IRDiRC has previously invested a lot of effort towards defining better data structures (ADA-M Task Force) and improved harmonization of consent clauses (Generalized consent clauses Task Force), in order to improve the access to patient data in RD registries and biological samples in RD biobanks. With the publication of the FAIR Guiding Principles for Scientific Data Management and Stewardship (Wilkinson et.al. 2016) and adoption of the FAIR principles in the guidelines for RD registries (Kodra et.al. 2018), it is important that this work is adapted to incorporate the FAIR principles.
The main objective of this Task Force is to explore and understand the current range of needs, activities and gaps around data tools and standards for digital management of consent and use conditions. Enabling machine readable representation of the consent of patient data in the biobanks and registries will contribute towards:
- More regularised consent forms and statements;
- Easier storage and less ambiguous exchange/communication of consent and use conditions;
- A basis for federated incorporation of such information into such things as discovery networks;
- Computer-readable/actionable semantic representation of consent and use conditions, towards enabling automated data sharing decisions.
Assembly of the Task Force Group (Q1, 2020)
Two manuscripts (1) DUC, (2) CCEs under preparation to be submitted Q2 2023.
Members (approximately 40)
- Esther van Enckevort – University Medical Center Groningen, The Netherlands (Co-chair)
- Anthony Brookes – University of Leicester, UK (Co-chair)
- Francis Jeanson – Datadex, Canada
- Pinar Alper – ELIXIR, Luxembourg
- Petr Holub – BBMRI-ERIC, Europe
- Stephanie Dyke – TFRI
- Alexander Bernier – McGill University, Centre of Genomics and Policy, Canada
- Mark Wilkinson – Centro de Biotecnología y Genómica de Plantas UPM-INIA, Spain
- Annalisa Landi – Benzi Foundation, Italia
- Ann Novakowski – Sage Bionetworks, USA