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As explained, informed consent (IC) is an essential component for collecting and reusing data. Research that falls under the WMO (Wet medisch-wetenschappelijk onderzoek met mensen, the Dutch Medical Research Involving Human Subjects Act) 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 the a MREC. Research is not allowed to start without a positive decision of the reviewing committee.
In this How to, guidance is provided to help you create an Informed Consent Form (ICF) and Subject Information Sheet (SIS) that are compatible with the FAIR principles. Note that, while this guidance aims to This guidance assumes you already know whether your study is subject to the WMO. If you’re uncertain, contact your local experts, see the CCMO website or the ELSI Servicedesk (in Dutch). 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!
Het schrijft makkelijker als ik step 0 laat staan, omdat we dan de CCMO makkelijker kunnen introduceren. We kunnen dat aanpassen. Even kijken wat beter loopt? Hieronder een stukje tekst voor als we step 0 niet willen.
This guidance assumes you already know whether your study is subject to the WMO (Wet medisch-wetenschappelijk onderzoek met mensen, the Dutch Medical Research Involving Human Subjects Act). If your study is subject to the WMO, go to Step 1 and otherwise go to Step 2. In Step 3, some special cases are described.
Step 0 - Determine whether your study is subject to the WMO
Determine whether your study is subject to the Medical Research Involving Human Subjects Act (WMO) or not. The Central Committee on Research Involving Human Subjects (CCMO) executes the WMO and the Embryo’s Act. Research that falls under the WMO or the Embryo’s Act must undergo a review by an accredited Medical Research Ethics Committees (MREC) or the CCMO. Research is not allowed to start without a positive decision of this committee.
Research is subject to the WMO if the following criteria are met:
It concerns medical scientific research and
Participants are subject to procedures or are required to follow rules of behaviour.
To learn more, contact your local experts, see the CCMO website or the ELSI Servicedesk (in Dutch).
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 question 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.
Please be aware that for <16 (oid) no information about data sharing (oid) is mentioned, oftewel → zelf toevoegen en laten beoordelen. → standaardzin aanrijken als dat even kan.
(Bespreken Susanne → gewoon de zin van de volwassenen gebruiken??)
Step 2 - Study is not subject to WMO
Niet-WMO studies worden door de lokale METC beoordeeld. Daarbij worden de PIF en ICF beoordeeld. Je krijgt dan een niet-WMO verklaring.
SdR: Wie toetst niet-WMO studies? Lokale METC? Stukje hieronder in dit deel?
Vraag bij de METC welke templates van informed consent worden geaccepteerd. Een ethische commissie mag geen adviezen geven, maar alleen beoordelen of een informed consent voldoet aan alle wettelijke eisen en verplichtingen.
Stel bij Privacy (functionaris gegevensbescherming of privacy officer) vragen over eventuele aanpassingen of toevoegingen van het informed consent.
To allow for the reuse of data and biomaterial collected in nonStep 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. (?????)
Additional FAIR considerations
Andere relevante zinnen om toe te voegen? Eventueel als aparte stap als we echt zinnen weten, zodat we daar voor zowel WMO als niet-WMO gebruik van kunnen maken?
Step 2 - Study is not subject to WMO
First, check if your local MREC has a SIS and ICF template that requrie you to use as a basis. Verify whether the 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 hierboven is vrij zwak, aangezien het mijn vertaling is. 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.
SdR: how is the second aspect handled in WMO-studies?
Add the applicable sections to your SIS to ensure it allows for FAIR usage of data and materials.
Subject Information Sheet
In English, without the full explanation, 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.
If no template exists, consider using the CCMO template, available in both English and Dutch, as a basis.
To allow for the reuse of data and biomaterial collected in non-WMO studies, the SIS and ICF must properly inform and request consent from the participant. This ELSI Servicedesk page provides more context and contains a link to a standardised text that can be used in the SIS and ICF (only available in Dutch).
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SdR: So I guess the collaboration is essential for the project and no consent is asked? If patient doesn’t want this, he/she can’t join the study? ELSI website: Binnenkort verschijnt op de ELSI Servicedesk de standaard PIF die otwikkeld is in het project ‘wederzijdse erkenning’ van de NFU.
SdR: Wie toetst niet-WMO studies? Lokale METC? Stukje hieronder in dit deel?
Vraag bij de METC welke templates van informed consent worden geaccepteerd. Een ethische commissie mag geen adviezen geven, maar alleen beoordelen of een informed consent voldoet aan alle wettelijke eisen en verplichtingen.
Stel bij Privacy (functionaris gegevensbescherming of privacy officer) vragen over eventuele aanpassingen of toevoegingen van het informed consent.
ELSI website: Binnenkort verschijnt op de ELSI Servicedesk de standaard PIF die otwikkeld is in het project ‘wederzijdse erkenning’ van de NFU. Hier zit ook een hergebruikvraag bij (en meer, ook bv koppelen) voor biobanken. En in het project implementatie nWMO toetsingskader (getrokken door Elyse) wordt ook gewerkt aan een standaard PIF, maar daar moet nog mee gestart worden.
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Check your institute for an IC template
Miriem: Zou hier niet ook verwezen moeten worden naar de CCMO templates: Subject information, informed consent and informed consent procedure | Onderzoekers | Centrale Commissie Mensgebonden Onderzoek (ccmo.nl)
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 a patient’s data for federated querying?”
Miriem: Meestal moet er voor gezondheidsdata een data sharing agreement opgezet worden. Binnen het informed consent wordt de context van de dataverzameling beschreven en mag data binnen eenzelfde context gedeeld worden (indien er toestemming is gegeven voor data delen). Dit betekent dat er voor iedere data aanvraag gecontroleerd moet worden of de doelen voor het gebruik overeenkomen met de doelen die beschreven staan in het informed consent.
Het is nog wel een idee om hier iemand met kennis van wetgeving naar te laten kijken.
Sander: The first, I want to publish the study in the HRI Catalogue, 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?
Meriem: De metadata over welke gegevens er zijn verzameld mogen vrij gedeeld worden (tenzij dit mogelijk valt onder geheimhouding vanwege mogelijke patenten oid). Maar ook hier zou ik iemand met meer kennis over het opzetten van (DSA) contracten naar laten kijken. Zij kunnen misschien meer toevoegen over de uitzonderingen.
Sander: 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?
Meriem: Ik weet niet of federated querying by default anoniem is. Volgens mij kan deze data nog steeds gepseudonimiseerd zijn. Daarom moet er nog steeds een goede infrastructuur worden opgezet waarbij de bescherming van persoonsgegevens gewaarborgd kan worden.
Federated querying is a method of querying and accessing distributed datasets without physically centralizing the data. In the healthcare context, federated querying allows researchers, clinicians, or data scientists to access and analyze health data across multiple systems (e.g., hospitals, research institutions) without transferring sensitive patient data to a central location.
When sharing or accessing health data via federated querying, compliance with the GDPR is crucial, particularly because health data is classified as special category data under Article 9 of the GDPR. Health data includes information such as medical history, diagnosis, treatment, and genetic data. Key GDPR principles relevant to federated querying include:Lawfulness, Fairness, and Transparency
Lawful Basis for Processing: You must have a lawful basis to access or share health data, such as explicit consent from the data subject, or processing for research purposes under Article 9(2)(j).
Transparency: Data subjects must be informed about how their data is used, even if it’s queried remotely. Transparent data-sharing policies and consent mechanisms are essential.
Data Minimization and Purpose Limitation
Minimization: The GDPR requires that only the data necessary for the specific purpose is accessed or processed. In federated querying, this means limiting access to the minimum amount of data required to answer the query.
Purpose Limitation: Health data accessed through federated queries must only be used for the specific purpose (e.g., research) for which it was originally collected, and not for secondary purposes unless additional consent is obtained or a legal basis exists.
Data Security and Confidentiality
Security of Processing: Federated querying must implement robust technical and organizational measures to secure health data. This includes encryption, anonymization, pseudonymization, and access controls to prevent unauthorized access.
Data Localization: Since data remains on local servers, federated systems reduce the risks associated with transferring health data, but the data controllers (entities holding the data) must ensure secure query execution and auditability.
Accountability and Governance
Data Controllers and Processors: Each institution participating in a federated querying system is likely to act as a data controller, responsible for ensuring GDPR compliance. Federated systems often require detailed Data Processing Agreements (DPAs) between the entities to govern how data is accessed and used.
Data Protection Impact Assessments (DPIAs): If federated querying involves high-risk processing of health data, organizations may need to conduct a DPIA to assess risks and ensure GDPR compliance.
Make sure the necessary lines are in the IC
Get the IC approved
[Meriem]
When sharing or linking health data with external registries (e.g., disease-specific databases, national health registries, or international research databases), the informed consent process must clearly define:
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What data will be shared or linked: The type and nature of the health data (e.g., genetic data, medical history, treatment outcomes) that will be shared or linked with external registries.
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Who the data will be shared with: This includes identifying the external registries, research institutions, or third parties that will have access to the data.
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Purpose of data sharing/linking: The consent form should explicitly state the research purposes for which the data will be shared, such as epidemiological research, clinical studies, or public health monitoring.
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de uitzonderingen.
Sander: 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?
Meriem: Ik weet niet of federated querying by default anoniem is. Volgens mij kan deze data nog steeds gepseudonimiseerd zijn. Daarom moet er nog steeds een goede infrastructuur worden opgezet waarbij de bescherming van persoonsgegevens gewaarborgd kan worden.
Federated querying is a method of querying and accessing distributed datasets without physically centralizing the data. In the healthcare context, federated querying allows researchers, clinicians, or data scientists to access and analyze health data across multiple systems (e.g., hospitals, research institutions) without transferring sensitive patient data to a central location.
When sharing or accessing health data via federated querying, compliance with the GDPR is crucial, particularly because health data is classified as special category data under Article 9 of the GDPR. Health data includes information such as medical history, diagnosis, treatment, and genetic data. Key GDPR principles relevant to federated querying include:Lawfulness, Fairness, and Transparency
Lawful Basis for Processing: You must have a lawful basis to access or share health data, such as explicit consent from the data subject, or processing for research purposes under Article 9(2)(j).
Transparency: Data subjects must be informed about how their data is used, even if it’s queried remotely. Transparent data-sharing policies and consent mechanisms are essential.
Data Minimization and Purpose Limitation
Minimization: The GDPR requires that only the data necessary for the specific purpose is accessed or processed. In federated querying, this means limiting access to the minimum amount of data required to answer the query.
Purpose Limitation: Health data accessed through federated queries must only be used for the specific purpose (e.g., research) for which it was originally collected, and not for secondary purposes unless additional consent is obtained or a legal basis exists.
Data Security and Confidentiality
Security of Processing: Federated querying must implement robust technical and organizational measures to secure health data. This includes encryption, anonymization, pseudonymization, and access controls to prevent unauthorized access.
Data Localization: Since data remains on local servers, federated systems reduce the risks associated with transferring health data, but the data controllers (entities holding the data) must ensure secure query execution and auditability.
Accountability and Governance
Data Controllers and Processors: Each institution participating in a federated querying system is likely to act as a data controller, responsible for ensuring GDPR compliance. Federated systems often require detailed Data Processing Agreements (DPAs) between the entities to govern how data is accessed and used.
Data Protection Impact Assessments (DPIAs): If federated querying involves high-risk processing of health data, organizations may need to conduct a DPIA to assess risks and ensure GDPR compliance.
Make sure the necessary lines are in the IC
Get the IC approved
[Meriem]
When sharing or linking health data with external registries (e.g., disease-specific databases, national health registries, or international research databases), the informed consent process must clearly define:
What data will be shared or linked: The type and nature of the health data (e.g., genetic data, medical history, treatment outcomes) that will be shared or linked with external registries.
Who the data will be shared with: This includes identifying the external registries, research institutions, or third parties that will have access to the data.
Purpose of data sharing/linking: The consent form should explicitly state the research purposes for which the data will be shared, such as epidemiological research, clinical studies, or public health monitoring.
Data security and anonymisation/pseudonymisation: Participants should be informed about how their data will be protected, whether the data will be anonymised or pseudonymised, and what security measures are in place during data sharing.
Step 0 - Determine whether your study is subject to the WMO
Determine whether your study is subject to the Medical Research Involving Human Subjects Act (WMO) or not. The Central Committee on Research Involving Human Subjects (CCMO) executes the WMO and the Embryo’s Act. Research that falls under the WMO or the Embryo’s Act must undergo a review by an accredited Medical Research Ethics Committees (MREC) or the CCMO. Research is not allowed to start without a positive decision of this committee.
Research is subject to the WMO if the following criteria are met:
It concerns medical scientific research and
Participants are subject to procedures or are required to follow rules of behaviour.
To learn more, contact your local experts, see the CCMO website or the ELSI Servicedesk (in Dutch).
Multi-center IC?
FAIRopoly
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