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Many different forms of IC exist. The image below highlights some variants of informed consent and how they are (generally) related.
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To enable machine actionability—the ability of a dataset to This step provides guidance on creating an Informed Consent Form (ICF) and a Subject Information Sheet (SIS) that align with the FAIR principles. It assumes you are aware of whether your study falls under the WMO (Medical Research Involving Human Subjects Act). If you are unsure, visit the CCMO website, consult the ELSI Servicedesk (available in Dutch) or seek assistance from your local experts
To ensure a dataset can be automatically accessed, processed , and used utilised by machines without significant manual intervention—the IC intervention (i.e. machine-actionable data), the IC must also be machine-actionable. This ensures that enables automated systems can to interpret consent terms, allowing data to be ethically and legally shared facilitating the ethical and legal sharing of data across systems while safeguarding participant rights [FAIR]. In this step we focus solely on the content of the SIS and ICF. For more information about on making the IC machine-actionable, see Step XYZ.
(Praktisch gezien lijkt her op dit moment op dat we dus met name Opt-In this step, guidance is provided to help you create an Informed Consent Form (ICF) and Subject Information Sheet (SIS) that are aligned with the FAIR principles. The guidance assumes you already know whether your study is subject to the WMO (Medical Research Involving Human Subjects Act) or not. If you’re uncertain, read more about this on the CCMO website, the ELSI Servicedesk (in Dutch) or contact your local experts for help.
(Praktisch gezien lijkt her op dit moment op dat we dus met name Opt-In Consent doen hier)
Why is this step important
The FAIR principles encourage making data more useful for both immediate research purposes and future secondary purposes, such as replication, validation and meta-analysis, while still protecting participants' privacy and rights. To accommodate for the FAIR data principles in the Informed Consent (IC) for health research data, the IC must include specific information that addresses both the immediate use of the data and its potential future uses in a way that aligns with GDPR requirements.
Current Research Purpose: The IC should clearly explain the primary purpose for which the health data is being collected (e.g., a specific clinical study, disease research, or a longitudinal health survey).
Potential Future Use: To align with the FAIR principles, the IC should also mention the possibility that the data may be used for future research purposes, which may not yet be fully known at the time of data collection. However, the scope of future research should be described as broadly but as clearly as possible, respecting GDPR’s transparency principle.
FAIR Data Goals: The IC should include a statement that aligns with the goals of FAIR data, explaining that the data will be made findable, accessible, interoperable, and reusable by other researchers and stakeholders in the scientific community.
Data Registries or Repositories: If applicable, the IC should state that the data will be deposited into data repositories or registries that adhere to FAIR principles, allowing it to be discoverable and reusable by others.
Who Will Access the Data: Provide clarity on who will be allowed to access the data. This includes mentioning both internal and external researchers and potential data-sharing partnerships.
Controlled vs. Open Access: Explain whether the data will be made available via open access (where anyone can access the data) or via controlled access (where only approved researchers or organizations can access it).
Cross-border Data Transfers: If the data may be shared internationally, the IC must comply with GDPR’s rules on cross-border data transfers. Explain if the data will be shared with researchers outside the EU and what safeguards are in place to protect the data in international transfers.
How to
As explained, informed consent (IC) is an essential component for collecting and reusing data. Research that falls under the WMO must undergo a review by an accredited Medical Research Ethics Committees (MREC) or the Central Committee on Research Involving Human Subjects (CCMO). Non-WMO studies are reviewed by an MREC. Research is not allowed to start without a positive decision of the approriate reviewing committee.
If your study is subject to the WMO go to Step 1 and for a non-WMO study go to Step 2. In Step 3, some special cases are described. Note that, while this guidance aims to provide up-to-date and accurate information, you should always check with your local privacy and legal specialists!
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.
Subject Information Sheet
The CCMO’s SIS has the following item relevant for FAIR:
Can we use your data and body material for other research?
Here, it is crucial that the researcher clearly explains the potential purposes for which collected data or materials may be reused. While these purposes can be broader than the original study's aim, they should not be overly vague. For instance, "cancer research" might be acceptable, but "any research" would not. If stored data/material is used for a different purpose, participants must give permission again or usage is not permitted.
Informed Consent Form
The CCMO’s SIS contains an ICF as an Appendix. The following items are relevant for FAIR:
I give consent to store my data to use for other research, as stated in the information sheet.
I give consent to have my (remaining) body material stored for use in other research, as stated in the information sheet. The body material is stored for this purpose for another [xx] years.
Participants < 16 years old (children)
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. (?????)
Next
Go to Step 3.
Step 2 - Study is not subject to WMO
First, check with your local MREC which SIS and ICF templates they 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).
Subject Information Sheet
In English, the SIS needs information concerning the following topics:
May we use your data <if applicable> [and biomaterial] for other scientific research?
<if applicable> If we collaborate with countries outside the European Union
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.
Informed Consent Form
In English, the ICF needs to include the following:
I give consent to use my data <if applicable> [and (residual (remaining?)) biomaterial] for other scientific research, as stated (explained?) in the subject information sheet.
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.
Participants < 16 years old (children)
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.
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.
Splitsen? Of lopen ze tegen dezelfde problemen aan? Consent doen hier)
Why is this step important
The FAIR principles aim to make data useful for immediate research and future purposes, such as replication, validation, and meta-analysis, while safeguarding participants' privacy and rights. Therefore, informed consent must address both current and potential future data use in compliance with GDPR requirements. This step offers guidance on creating an effective informed consent form and subject information sheet to meet these standards.
How to
IC is an essential component for collecting and reusing data. Research that falls under the WMO must undergo a review by an accredited Medical Research Ethics Committees (MREC) or the Central Committee on Research Involving Human Subjects (CCMO). Non-WMO studies are reviewed by an MREC. Research is not allowed to start without a positive decision of the approriate reviewing committee.
If your study is subject to the WMO go to Step 1 and for a non-WMO study go to Step 2. In Step 3, some special cases are described. Note that, while this guidance aims to provide up-to-date and accurate information, you should always check with your local privacy and legal specialists!
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.
Subject Information Sheet
The CCMO’s SIS has the following item relevant for FAIR:
Can we use your data and body material for other research?
Here, it is crucial that the researcher clearly explains the potential purposes for which collected data or materials may be reused. While these purposes can be broader than the original study's aim, they should not be overly vague. For instance, "cancer research" might be acceptable, but "any research" would not. If stored data/material is used for a different purpose, participants must give permission again or usage is not permitted.
Informed Consent Form
The CCMO’s SIS contains an ICF as an Appendix. The following items are relevant for FAIR:
I give consent to store my data to use for other research, as stated in the information sheet.
I give consent to have my (remaining) body material stored for use in other research, as stated in the information sheet. The body material is stored for this purpose for another [xx] years.
These can just be reused the way they are provided.
Participants < 16 years old (children)
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 before subjecting the documents for review. (?????)
Next
Go to Step 3.
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).
Subject Information Sheet
In English, the SIS needs information concerning the following topics:
May we use your data <if applicable> [and biomaterial] for other scientific research?
<if applicable> If we collaborate with countries outside the European Union
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.
Informed Consent Form
In English, the ICF needs to include the following:
I give consent to use my data <if applicable> [and (residual (remaining?)) biomaterial] for other scientific research, as stated (explained?) in the subject information sheet.
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.
Participants < 16 years old (children)
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.
Next
Go to Step 3.
Step 3 - Additional FAIR consideration
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.
3.2 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.
Next
Go to Step 4.
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:
Evolving laws and consent requirements. Long-term cohort studies often encounter changes in laws and regulations over time, including evolving IC requirements. Consider how earlier IC agreements may differ from current standards, such as permissions for sharing data outside the EU.
Participant dropouts. Account for participants who drop out between measurement rounds. For example, if a participant last contributed 10 years ago, their original IC remains valid, which can create complexities.
Transition to adulthood in birth cohorts. For birth cohorts, consider how IC changes when children reach adulthood. While parents initially provide consent, adults may decide to withdraw or modify the use of their previously collected data.
Future data retrieval and linkage. Plan for potential future data uses, such as retrieving cause-of-death information from CBS or updating addresses through the BRP. Ensure IC explicitly addresses these possibilities.
Retention period for data. Clearly define the data retention period in IC materials. Specify whether the 15-year period (or similar) begins after the study concludes to avoid premature data deletion. Alternatively, consider specifying periodic evaluations of data retention (e.g., every 5 years) with participant notification.
Always consult your data protection officer for guidance.
Quint Olislagers 16-12-2024:
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Step 4 - Finally
With your SIS and ICF now complete and fully FAIR ready and (checked/approved?) by your data protection officer, get it reviewed by the appropriate committee:
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