Ethics issues

Ethics are central to patient care, scientific integrity and research excellence and therefore must be given highest priority at all stages of research from conception to implementation. The ethical issues are manifold and require careful consideration, especially in view of the focussed target group. This section therefore sets out the main ethical issues and challenges we foresee in ESPOIR and outlines the consortium’s strategy to take account of and address these in the design and implementation of the project. 

The ESPOIR consortium will be assisted and advised by an independent Ethics and Governance Council (EGC), which has been established in addition to the safety and oversight requirements of Good Clinical Practice. The role of the EGC is to provide independent external supervision and advice regarding the ethical, legal and safety (including data safety) aspects concerning the clinical trial, in particular on all aspects concerning studies in children and donated human tissue. 

ESPOIR Ethics and Governance Council see About ESPOIR - Organisation