How to Organise an International Register in Compliance with the European GDPR: Walking in the Footsteps of the PAMI Project (Paediatric ACL Monitoring Initiative)

Daniel Theisen, Havard Moksnes, Cyrille Hardy, Lars Engebretsen, Romain Seil

    Research output: Chapter in Book/Report/Conference proceedingChapterpeer-review

    Abstract

    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.
    Original languageEnglish
    Title of host publicationBasic methods handbook for clinical orthopaedic research: A practical guide and case based research approach
    EditorsVolker Musahl, Jón Karlsson, Michael T. Hirschmann, Olufemi R. Ayeni, Robert G. Marx, Jason L. Koh, Norimasa Nakamura
    Place of PublicationBerlin, Heidelberg
    PublisherSpringer
    Pages427-434
    Number of pages8
    ISBN (Electronic)978-3-662-58254-1
    ISBN (Print)978-3-662-58253-4
    DOIs
    Publication statusPublished - 23 Jan 2019

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