International Journal of Health Research and Innovation

Issues of ethics in pediatric clinical research

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  • Abstract

    Introduction: New methods of diagnosis, treatment and medications have proved to improve the quality of community’s life. This is directly related to the implementation of clinical investigations, however in children diverse ethical issues are posed. Purpose: The description of the basic ethical principles for pediatric clinical research. Material and Methods: A literature review took place in the electronic database "PubMed", "Google Scholar" and "WHO" during the period of 2000 to 2015. Finally, thirty seven articles were included, while ten articles written in languages different from English and Greek and twenty articles with no full access were excluded. Results: The Code of Nuremberg and later the Helsinki Declaration contributed to establishing ethical principles in clinical research in humans, ensuring individual’s benefit and the establishment of informed consent form. In pediatric population, the process of participation in a clinical trial carris out only after obtaining the consent of the parents or the legal guardian, while the consent of the child himself is recommended, as well, depending of his age.Finally, they have the right to withdraw the pediatric clinical trial at any time without consequences. Conclusions: Children constitute a vulnerable and sensitive population which entails the necessity of establishing certain ethical criteria in order to consider a clinical research as ethical. It is also important to point out that children have their own personality and their point of view is needed to be taken into consideration.