Pediatric Drugs

, Volume 17, Issue 1, pp 23–30 | Cite as

Ethics Review of Pediatric Multi-Center Drug Trials

  • Allison C. Needham
  • Mufiza Z. Kapadia
  • Martin Offringa
Leading Article
Part of the following topical collections:
  1. Ethics of Pediatric Drug Research

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.

Keywords

Research Ethic Board Pediatric Research Common Ethic Ethical Oversight Multiple Submission 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Notes

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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Copyright information

© Springer International Publishing Switzerland 2014

Authors and Affiliations

  • Allison C. Needham
    • 1
  • Mufiza Z. Kapadia
    • 1
  • Martin Offringa
    • 1
  1. 1.Child Health Evaluative Sciences CHES, The Hospital for Sick ChildrenUniversity of TorontoTorontoCanada

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