Children’s participation in clinical trial: ethical and legal issues

Abstract

Clinical trials are essential to obtain effective medicines to f ight our illnesses. Clinical trials with children  are needed  many times in order to have secure and effective  medicines for this group of population. There are a lot of rulings about children participation  in clinical trials, which try to integrate  research  for medicines  with protection  of children’s welfare. This paper proposes a coherent interpretation of the Spanish confuse regulation on this matter. As a general principle, it requires not only the informed consent of the parents (or legal representatives)  but also the children’s assent until they arrive to the age of legal competence.