of Critical Care, vol. 59, pp. 6-15. https://doi.org/10.1016/j.jcrc.2020.05.004

APA

van Wijk, R. P. J., van Dijck, J. T. J. M., Timmers, M., van Veen, E., Citerio, G., Lingsma, H. F., Maas, A. I. R., Menon, D. K., Peul, W. C., Stocchetti, N., Kompanje, E. J. O., Åkerlund, C., Amrein, K., Andelic, N., Andreassen, L., Anke, A., Antoni, A., Audibert, G., Azouvi, P., ... The CENTER-TBI investigators and participants (2020). Informed consent procedures in patients with an acute inability to provide informed consent: Policy and practice in the CENTER-TBI study. Journal of Critical Care, 59, 6-15. https://doi.org/10.1016/j.jcrc.2020.05.004

Vancouver

van Wijk RPJ, van Dijck JTJM, Timmers M, van Veen E, Citerio G, Lingsma HF et al. Informed consent procedures in patients with an acute inability to provide informed consent: Policy and practice in the CENTER-TBI study. Journal of Critical Care. 2020;59:6-15. https://doi.org/10.1016/j.jcrc.2020.05.004

Author

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 ; Fabricius, Martin ; Kondziella, Daniel ; Nelson, David ; The CENTER-TBI investigators and participants. / Informed consent procedures in patients with an acute inability to provide informed consent : Policy and practice in the CENTER-TBI study. In: Journal of Critical Care. 2020 ; Vol. 59. pp. 6-15.

Bibtex

@article{1d1e93a2536841a08de9b254c5b1c20c,
title = "Informed consent procedures in patients with an acute inability to provide informed consent: Policy and practice in the CENTER-TBI study",
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. We aimed 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 from 57 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.",
keywords = "Ethics, European Union, Informed consent, Traumatic brain injury",
author = "{van Wijk}, {Roel P.J.} and {van Dijck}, {Jeroen T.J.M.} and Marjolein Timmers and {van Veen}, Ernest and Giuseppe Citerio and Lingsma, {Hester F.} and Maas, {Andrew I.R.} and Menon, {David K.} and Peul, {Wilco C.} 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 Martin Fabricius and Daniel Kondziella and David Nelson and {The CENTER-TBI investigators and participants}",
year = "2020",
doi = "10.1016/j.jcrc.2020.05.004",
language = "English",
volume = "59",
pages = "6--15",
journal = "Journal of Critical Care",
issn = "0883-9441",
publisher = "W.B.Saunders Co.",

}

RIS

TY - JOUR

T1 - Informed consent procedures in patients with an acute inability to provide informed consent

T2 - Policy and practice in the CENTER-TBI study

AU - van Wijk, Roel P.J.

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

AU - Timmers, Marjolein

AU - van Veen, Ernest

AU - Citerio, Giuseppe

AU - Lingsma, Hester F.

AU - Maas, Andrew I.R.

AU - Menon, David K.

AU - Peul, Wilco C.

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 - Fabricius, Martin

AU - Kondziella, Daniel

AU - Nelson, David

AU - The CENTER-TBI investigators and participants

PY - 2020

Y1 - 2020

N2 - 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. We aimed 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 from 57 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.

AB - 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. We aimed 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 from 57 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.

KW - Ethics

KW - European Union

KW - Informed consent

KW - Traumatic brain injury

U2 - 10.1016/j.jcrc.2020.05.004

DO - 10.1016/j.jcrc.2020.05.004

M3 - Journal article

C2 - 32485440

AN - SCOPUS:85085505275

VL - 59

SP - 6

EP - 15

JO - Journal of Critical Care

JF - Journal of Critical Care

SN - 0883-9441

ER -

ID: 255451455