Evidence map›Paper›PMID 32398066›Full record

ArticleBMC medical ethics2020

How do 66 European institutional review boards approve one protocol for an international prospective observational study on traumatic brain injury? Experiences from the CENTER-TBI study.

Marjolein Timmers, Jeroen T J M van Dijck, Roel P J van Wijk, Valerie Legrand, Ernest van Veen, Andrew I R Maas, David K Menon, Giuseppe Citerio, Nino Stocchetti, Erwin J O Kompanje and 1 more

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Article in BMC medical ethics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Marjolein TimmersDepartment of Intensive Care, Erasmus MC - University Medical Centre Rotterdam, P.O. Box 2040, 3000 CA, Rotterdam, the Netherlands.
Jeroen T J M van DijckDepartment of Neurosurgery, University Neurosurgical Center Holland, LUMC, HMC & Haga Teaching Hospital, Leiden, The Hague, The Netherlands.
Roel P J van WijkDepartment of Neurosurgery, University Neurosurgical Center Holland, LUMC, HMC & Haga Teaching Hospital, Leiden, The Hague, The Netherlands.
Valerie LegrandICON plc, South County Business Park Leopardstown, Dublin 18, Ireland.
Ernest van VeenDepartment of Intensive Care, Erasmus MC - University Medical Centre Rotterdam, P.O. Box 2040, 3000 CA, Rotterdam, the Netherlands.
Andrew I R MaasDepartment of Neurosurgery, Antwerp University Hospital, Edegem, Belgium.
David K MenonDepartment of Anaesthesia, University of Cambridge, Cambridge, UK.
Giuseppe CiterioSchool of Medicine and Surgery, University of Milan-Bicocca, Milan, Italy.
Nino StocchettiDepartment of Physiopathology and Transplantation, Milan University, Milan, Italy.
Erwin J O KompanjeDepartment of Intensive Care, Erasmus MC - University Medical Centre Rotterdam, P.O. Box 2040, 3000 CA, Rotterdam, the Netherlands. erwinkompanje@me.com.ORCID 0000-0002-0649-4019
CENTER-TBI investigators and participants

Funding

European Commission 602150
6 · The paper itself

Abstract

backgroundThe European Union (EU) aims to optimize patient protection and efficiency of health-care research by harmonizing procedures across Member States. Nonetheless, further improvements are required to increase multicenter research efficiency. We investigated IRB procedures in a large prospective European multicenter study on traumatic brain injury (TBI), aiming to inform and stimulate initiatives to improve efficiency.

methodsWe reviewed relevant documents regarding IRB submission and IRB approval from European neurotrauma centers participating in the Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI). Documents included detailed information on IRB procedures and the duration from IRB submission until approval(s). They were translated and analyzed to determine the level of harmonization of IRB procedures within Europe.

resultsFrom 18 countries, 66 centers provided the requested documents. The primary IRB review was conducted centrally (N = 11, 61%) or locally (N = 7, 39%) and primary IRB approval was obtained after one (N = 8, 44%), two (N = 6, 33%) or three (N = 4, 23%) review rounds with a median duration of respectively 50 and 98 days until primary IRB approval. Additional IRB approval was required in 55% of countries and could increase duration to 535 days. Total duration from submission until required IRB approval was obtained was 114 days (IQR 75-224) and appeared to be shorter after submission to local IRBs compared to central IRBs (50 vs. 138 days, p = 0.0074).

conclusionWe found variation in IRB procedures between and within European countries. There were differences in submission and approval requirements, number of review rounds and total duration. Research collaborations could benefit from the implementation of more uniform legislation and regulation while acknowledging local cultural habits and moral values between countries.

Indexed as

Brain Injuries, TraumaticEthics Committees, ResearchObservational Studies as TopicEuropeHealth Services ResearchHumansMulticenter Studies as TopicProspective StudiesCENTER-TBIEuropean UnionHarmonizationHealth-care researchResearch ethic committees

Identifiers

PMID32398066
PMCPMC7216427

What Socratic holds

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LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.