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Ethical and Legal Debates In Irish HealthcareConfronting complexities$
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Mary Donnelly and Claire Murray

Print publication date: 2016

Print ISBN-13: 9780719099465

Published to Manchester Scholarship Online: May 2016

DOI: 10.7228/manchester/9780719099465.001.0001

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PRINTED FROM MANCHESTER SCHOLARSHIP ONLINE (www.manchester.universitypressscholarship.com). (c) Copyright Manchester University Press, 2022. All Rights Reserved. An individual user may print out a PDF of a single chapter of a monograph in MSO for personal use.date: 28 June 2022

Children in clinical trials in Ireland

Children in clinical trials in Ireland

addressing the gaps in the legal framework

(p.163) 11 Children in clinical trials in Ireland
Ethical and Legal Debates In Irish Healthcare

Katherine Wade

Manchester University Press

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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