The European Union General Data Protection Regulation (GDPR) has come into force in May 2018. It regulates the processing of personal data of data subjects residing in the European Union and concerns all organisations, independently of where they are located. The GDPR applies also to research organisations and concerns the vast majority of scientific activities. Researchers active in the field of clinical orthopaedics need to understand the principles underlying the GDPR when organising their research projects involving human data subjects residing in the European Union. This chapter presents the most important ones and should be considered as a mere introduction to the topic. In the framework of an international research project, the data controller and the data processor must be clearly identified and are responsible to ensure compliance to the GDPR when processing personal data of EU residents. Explicit consent must be obtained from study participants, who benefit from additional rights that must be guaranteed. The Paediatric ACL Monitoring Initiative (PAMI) is an international register recently implemented in Luxembourg, Europe, and is presented here to illustrate important aspects related to the GDPR. The reader is advised to seek help from a qualified data protection officer already at the planning stage of a new research project.
|Title of host publication||Basic methods handbook for clinical orthopaedic research: A practical guide and case based research approach|
|Editors||Volker Musahl, Jón Karlsson, Michael T. Hirschmann, Olufemi R. Ayeni, Robert G. Marx, Jason L. Koh, Norimasa Nakamura|
|Place of Publication||Berlin, Heidelberg|
|Number of pages||8|
|Publication status||Published - 23 Jan 2019|