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Ethics Review of Pediatric Multi-Center Drug Trials

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Abstract

The assessment of safety and efficacy of therapeutics for children and adolescents requires the use of multi-centered designs. However, the need to obtain ethical approval from multiple independent research ethics boards (REBs) presents as a challenge to investigators and sponsors who must consider local requirements while ensuring that the protection of human subjects is consistent across sites. In pediatrics, this requirement is complicated by pediatric-specific ethical concerns such as the acquisition of assent and consent and the need for pediatric expertise to assess the scholarly merit of the proposed research. Efforts to tackle these challenges have focused on the process of ethics review, which will improve efficiency. In addition to improving process, we suggest further research to fill gaps in the evidence base for recommendations and decisions made by REBs, specifically their effectiveness to protect human subjects. Evidence gathered will contribute to the successful development, adoption and implementation of harmonized guidance to apply ethics principles in order to protect children through research rather than from research.

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Acknowledgments

This work has received funding support from Global Research in Paediatrics (GRiP). A.C. Needham, M.Z. Kapadia and M. Offringa report no potential conflicts of interest.

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  1. Child Health Evaluative Sciences CHES, The Hospital for Sick Children, University of Toronto, 555 University Ave, Toronto, ON, M5G 1X8, Canada

    Allison C. Needham, Mufiza Z. Kapadia & Martin Offringa

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  1. Allison C. Needham
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  2. Mufiza Z. Kapadia
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  3. Martin Offringa
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Correspondence to Allison C. Needham.

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This article is part of the topical collection on Ethics of Pediatric Drug Research.

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Needham, A.C., Kapadia, M.Z. & Offringa, M. Ethics Review of Pediatric Multi-Center Drug Trials . Pediatr Drugs 17, 23–30 (2015). https://doi.org/10.1007/s40272-014-0098-9

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