...
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
Opt-in, opt-out? What about the PIF?
[Miriem]
Zoals net besproken zou het ook interessant zijn om te kijken naar
Welk type consent heb ik nodig:
Prospectief onderzoek: expliciet informed consent
Retrospectief:
opt-in of opt-out consent: wat is het verschil en wanneer pas je welke toe?
Expliciet consent wanneer je de retrospectieve data ook weer opnieuw zou willen gebruiken of beschikbaar willen stellen: voor hergebruik moet expliciet consent zijn gegeven.
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.
Zijn er standaardzinnen of paragrafen die je per onderwerp zou kunnen toevoegen aan een ICF-template?
Toevoegingen over het koppelen van data aan externe registries
Toevoegingen over samenwerkingen met externe partijen, bijvoorbeeld voor opschoning en analyses van de data
[Sander / Miriem]
Question: what is specific information that should be in your IC to accomodate for FAIR data and its further usage. IC information concerning secondary use of data / materials, potential data linkage to external registries (e.g. PALGA, IKNL)?
Step-wise how about something like:
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:
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.
Starting a new study may require a multitude of documents. Here, we focus specifically on the FAIR components that can be included in the Subject Information Sheet (SIS, Dutch: PIF - proefpersoneninformatieformulier) and the Informed Consent Form (ICF).
Step 1 - 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, see the CCMO website or the ELSI Servicedesk (ToDo: check whether they have great pages about this)
TBD: perhaps we don’t need this step? Since this guidance isn’t about “how to get your study approved”?
Step 2 - Study is subject to WMO
Subject Information Sheet
The CCMO has published a model SIS and strongly recommends its usage. Chapter 10, “What will be done with your data and body material?“ contains several questions relevant for FAIR data. (or maybe just one??)
Can we use your data and body material for other research?
Here, it is of the utmost importance that the researcher clearly explains for which purposes collected data/materials may be reused. This may be broader than the original purpose of the study, but not too broad. For example, “cancer research” may be acceptable but “any research” is not. If stored data/material is used for a different purpose, participants must give permission again or usage is not permitted.
We send your data to countries outside the European Union
If I read correctly, you only give permission for this study. So my interpretation is that for other research you are never allowed to send the data outside the European Union. Is that correct?
(same goes for e.g. the coincidental findings)
Informed Consent Form
The CCMO’s SIS also contains an Informed Consent Form as an Appendix, Of particular interest for FAIR data is the table with Yes/No questions:
<if applicable> I give consent to store my data to use for other research, as stated in the information sheet.
<if applicable> 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.
<if applicable> I give consent to ask me after this study if I want to participate in a follow-up study.
Actually.. this is probably not relevant, since it will generate NEW data and is not about reusing the data already collected. Remove?
Q:
...
If the current study does not require linkage to external registries, can (should? / is it even allowed?) you ask permission for this for future research, e.g. “In future research we would like to be able to link your data to external registries, such as PALGA, CBS and IKNL”
...
I don’t see any mention of sharing data/materials with commercial parties. Does that mean that you can share it or not?
Ik geef toestemming voor het zo nodig contact opnemen met de Basisregistratie persoonsgegevens om geen fouten te maken bij het benaderen van de juiste personen.
Ik geef toestemming voor koppeling met andere Nederlandse registratiesystemen voor het opvragen van gegevens.
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.
Ik geef wel/geen (doorhalen wat niet van toepassing is) voor onderzoek met mijn gegevens en materiaal door commerciële partijen.
Ik geef wel/geen (doorhalen wat niet van toepassing is) toestemming om in de toekomst benaderd te worden voor eventueel vervolg onderzoek.
Ik geef toestemming om gegevens op te vragen bij bestaande Nederlandse registratiesystemen om meer inzicht te krijgen in het verloop van bepaalde aandoeningen. Deze registratiesystemen staan vermeld in deze informatiebrief
If you intend to collect cause of death data via CBS (Statistics Netherlands) in the future, please include the following sentence with yes/no option in the consent form: 'If I die during the course of the study, I give consent to request my official cause of death data from the CBS (Statistics Netherlands)'.
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.
Voor koppelen met de CBS doodsoorzakenstatistiek staat in de comments nog dit:
...
De meest up-to-date formulering vind je hier op de CBS-website.
Step 3 - Study is not subject to WMO
Gebruik https://elsi.health-ri.nl/gedragscode/opzet-en-voorbereiding/anticiperen-op-vervolgactiviteiten
copy-paste:
Om de mogelijkheid open te houden dat gegevens of lichaamsmateriaal, die verzameld zijn om een specifieke onderzoeksvraag te beantwoorden, hergebruikt kunnen worden voor andere onderzoeksvragen die buiten de reikwijdte van de oorspronkelijke onderzoeksvraag vallen, is het belangrijk de zeggenschap hier vooraf voor te regelen. Het uitgangspunt in de gedragscode is dat hier apart toestemming voor wordt gevraagd. Uitzonderingen zijn mogelijk, bijvoorbeeld bij cohortstudies, waar het brede gebruik een inherent onderdeel van het onderzoek is. Een standaardtekst om op te nemen in niet-WMO-PIFs om deelnemers te informeren en om toestemming te vragen voor hergebruik vindt u hier.
Chapter 10
What data do we store?
<if applicable> What body material do we store?
Why do we collect, use and store your data <if applicable> and body material?
How do we protect your privacy?
Who can see your data?
For how long do we store your data and body material?
<if applicable> Can we use your data and body material for other research?
<If applicable> What happens if there are coincidental findings?
Can you take back your consent for the use of your data?
<If applicable> We send your data to countries outside the European Union
Do you want to know more about your privacy?
Where can you find more information about the study?
[ELSI Servicedesk]
Hoi Sander,
Bij deze een antwoord op je vraag aan de ELSI Servicedesk, Susanne heeft een aantal dingen op een rij gezet. Er zijn zeker standaardzinnen of ‘best practices’ beschikbaar. Voor WMO-studies volgen onderzoekers natuurlijk de standaard PIF van de CCMO. In die zin zou je dan ook van ‘goedgekeurd’ kunnen spreken. Hierin wordt onderscheid gemaakt tussen materiaal en data.
Uiteraard moet de vraag voorafgegaan worden aan de passende informatie in de folder zelf. Uitgangspunt hierbij is dat de onderzoeker duidelijk aangeeft voor welk doel of welke doelen de data/materialen hergebruikt mogen worden. Dit mag breder zijn dan het oorspronkelijke doel van de studie, maar niet te breed. Doelen in de lijn van ‘onderzoek naar kanker’ of ‘onderzoek naar gezond ouder worden’ worden meestal als passend gezien.
Voor koppelen met de CBS doodsoorzakenstatistiek staat in de comments nog dit:
...
De meest up-to-date formulering vind je hier op de CBS-website.
In het implementatieproject gedragscode hebben we gewerkt aan een standaard alinea plus vraag over hergebruik. Je ziet dat de vraag wel gebaseerd is op die van de CCMO, maar materiaal en data worden in 1 vraag opgenomen. Deze tekst vind je hier.
Meer informatie staat hier.
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.
Susanne zegt: ik ben zelf van harte bereid om deze pagina voor jullie te reviewen. Hergebruik aan de voorkant goed regelen is zeg maar mijn ding ;). Je voorkomt er achteraf een hoop gedoe mee. Tegelijkertijd vind ik het ook heel belangrijk om patienten niet onnodig 10 toestemmingsvragen te stellen. Als een onderdeel (bv koppelen, organoids) een inherent onderdeel van een project is, hoort het allemaal in de hoofd-toestemmingsvraag.Starting a new study may require a multitude of documents. Here, we focus specifically on the FAIR components that can be included in the Subject Information Sheet (SIS, Dutch: PIF - proefpersoneninformatieformulier) and the Informed Consent Form (ICF).
Step 1 - 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, see the CCMO website or the ELSI Servicedesk (ToDo: check whether they have great pages about this)
TBD: perhaps we don’t need this step? Since this guidance isn’t about “how to get your study approved”?
Step 2 - Study is subject to WMO
The CCMO has published Subject Information Sheet (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 Informed Consent Form (ICF). Note, that 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
In the aforementioned model, chapter 10, “What will be done with your data and body material?“, contains several topics relevant for FAIR data. (or is there just one??):
<if applicable> Can we use your data and body material for other research?
Your collected data <if applicable> and your (remaining) body material may also be important for other medical research on [your condition and/or the further development of the product/treatment method]. For this purpose, your data <if applicable> and body material will be stored [in the hospital/research centre/...] for [...] years. Please indicate in the consent form whether you agree with this. Do you not want to give your consent? Then you can still take part in this study. You will get the same healthcare.
Here, it is of the utmost importance that the researcher clearly explains for which purposes collected data/materials may be reused. This may be broader than the original purpose of the study, but not too broad. For example, “cancer research” may be acceptable but “any research” is not. If stored data/material is used for a different purpose, participants must give permission again or usage is not permitted.
<If applicable> We send your data to countries outside the European Union
In this study, we will send your coded data <if applicable> and body material also to countries outside the European Union. The privacy rules of the European Union do not apply in those countries. Choice> But your privacy will be protected at a similar level . OR We ask your permission for this.
SdR: If I read correctly, you only give permission for this study. So my interpretation is that for other research you are never allowed to send the data outside the European Union. Is that correct?
Is this a FAIR point? It’s
Add these section(s) (tbd) to ensure the SIS allows for FAIR usage of data and materials.
Informed Consent Form
The CCMO’s SIS contains an ICF as an Appendix, Of particular interest for FAIR data are the following items from the table with Yes/No questions:
<if applicable> I give consent to store my data to use for other research, as stated in the information sheet.
<if applicable> 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.
<if applicable> I give consent to ask me after this study if I want to participate in a follow-up study.
SdR: this is probably not relevant, since it will generate NEW data and is not about reusing the data already collected. Remove?
Add these questions to your ICF to ensure the FAIR usage of data and materials.
SdR:
If the current study does not require linkage to external registries, can you ask permission for this for future research, e.g. “In future research we may want to link your data to external registries, such as PALGA, CBS and IKNL”. Probably not?
If the current study does request permission for linkage to external registries, does permission automatically carry over to follow-up research? So, let’s say for the initial study I need some fields from the NKR and ask permission for data linkage. If participant asks permission for linkage and gives permission for other research, does this imply participant gives permission for linkage in other research? Meaning other research could fetch other fields from the NKR?
I don’t see any mention of sharing data/materials with commercial parties. Does that mean that you can share it or not? Probably not? How does that work for “other research”?
Some sentences I found in AOCR and COMPRAYA (for my mental reference)
Ik geef toestemming voor koppeling met andere Nederlandse registratiesystemen voor het opvragen van gegevens.
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.
Ik geef wel/geen (doorhalen wat niet van toepassing is) voor onderzoek met mijn gegevens en materiaal door commerciële partijen.
Ik geef wel/geen (doorhalen wat niet van toepassing is) toestemming om in de toekomst benaderd te worden voor eventueel vervolg onderzoek.
Ik geef toestemming om gegevens op te vragen bij bestaande Nederlandse registratiesystemen om meer inzicht te krijgen in het verloop van bepaalde aandoeningen. Deze registratiesystemen staan vermeld in deze informatiebrief
Susanne also pointed out the following:
If you intend to collect cause of death data via CBS (Statistics Netherlands) in the future, please include the following sentence with yes/no option in the consent form: 'If I die during the course of the study, I give consent to request my official cause of death data from the CBS (Statistics Netherlands)'.
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.
SdR: is this relevant for FAIR data though? Are you even allowed to publish the data of death data from CBS, or does CBS require you to delete their data after x years / the study is finished?
Step 3 - Study is not subject to WMO
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 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).
Subject Information Sheet
In English, without the full explanation, 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. 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.
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. 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.
SdR: wat is het verschil tussen die standaard PIFs, waarom komt er meer dan 1 standaard PIF en wanneer moet je welke gebruiken?
Chapter 10
What data do we store?
<if applicable> What body material do we store?
Why do we collect, use and store your data <if applicable> and body material?
How do we protect your privacy?
Who can see your data?
For how long do we store your data and body material?
<if applicable> Can we use your data and body material for other research?
<If applicable> What happens if there are coincidental findings?
Can you take back your consent for the use of your data?
<If applicable> We send your data to countries outside the European Union
Do you want to know more about your privacy?
Where can you find more information about the study?
Susanne: ik ben zelf van harte bereid om deze pagina voor jullie te reviewen. Hergebruik aan de voorkant goed regelen is zeg maar mijn ding ;). Je voorkomt er achteraf een hoop gedoe mee. Tegelijkertijd vind ik het ook heel belangrijk om patienten niet onnodig 10 toestemmingsvragen te stellen. Als een onderdeel (bv koppelen, organoids) een inherent onderdeel van een project is, hoort het allemaal in de hoofd-toestemmingsvraag.
Opt-in, opt-out? What about the PIF?
[Miriem]
Zoals net besproken zou het ook interessant zijn om te kijken naar
Welk type consent heb ik nodig:
Prospectief onderzoek: expliciet informed consent
Retrospectief:
opt-in of opt-out consent: wat is het verschil en wanneer pas je welke toe?
Expliciet consent wanneer je de retrospectieve data ook weer opnieuw zou willen gebruiken of beschikbaar willen stellen: voor hergebruik moet expliciet consent zijn gegeven.
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.
Zijn er standaardzinnen of paragrafen die je per onderwerp zou kunnen toevoegen aan een ICF-template?
Toevoegingen over het koppelen van data aan externe registries
Toevoegingen over samenwerkingen met externe partijen, bijvoorbeeld voor opschoning en analyses van de data
[Sander / Miriem]
Question: what is specific information that should be in your IC to accomodate for FAIR data and its further usage. IC information concerning secondary use of data / materials, potential data linkage to external registries (e.g. PALGA, IKNL)?
Step-wise how about something like:
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:
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.
Multi-center IC?
FAIRopoly
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