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Obtaining patients’ informed consent for collecting their data for scientific purposes is usually required [De novo]. Furthermore, patient consent may be necessary for archiving and sharing [uu_consent] and linkage with e.g. external registries [source?]. Furthermore, consent information is necessary for the data to be machine-actionable, as without such data a computer cannot know whether it is allowed to use the data [FAIR]. 

A general informed consent form may be available, but a local Institutional Ethical Review Board may demand changes after reviewing. It is crucial that essential data sharing aspects are explicitly handled in the informed consent form [De novoNovo]. The consent information should be made available as metadata.  

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References & Further reading

[FAIRopolyDe Novo] FAIRopoly https://wwwojrd.ejprarediseasesbiomedcentral.orgcom/fairopoly/ 

[Generic] A Generic Workflow for the Data FAIRification Process: https://direct.mit.edu/dint/article/2/1-2/56/9988/A-Generic-Workflow-for-the-Data-FAIRification  

[Elixir] https://faircookbook.elixir-europe.org/content/recipes/introduction/fairification-process.html  

[Elixir] A framework for FAIRification processes: https://faircookbook.elixir-europe.org/content/recipes/introduction/metadata-fair.html  

[GOFAIRarticles/10.1186/s13023-021-02004-y  

[FAIR] https://www.go-fair.org/fair-principles/f2-data-described-rich-metadata/ 

[RDMkit] https://rdmkit.elixir-europe.org/machine_actionability.html 

[De Novo] https://ojrd.biomedcentral.nature.com/articles/10.1186/s13023-021-02004-y   sdata201618  

[uu_consent] https://www.uu.nl/en/research/research-data-management/guides/informed-consent-for-data-sharing [FAIR] https://www.nature.com/articles/sdata201618 

Authors / Contributors 

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