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.

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 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 

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.