Published July 31, 2023 | Version pre-print
Journal article Open

Common Conditions of Use Elements. Atomic Concepts for Consistent and Effective Information Governance.

Creators

  • 1. Myriad policy, ethical and legal considerations underpin the sharing of biological resources, implying the need for standardised and yet flexible ways to digitally represent diverse 'use conditions'. We herein report a core taxonomy of atomic, non-directional 'concepts of use', called Common Conditions of Use Elements (CCE). This work engaged biobanks and registries relevant to the European Joint Programme for Rare Disease (EJP-RD) and aimed to produce a taxonomy that would have generalised utility. Seventy-six concepts were initially identified from diverse real-world settings, and via iterative rounds of deliberation and user-testing these were optimised and condensed down to 20 items. To validate utility, support software and training information was provided to biobanks and registries who were asked to create sharing "Policy Profiles". This succeeded and involved adding standardised directionality and scope annotations to employed CCEs. The addition of free-text parameters was also explored. The CCE approach is now being adopted by several real-world projects, enabling this standard to evolve progressively into a universal basis for representing and managing conditions of use.
  • 2. VASCERN ERN & Radboud University Medical Center
  • 3. Istituto Neurologico "Carlo Besta" | Fondazione IRCCS Via Giovanni Celoria
  • 4. ELSI Services & Research Unit, BBMRI-ERIC
  • 5. University of Leicester
  • 6. Centro de Biotecnología y Genómica de Plantas (CBGP, UPM-INIA/CSIC), Universidad Politécnica de Madrid
  • 7. University Medical Center Groningen
  • 8. Fondazione per la Ricerca Farmacologica Gianni Benzi onlus
  • 9. European Joint Programme on Rare Diseases coordination
  • 10. Center for Pediatrics and Adolescent Medicine, Heidelberg University Hospita
  • 11. Istituto Giannina Gaslini
  • 12. Research Biobank, IRCCS Bambino Gesù Children's Hospital
  • 13. Institute of Genetics and Biophysics "Adriano Buzzati- Traverso" IGB-ABT.
  • 14. ERN for Rare Urogenital Diseases and Complex Conditions (ERN eUROGEN), Radboud University Medical Center.
  • 15. Centre of Genomics and Policy, McGill University.

Contributors

  • 1. ERN eUROGEN - ERN for Rare Urogenital Diseases and Complex Conditions
  • 2. World Duchenne Organization, Veenendaal, The Netherlands

Description

Myriad policy, ethical and legal considerations underpin the sharing of biological resources, implying the need for standardised and yet flexible ways to digitally represent diverse 'use conditions'. We herein report a core taxonomy of atomic, non-directional 'concepts of use', called Common Conditions of Use Elements (CCE). This work engaged biobanks and registries relevant to the European Joint Programme for Rare Disease (EJP-RD) and aimed to produce a taxonomy that would have generalised utility. Seventy-six concepts were initially identified from diverse real-world settings, and via iterative rounds of deliberation and user-testing these were optimised and condensed down to 20 items. To validate utility, support software and training information was provided to biobanks and registries who were asked to create sharing “Policy Profiles”. This succeeded and involved adding standardised directionality and scope annotations to employed CCEs. The addition of free-text parameters was also explored. The CCE approach is now being adopted by several real-world projects, enabling this standard to evolve progressively into a universal basis for representing and managing conditions of use. 

Notes

The published version of this manuscript can be accessed at https://www.nature.com/articles/s41597-024-03279-z. Scientific Data is a fully open access journal. 

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Additional details

Related works

Is cited by
Journal article: 10.5281/zenodo.8200044 (DOI)

Funding

EJP RD – European Joint Programme on Rare Diseases 825575
European Commission

References

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