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Legal obstacles jeopardise research in personalised medicine - experiences from a Nordic collaboration within rheumatology
Copenhagen Univ Hosp Rigshosp, Denmark; Univ Copenhagen, Denmark.
Uppsala Univ, Sweden.
Diakonhjemmet Hosp, Norway; Univ Oslo, Norway.
Karolinska Inst, Sweden; Karolinska Univ Hosp, Sweden.
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2024 (English)In: Scandinavian Journal of Public Health, ISSN 1403-4948, E-ISSN 1651-1905, Vol. 52, no 8, p. 1019-1025Article in journal, Editorial material (Other academic) Published
Abstract [en]

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.

Place, publisher, year, edition, pages
SAGE PUBLICATIONS LTD , 2024. Vol. 52, no 8, p. 1019-1025
Keywords [en]
Personalised medicine; rheumatoid arthritis; biobank; Nordic collaboration; legal infrastructure; GDPR
National Category
Health Care Service and Management, Health Policy and Services and Health Economy
Identifiers
URN: urn:nbn:se:liu:diva-210762DOI: 10.1177/14034948231212711ISI: 001374480400004PubMedID: 39651649Scopus ID: 2-s2.0-85211772677OAI: oai:DiVA.org:liu-210762DiVA, id: diva2:1926693
Note

Funding Agencies|Vinnova (Sweden); Innovationsfonden (Denmark); Research Council of Norway (Norway) [90825]; Swedish Research Council; Innovationsfonden; Federal Ministry of Education and Research in Germany; Research Council of Norway, under the frame of ERA PerMed (Project ScandRA)

Available from: 2025-01-13 Created: 2025-01-13 Last updated: 2025-01-13

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Benson, Mikael
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Division of Children's and Women's HealthFaculty of Medicine and Health SciencesH.K.H. Kronprinsessan Victorias barn- och ungdomssjukhus
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