STATUS: IN DEVELOPMENT
Short description
‘A great quote’ (source)
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.
Many different forms of IC exist. The image below highlights some variants of informed consent and how they are (generally) related.
This step provides guidance in setting up an Informed Consent Form (ICF) and a Subject Information Sheet (SIS) that align with the FAIR principles. It assumes you are aware of whether your study falls under the WMO (Medical Research Involving Human Subjects Act). If you are unsure, visit the CCMO website, consult the ELSI Servicedesk (available in Dutch) or seek assistance from your local experts
To ensure a dataset can be automatically accessed, processed and utilised by machines without significant manual intervention (i.e. machine-actionable data), the IC must also be machine-actionable. This enables automated systems to interpret consent terms, facilitating the ethical and legal sharing of data across systems while safeguarding participant rights [FAIR]. For more information on making the IC machine-actionable, see Step XYZ.
Why is this step important
The FAIR principles aim to make data useful for immediate research and future purposes, such as replication, validation, and meta-analysis, while safeguarding participants' privacy and rights. Therefore, informed consent must address both current and potential future data use in compliance with GDPR requirements. This step offers guidance on creating an effective informed consent form and subject information sheet to meet these standards.
How to
IC is an essential component for collecting and reusing data. To ensure an IC complies to laws and regulations it has to be checked. Research that falls under the WMO 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 should be reviewed by an ethical committee, such as an MREC. Research is not allowed to start without a positive decision of the appropriate reviewing committee.
If your study is subject to the WMO go to Step 1 and for a non-WMO study go to Step 2. Step 3 describes additional paragraphs relevant for FAIR, which you could consider for your ICF and SIS. In Step 4, issues you may encounter in specific cases are highlighted, for example, when you’re setting up a cohort study.
Note: while this guidance aims to provide up-to-date and accurate information, you should always check with your local privacy and legal specialists! Also, where examples are provided, always check the actual templates to ensure you have the most up-to-date information.
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 (SIS)
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 (ICF)
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.
These can just be reused the way they are provided.
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, add the information from the adult versions to your SIS and ICF and then consult your local experts, such as the data protection / privacy officer, for exact integration before subjecting the documents for review .
Step 2 - Study is not subject to WMO
First, check with your local MREC which SIS and ICF templates they have available and accept. Verify whether these 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 (SIS)
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 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 Dutch templates (sources: Amsterdam UMC: E1E2. Niet-WMO model informatiebrief met toestemmingsformulier versie d.d. 15-08-2024 and standardised text van de ELSI Servicedesk). If you decide to use these passages, please verify with your local experts.
<Todo: vertaal>
3.1 Sharing data with parties outside of the EU
Subject Information Sheet
(Vertaalde versie van standardised text van de 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
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.
Amsterdam UMC
Subject Information Sheet
Toestemming voor het delen van gegevens en lichaamsmateriaal met commerciële partijen
In dit onderzoek delen we uw gegevens met [naam bedrijf of bedrijven]. Als u niet wilt dat we uw gegevens delen met commerciële partijen, kunt u dit aangeven op het toestemmingsformulier.
Informed Consent Form
Ik geef wel/geen (doorhalen wat niet van toepassing is) toestemming voor het delen van mijn gegevens/lichaamsmateriaal met commerciële bedrijven waarvan de naam in de brief is genoemd.
3.2 Sharing data with commercial parties
Subject Information Sheet
(Gebaseerd op de vorige, waarschijnlijk niet goed…………) → weghalen, omdat we amsterdam umc al hebben?
In this study, your data [and biological material] may be shared with commercial parties for research purposes, such as [explain the reason here]. It is also possible that the data will be shared with commercial entities for the development of new products or services.
We only share your data [and biological materials] with commercial parties if they handle your data [and biological materials] securely and in accordance with the same standards required for researchers within the EU. We will also make written agreements with them to ensure your privacy and the protection of your data.
Informed Consent Form
Ik geef wel/geen (doorhalen wat niet van toepassing is) voor onderzoek met mijn gegevens en materiaal door commerciële partijen.
Amsterdam UMC
Subject Information Sheet
We sturen uw gegevens naar landen buiten de Europese Economische Ruimte (EER)
In dit onderzoek sturen we uw gecodeerde gegevens en lichaamsmateriaal ook naar landen buiten de Europese Economische Ruimte. In die landen gelden niet dezelfde privacyregels als binnen de EU. Maar wij trachten uw privacy zo goed mogelijk te beschermen met goede contracten. Wij vragen u op het toestemmingsformulier apart toestemming voor het doorsturen van uw gecodeerde gegevens en/of lichaamsmateriaal. Wanneer u besluit ons die toestemming niet te geven, kunt u [niet/toch] meedoen met het onderzoek.
Informed Consent Form
Ik geef wel/geen (doorhalen wat niet van toepassing is) toestemming om mijn gegevens/lichaamsmateriaal in het kader van dit onderzoek over te dragen aan [landen binnen de EER]/ waar de Europese richtlijnen voor de bescherming van persoonsgegevens gelden. De gegevens/ lichaamsmateriaal moeten dan gecodeerd worden overgedragen en zonder mijn naam.
Ik geef wel/geen (doorhalen wat niet van toepassing is) toestemming om mijn gegevens/lichaamsmateriaal in het kader van dit onderzoek over te dragen aan landen buiten de EER waar de Europese richtlijnen voor de bescherming van persoonsgegevens niet gelden. De gegevens/lichaamsmateriaal moeten dan gecodeerd worden overgedragen en zonder mijn naam.
3.3 CBS linkage
Susanne: 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.
Amsterdam UMC
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.
ELSI expert - ELSI experts provide guidance and answers to the ethical, legal and social implications of research.
Practical examples from the community
Examples of how this step is applied in a project (link to demonstrator projects).
Training
Add links to training resources relevant for this step. Since the training aspect is still under development, currently many steps have “Relevant training will be added in the future if available.”
Suggestions
Visit our How to contribute page for information on how to get in touch if you have any suggestions about this page.