Legal and ethical issues in integrating and sharing databases for translational medical research within the EU

Apart from technical challenges, legal and ethical issues form part of the considerations when pooling together and sharing databases for translational medical research. Questions referring to data protection, data security and intellectual property rights, which are even made more complex because of the transnational aspect of such research, have to be addressed in order to make data sharing legally compliant. Additionally, medical research brings along ethical requirements such as protecting the autonomy and the well-being of the patients. In all, a wide net of rules has to be considered, and in most cases this may hinder the flexibility needed for clinical researches. This paper aims to give an overview of these issues and an insight of the p-medicine´s approach at navigating these requirements, which can serve as a guide to similar projects, especially within the EU.