Research with Human Participants in the European Union

This chapter examines research with human participants in the European Union. In the EU, the driving force for legislation is the creation of the single market. Research with human participants is both a response to the urgent demand to advance the health of EU citizens through the efficiencies of the single market, and to the commitment of the EU to act in accordance with the shared social and cultural values of the Member States. One might expect, therefore, that EU legislation on research with human participants would be clear, creating a harmonized framework within the single market both for internal consistency and to enhance external competitiveness. However, each of the 27 Member States of the EU operates with a large amount of independence in relation to the governance of research with human participants. The chapter then describes the EU legislation on clinical trials and considers the protection of privacy through the General Data Protection Regulation.