Ethical, legal and regulatory issues in paediatric translational research

Jun 29, 2020

Fondazione Gianni Benzi collaborated in the article “Ethical, Legal and Regulatory Issues of Paediatric Translational Research. Call for an Adequate Model of Governance” that was published on the European Journal of Health Law.

The lack of paediatric medicines, including innovative and advanced ones, is a long-lasting and well-known problem at European and international levels. Despite the existing legal frameworks and incentives, children remain deprived of many therapies tailored for them.

The authors clarify the concept of translational research in the perspective of the establishment of European Paediatric Research Infrastructure. Moreover, ethical, legal and regulatory issues particularly relevant in a children’s rights perspective are identified and pointed out.  It is underlined the need to set up an adequate model of governance within the research infrastructure, including adequate and independent ethical oversight and a pluridisciplinary common service dealing with ethical, legal and societal issues relevant for children.

You can read the article here!