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Short description 

‘A great quite’ quote’ (source)

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. 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]. 

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Do we want to mention things like dynamic IC, electronic IC, Toestemming aan de poort?

Does a PIF also contain information about data collection / how data will be used? Or is the PIF only medical?

Why is this step important 

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  1. Check your institute for an IC template

  2. Check whether it allows for “whatever it is we need for making this data FAIR and its sharing”

    1. I know there are factors which depend on the study, like e.g. linkage with PALGA, IKNL, etc.

    2. Does this depend on FAIR Objectives? Does “I want to publish the study in the HRI Catalogue” require something different in an IC than “I want to use a patient’s data for federated querying?”

      1. The first doesn’t require anything special in the IC I think? Only when the data owner actually wants to share your data does the IC become relevant?

      2. Is “sharing” by sending someone the data and “sharing via federated querying” different?

        1. If federated querying is anonymous by default, since the data never leaves a center, does IC about sharing the data still matter?

  3. Make sure the necessary lines are in the IC

  4. Get the IC approved

Multi-center IC?

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.

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