Zeiler, Frederick A. http://orcid.org/0000-0003-1737-0510
,
Ercole, Ari
Cabeleira, Manuel
Beqiri, Erta
Zoerle, Tommaso
Carbonara, Marco
Stocchetti, Nino
Menon, David K.
Smielewski, Peter
Czosnyka, Marek
Funding for this research was provided by:
Seventh Framework Programme (602150)
Article History
Received: 27 February 2019
Accepted: 13 April 2019
First Online: 3 May 2019
Compliance with ethical standards
:
: Funding was obtained from the Hannelore Kohl Stiftung (Germany), from OneMind (USA) and from Integra LifeSciences Corporation (USA). PS and MC receive part of licensing fees for the software ICM+ (Cambridge Enterprise Ltd., UK) used for data collection and analysis in this study. All other authors certify that they have no affiliations with or involvement in any organization or entity with any financial interest (such as honoraria; educational grants; participation in speakers’ bureaus; membership, employment, consultancies, stock ownership, or other equity interest; and expert testimony or patent-licensing arrangements), or non-financial interest (such as personal or professional relationships, affiliations, knowledge or beliefs) in the subject matter or materials discussed in this manuscript.
: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee for each participating center and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
: Informed consent was obtained from all individual participants included in the study.Data used in these analyses were collected as part of the CENTER-TBI study which had individual national or local regulatory approval; the UK Ethics approval is provided as an exemplar: (IRAS No: 150943; REC 14/SC/1370). The CENTER-TBI study (EC grant 602,150) has been conducted in accordance with all relevant laws of the EU if directly applicable or of direct effect and all relevant laws of the country where the recruiting sites were located, including but not limited to, the relevant privacy and data protection laws and regulations (the “Privacy Law”), the relevant laws and regulations on the use of human materials, and all relevant guidance relating to clinical studies from time to time in force including, but not limited to, the ICH Harmonised Tripartite Guideline for Good Clinical Practice (CPMP/ICH/135/95) (“ICH GCP”) and the World Medical Association Declaration of Helsinki entitled “Ethical Principles for Medical Research Involving Human Subjects”. Informed consent by the patients and/or the legal representative/next of kin was obtained, accordingly to the local legislations, for all patients recruited in the Core Dataset of CENTER-TBI and documented in the e-CRF.