Reforming the legal framework for clinical trials with neonates in Ireland: a children’s rights approach

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dc.check.date10000-01-01
dc.check.embargoformatE-thesis on CORA onlyen
dc.check.entireThesisEntire Thesis Restricted
dc.check.infoIndefiniteen
dc.check.opt-outYesen
dc.check.reasonThis thesis is due for publication or the author is actively seeking to publish this materialen
dc.contributor.advisorMadden, Deirdreen
dc.contributor.advisorKilkelly, Ursulaen
dc.contributor.authorWade, Katherine
dc.contributor.funderDepartment of Children and Youth Affairs, Irelanden
dc.date.accessioned2015-11-26T12:06:00Z
dc.date.issued2015
dc.date.submitted2015
dc.description.abstractThis thesis assesses the current regulatory framework regarding clinical trials with neonates in Ireland from a children’s rights perspective, as derived from the UN Convention on the Rights of the Child 1989 (UN CRC) and its supporting instruments. The focus on neonates in the thesis is due to the particular need for clinical research with this group of children, their dependency on others for their protection and the lack of attention which has been given to them in the regulatory framework. The importance of children’s rights in this area is linked to the role of human rights in the regulation of clinical research in general. A rights-based approach is of great practical relevance in reforming law, policy and practice. For example, the CRC contains a set of commonly agreed legal benchmarks which can be used to assess the current framework and shape recommendations for reform. In this way, it provides a set of binding norms under international law, which must be complied with by states and state actors in all law, policy and practice affecting children. However, the contribution which a children’s rights approach could make to the regulation of research with children has not, to date, been explored in detail. This thesis aims to address this gap by developing a set of children’s rights-based benchmarks, which are used to assess the Irish regulatory framework for clinical trials with neonates and to develop recommendations for reform. The purpose of the analysis and recommendations is to assess Ireland’s compliance with international children’s rights law in the area and to analyse the potential of children’s rights to effectively address inadequacies in the Irish framework. The recommendations ultimately aim to develop a framework which will enhance the protection of neonates’ rights in this important area of children’s lives.en
dc.description.statusNot peer revieweden
dc.description.versionAccepted Version
dc.format.mimetypeapplication/pdfen
dc.identifier.citationWade, K. 2015. Reforming the legal framework for clinical trials with neonates in Ireland: a children’s rights approach. PhD Thesis, University College Cork.en
dc.identifier.urihttps://hdl.handle.net/10468/2104
dc.language.isoenen
dc.publisherUniversity College Corken
dc.rights© 2015, Katherine Wade.en
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/3.0/en
dc.subjectIrelanden
dc.subjectClinical trialsen
dc.subjectNeonatesen
dc.subjectChildren's rightsen
dc.thesis.opt-outtrue
dc.titleReforming the legal framework for clinical trials with neonates in Ireland: a children’s rights approachen
dc.typeDoctoral thesisen
dc.type.qualificationlevelDoctoralen
dc.type.qualificationnamePhD (Law)en
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