Finland Minor Consent and Assent Requirements

This is a variation of the main consent set

Use the Finland Patient Information and Consent Requirements guide for the shared content. The minor package then adapts language, risks, procedures and signatures to the child's age, maturity and legal position.

Tukija does not prescribe fixed drafting bands such as 6 to 11 and 12 to 17. It allows case-by-case groups such as pre-school children and adolescents. Choose bands that reflect developmental understanding and the protocol, then justify them in the recruitment and consent procedure.

Finland age and consent pathways

Children and adolescents under 15

Mandatory. The guardian or other legal representative gives informed consent. If the minor can form an opinion and evaluate the trial information, Finnish law also requires the minor's written consent. The child must receive information adapted to age and mental maturity and take part in the process.

Prepare a guardian information sheet and consent form, plus one or more child or adolescent information and written-consent documents appropriate to the planned developmental groups. A very young child who cannot form an opinion may not need a signature form, but still needs respectful, age-appropriate involvement where possible.

Adolescents aged 15 to 17 in a qualifying direct-benefit trial

Conditional independent consent. An adolescent aged at least 15 may consent independently when the trial falls within Article 32(1)(g)(i), meaning there are scientific grounds to expect a direct benefit for that adolescent that outweighs the risks and burdens. The adolescent must also be capable of understanding the significance of the trial and procedure, considering age, development, illness and trial nature.

When these conditions are met, inform the guardian or legal representative of the adolescent's participation. Describe the assessment of understanding and the guardian-notification process in the submission.

Adolescents aged 15 to 17 outside that exception

Mandatory representative consent. If the direct-benefit condition is not met, or the adolescent cannot understand enough to consent independently, the guardian or legal representative consents. A capable adolescent must also provide written consent. Do not treat age 15 as an automatic age of full consent for every Finnish clinical trial.

Required document set

Prepare as applicable:

• guardian or legal-representative Participant Information Sheet
• guardian or legal-representative Informed Consent Form
• age-appropriate information sheet for each justified developmental group
• minor written-consent or assent form for minors able to form an opinion
• independent adolescent consent form for the qualifying age-15 pathway
• Finnish and/or Swedish Recruitment and Informed Consent Procedure describing every pathway
• re-consent plan for changes in age or capacity

The participant and guardian documents should explain the same trial accurately but address each reader's role. Do not give a child an adult document with simplified headings only.

Content adaptations for minors

Explain procedures, pain, fear, time, school or family disruption and the right to say no in terms the child can understand. State clearly that the child is not obliged to participate. Avoid promises that participation will make the child better.

The guardian version should explain benefit and risk criteria, alternatives, compensation limits, data, samples, insurance and the child's role in the decision. Pregnancy and contraception content should generally not appear in information for children under 12. Include age-appropriate reproductive information only for groups to whom it is relevant.

Refusal, dissent and withdrawal

The explicit wish of a minor who can form an opinion and evaluate the information to refuse or withdraw must be respected at any time. Guardian consent does not override the child's capable refusal.

Document how verbal and behavioural signs of dissent will be considered for younger children. The procedure should tell staff how to stop optional activities and escalate concerns without pressuring the child.

Signatures and re-consent

At consent, the required guardian or legal representative signs and dates the approved form. A capable minor under the representative pathway also signs the age-appropriate written-consent document. The qualified person receiving consent signs and dates the relevant form. Provide copies to the family and archive the originals.

Reassess consent when the participant's age or capacity changes. Regulation (EU) No 536/2014 requires express informed consent before a participant continues after reaching national legal competence. In Finland this normally means obtaining adult informed consent at age 18. A new consent may also be needed when a participant aged 15 becomes eligible for the independent direct-benefit pathway, but the protocol should define the transition clearly.

If material safety information changes, assess whether re-consent is needed and clearly identify the changes in the revised documents.

Use the Finland patient-facing document QC checklist before submission. The Finland CTIS hub links the related limited-capacity, emergency and witness guides.