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Short description 

‘A great quote’ (source)

Short description

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 of the relevant details. Collecting data for scientific purposes typically requires participants' IC [De Novo]. To align with the FAIR principles, it is essential that data-sharing practices are explicitly addressed in the informed consent form. Additionally, consent may also be required for activities such as data archiving and linkage to external registries.

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The CCMO’s SIS contains an ICF as an Appendix. The following items are relevant for FAIR and should be used as provided:

• 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)

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Subject Information Sheet (SIS)

In Translated to English, the SIS needs information concerning the following topics (see the standardised text for the full details):

• May we use your data <if applicable> [and biomaterial] for other scientific research?

Add the applicable sections such a section to your SIS to ensure it allows for FAIR usage of data and materials.

Informed Consent Form (ICF)

In Translated to English, the ICF needs to include the following:

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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 it does not contain FAIR components, consider reusing the entries entry described above and consult your local experts, such as the a data protection / privacy officer, for exact integration before subjecting the documents for review .

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The information below is translated from Amsterdam UMC’s Dutch Non-WMO template and the ELSI Servicedesk’s standardised text (3.1). If you decide to use any of these passages, please verify with your local experts.

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• 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. Depending on the circumstances, it may be possible to switch to an op-out if their is a proper legal basis. Check with your local specialists.

• 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 (see 3.3) or updating addresses through the BRP. Ensure IC explicitly addresses these possibilities.

  Dit hebben we ook bij step 3.3

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  Zou de informatie die daar staat jou geholpen hebben?

• Heb je eventueel zelf een voorbeeld van wat je hebt toegevoegd? Dit kunnen we ook gebruiken bij “Examples from the community”

• Retention period for data and biomaterial. Clearly define the data retention period in the SIS/ICF. 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.

  • Dit hebben we ook bij step 3.x.

    • Zou dat jou geholpen hebben? Ik heb het idee dat dat niet specifiek genoeg is voor jou case, omdat er niet iets staat in de trend van “after the study concludes”?

  • Heb je eventueel zelf een voorbeeld van wat je hebt toegevoegd? Dit kunnen we ook gebruiken bij “Examples from the community”

  • Geldt dit niet ook voor biomateriaal?

Always consult your data protection officer for guidance.

Quint Olislagers 16-12-2024:

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One other common situation is when children in birth cohorts reach adulthood. Before they become adults, their parent or caregivers will have given informed consent for data collections concerning their child. As a adult they might not want their previous collected data to be used.

It is also advisable to think carefully from the beginning of a study about the possible retrieval or linking of data with other institutes in the future. An important point here could be asking permission to request the cause of death from CBS when a participant dies. Updating address information through the BRP can also be very important in cohort studies to ensure that participants are not lost from sight. Informed consent should also be requested for this.

Furthermore, an informed consent or the accompanying information material describes the retention period of the data, often 15 years. It is important that it then says 15 years after the study has ended. Otherwise, there could be situations where a cohort that has had measurement rounds for 20 years has to destroy data from its first measurement rounds. This can also be avoided by saying that instead of doing a specific number of years as the retention period, it will be evaluated every x number of years as to whether the data should still be retained and the participant will be informed of this.

Research involving animals.

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• ELSI expert

  • National level

    • The ELSI servicedesk for general information and questions (website)

  • Local level

    • Amsterdam UMC - Privacy Bescherming & Informatie Beveiliging (privacy@amsterdamumc.nl)

Policy maker - Policy makers gather information through consultation and research, and reduce and extract from the information a policy, set of policies or a strategic framework which serve to promote a preferred course of action and could include financial support to research.

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Practical examples from the community 

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