Erschienen in:
01.07.2003 | Original Paper
Guidelines for informed consent in biomedical research involving paediatric populations as research participants
verfasst von:
Dennis Gill, Ethics Working Group of the Confederation of European Specialists in Paediatrics: Francis P. Crawley (Belgium), Milena LoGiudice (Italy), Stefan Grosek (Slovenia), Ronald Kurz (Austria), Maria de Lourdes-Levy (Portugal), Staffan Mjönes (Sweden), Demetre Nicolopoulos (Greece), Armido Rubino (Italy), Pieter J.J. Sauer (Netherlands), Martti Siimes (Finland), Michael Weinding (UK), Maximilian Zach (Austria), Timothy L. Chambers (UK)
Erschienen in:
European Journal of Pediatrics
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Ausgabe 7-8/2003
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Abstract
To promote and protect the best interests of children involved in biomedical research, paediatricians have to ensure that participating minors and their parents/legal representatives have understood and assented/consented to the research. Therefore guidelines providing child-specific guidance that are compatible with other international guidelines on informed consent are laid down. Special regard is paid to the willingness to participate and the social and cultural background of the patients, the legal conditions of the countries, the capacity of the child to understand and give his/her informed assent, the adequate communication with the child and the parents, the respect of the will of the patient, the understandable written informed consent of legal representatives and to the evaluation of the informed consent/assent process by competent ethics committees.