ABSTRACT
The Spanish General Health Law of 25 April 1986 outlines patients’ rights in a general perspective. Among them, it details the patient’s rights to be informed and to give his or her informed consent to treatment. In any case, the restrictive provisions established when minors are involved are equally valid for newborns and neonatal clinical research. There is also control on the part of the Health Administration, whose prior authorisation is required. It is currently felt that all experimental subjects should have insurance cover for all the risks entailed. The Spanish Drugs and Medicines Law establishes this as a prior condition in all cases and makes the sponsor of the trial, the principal researcher or project leader and the medical directors of the hospitals where the trial is to be carried out, jointly liable for any injury sustained that is not covered by insurance, even where they are not at fault.
