The inclusion of children in longitudinal research using biobanks raises specific ethical and legal issues. This article analyzes ethical frameworks concerning participation in biobanks and suggests that such frameworks, developed in the context of competent adults as research subjects, are not adapted for research involving children. It concludes that there is a need to elaborate guidelines specific to biobanks and longitudinal studies involving children and provides recommendations regarding parental authorization, the child’s assent and consent, and on the return of results in this context.

Biobanks and Longitudinal Studies: Where Are the Children?

Improved understanding of genetic and genomic influences on drug disposition and action : implications for children.

La inclusión de niños en investigaciones longitudinales utilizando biobancos plantea cuestiones éticas y legales específicas. El presente artículo analiza los marcos éticos relacionados con la participación en biobancos y sugiere que dichos marcos, desarrollados en el contexto de la participación de adultos competentes como sujetos de investigación no son adaptados para investigaciones que conlleven una participación de niños. Concluye que existe la necesidad de elaborar lineamientos específicos para los biobancos y estudios longitudinales que incluyan a niños y ofrece recomendaciones con respecto a la autorización de los padres, el asentimiento y consentimiento del niño y la comunicación de los resultados a los participantes en este contexto.

Biobancos y estudios longitudinales: ¿dónde están los niños?

There is an urgency to improve the evaluation of pediatric drug safety in the pre-market and post-market phases of drug evaluation. The need to improve pharmacovigilance methods concerns not only new drugs but also existing drugs that have been used for many years in an off-label manner in children. Effective methods for early detection of adverse drug reactions (ADRs) and drug safety epidemiologic studies are a pressing need in pediatrics. Moreover, the nature and severity of an ADR as well as the extent to which the suspected drug is being used, will determine how quickly the information about risk needs to be made available to users and what would be the most appropriate method of communication. Based on our experience through the Genotype-specific Approaches to Therapy in Children study, an active ADR surveillance network of pediatric hospitals across Canada, we present five strategic elements that should be included in pharmacovigilance initiatives in pediatrics: active ADR surveillance; drug or ADR targeted pharmacovigilance; trained surveillance clinicians; case-control methodology and standardized procedures for recognition; reporting and evaluating drug-induced harm. In addition, linking pharmacovigilance with pharmacogenomics to find drug safety solutions is presented as a promising strategy for knowledge generation. Finally, we discuss the importance of an efficient translation of the pharmacovigilance knowledge into clinical practice to achieve safer drug therapy in children.

Improving pediatric drug safety: need for more efficient clinical translation of pharmacovigilance knowledge.

Background: This paper presents the results of an exploratory qualitative study that assesses Canadian pediatric researchers’ perceptions of a pre-selected group of ethical issues r

/pdf/researchers-perceptions-of-the-ethical-implications-of-27ou1vl8w2.pdf

Researchers' perceptions of the ethical implications of pharmacogenomics research with children.

Pharmacogenomics: Dont Forget the Children

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Pharmacogenomics: Dont Forget the Children