Overview of European legislation on informed consent for neonatal research

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.