Abstract
Background: Novel interventions, including cell therapies, are currently under investigation in adults with type 1 diabetes. As some clinical trials are beginning to recruit pediatric participants, it is timely to consider pediatric-specific ethical issues. Most pediatric trials require parental consent, which is influenced by disease severity, age of the child, trial risks, potential benefits and logistics. Adding to the complexity, ethics requirements and regulatory standards for design and conduct of pediatric trials are not harmonized internationally.
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