ABSTRACT
This chapter discusses areas of consistency and inconsistency in the law or practice governing informed consent for neonatal research in ten European countries. It examines whether there is specific law governing informed consent for research. The chapter then explores 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 is legally permitted in minors – for example the taking of extra blood samples purely for research purposes. A variety of laws and a plethora of ethical and professional guidelines govern the conduct of research within individual countries and across Europe. The Declaration of Helsinki, first adopted by the World Medical Assembly in 1964 and last amended in 1996, acts as a universal, ethical guide. Six of the ten countries have specific legislation governing pharmaceutical trials. Proxy consent by legal guardians is the norm for neonatal research.
