ABSTRACT
The need for research is fully recognised in the Spanish legal system, but when it comes to experimentation on human subjects a series of provisions directly or indirectly seeks to prevent any injury or harm to the person, given that his or her most prized legal interests are at stake. There do not exist any specific rules concerning experimentation with newborns. In any case, the restrictive provisions established when minors are involved are equally valid for newborns and neonatal clinical research. In certain cases the Ministry of Health and Consumer Affairs may interrupt a clinical trial or insist that modifications be made to the protocol. This is possible in situations where the law has been broken, where the conditions under which authorisation was granted are altered, or where the ethical principles are not adhered to. It is currently felt that all experimental subjects should have insurance cover for all the risks entailed.
