Improving patient care and advancing scientific discovery requires responsible sharing of research data, healthcare records, biosamples, and biomedical resources that must also respect applicable use conditions. Defining a standard to structure and manage these use conditions is a complex and challenging task. This is exemplified by a near unlimited range of asset types, a high variability of applicable conditions, and differing applications at the individual or collective level. Furthermore, the specifics and granularity required are likely to vary depending on the ultimate contexts of use. All these factors confound alignment of institutional missions, funding objectives, regulatory and technical requirements to facilitate effective sharing. The presented work highlights the complexity and diversity of the problem, reviews the current state of the art, and emphasises the need for a flexible and adaptable approach. We propose Digital Use Conditions (DUC) as a framework that addresses these needs by leveraging existing standards, striking a balance between expressiveness versus ambiguity, and considering the breadth of applicable information with their context of use.

BBMRI ERIC Graz Austria

Biomedical Data and Bioethics Group Fraunhofer Institute for Biomedical Engineering Sulzbach Saar Germany

Center for Radiology and Nuclear Medicine VASCERN ERN Radboud University Medical Center Nijmegen Netherlands

Centre for Analytics Ontario Brain Institute Toronto Canada

Departamento de Biotecnología Biología Vegetal ETSI Agronómica Alimentaria y de Biosistemas Centro de Biotecnología y Genómica de Plantas Universidad Politécnica de Madrid Madrid Spain

Department of Genetics University Medical Center Groningen Groningen Netherlands

Faculty of Medicine and Health Sciences McGill University Montreal Canada

Genetics and Genome Biology University of Leicester Leicester UK

Governance Innovation Sage Bionetworks Seattle USA

Institute for Rare Diseases Research Instituto de Salud Carlos 3 Madrid Spain

Institute of Computer Science Masaryk University Brno Czechia

Legal Signatu AS Oslo Norway

Luxembourg National Data Service Esch sur Alzette Luxembourg

Medical Laboratory Diagnostics Department Medical University of Gdańsk Gdańsk Poland

Nuffield Department of Population Health University of Oxford Oxford UK

Research Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus Bari Italy

Ronin Institute for Independent Scholarship Montclair USA

University of Groningen Groningen Netherlands

University of Luxembourg Esch sur Alzette Luxembourg

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Shabani M, Knoppers BM, Borry P. From the principles of genomic data sharing to the practices of data access committees. Embo. Mol. Med. 2015;7:507–509. doi: 10.15252/emmm.201405002. PubMed DOI PMC

Wilkinson M, et al. The FAIR guiding principles for scientific data management and stewardship. Sci. Data. 2016;3:160018. doi: 10.1038/sdata.2016.18. PubMed DOI PMC

Dyke SOM, et al. Consent Codes: upholding standard data use conditions. PLoS Genet. 2016;12(1):e1005772. doi: 10.1371/journal.pgen.1005772. PubMed DOI PMC

Dyke SOM, et al. Consent Codes: Maintaining Consent in an Ever-expanding Open Science Ecosystem. Neuroinform. 2023;21:89–100. doi: 10.1007/s12021-022-09577-4. PubMed DOI PMC

Lawson, J. et al. The Data Use Ontology to streamline responsible access to human biomedical datasets. Cell Genomics. 1, 2, 100028, ISSN 2666-979X, 10.1016/j.xgen.2021.100028 (2021). PubMed PMC

Holub P, et al. BBMRI-ERIC directory: 515 biobanks with over 60 million biological samples. Biopreservation and Biobanking. 2016;14(6):559–562. doi: 10.1089/bio.2016.0088. PubMed DOI PMC

Lappalainen I, et al. The European Genome-phenome Archive of human data consented for biomedical research. Nat. Genet. 2015;47:692–695. doi: 10.1038/ng.3312. PubMed DOI PMC

Lin, Y. et al. Development of a BFO-based Informed Consent Ontology (ICO). Proc. of the 5th Intern. Conf. on Biomedical Ontologies (ICBO)http://ceur-ws.org/Vol-1327/icbo2014_paper_54.pdf (2014).

Car, N. The agreements ontologyhttps://github.com/nicholascar/agr-ont (2017).

Woolley JP, et al. Responsible sharing of biomedical data and biospecimens via the “Automatable Discovery and Access Matrix” (ADA-M) npj Genomic Med. 2018;3:17. doi: 10.1038/s41525-018-0057-4. PubMed DOI PMC

Iannella, R. et al. ODRL vocabulary & expression 2.2: W3C recommendation.https://www.w3.org/TR/odrl-vocab/ (2018).

Dodds, L. Open data rights statement vocabulary.http://schema.theodi.org/odrs (2013).

Alter G, Gonzalez-Beltran A, Ohno-Machado L, Rocca-Serra P. The Data Tags Suite (DATS) model for discovering data access and use requirements. GigaScience. 2020;9(2):giz165. doi: 10.1093/gigascience/giz165. PubMed DOI PMC

Pezoa, F., Reutter, J. L., Suarez, F., Ugarte, M. & Vrgoc, D. Foundations of JSON schema. Proc. 25th International Conference on World Wide Web 263–273 10.1145/2872427.2883029 (2016).

Sanchez Gonzalez, M. C. et al. Common conditions of use elements. Atomic concepts for consistent and effective information governance. Sci. Data.10.1038/s41597-024-03279-z (2024). PubMed PMC