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

Roel P. J. van Wijk; Jeroen T. J. M. van Dijck; Marjolein Timmers; Ernest van Veen; Giuseppe Citerio; Hester F. Lingsma; Andrew I. R. Maas; David K. Menon; Wilco C. Peul; Nino Stocchetti; Erwin J. O. Kompanje; Emiliana Calappi; CENTER-TBI Investigators and Participants

doi:10.1016/j.jcrc.2020.05.004

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

Roel P. J. van Wijk, Jeroen T. J. M. van Dijck, Marjolein Timmers, Ernest van Veen, Giuseppe Citerio, Hester F. Lingsma, Andrew I. R. Maas, David K. Menon, Wilco C. Peul, Nino Stocchetti, Erwin J. O. Kompanje^*, Emiliana Calappi, CENTER-TBI Investigators and Participants

^*Corresponding author for this work

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

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Abstract

Purpose: Enrolling traumatic brain injury (731) 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. (C) 2020 Published by Elsevier Inc.

Original language	English
Pages (from-to)	6-15
Number of pages	10
Journal	Journal of Critical Care
Volume	59
DOIs	https://doi.org/10.1016/j.jcrc.2020.05.004
Publication status	Published - Oct 2020
Externally published	Yes

Keywords

Traumatic brain injury
Informed consent
European Union
Ethics
TRAUMATIC BRAIN-INJURY
SURROGATE DECISION-MAKERS
DEFERRED CONSENT
RESUSCITATION RESEARCH
CAPACITY ASSESSMENT
PROXY CONSENT
MULTICENTER
OUTCOMES

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10.1016/j.jcrc.2020.05.004

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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., Calappi, E., & 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

@article{fb14fcc5f923490b9305d8938b5c0c5e,

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 (731) 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. (C) 2020 Published by Elsevier Inc.",

keywords = "Traumatic brain injury, Informed consent, European Union, Ethics, TRAUMATIC BRAIN-INJURY, SURROGATE DECISION-MAKERS, DEFERRED CONSENT, RESUSCITATION RESEARCH, CAPACITY ASSESSMENT, PROXY CONSENT, MULTICENTER, OUTCOMES",

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 Emiliana Calappi and {CENTER-TBI Investigators and Participants} and {van Heugten}, Caroline",

note = "Funding Information: CENTER-TBI was supported by the European Union 7th Framework program (EC grant 602150). Additional funding was obtained from the Hannelore Kohl Stiftung (Germany), from OneMind (USA) and from Integra LifeSciences Corporation (USA). David K. Menon was supported by a Senior Investigator Award from the National Institute for Health Research (UK). Funding Information: CENTER-TBI was supported by the European Union 7th Framework program (EC grant 602150 ). Additional funding was obtained from the Hannelore Kohl Stiftung (Germany), from OneMind (USA) and from Integra LifeSciences Corporation (USA). David K. Menon was supported by a Senior Investigator Award from the National Institute for Health Research (UK). Publisher Copyright: {\textcopyright} 2020",

year = "2020",

month = oct,

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",

}

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, Calappi, E & 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

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 - Calappi, Emiliana

AU - CENTER-TBI Investigators and Participants

AU - van Heugten, Caroline

N1 - Funding Information: CENTER-TBI was supported by the European Union 7th Framework program (EC grant 602150). Additional funding was obtained from the Hannelore Kohl Stiftung (Germany), from OneMind (USA) and from Integra LifeSciences Corporation (USA). David K. Menon was supported by a Senior Investigator Award from the National Institute for Health Research (UK). Funding Information: CENTER-TBI was supported by the European Union 7th Framework program (EC grant 602150 ). Additional funding was obtained from the Hannelore Kohl Stiftung (Germany), from OneMind (USA) and from Integra LifeSciences Corporation (USA). David K. Menon was supported by a Senior Investigator Award from the National Institute for Health Research (UK). Publisher Copyright: © 2020

PY - 2020/10

Y1 - 2020/10

N2 - Purpose: Enrolling traumatic brain injury (731) 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. (C) 2020 Published by Elsevier Inc.

AB - Purpose: Enrolling traumatic brain injury (731) 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. (C) 2020 Published by Elsevier Inc.

KW - Traumatic brain injury

KW - Informed consent

KW - European Union

KW - Ethics

KW - TRAUMATIC BRAIN-INJURY

KW - SURROGATE DECISION-MAKERS

KW - DEFERRED CONSENT

KW - RESUSCITATION RESEARCH

KW - CAPACITY ASSESSMENT

KW - PROXY CONSENT

KW - MULTICENTER

KW - OUTCOMES

U2 - 10.1016/j.jcrc.2020.05.004

DO - 10.1016/j.jcrc.2020.05.004

M3 - Article

SN - 0883-9441

VL - 59

SP - 6

EP - 15

JO - Journal of Critical Care

JF - Journal of Critical Care

ER -

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

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Keywords

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