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The CCMO’s SIS model for children does not contain these FAIR items. Hence, to support reuse of this data, these items should be added to the SIS and ICF before subjecting the documents for review. (?????)
Additional FAIR consideration for your SIS and ICF
Andere relevante zinnen om toe te voegen?
Delen met commerciele partijen??
<if applicable> If we collaborate with countries outside the European Union?? Met die veiligheidseisen
Next
Go to Step 3.
Step 2 - Study is not subject to WMO
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May we use your data <if applicable> [and biomaterial] for other scientific research?
<if applicable> If we collaborate with countries outside the European Union
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SdR: dit is vrij zwak, aangezien het mijn vertalingen zijn. Is het een optie om de inhoud te vertalen naar het Engels en de inhoud of bij ELSI neer te zetten of desnoods hier? Overleggen met Susanne.
Add the applicable sections to your SIS to ensure it allows for FAIR usage of data and materials.
Subject Information SheetInformed Consent Form
In English, the ICF needs to include the following:
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If the MREC requires you to use a specific SIS/ICF template for children, check whether it contains FAIR components. If not, consider reusing the entries described above.
Additional FAIR consideration for your SIS and ICF
Andere relevante zinnen om toe te voegen?
Next
Go to Step 3.
Step 3 - Additional FAIR consideration
Sharing data with parties outside of the EU
Subject Information Sheet
(Vertaalde versie van standardised text van de ELSI Servicedesk)
<if applicable> If we collaborate with countries outside the European Union
In this study, we send encoded data [and biological material] to countries outside the EU because [explain the reason here]. It is [also] possible that the data will be shared outside the EU for other scientific research.
We only share your data [and biological materials] with researchers outside the EU if they handle your data [and biological materials] as securely as required for researchers within the EU. We also make written agreements with them regarding this.
Informed Consent Form
Ik geef wel/geen (doorhalen wat niet van toepassing is) toestemming voor onderzoek met mijn gegevens en materiaal door instellingen in het buitenland ook als het privacybeschermingsniveau minder is dan in Nederland.
Sharing data with commercial parties
Subject Information Sheet
(Gebaseerd op de vorige, waarschijnlijk niet goed…………)
In this study, your data [and biological material] may be shared with commercial parties for research purposes, such as [explain the reason here]. It is also possible that the data will be shared with commercial entities for the development of new products or services.
We only share your data [and biological materials] with commercial parties if they handle your data [and biological materials] securely and in accordance with the same standards required for researchers within the EU. We will also make written agreements with them to ensure your privacy and the protection of your data.
Informed Consent Form
Ik geef wel/geen (doorhalen wat niet van toepassing is) voor onderzoek met mijn gegevens en materiaal door commerciële partijen.
Step 4 - Special cases
Cohort studies and biobanks.
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