Sweden Minor Consent and Assent CTIS

Swedish age and consent pathways

Minors under 15

Mandatory. The legally designated representative gives informed consent. In Sweden, the guardians are the legally designated representatives for a minor.

The child must receive information adapted to age and mental maturity from an investigator or trial-team member trained or experienced in working with children. A child who can form an opinion and assess the information has the right to refuse or withdraw, and that explicit wish must be respected.

Swedish law does not create one fixed national set of child-information age bands below 15 in the official sources reviewed. Build age-appropriate versions based on the protocol population and the child's expected ability to understand.

Minors aged 15 to 17 who understand the trial

Mandatory. Guardian consent is required and the minor must also provide their own informed consent.

The adolescent's information should be written to support a genuine informed decision, not only an assent acknowledgement. The consent form should make the two legal roles clear.

Minors aged 15 to 17 who do not understand what participation means

Guardian consent remains the legal basis described in Swedish law. The minor should still be informed and involved according to their ability, and any explicit refusal by a minor capable of forming an opinion must be respected.

Guardian signatures

Läkemedelsverket states that where a minor has two guardians, both guardians should sign and date the consent before any study-related procedure. The signatures do not have to be provided at the same time.

In an urgent situation, the authority guidance allows the absent guardian's consent to be transmitted digitally, for example by email, with subsequent confirmation of the original consent. This should not be confused with Article 35 emergency enrollment before prior consent, which has its own conditions.

At CTIS submission, upload the blank Swedish guardian and minor documents. Do not collect trial-specific signatures before the participant is actually approached through the approved process.

Re-consent when age changes

If a participant turns 15 during the trial and now falls within the Swedish own-consent rule, Läkemedelsverket states that the participant's explicit informed consent must be obtained before continued participation.

If a participant has already provided valid own informed consent after age 15, Läkemedelsverket states that a new consent is not required solely because the participant later turns 18 during the same trial.

A protocol amendment, new risk information or other change may still create a separate re-consent need.

Child information and dissent

The written and oral information should be adapted to age and maturity. The child should understand, as far as possible:

why the trial is being done
what will happen to them
foreseeable discomforts and risks
whether there may be benefit
that participation is voluntary
that they can say no or ask to stop

Do not make the child's assent document contradict the guardian consent form. Both should describe the same trial activities and withdrawal rights.

Required document set

For a typical paediatric submission, prepare:

Swedish guardian Participant Information Sheet and Informed Consent Form
Swedish age-appropriate child information for younger participants
Swedish adolescent information and own informed-consent form for the 15 to 17 group when they can understand the trial
the Swedish recruitment and consent procedure explaining how guardians and minors are approached
any sample-specific or optional future-use documents that apply

No single statutory Swedish paediatric template was identified in the official sources reviewed. The content and signatures must follow the CTR and Swedish law.

Return to the Sweden CTIS Part II hub and use the patient-facing QC checklist to verify every planned age group.