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Short description 

‘A great quote’ (source)

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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.

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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 :

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(see the standardised text for the full details):

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

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

Informed Consent Form (ICF)

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

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<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 (ICF)

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 and consult your local experts, such as the data protection / privacy officer, for exact integration before subjecting the documents for review .

Step 3 - Additional FAIR consideration

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 these passages, please verify with your local experts.

3.1 Sharing data with parties outside of the EU

Subject Information Sheet (ELSI Servicedesk)

<if applicable> If we collaborate with countries outside the European Union

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• I consent to my data <if applicable> [and (residual) bodily material] being used for other scientific research, as outlined in the information letter.

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

Step 3 - Additional FAIR consideration

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

3.1 Sharing data with parties outside of the EU

Subject Information Sheet (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

• I do/do not (cross out what does not apply) consent to research using my data and material by institutions abroad, even if the level of privacy protection is lower than in the Netherlands.

Subject Information Sheet (Amsterdam UMC)

• We send your data to countries outside the European Economic Area (EEA)

  • In this study, we also send your coded data and bodily material to countries outside the European Economic Area. These countries do not have the same privacy regulations as those within the EU. However, we strive to protect your privacy as much as possible through proper contracts. On the consent form, we will ask for your separate consent to send your coded data and/or bodily material. If you decide not to provide this consent, you [cannot/can still] participate in the study.

Informed Consent Form

• I do/do not (cross out what does not apply) consent to research using the transfer of my data and material by institutions abroad, even if the level of privacy protection is lower than in the Netherlands.

Subject Information Sheet (Amsterdam UMC)

Consent for sharing data and bodily material with commercial parties

In this study, we share your data with [name of company or companies]. If you do not want us to share your data with commercial parties, you can indicate this on the consent form.

Informed Consent Form

• I do/do not (cross out what does not apply) consent to the sharing of my data/bodily material with commercial companies mentioned in the letter.

3.2 Sharing data with commercial parties

Subject Information Sheet (Amsterdam UMC)

We send your data to countries outside the European Economic Area (EEA)

In this study, we also send your coded data and bodily material to countries outside the European Economic Area. These countries do not have the same privacy regulations as those within the EU. However, we strive to protect your privacy as much as possible through proper contracts. On the consent form, we will ask for your separate consent to send your coded data and/or bodily material. If you decide not to provide this consent, you [cannot/can still] participate in the study.

Informed Consent Form

• I do/do not (cross out what does not apply) consent to the transfer of my data/bodily material within the scope of this study to [countries within the EEA]/where the European guidelines for the protection of personal data apply. The data/bodily material must then be transferred in coded form and without my name.

• I do/do not (cross out what does not apply) consent to the transfer of my data/bodily material within the scope of this study to countries outside the EEA where the European guidelines for the protection of personal data do not apply. The data/bodily material must then be transferred in coded form and without my name.

3.3 CBS linkage

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.

Subject Information Sheet

Mogen wij gegevens van u opvragen bij het CBS?

Het Centraal Bureau voor de Statistiek (CBS) is de officiële instantie in Nederland die doodsoorzaken registreert. Mocht u tijdens het onderzoek onverhoopt komen te overlijden dan vragen wij u om toestemming om de gegevens over uw doodsoorzaak bij het CBS op te vragen. Wij vragen uw gegevens alleen op wanneer die gegevens van belang kunnen zijn voor dit onderzoek.

Informed Consent Form

• Ik geef wel/geen (doorhalen wat niet van toepassing is) toestemming voor het opvragen van mijn gegevens bij het CBS.

• Susanne: 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) [yes/no]

3.4 Generic database linkage

Amsterdam UMC

Subject Information Sheet

No template text currently available?

Binnen AOCR gekoppeld met o.a. PALGA. Dus even kijken wat we daar hadden staan en dat misschien herbruiken?

Informed Consent Form

• Ik geef wel/geen (doorhalen wat niet van toepassing is) toestemming voor [het koppelen met / opvragen van] mijn gegevens uit [naam database].

3.5 Hoe lang bewaren we uw gegevens?

Let op dat er vaste retentieperiodes zijn voor het type onderzoek. Je bent verplicht om je aan de termijn die in je IC staat te houden, ook voor publicaties.

Amsterdam UMC

Subject Information Sheet

We bewaren uw gegevens [xx] jaar [in het ziekenhuis/ huisartsenpraktijk/ onderzoekscentrum]. En [xx] jaar bij [ naam instelling / naam bedrijf].

Uw lichaamsmateriaal bewaren we [in het ziekenhuis/ onderzoekscentrum/ …]. Het wordt [xx] jaar bewaard om het voor dit onderzoek te kunnen gebruiken. Zodra dit niet meer nodig is, vernietigen we uw lichaamsmateriaal.

Informed Consent Form

• Ik geef toestemming om mijn lichaamsmateriaal nog [aantal] jaar na dit onderzoek te bewaren. Mogelijk kan dit later nog voor ander/meer onderzoek worden gebruikt, zoals in de informatiebrief staat.

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.

  • Dit hebben we ook bij step 3.3. 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. 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:

Long-term cohort studies often face changing laws and regulations over the course of the study. Informed consent requirements have also changed over the years. The most recent informed consent applies to the participant's data. So it may be that 10 years ago no participant was asked whether their data may be shared outside the EU, but that this was done in a new round this year. With a cohort, however, you always face participants dropping out between measurement rounds. Therefore, it is possible that certain participants participated for the last time 10 years ago and have not participated since then. Therefore the informed consent of 10 years ago remains valid. This can lead to complicated situations within cohorts, for which it is advisable to contact the data protection officer of your institute.

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.

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.

Step 5 - Finally

With your SIS and ICF fully FAIR ready and (checked/approved?) by your data protection officer, get it reviewed by the appropriate committee:

• An accredited MREC for Non-WMO studies (tbd)

• An accredited MREC or the CCMO for WMO studies

Expertise requirements for this step 

This section could describe the expertise required. Perhaps the Build Your Team step could then be an aggregation of all the “Expertise requirements for this step” steps that someone needs to fulfil his/her FAIRification goals.  

• 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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• /bodily material within the scope of this study to countries outside the EEA where the European guidelines for the protection of personal data do not apply. The data/bodily material must then be transferred in coded form and without my name.

• Related:

  • I do/do not (cross out what does not apply) consent to the transfer of my data/bodily material within the scope of this study to [countries within the EEA]/where the European guidelines for the protection of personal data apply. The data/bodily material must then be transferred in coded form and without my name.

3.2 Sharing data with commercial parties

Subject Information Sheet (Amsterdam UMC)

• Consent for sharing data and bodily material with commercial parties

  • In this study, we share your data with [name of company or companies]. If you do not want us to share your data with commercial parties, you can indicate this on the consent form.

Informed Consent Form

• I do/do not (cross out what does not apply) consent to the sharing of my data/bodily material with commercial companies mentioned in the letter.

3.3 CBS linkage

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.

Subject Information Sheet (Amsterdam UMC)

• May we request data about you from CBS?

  • Statistics Netherlands (CBS) is the official authority in the Netherlands that records causes of death. If you were to pass away during the study, we ask for your consent to request information about the cause of your death from CBS. We will only request this information if it is relevant to this study.

Informed Consent Form

• I do/do not (cross out what does not apply) consent to the request for my data from CBS.

• Susanne: 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) [yes/no]

3.4 Generic database linkage

Amsterdam UMC

Subject Information Sheet

No template text available. Maybe something like (+/- AOCR):

• Linking with existing Dutch registration systems.

  • To gain more insight into the development and progression of your condition, we require additional data. This data will be obtained by requesting information from existing Dutch health-related registration systems, such as [name of database]. Any linking with Dutch health-related registration systems will only take place after consultation with the {(voorbeeld was “Biobank Toetsings Commissie”)}.

Informed Consent Form

• I do/do not (cross out what does not apply) consent to [the linking of/requesting] my data from [name of database].

3.5 How long do we retain your data?

Please note that fixed retention periods apply to the type of research. You are required to adhere to the retention period stated in your informed consent (IC), also for publications.

Subject Information Sheet (Amsterdam UMC)

• We retain your data for [xx] years [at the hospital/general practice/research centre]. It will also be retained for [xx] years at [name of institution/company].

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. 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.

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

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.

Step 5 - Finally

With your SIS and ICF fully FAIR ready and (checked/approved?) by your data protection officer, get it reviewed by the appropriate committee:

• An accredited MREC for Non-WMO studies (tbd)

• An accredited MREC or the CCMO for WMO studies

Expertise requirements for this step 

This section could describe the expertise required. Perhaps the Build Your Team step could then be an aggregation of all the “Expertise requirements for this step” steps that someone needs to fulfil his/her FAIRification goals.  

• ELSI expert

  • National level

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

  • Local level

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

Practical examples from the community 

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