Evidence map›Paper›PMID 31064358›Full record

ArticleBMC medical ethics2019

Methodological challenges in European ethics approvals for a genetic epidemiology study in critically ill patients: the GenOSept experience.

Ascanio Tridente, Paul A H Holloway, Paula Hutton, Anthony C Gordon, Gary H Mills, Geraldine M Clarke, Jean-Daniel Chiche, Frank Stuber, Christopher Garrard, Charles Hinds and 2 more

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In one paragraph

Article in BMC medical ethics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing 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

11 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

12 authors.

Ascanio TridenteWhiston Hospital, Prescot, Merseyside and Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK. ascanio.tridente@doctors.org.uk.ORCID 0000-0003-1500-447X
Paul A H HollowayImperial College, London, UK.
Paula HuttonIntensive Care Unit, John Radcliffe Hospital, Oxford, UK.
Anthony C GordonImperial College, London, UK.
Gary H MillsUniversity of Sheffield, Sheffield, UK.
Geraldine M ClarkeThe Health Foundation, London, UK.
Jean-Daniel ChicheHospital Cochin, Paris, France.
Frank StuberDepartment of Anaesthesiology and Pain Medicine, Bern University Hospital and University of Bern, Bern, Switzerland.
Christopher GarrardThe Health Foundation, London, UK.
Charles HindsBarts and the London Queen Mary School of Medicine, London, UK.
Julian BionInstitute of Clinical Sciences, University of Birmingham, Birmingham, UK.
GenOSept National Coordinators, European Society of Intensive Care Medicine

Funding

Department of Health RP-2015-06-018Medical Research Council G0900747 91070Wellcome TrustWellcome Trust 090532/Z/09/Z
6 · The paper itself

Abstract

backgroundDuring the set-up phase of an international study of genetic influences on outcomes from sepsis, we aimed to characterise potential differences in ethics approval processes and outcomes in participating European countries.

methodsBetween 2005 and 2007 of the FP6-funded international Genetics Of Sepsis and Septic Shock (GenOSept) project, we asked national coordinators to complete a structured survey of research ethic committee (REC) approval structures and processes in their countries, and linked these data to outcomes. Survey findings were reconfirmed or modified in 2017.

resultsEighteen countries participated in the study, recruiting 2257 patients from 160 ICUs. National practices differed widely in terms of composition of RECs, procedures and duration of the ethics approval process. Eight (44.4%) countries used a single centralised process for approval, seven (38.9%) required approval by an ethics committee in each participating hospital, and three (16.7%) required both. Outcomes of the application process differed widely between countries because of differences in national legislation, and differed within countries because of interpretation of the ethics of conducting research in patients lacking capacity. The RECs in four countries had no lay representation. The median time from submission to final decision was 1.5 (interquartile range 1-7) months; in nine (50%) approval was received within 1 month; six took over 6 months, and in one 24 months; had all countries been able to match the most efficient approvals processes, an additional 74 months of country or institution-level recruitment would have been available. In three countries, rejection of the application by some local RECs resulted in loss of centres; and one country rejected the application outright.

conclusionsThe potential benefits of the single application portal offered by the European Clinical Trials Regulation will not be realised without harmonisation of research ethics committee practices as well as national legislation.

Indexed as

Ethics Committees, ResearchConfidentialityCritical IllnessEuropeHumansInformed ConsentInternational CooperationMental CompetencyMolecular EpidemiologySurveys and QuestionnairesDecision-makingGenetic epidemiologyGenOSeptHuman geneticsIntensive careResearch ethics

Identifiers

PMID31064358
PMCPMC6503539

What Socratic holds

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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.