ABSTRACT

This chapter examines some of the basic elements of medical research on minors in Finland, emphasising the aspects that touch on research on neonates specifically. It also examines the authority to consent on behalf of the child, the formal and material requirements as well as limits of proxy consent, together with the relevance of consent in situations of urgency. The chapter then provides a brief overview on control mechanisms other than decision-making by a proxy. The formal requirements for valid informed consent in neonatal research fundamentally follow the same criteria as consent by an adult subject, except that consent is given by a proxy. Medical research on human beings may not be conducted without a written informed consent by the research subject or by her proxy. The most efficient control mechanism outside legislation should, of course, be the private and professional ethical judgement of the researchers themselves.