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Obtaining patients’ informed consent for collecting their 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 is usually required typically requires participants' IC [De novo]. Furthermore, patient consent may be necessary for archiving and sharing [uu_consent] and linkage with e.g. external registries. Furthermore, consent information is necessary for the data to be machine-actionable, as without such data a computer cannot know whether it is allowed to use the data [FAIR].
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.
[uu_consent] https://www.uu.nl/en/research/research-data-management/guides/informed-consent-for-data-sharing
Why is this step important
A properly designed informed consent is crucial for data reuse. Without it, archiving, sharing, etc may not be possible.
How to
[Sander]
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
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?”
The first 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?
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?
Make sure the necessary lines are in the IC
Get the IC approved
FAIRopoly
The development of this ICF benefited from previous experience with ICF submissions by 4 ERN Registries (ERKReg, EuRRECa, ENROL, VASCA) and from the utilization of “machine-readable” consent-related Ontologies (Data Use Ontology and Informed Consent Ontology). Several iterative expert reviews (including patient organizations and ERN representatives) were conducted to finalize the ICF.
Some potential sources:
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ELSI Servicedesk? Unfortunately in Dutch.
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Templates for ICs?
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https://rdmkit.elixir-europe.org/human_data
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https://rdmkit.elixir-europe.org/ethics
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https://book.the-turing-way.org/project-design/sdpm/informed.html
[HANDS] - chapter privacy and autonomy
Consent
Consent aims at informing potential study subjects of all aspects of participation, including the procedures for data handling, data access and anonymity. An informed person can freely decide to participate or not. If someone does participate, he or she understands and accepts the risks and burdens involved in participation.
The Central Committee on Research Involving Human Subjects (CCMO) has produced guidelines for obtaining informed consent and has adapted the nationally mandatory proefpersonen-informatieformulier in light of the GDPR (for WMO research). In addition, the NFU working group ‘Privacy, ethiek & recht in gezondheidsonderzoek’ is currently developing a UMC format for broad consent, which may be applicable to certain non-WMO research. Advice on how to inform donors and patients about the use of their biomaterials and/or data in scientific research can be found at the ELSI servicedesk.
The ethical committee at your UMC can help you design your informed consent procedure. Regarding data management, the informed consent should include the person's wishes about:
the use and reuse of patient data for research in the current and future projects;
notification about the research results, including incidental research findings (special concern is required for results that cannot be interpreted now, but may be interpretable in the near future);
which data he/she can access, if applicable;
the possibility to withdraw certain aspects of informed consent and the consequences;
data use by commercial parties.
Consent should be documented along with the collected data, so subsequent users of the data are aware of the conditions agreed to by study subjects.
In general, it is very difficult to re-contact patients or study subjects to extend or change the consent. So, we advise you to obtain informed consent for storing clinical and personal data for the purpose of both healthcare and future scientific research, each with a separate specific informed consent (also see: care and research environment). In addition, patients should always be able to retract their consent.
Frequently Asked Questions
What does the EU General Data Protection Regulation state about consent?
“Consent should be given by a clear affirmative act establishing a freely given, specific, informed and unambiguous indication of the data subject's agreement to the processing of personal data relating to him or her, such as by a written statement, including by electronic means, or an oral statement. This could include ticking a box when visiting an internet website, choosing technical settings for information society services or another statement or conduct which clearly indicates in this context the data subject's acceptance of the proposed processing of his or her personal data. Silence, pre-ticked boxes or inactivity should not therefore constitute consent. Consent should cover all processing activities carried out for the same purpose or purposes. When the processing has multiple purposes, consent should be given for all of them. If the data subject's consent is to be given following a request by electronic means, the request must be clear, concise and not unnecessarily disruptive to the use of the service for which it is provided.”
And, regarding broad consent for scientific research: “It is often not possible to fully identify the purpose of personal data processing for scientific research purposes at the time of data collection. Therefore, data subjects should be allowed to give their consent to certain areas of scientific research when in keeping with recognized ethical standards for scientific research. Data subjects should have the opportunity to give their consent only to certain areas of research or parts of research projects to the extent allowed by the intended purpose.”
When and with what procedure should patients give consent for the use of their data or biomaterial for scientific research?
This is described at ‘Toestemmings- en bezwaarprocedures’ at the ELSI Servicedesk.
What if it is impossible to ask for consent?
In some exceptional cases, you are legally allowed to perform scientific research without a consent. More information about this can be found at ‘Toestemmings- en bezwaarprocedures’ at the ELSI Servicedesk. Always minimise the data and specifically describe the arguments for not asking for consent and make sure that your institute or its Data Protection Officer has accepted your arguments, before you start your research.
Do I need informed consent to use anonymous data?
Informed consent is not mandatory if your data is truly anonymous. However, you should carefully consider whether your data indeed is anonymous: it may be possible to trace ‘anonymous’ data to an individual person by combining the data with other data sources. You should always be aware of this possibility when sharing your data with third parties. It is advisable to let an independent party (for instance a Data Access Committee or Board) objectively assess your proposed data sharing.
What does my institute need to do to inform patients?
Your institute needs to actively inform patients that they may be asked to participate in scientific research. Also, they should be informed that in some exceptional cases, it can legally be allowed to perform scientific research without a consent. Patients are offered the right to refuse to such use. Your institute needs to install a procedure to ensure that such refusals are followed through, i.e., if people have refused sharing their data for scientific research, these data should not be used in research.
What about genetic data?
The EU General Data Protection Regulation states that ‘Genetic data should be defined as personal data relating to the inherited or acquired genetic characteristics of a natural person which result from the analysis of a biological sample from the natural person in question, in particular chromosomal, deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) analysis, or from the analysis of another element enabling equivalent information to be obtained.’
Most genetic studies will involve restricted access to individual level genotype and phenotype due to privacy concerns that are associated with this type of data.
The ELSI Servicedesk answers the question to what extent the data from whole genome sequencing are regarded as (directly) identifying. Also it advises on whether an informed consent form should state that genetic data is being processed.
Who can help me at my UMC?
Use the Toolbox to find support on informed consent at your UMC.
Further reading
For more information on incidental findings, please take a look at the BBMRI publication: Handreiking voor het constateren van, omgaan met en informeren over nevenbevindingen voor biobanken in BBMRI-NL.
The How to section should:
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be split into easy to follow steps;
Step 1
Step 2
etc.
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help the reader to complete the step;
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aspire to be readable for everyone, but, depending on the topic, may require specialised knowledge;
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be a general, widely applicable approach;
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if possible / applicable, add (links to) the solution necessary for onboarding in the Health-RI National Catalogue;
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aim to be practical and simple, while keeping in mind: if I would come to this page looking for a solution to this problem, would this How-to actually help me solve this problem;
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contain references to solutions such as those provided by FAIR Cookbook, RMDkit, Turing way and FAIR Sharing;
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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.
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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 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.
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)
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 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:
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 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.
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.
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. 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 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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