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  1. Ethical and Procedural Issues for Applying Researcher-Driven Multi-National Paediatric Clinical Trials in and Outside the European Union: The Challenging Experience of the DEEP Project.Adriana Ceci, Giorgio Reggiardo, Bianca Tempesta, Slaheddine Fattoum, Lamis Ragab, George Papanikolaou, Hugo Devlieger, Donato Bonifazi, Mariagrazia Felisi & Viviana Giannuzzi - 2021 - BMC Medical Ethics 22 (1):1-11.
    BackgroundWe describe our experience from a multi-national application of a European Union-funded research-driven paediatric trial. This paper aims to evaluate the impact of the local and national rules on the trial authorisation process in European and non-European countries. National/local provisions and procedures, number of Ethics Committees and Competent Authorities to be addressed, documentation required, special provisions for the paediatric population, timelines for completing the authorisation process and queries received were collected; compliance with the European provisions were evaluated. Descriptive analysis, Wilcoxon (...)
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  • Huge Variation in Obtaining Ethical Permission for a Non-Interventional Observational Study in Europe.Dylan W. de Lange, Bertrand Guidet, Finn H. Andersen, Antonio Artigas, Guidio Bertolini, Rui Moreno, Steffen Christensen, Maurizio Cecconi, Christina Agvald-Ohman, Primoz Gradisek, Christian Jung, Brian J. Marsh, Sandra Oeyen, Bernardo Bollen Pinto, Wojciech Szczeklik, Ximena Watson, Tilemachos Zafeiridis & Hans Flaatten - 2019 - BMC Medical Ethics 20 (1):39.
    Ethical approval must be obtained before medical research can start. We describe the differences in EA for an pseudonymous, non-interventional, observational European study. Sixteen European national coordinators of the international study on very old intensive care patients answered an online questionnaire concerning their experience getting EA. N = 8/16 of the NCs could apply at one single national ethical committee, while the others had to apply to various regional ECs and/or individual hospital institutional research boards. The time between applying for (...)
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