Legal obstacles jeopardise research in personalised medicine – experiences from a Nordic collaboration within rheumatology
Year: 2024
Type: article
Abstract: Aims: Personalised medicine in chronic complex diseases such as rheumatoid arthritis (RA) is within reach but requires international multi-stakeholder collaboration. We exemplify how national implementations of the General Data Protection Regulation (GDPR) have introduced administrative delays and created disincentives for data sharing and collaborative research. Methods: Our Danish/Swedish/Norwegian research collaboration (the 3-year NordForsk-funded “NORA” project) aims to develop a personalised medicine approach for the management of RA, built on the exploitation of unique existing data sources: longitudinal data from clinical rheumatology registries, research cohorts, nationwide health care registries, and biobank material from >20 sample collections. Data and results are shared and accessed remotely by collaborators at secure servers. New biomarker assays and patient-centric implementations of the results are to be explored, validated, and disseminated to patients and health care via the development of digital tools. Results: Following the advice of legal experts at the involved academic or public institutions and private companies, GDPR compliance resulted in >20 legal documents to govern the collaboration (consortium-, joint controller-, research collaboration-, data sharing-, and a series of unique two-way data processing-, and material transfer agreements). Lack of agreed-upon templates, policies, procedures, and a shortage of legal resources have caused considerable delays. Thus, our research consortium has spent more time ensuring GDPR compliance than on actual research activities. Conclusions: The current interpretation and implementation of the legal premises (rather than the GDPR per se) for research collaborations caused unnecessary barriers and delays. Our experiences call for Nordic trust-based code-of-conduct-like framework agreements, and for harmonisation of procedures and templates, lest the Nordic advantage in research be lost.
Authors: Bente Glintborg, Mats Hansson, Hilde Berner Hammer, Lars Klareskog, Saedis Saevarsdottir, Helga Westerlind, Johan Rönnelid, Isabel Gehring, Mikael Benson, Bente Appel Esbensen, Merete Lund Hetland, Leonid Padyukov, Tue Wenzel Kragstrup, Ellen-Margrethe Hauge, Barbara Bislawska AxnÄs, Niels Steen Krogh, Martina Johannesson, Johan Askling
Institutions: University of Copenhagen, Copenhagen University Hospital, Rigshospitalet, Uppsala University, University of Oslo, Diakonhjemmet Hospital, Karolinska University Hospital, Karolinska Institutet, University of Iceland, Thermo Fisher Scientific (Germany), Linköping University, Aarhus University, Aarhus University Hospital
Language: English
Topic: Ethics in Clinical Research
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W4405192755