Denmark CTIS Part II Minor Consent and Assent Requirements

Under 15 years

Mandatory. Consent is obtained from the holder or holders of parental authority. Where parental authority is joint, the Danish CTR-specific emergency guidance states that both holders give surrogate consent. VMK also publishes a CTR consent form for holders of parental authority and a parental-authority power-of-attorney form.

The child should be informed and involved as far as the child's age and maturity allow. Danish ethics guidance states that the child's own wishes must be given weight when relevant and that parental consent does not permit research to be conducted against the child's will. Opposition can be verbal or shown through behaviour or resistance.

Prepare age-appropriate written information where the child is capable of understanding it. The oral explanation should also be adapted to the child. The person conducting the participant information process in a CTR medicinal trial must still meet the Denmark-specific medical-doctor requirement for the consent process.

Do not treat a child's agreement or assent as a substitute for the legally required parental consent.

Ages 15 to 17

Mandatory. A capable participant aged 15 to 17 should receive written and oral information adapted to the young person's age and understanding.

Under the Danish medicinal-trial rule described by VMK, when a 15 to 17 year old is able to consent, the young person gives their own consent together with the consent from the parent or parents who hold parental authority. VMK publishes a dedicated CTR consent form for 15 to 17 year olds and holders of parental authority.

If a 15 to 17 year old is temporarily unable to consent, such as unconsciousness in an emergency trial, the applicable parental surrogate pathway can be used. When the young person later becomes able to receive the information and consent, their own consent must then be obtained.

For medicinal-product trials under the CTR, do not rely on exceptions described in general Danish research guidance for certain low-burden non-drug projects unless VMK has expressly confirmed that the exception applies to the CTR trial. The CTR-specific route and the trial's authorised Part II documents control the consent process.

Parent or guardian document set

The Part II package should normally include:

• parent or parental-authority Participant Information Sheet
• applicable parental-authority ICF
• age-appropriate child information for younger participants who can understand it
• dedicated 15 to 17 year Participant Information Sheet when that age group is enrolled
• dedicated 15 to 17 year consent form together with the parental consent pathway
• parental-authority power of attorney where the approved Danish route uses it
• translated versions when a child or parent does not understand Danish

The exact set should follow the protocol age bands. Avoid creating arbitrary age bands that do not correspond to how the study communicates risk and procedures.

Information content for the minor

The minor's information should explain the same study realities as the parent document, but at an age-appropriate level. Cover what will happen, what may hurt or be uncomfortable, how long visits take, whether samples are collected, what choices the child can make, and whom the child can speak to.

For older minors, explain trial treatment, randomisation, important risks, pregnancy prevention where relevant, privacy, samples and withdrawal in a way that respects the young person's increasing ability to make decisions.

The parent information should additionally make the legal consent role clear and explain how the child will be involved.

Dissent and refusal

Mandatory. conduct rule. A minor should not be forced to participate against an expressed current objection. Danish guidance gives weight to both spoken refusal and non-verbal resistance.

The protocol and Part II consent procedure should explain how the team will respond if a child or adolescent refuses a procedure or wishes to stop participation. This is especially important when the protocol contains repeated invasive procedures.

Re-consent as age or legal status changes

Mandatory. when the participant reaches legal adulthood during the trial. Once the young person becomes legally competent as an adult, obtain a new written informed consent from the participant for continued participation. The current European Commission CTR Q&A also states that consent should be obtained after the person reaches the age of legal competence and before further trial-specific actions, without causing harmful interruption of treatment or care.

Plan the timing in the protocol and consent procedure. Do not wait until trial closeout if the participant becomes an adult while trial activities continue.

Language and signatures

Danish is the normal language for Danish-speaking minors and parents. If a child, adolescent or parental representative does not understand Danish, use validated written translations and an appropriate oral language-support process.

The blank forms submitted in Part II are not signed at CTIS submission. At the actual consent event, obtain the signatures required for the applicable age and parental-authority pathway, together with the signature and date of the Danish-authorised physician who conducted the interview.

For a genuine emergency enrollment where consent is obtained after inclusion, use the Denmark emergency enrollment consent guide, because the timing and documentation differ. Return to the Denmark CTIS hub for the other Part II guides.