Paving the road to negligence: the compensation for research-related injuries in Spain.

The planned reform of the regulation of clinical trials in Spain has reopened the debate over how to regulate research-related injuries. Act 29/2006 and Royal Decree 223/2004 regulate the insurance of research-related injuries, and they include a general clause requiring mandatory insurance and imposing a no-fault compensation system; they also contain an exception clause enabling clinical trials to be carried out without insurance under some conditions, and an exclusion clause excluding compensation when there is no causal connection between injuries and a clinical trial. National legislation is under review, affecting the requirement of mandatory insurance and paving the road to a liability system based on negligence, which will affect the level of protection of the persons enrolled in clinical trials because it would not ensure compensation. Regulatory texts on individuals' participation as research subjects should include not only mandatory insurance, but also a no-fault compensation system for cases when voluntary research subjects are injured, irrespective of negligence.