Overview of European legislation on informed consent for neonatal research.

Euricon, a European Union funded study, had the objective of examining the issue of obtaining informed consent for neonatal research across Europe. As part of that project, legal representatives from these countries (see acknowledgements) were invited to a colloquium to report, discuss, and analyse European legal frameworks governing informed consent for neonatal research. The first author (PDV) presented a general overview of European law, which is the basis for this report. Furthermore, specific supplemental information from diVerent countries was given by legal representatives from these countries, and is summarised in table 1. Legally and ethically, informed consent of the subject is a requirement for biomedical research. However, there are diVering interpretations in European Law of this requirement for neonatal research. Increasingly, to answer many neonatal research questions, there is a need for multinational recruitment to randomised controlled trials and studies, and thus a need for investigators to be aware of the diVering, relevant, national legislation. The aim of this paper is to discuss areas of consistency and inconsistency in the law or practice governing informed consent for neonatal research in ten European countries (Denmark, Finland, France, Germany, Greece, Ireland, Norway, Spain, Sweden, and the United Kingdom). In particular, the following areas are examined: whether there is specific law governing informed consent for research and, if so, what it is; the ethical review system, whether there are specific requirements for consent, whether benefit for the individual child is a specific requirement, and whether research of no direct benefit (so called non-therapeutic research) is legally permitted in minors—for example, the taking of extra blood samples purely for research purposes.