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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http://hdl.handle.net/10138/330373

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CENTER-TB1 Investigators , van Wijk , R P J , van Dijck , J T J M , Timmers , M , Palotie , A , Piippo-Karjalainen , A , Pirinen , M , Raj , R & Ripatti , S 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

Title: Informed consent procedures in patients with an acute inability to provide informed consent : Policy and practice in the CENTER-TBI study
Author: CENTER-TB1 Investigators; van Wijk, Roel P. J.; van Dijck, Jeroen T. J. M.; Timmers, Marjolein; Palotie, Aarno; Piippo-Karjalainen, Anna; Pirinen, Matti; Raj, Rahul; Ripatti, Samuli
Contributor organization: Centre of Excellence in Complex Disease Genetics
Aarno Palotie / Principal Investigator
Institute for Molecular Medicine Finland
Genomics of Neurological and Neuropsychiatric Disorders
University of Helsinki
HUS Neurocenter
Neurokirurgian yksikkö
Helsinki University Hospital Area
Statistical and population genetics
Biostatistics Helsinki
Staff Services
Samuli Olli Ripatti / Principal Investigator
Complex Disease Genetics
Date: 2020-10
Language: eng
Number of pages: 10
Belongs to series: Journal of Critical Care
ISSN: 0883-9441
DOI: https://doi.org/10.1016/j.jcrc.2020.05.004
URI: http://hdl.handle.net/10138/330373
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.
Subject: Traumatic brain injury
Informed consent
European Union
Ethics
TRAUMATIC BRAIN-INJURY
SURROGATE DECISION-MAKERS
DEFERRED CONSENT
RESUSCITATION RESEARCH
CAPACITY ASSESSMENT
PROXY CONSENT
MULTICENTER
OUTCOMES
3126 Surgery, anesthesiology, intensive care, radiology
3121 General medicine, internal medicine and other clinical medicine
Peer reviewed: Yes
Rights: cc_by_nc_nd
Usage restriction: openAccess
Self-archived version: acceptedVersion


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