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If your study is subject to the WMO go to Step 1 and for a non-WMO study go to Step 2. Step 3 describes additional paragraphs relevant for FAIR, which you could consider for your ICF and SIS. In Step 4, issues you may encounter in specific cases are highlighted,for example, when you’re setting up a cohort study.
Note: while this guidance aims to provide up-to-date and accurate information, you should always check with your local privacy and legal specialists! Also, where examples are provided, always check the actual templates to ensure you have the most up-to-date information.
Step 1 - Study is subject to WMO
The CCMO has published SIS models for both adults and children and strongly recommends their usage. The models are available in both English and Dutch. The MREC/CCMO reviewing committee only assesses the Dutch SIS and ICF. However, if a participant who is not adequately fluent in Dutch is asked to participate in a study, the information must be provided in a language the participant is proficient in.
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The CCMO’s SIS model for children does not contain these FAIR items. Hence, to support reuse of this data, add the information from the adult versions to your SIS and ICF and then consult your local experts, such as the data protection / privacy officer, for exact integration before subjecting the documents for review .
Step 2 - Study is not subject to WMO
First, check with your local MREC which SIS and ICF templates they have available and accept. Verify whether these templates contain FAIR components. The ELSI Servicedesk provides standardised text that can be used in the SIS and ICF (only available in Dutch).
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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 and consult your local experts, such as the data protection / privacy officer, for exact integration before subjecting the documents for review .
Step 3 - Additional FAIR consideration
The information below is translated from Dutch templates (sources: Amsterdam UMC: E1E2. Niet-WMO model informatiebrief met toestemmingsformulier versie d.d. 15-08-2024 and standardised text van de ELSI ServicedeskAmsterdam UMC’s Dutch Non-WMO template and the ELSI Servicedesk’s standardised text (3.1). If you decide to use these passages, please verify with your local experts.
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3.1 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.
Amsterdam UMC
Subject Information Sheet
Toestemming voor het delen van gegevens en lichaamsmateriaal met commerciële partijen
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I do/do not (cross out what does not apply) consent to research using my data and material by institutions abroad, even if the level of privacy protection is lower than in the Netherlands.
Subject Information Sheet (Amsterdam UMC)
Consent for sharing data and bodily material with commercial parties
In this study, we share your data with [name of company or companies]. If you do not want us to share your data with commercial parties, you can indicate this on the consent form.
Informed Consent Form
Ik geef wel/geen (doorhalen wat niet van toepassing is) toestemming voor het delen van mijn gegevens/lichaamsmateriaal met commerciële bedrijven waarvan de naam in de brief is genoemdI do/do not (cross out what does not apply) consent to the sharing of my data/bodily material with commercial companies mentioned in the letter.
3.2 Sharing data with commercial parties
Subject Information Sheet (Amsterdam UMC)(Gebaseerd op de vorige, waarschijnlijk niet goed…………) → weghalen, omdat we amsterdam umc al hebben?
We send your data to countries outside the European Economic Area (EEA)
In this study, we also send your coded 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 databodily material to countries outside the European Economic Area. These countries do not have the same privacy regulations as those within the EU. However, we strive to protect your privacy as much as possible through proper contracts. On the consent form, we will ask for your separate consent to send your coded data and/or bodily material. If you decide not to provide this consent, you [cannot/can still] participate in the study.
Informed Consent Form
Ik geef wel/geen (doorhalen wat niet van toepassing is) voor onderzoek met mijn gegevens en materiaal door commerciële partijen.
Amsterdam UMC
Subject Information Sheet
We sturen uw gegevens naar landen buiten de Europese Economische Ruimte (EER)
In dit onderzoek sturen we uw gecodeerde gegevens en lichaamsmateriaal ook naar landen buiten de Europese Economische Ruimte. In die landen gelden niet dezelfde privacyregels als binnen de EU. Maar wij trachten uw privacy zo goed mogelijk te beschermen met goede contracten. Wij vragen u op het toestemmingsformulier apart toestemming voor het doorsturen van uw gecodeerde gegevens en/of lichaamsmateriaal. Wanneer u besluit ons die toestemming niet te geven, kunt u [niet/toch] meedoen met het onderzoek.
Informed Consent Form
Ik geef wel/geen (doorhalen wat niet van toepassing is) toestemming om mijn gegevens/lichaamsmateriaal in het kader van dit onderzoek over te dragen aan [landen binnen de EER]/ waar de Europese richtlijnen voor de bescherming van persoonsgegevens gelden. De gegevens/ lichaamsmateriaal moeten dan gecodeerd worden overgedragen en zonder mijn naam.
Ik geef wel/geen (doorhalen wat niet van toepassing is) toestemming om mijn gegevens/lichaamsmateriaal in het kader van dit onderzoek over te dragen aan landen buiten de EER waar de Europese richtlijnen voor de bescherming van persoonsgegevens niet gelden. De gegevens/lichaamsmateriaal moeten dan gecodeerd worden overgedragen en zonder mijn naamI do/do not (cross out what does not apply) consent to the transfer of my data/bodily material within the scope of this study to [countries within the EEA]/where the European guidelines for the protection of personal data apply. The data/bodily material must then be transferred in coded form and without my name.
I do/do not (cross out what does not apply) consent to the transfer of my data/bodily material within the scope of this study to countries outside the EEA where the European guidelines for the protection of personal data do not apply. The data/bodily material must then be transferred in coded form and without my name.
3.3 CBS linkage
Susanne: Please note: The cause of death data must be intended for scientific research in the field of public health and the study must be carried out by a university, university hospital, planning bureau or other institution, as referred to in Art. 41 of the Statistics Netherlands Act.Amsterdam UMC
Subject Information Sheet
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Ik geef toestemming om mijn lichaamsmateriaal nog [aantal] jaar na dit onderzoek te bewaren. Mogelijk kan dit later nog voor ander/meer onderzoek worden gebruikt, zoals in de informatiebrief staat.
Step 4 - Special cases
4.1 Cohort studies
If you are setting up an ICF and SIS for a cohort study, keep the following in mind:
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If data is anonymised, it is no longer considered personal data under regulations like the GDPR.
Step 5 - Finally
With your SIS and ICF fully FAIR ready and (checked/approved?) by your data protection officer, get it reviewed by the appropriate committee:
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