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

This 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.