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. 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. The basic requirement of voluntariness to medical procedures is already secured as a right to physical integrity at the constitutional level, although the Constitutional provisions do not specifically address medical research. The Governmental Bill for the Research Act seeks to explain what has been meant by 'information shall be given in a way that research subjects are in a position to give their informed consent'. As the Finnish Medical Research Act has only entered into force in November 1999, it is difficult to evaluate how the minimal risk criteria is going to be interpreted in practice in Finland.