Norway CTIS Minor Consent and Assent Requirements

Norway age bands and required documents

Children under 12

Mandatory. Prepare a Norwegian guardian information and consent form and an age-appropriate Norwegian information leaflet for the child. REK KULMU publishes a specific under-12 information template. If the age range is broad, more than one child version may be needed so that language and illustrations match development and understanding.

The child may sign the information form as an expression of willingness to participate. This is assent, not the legal consent replacing guardian authorization.

Children and adolescents aged 12 to 15

Mandatory. Prepare the guardian information and consent form and a Norwegian participant information form suited to ages 12 to 15. REK KULMU publishes a dedicated template. Seek and document the young person's assent in a manner suited to maturity.

Adolescents aged 16 and 17

Mandatory. Give the adolescent the same level of information provided to an adult participant. The 16- or 17-year-old must consent to trial participation in addition to the guardian or guardians, as applicable.

If a participant was enrolled before age 16, obtain the participant's own informed consent when they turn 16 before continued participation under the Norwegian pathway.

Guardian consent and child involvement

CTR Article 32 requires informed consent from the legally designated representative and age-appropriate information for the minor. Norway describes this as consent from the guardian or guardians, as applicable. Confirm the authorized guardian for the individual case rather than assuming that any accompanying adult may sign.

The investigator must respect an explicit wish to refuse or withdraw from a child who can form an opinion and assess the information. A guardian signature does not permit the team to override the child's dissent.

No incentives or financial inducements may be given to minors or guardians beyond compensation for expenses and loss of earnings directly related to participation. Explain reimbursement without using it to influence the decision.

Content differences from the adult form

Use concrete language to explain what will happen, including procedures, discomfort, pain, time, hospital stays, blood samples and the right to stop. Avoid adult privacy or biological-sample language that a child cannot understand. The guardian version can carry the full legal and data-protection detail.

Explain who may access information, which discussions may be private, and when safety information must be shared with guardians. Match pregnancy testing and contraception information to age, maturity and the protocol.

Broad consent and future research

Norway treats broad consent separately from trial participation. From age 16, a minor may consent to future research without guardian consent where the future-research participation does not involve bodily intervention. REK KULMU states that minors should not generally be included in future research and will assess the proposal case by case.

Do not make future-use consent a condition of joining the clinical trial. Use the Norway secondary-use consent guide for the separate document set.

Submission and signatures

Submit all required Norwegian guardian and minor versions as blank Part II documents. At enrollment, the authorized guardian or guardians sign and date the consent form as applicable. The adolescent also signs where Norway requires their consent. The person conducting the consent interview signs and dates the record. Give the family copies of the completed documents.

Use the Norway patient-facing QC checklist to confirm every age group in the protocol has a suitable form. The Norway CTIS hub contains the complete guide series.