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_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].
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.
[uu_consent] https://www.uu.nl/en/research/research-data-management/guides/informed-consent-for-data-sharing
Why is this step important
A properly designed informed consent is crucial for data reuse. Without it, archiving, sharing, etc may not be possible.
How to
[Sander]
In my opinion the main question is: what is the specific information that should be in your IC to accomodate for FAIR data and its further usage. So it’s probably about data sharing for further research as well as potential data linkage?
So step-wise I would think maybe something like:
Check your institute for an IC template
Check whether it allows for “whatever it is we need for making this data FAIR and its sharing”
I know there are factors which depend on the study, like e.g. linkage with PALGA, IKNL, etc.
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 your data for federated querying?”
The first doesn’t require anything special in the IC I think? Only when the owner actually share your data does the IC become relevant.
Is “sharing” by sending someone the data and “sharing via federated querying” different?
If federated querying is anonymous by default, since the data never leaves a center, does IC about sharing the data still matter?
Add these lines
Get the IC approved
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.
Some potential sources:
ELSI Servicedesk? Unfortunately in Dutch.
Templates for ICs?
HANDS, chapter privacy and autonomy has a section about IC
https://the-turing-way.netlify.app/ethical-research/ethical-research
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.
Practical examples from the community
Examples of how this step is applied in a project (link to demonstrator projects).
Training
Add links to training resources relevant for this step. Since the training aspect is still under development, currently many steps have “Relevant training will be added in the future if available.”