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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

Citerio Giuseppe; Legrand Valerie; van Veen Ernest; Timmers Marjolein; Maas Andrew IR; van Wijk Roel PJ; van Dijck Jeroen TJM; Kompanje Erwin JO; CENTER-TBI investigators and participants; Stocchetti Nino; Menon David K

dc.contributor.authorCiterio Giuseppe
dc.contributor.authorLegrand Valerie
dc.contributor.authorvan Veen Ernest
dc.contributor.authorTimmers Marjolein
dc.contributor.authorMaas Andrew IR
dc.contributor.authorvan Wijk Roel PJ
dc.contributor.authorvan Dijck Jeroen TJM
dc.contributor.authorKompanje Erwin JO; CENTER-TBI investigators and participants
dc.contributor.authorStocchetti Nino
dc.contributor.authorMenon David K
dc.date.accessioned2022-10-28T13:46:42Z
dc.date.available2022-10-28T13:46:42Z
dc.identifier.urihttps://www.utupub.fi/handle/10024/167345
dc.description.abstract<p>Background</p><p>The 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.</p><p>Methods<br /></p><p>We 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.</p><p>Results<br /></p><p>From 18 countries, 66 centers provided the requested documents. The primary IRB review was conducted centrally (<i>N</i> = 11, 61%) or locally (<i>N</i> = 7, 39%) and primary IRB approval was obtained after one (<i>N</i> = 8, 44%), two (<i>N</i> = 6, 33%) or three (<i>N</i> = 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).</p><p>Conclusion<br /></p><p>We 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.</p>
dc.language.isoen
dc.publisherBIOMED CENTRAL
dc.titleHow 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
dc.identifier.urlhttps://bmcmedethics.biomedcentral.com/articles/10.1186/s12910-020-00480-8
dc.identifier.urnURN:NBN:fi-fe2021042713511
dc.relation.volume21
dc.contributor.organizationfi=anestesiologia ja tehohoito|en=Anaesthesiology, Intensive Care, Emergency Care and Pain Medicine|
dc.contributor.organizationfi=tyks, vsshp|en=tyks, vsshp|
dc.contributor.organizationfi=kliiniset neurotieteet|en=Clinical Neurosciences|
dc.contributor.organization-code2607314
dc.contributor.organization-code2607301
dc.converis.publication-id49993654
dc.converis.urlhttps://research.utu.fi/converis/portal/Publication/49993654
dc.identifier.eissn1472-6939
dc.identifier.jour-issn1472-6939
dc.okm.affiliatedauthorDataimport, tyks, vsshp
dc.okm.affiliatedauthorTakala, Riikka
dc.okm.affiliatedauthorPosti, Jussi
dc.okm.affiliatedauthorTenovuo, Olli
dc.okm.discipline3126 Kirurgia, anestesiologia, tehohoito, radiologiafi_FI
dc.okm.discipline3126 Surgery, anesthesiology, intensive care, radiologyen_GB
dc.okm.internationalcopublicationinternational co-publication
dc.okm.internationalityInternational publication
dc.okm.typeA2 Review article
dc.publisher.countryUnited Kingdomen_GB
dc.publisher.countryBritanniafi_FI
dc.publisher.country-codeGB
dc.relation.articlenumber36
dc.relation.doi10.1186/s12910-020-00480-8
dc.relation.ispartofjournalBMC Medical Ethics
dc.relation.issue1
dc.year.issued2020


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