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001-es BibID:BIBFORM107454
035-os BibID:(cikkazonosító)36 (scopus)85084535573 (wos)000535606600002
Első szerző:Timmers, Marjolein
Cím: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 / Timmers, Marjolein; van Dijck, Jeroen T. J. M.; van Wijk, Roel P. J.; Legrand, Valerie; van Veen, Ernest; Maas, Andrew I. R.; Menon, David K.; Citerio, Giuseppe; Stocchetti, Nino; Kompanje, Erwin J. O., CENTER-TBI investigators and participants
Dátum:2020
ISSN:1472-6939
Megjegyzések:Background: 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. Methods: 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. Results: From 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). Conclusion: 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.
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
Research ethic committees
European Union
Health-care research
CENTER-TBI
Harmonization
Megjelenés:BMC Medical Ethics. - 21 : 1 (2020), p. 1-14. -
További szerzők:van Dijck, Jeroen T. J. M. van Wijk, Roel P. J. Legrand, Valerie van Veen, Ernest Maas, Andrew I. R. Menon, David Krishna Citerio, Giuseppe Stocchetti, Nino Kompanje, Erwin J. O. Sándor János (1966-) (orvos-epidemiológus) CENTER-TBI Participants and Investigators
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001-es BibID:BIBFORM107438
035-os BibID:(scopus)85085505275 (wos)000581019400002
Első szerző:van Wijk, Roel P. J.
Cím:Informed consent procedures in patients with an acute inability to provide informed consent : Policy and practice in the CENTER-TBI study / van Wijk Roel P. J., van Dijck Jeroen T. J. M., Timmers Marjolein, van Veen Ernest, Citerio Giuseppe, Lingsma Hester F., Maas Andrew I. R., Menon David K., Peul Wilco C., Stocchetti Nino, Kompanje Erwin J. O., CENTER-TBI investigators and participants
Dátum:2020
ISSN:0883-9441
Megjegyzések:Purpose: Enrolling traumatic brain injury (TBI) 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 prac- tice. 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 ac- tively 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 dif- ferent informed consent procedures. Variation could be caused by several reasons, including inconsistencies in clear legislation or knowledge of such legislation amongst researchers.
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
Traumatic brain injury
Informed consent
European Union Ethics
Megjelenés:Journal Of Critical Care. - 59 (2020), p. 6-15. -
További szerzők:van Dijck, Jeroen T. J. M. Timmers, Marjolein van Veen, Ernest Citerio, Giuseppe Lingsma, Hester Maas, Andrew I. R. Menon, David Krishna Peul, Wilco C. Stocchetti, Nino Kompanje, Erwin J. O. Sándor János (1966-) (orvos-epidemiológus) CENTER-TBI Participants and Investigators
Internet cím:Szerző által megadott URL
DOI
Intézményi repozitóriumban (DEA) tárolt változat
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