The Spanish Agency for Medicines and Health Products (AEMPS) recommends the promoters of paediatric clinical trials from all over Spain, whether pharmaceutical industry or researchers themselves, to follow a recommendations guide made by the young scientific council of the Hospital Sant Joan de Déu, when drafting the informed consent document.

The guide has been included by the AEMPS in the "Instructions document for the conduct of clinical trials in Spain" agreed with the drug research ethics committees with and, in particular, in the appendix "Guide for the correct elaboration of a model, an information sheet for the patient and an informed consent ". The regulation establishes that children over 12 years old who participate in a clinical trial, must give their writen consent through signing a document called assent.

In order to ensure that the child has all the information of the study and knows hs/her rights, the 16 children and teenagers that are part of the scientific council of Sant Joan de Déu, and that since last year advise the researchers of the Hospital, have prepared a guide that proposes, among other things, a concise and simple informed consent, with the support of audiovisual such as videos or comics when appropriate, information about what a clinical trial is, what are the possible side effects, and what must be done in case of emergency (who to warn, how to act ...).

For the moment, the teenagers of the council are working on the development of an interactive application that allows learning the purpose of a clinical trial and its phases. Also, working in the creation of a comic book that tries to give answers to the main questions that can arise to a child who is participating in an essay, and creating a website that will provide information to patients and families about clinical trials, as well as educational resources for schools to spread this area of ​​medical science.

They have also brought science to schools with the organization of an informative day that recently accounted with the presence of 400 high school students. All these actions have been funded thanks to the collaboration of the Spanish Foundation for Science and Technology (FECYT) from the Ministry of Economy, Competitiveness and Industry and La Caixa Social Work.