Children in clinical trials in Ireland
Children in clinical trials in Ireland
addressing the gaps in the legal framework
This chapter focuses on two key areas which require further clarity and elaboration in the context of research with children, namely, the requirements for research which does not offer the child the prospect of a direct benefit and the provisions around child assent and parental consent. The chapter examines legal and ethical guidance regarding these issues, setting out areas of uncertainty and ambiguity between the various governing instruments. It argues that the lack of clarity in these areas needs to be addressed in order to provide a robust system of protection for children, parents and those involved in clinical research with children. It makes proposals for reform drawing on the legal, ethical and academic guidance in the area and best practice in other countries.
Keywords: Children, Clinical trials, Clinical research with children, Child assent, Parental consent, Direct benefit
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