For many years, procedures, medicines and tests performed in children, have not been studied or authorized specifically for them. The dynamic was based in transferring the results obtained from adult population to paediatric population. The same happened with Informed Consent (IC) in clinical research. The same document used for adult participation was passed on to the parents or tutors in order to get the child to enrol in the clinical trial.
In this process, it is essential to have parents accept their children’s participation in the trial but it is required an affirmative agreement or assent from the subject. The correct understanding of the information, the procedure and what the participation involves, plays a fundamental roll in the infants’ autonomy in decision making and freedom of speech.
The level of comprehension of IC documents in research projects involving minors is currently measured through none validated questionnaires or interviews with a high biased component, investigations say. These studies, carried out within de i-CONSENT project (H2020), reveal the urgency to elaborate a validated tool, applicable in different types of clinical trials, which allows measuring the understanding of informed consents (IC) in preadolescents and adolescents. This will help researchers adapt and transform the current documentation into a more inclusive, personalizes and innovative instrument.
i-CONSENT, working towards the inclusion of gender, age and vulnerable population perspective in IC, has stated that each scenario requires different communication tools coming from the professionals involved in order to achieve an effective interaction doctor-patient. The trend will be creating more readable, complete and simplified IC documents through different platforms in pursuit of a better understanding for minors.
These first conclusions where provided by a systematic review and report of experimental, observational and theoretical articles from PubMed and presented by FISABIO, Lluís Alcanyís Hospital Paediatric Services and Universidad Católica de Valencia during the V ANCEI Congress.
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