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Informed consent (IC) is the process by which a patient voluntarily agrees to a medical procedure, treatment, or participation in research after being fully informed about the relevant details. Obtaining patients’ informed consent is usually required when collecting their data for scientific purposes [De novo]. To align with the FAIR principles, it is crucial that data sharing aspects are explicitly handled in the informed consent form [De Novo]. Furthermore, consent may be necessary for, for example, sharing and archiving [uu_consent] of the data and linkage with external registries.
For the data to be machine-actionable, allowing automated systems or software to interpret, process, and take predefined actions on it without human intervention, the IC information must be provided in a digital, standardised fashion, as without such information a computer cannot know whether it is allowed to use the data [FAIR].
The image below highlights some variants of informed consent and how they are (generally) related.
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Depending on the type of study and the goals, specific rules for the allowed form of consent can exist. For example, an invasive study involving human subjects need to adhere to the rules set by the CCMO.
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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 support machine actionability of data and metadata, it is essential that informed consent is also machine-actionable. This enables automated systems to interpret consent terms, ensuring that data can be ethically and legally shared across systems while maintaining participant rights [FAIR]. In this step we focus solely on the content of the SIS and ICF. For more information about making the informed consent machine actionable, see Step XYZ.
In this step, guidance is provided to help you create an Informed Consent Form (ICF) and Subject Information Sheet (SIS) that support 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 learn more about this on the CCMO website, the ELSI Servicedesk (in Dutch) and contact your local experts for help.
Depending on the type of study and the goals, specific rules for the allowed form of consent can exist. For example, an invasive study involving human subjects need to adhere to the rules set by the CCMO.
A general informed consent form may be available, but a local Institutional Ethical Review Board may demand changes after reviewing. It is crucial that essential data sharing aspects are explicitly handled in the informed consent form [De Novo]. The consent information should be made available as metadata.
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It ensures that the consent form is written in a way that participants in that particular region can understand.
The local committee will assess whether the consent form adequately explains the data processing activities, the purpose of data collection, and participants' rights (e.g., the right to withdraw consent).
The committee ensures that the study adheres to local regulations regarding the use of personal and sensitive health data.
It is crucial that essential data sharing aspects are explicitly handled in the informed consent form [De Novo]. The consent information should be made available as metadata. [uu_consent] https[uu_consent] https://www.uu.nl/en/research/research-data-management/guides/informed-consent-for-data-sharing
[uu_consent] https://www.uu.nl/en/research/research-data-management/guides/informed-consent-for-data-sharing
SdR: The step is call Obtain informed consent. Can you “obtain” IC with an opt-out model?
Do we want to mention things like dynamic IC, electronic IC, Toestemming aan de poort?
Does a PIF also contain information about data collection / how data will be used? Or is the PIF only medical?
Why is this step important
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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.
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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 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 approriate 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. 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!
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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 considerationsconsideration for your SIS and ICF
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?
Next
Go to Step 3.
Step 2 - Study is not subject to WMO
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Subject Information Sheet
In English, without the full explanation, the ICF needs to include the following:
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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.
Additional FAIR considerations
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.
Additional FAIR consideration for your SIS and ICF
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?
If you have questions regarding the changes to make, contact your local privacy officer or the ELSI Servicedesk.
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? Hoe kunnen we onderzoekers helpen met het kiezen van de juiste?
Step 3 - Special cases
Cohort studies and biobanks.
Splitsen? Of lopen ze tegen dezelfde problemen aan?
Research involving animals.
Here, informed consent is not applicable in the same way it is for human research. Instead, ethical approval is required to ensure the humane treatment of animals.
Deceased participants.
Informed consent is generally not required for the use of data or biological specimens from deceased individuals, provided that the research adheres to ethical guidelines and legal regulations.
Anonymised data.
If data is anonymised, it is no
Next
Go to Step 3.
Step 3 - Special cases
Cohort studies and biobanks.
Splitsen? Of lopen ze tegen dezelfde problemen aan?
Research involving animals.
Here, informed consent is not applicable in the same way it is for human research. Instead, ethical approval is required to ensure the humane treatment of animals.
Deceased participants.
Informed consent is generally not required for the use of data or biological specimens from deceased individuals, provided that the research adheres to ethical guidelines and legal regulations.
Anonymised data.
If data is anonymised, it is no longer considered personal data under regulations like the GDPR.
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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 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? Hoe kunnen we onderzoekers helpen met het kiezen van de juiste?
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.
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