Short Description 

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] 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 novo]. The consent information should be made available as metadata.  

Working Group

Why is this step important 

A properly designed informed consent is crucial for data reuse. Without it, archiving, sharing, etc may not be possible. 

Expertise requirements for this step 

This section could describe the expertise required. Perhaps the Build Your Team step could then be an aggregation of all the “Expertise requirements for this step” steps that someone needs to fulfil his/her FAIRification goals.  

How to 

FAIRopoly 

The development of this ICF benefited from previous experience with ICF submissions by 4 ERN Registries (ERKReg, EuRRECa, ENROL, VASCA) and from the utilization of “machine-readable” consent-related Ontologies (Data Use Ontology and Informed Consent Ontology). Several iterative expert reviews (including patient organizations and ERN representatives) were conducted to finalize the ICF. 

References & Further

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reading

[FAIRopoly] FAIRopoly https://www.ejprarediseases.org/fairopoly/ 

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