Netherlands CTIS Secondary Use Consent Requirements

When separate secondary-use consent is needed

Conditional. Add a secondary-use section when the sponsor plans to retain or use data or samples beyond the objectives and analyses required by the authorised clinical trial.

Examples include:

• future research into the same condition or treatment area
• method development not required for the trial endpoints
• future biomarker or genetic research
• storage of remaining blood, tissue or other bodily material
• sharing coded datasets or samples with other researchers
• future contact about another study

Do not label a trial-required analysis as secondary use. If it is needed to answer the protocol question, describe it in the core trial information and consent.

Separate data and bodily material

The Dutch IVO uses separate optional choices for future use of data and for future use of remaining bodily material. Preserve this distinction.

Optional. A participant may agree to future use of coded data and decline storage of samples, or the reverse. Neither refusal should block trial participation.

Where DNA analysis, artificial-intelligence analysis or future contact is optional, give each its own choice when it is not already within a clearly defined secondary-use scope.

Define the future-research scope

The General Data Protection Regulation requires future-use consent to be sufficiently specific. CCMO explains that a valid general scope can be defined by a condition, treatment or research field. Use plain language a participant can understand.

State:

• the health condition, treatment area or scientific field
• the data and samples that may be used
• whether genetic analysis is included
• who may conduct the research
• whether commercial organisations may receive or analyse material
• whether use can occur inside and outside the European Union
• how proposals will be reviewed
• how long data and samples will be stored

If a later project falls outside the described scope, obtain new consent or confirm that a specific legal research exemption applies. Do not assume that the original optional tick box covers unrelated work.

Dutch information and consent document

Mandatory when optional future use is planned. Explain the future use in the Dutch participant information and place the separate choices in the consent form. For participants aged 16 or older, use the current Dutch IVO structure.

The information should state that:

• data and material are coded rather than shared with the participant's name
• other researchers may use them under the stated conditions
• sharing may occur inside or outside the EU
• refusing does not affect the trial or care
• the participant can later withdraw the optional permission

Submit the blank Dutch document under Subject information and informed consent form, normally as part of L1. A separate secondary-use ICF may be used when it improves clarity, but it must remain linked to the authorised information and consent process.

Part II biological-samples form

Conditional on biological-sample collection, storage or future use. Complete the official template under Compliance with use of biological samples. The Dutch form is aligned with the EudraLex Volume 10 template.

Describe collection, processing, storage, location, retention, transfer, access, future use and destruction. The form, protocol and participant information must agree. A statement in the samples form does not replace participant consent.

Storage period and location

Give a fixed storage period for secondary use. The current IVO instructions specifically say to provide a deadline and not use only "at least" a stated number of years.

Identify where data and samples will be stored and what happens at the end of the period. Explain whether they are destroyed, anonymised or retained under another lawful and authorised arrangement.

For trial records, do not confuse optional future-use storage with the 25-year minimum archiving period for clinical-trial documentation under the CTR. The purpose and legal basis differ.

Data protection and sharing

Pseudonymised data remains personal data. Explain who holds the code key, who receives coded data, and which people may access identifiable records for monitoring, audit or inspection.

Describe transfers outside the European Union and how comparable privacy protection is arranged. Avoid saying that coded data can never identify a person.

Align the participant document with the mandatory Dutch R1 data-protection form and the application-level GDPR statement. Identify the controller or joint controllers and provide data-protection contacts.

Human tissue and traceability

CCMO explains that when human tissue remains traceable to a person, including through a code, information and consent are required for further use. Completely non-traceable tissue can follow a different legal route, but true anonymisation is a high threshold.

Do not call coded samples anonymous. Explain who can link the code, the conditions for sharing and whether the participant may request destruction of remaining identifiable or coded material.

Withdrawal of secondary-use consent

Explain how the participant can withdraw permission and who to contact. The Dutch IVO states that remaining bodily material should then be destroyed, while data already collected and results from analyses already performed may continue to be used.

Make these limits clear before consent. Do not promise to retrieve data or samples already irreversibly anonymised, distributed or used in completed analyses when that is not possible.

Withdrawal from optional future use does not automatically withdraw the person from the active clinical trial. Conversely, stopping trial participation should trigger the site to ask what the person wants for optional future use where the authorised documents allow separate choices.

Minors and adults lacking capacity

For a child, align the optional choices with the Dutch age and parent or guardian consent pathway. A child reaching age 12 must give their own consent to continued trial participation. Consider whether the secondary-use permission also needs to be revisited in the approved process.

For an adult lacking capacity, the representative may decide only within the authorised legal pathway and the participant's interests. If capacity returns, ask the participant to make their own future-use decision.

The Netherlands minor consent guide and Netherlands limited-capacity consent guide explain the relevant signatures.

Final checks

• Core trial use and optional future use are separated.
• Data and bodily material have different Yes or No choices.
• Refusal does not affect participation, payment or care.
• The research field and allowed users are understandable.
• Genetic, artificial-intelligence and commercial use are explicit where applicable.
• The storage period is fixed and the location is named.
• Coded material is not called anonymous.
• EU and non-EU sharing is described.
• The IVO, protocol, R1 form and biological-samples form agree.
• Withdrawal explains destruction of remaining samples and limits for prior data and results.
• Age, capacity and re-consent changes are operationally planned.

Return to the Netherlands English CTIS hub for the complete guide series.