Netherlands CTIS Minor Consent and Assent Requirements

When minors may be included

Dutch law applies a protective "no, unless" approach. Research with people under 16 is permitted when it may directly benefit the child, or when non-therapeutic research can be conducted only with that group and the risks and burden are minimal compared with the standard treatment or the nature and severity of the condition.

These eligibility conditions belong in the protocol and assessment justification. The participant documents should explain what the child will experience without asking the family to evaluate the legal test.

Dutch age bands and documents

Children under 12

Mandatory. Both parents who have parental authority sign the parent or guardian consent form. If there is a guardian, the guardian signs in place of the parents according to the legal arrangement.

Give the child information suited to age and understanding. CCMO provides a simplified Dutch discussion-sheet model for children under 12. It supports the conversation but is not a substitute for the parent or guardian consent form.

The child should be involved as far as possible. A child who resists must not be forced to continue merely because the adults signed.

Children aged 12 through 15

Mandatory. The child signs their own Dutch information and consent form. Both parents with parental authority, or the guardian, also sign the parent or guardian form.

CCMO provides a Dutch information-sheet model for children aged 12 to 16 and a manual for the minor templates. Use age-appropriate explanations of procedures, risks, randomisation, pregnancy prevention, privacy and withdrawal.

Participants aged 16 or older

A capable participant aged 16 or older signs for themselves. Use the adult Dutch IVO pathway. Parent signatures are no longer required solely because the person is under 18.

If a participant aged 16 or older lacks decision-making capacity, apply the legal-representative pathway rather than the minor pathway. See the Netherlands limited-capacity and legal representative consent guide.

Parent and guardian information

The parent or guardian document should explain the same trial facts as the child's document, with enough detail for the adult to make the legal decision. It should cover the purpose, procedures, burden, risks, alternatives, data, samples, insurance, compensation, withdrawal and contacts.

Identify which adults have parental authority before consent. Do not assume that a parent attending the visit can sign for the other parent. The site process should address separated parents, remote signatures and a sole guardian before recruitment begins.

The official IVO includes a parent or guardian consent model with signature lines for both parents or guardians and the researcher or authorised representative.

Consent, assent and resistance

For Dutch children under 12, the child's agreement is ethically important even though the legal signatures come from the parents or guardian. From age 12, the child's written consent is legally required.

Mandatory. The parent consent declaration must state that if the minor resists participation, consent for continued participation no longer applies. Resistance can be expressed in words or behaviour. The protocol should explain how investigators recognise, document and respond to it.

Do not describe silence or lack of protest as assent. Give the child a genuine chance to ask questions and decline.

Re-consent as the child gets older

Reaching age 12

Mandatory. A child enrolled before age 12 must give explicit consent before continuing after turning 12. The parents or guardian have already consented, so add the child's age-appropriate information, discussion and signature.

Plan the timing in the protocol and documents. Obtain the child's consent before further trial procedures once the age threshold is reached.

Reaching age 16

CCMO states that no new consent action is needed solely because the participant turns 16 during the trial, because a participant enrolled between 12 and 15 has already signed their own consent. New consent may still be needed for another reason, such as important new trial information.

Main document differences

Use different reading levels and levels of detail rather than shrinking the adult form. The child document should explain:

• why the child is being asked
• what will happen at each visit
• what may hurt, feel uncomfortable or be frightening
• whether treatment may help
• other treatment choices where relevant
• that the child can ask questions and say no
• how privacy is protected
• what happens to blood, tissue or other samples
• who to contact

The parent document should add the legal and practical details needed to decide and support the child. Avoid giving optional future-use choices only to the parent when an older child's own decision is also required by the authorised consent pathway.

Pregnancy and sensitive topics

Conditional. For adolescents, explain pregnancy testing, contraception, sexual-health questions and reproductive risks in age-appropriate language. Plan confidential discussion within Dutch law and site policy while keeping the parent-consent process accurate.

If pregnancy follow-up would collect data directly from a pregnant adolescent or another pregnant person, prepare the appropriate consent and privacy pathway. See the Netherlands pregnancy follow-up guide.

Optional data and sample use

Keep optional future research separate from consent to join the trial. Use distinct choices for the child's data and bodily material. Explain that refusal does not affect participation or care.

Consider who should decide at enrolment, how the child's view is recorded, and whether new consent is needed when age or capacity changes. The Netherlands secondary-use consent guide explains the Dutch optional structure.

Signatures at consent

For a child under 12, both parents with parental authority, or the guardian, sign and date. The researcher or authorised interviewer also signs and dates. The child discussion sheet can document the conversation but does not replace the legal signatures.

For a child aged 12 through 15, the child signs and dates their own form. Both parents with parental authority, or the guardian, sign and date the adult form. The researcher or authorised interviewer signs and dates the process.

Give the family the information sheets and signed copies. Record any remote or staged signing method in a way that proves all required consent was in place before trial procedures.

Final checks

• Every minor population has a Dutch age-appropriate document.
• The under-12 discussion sheet and 12-to-15 information sheet use the official Dutch models where applicable.
• Both parents with parental authority, or the guardian, are correctly identified.
• The 12-to-15 child signature is not omitted.
• Resistance language appears in the parent consent declaration.
• The protocol explains how resistance is recognised and handled.
• Re-consent at age 12 is scheduled operationally.
• Turning 16 is handled according to the current CCMO position.
• Optional future use does not affect trial participation.
• Risks, procedures and pregnancy language fit the child's age.

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