Zusammenfassung
In der Pädiatrie besteht der Bedarf an besserer wissenschaftlich fundierter medizinischer Praxis auf der Grundlage qualitativ hochwertiger Forschung über Wirksamkeit und Sicherheit der medizinischen Behandlung von Kindern. Um die „besten Interessen des Kindes“ zu wahren, muss ein Gleichgewicht bestehen zwischen den ethischen Forderungen nach klinischer Forschung und gleichzeitiger Verhinderung jeglichen Schadens. Somit müssen die Grundsätze der „guten klinischen Praxis“, die in der Deklaration von Helsinki und in den Richtlinien der ICH, der EU-Direktive und anderen einschlägigen Dokumenten festgelegt wurden, in der pädiatrischen Forschung eingehalten werden. Evidente Unterschiede in Physiologie, Pathologie, Pharmakokinetik und -dynamik zwischen verschiedenen Altersgruppen und zwischen Kindern und Erwachsenen verlangen einwandfrei geplante und durchgeführte Studien, die die speziellen somatischen, emotionalen und mentalen Bedürfnisse der Kinder berücksichtigen. Um ein Forschungsprojekt beim Kind zu rechtfertigen, müssen die erwarteten Vorteile die erkennbaren Risken übersteigen, kompetentes Personal zur Verfügung stehen, die adäquate Information und Zustimmung erfolgen und jedes Forschungsprojekt durch eine mit den Rechten und Bedürfnissen der Kinder vertraute Ethikkommission approbiert worden sein.
Abstract
A child has the full right to protection of his/her life by provision of optional medical care. Better evidence-based practice is needed in pediatrics based on quality research into efficacy and safety of children’s medications. To protect the best interests of the child, one must balance the ethical demands for clinical research with the necessity of avoiding harm. To achieve this end good clinical practice in pediatric research demands that studies comply with the Declaration of Helsinki, ICH topic E11, EU Directives, and other relevant international guidelines. Evident differences in physiology, pharmacology, pharmacokinetics, and pharmacodynamics between children of differing ages and between children and adults demand properly constructed and conducted studies that respect the special somatic, emotional, and mental needs of children. To justify any research project one must balance the benefit/risk ratio, provide experienced, competent personnel and infrastructure, obtain adequate informed consent/assent, and have the study evaluated and approved by an ethics committee experienced in the rights and needs of children.
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Kurz, R. Ethik in der pädiatrischen Forschung. Monatsschr Kinderheilkd 151, 1276–1281 (2003). https://doi.org/10.1007/s00112-003-0848-1
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DOI: https://doi.org/10.1007/s00112-003-0848-1