Estonia CTIS Minor Consent and Assent Requirements

Start from the main Estonia consent requirements

Minor materials are a variation of the standard PIS/ICF. Use the Estonia Patient Information and Consent Requirements guide for the common language, privacy, compensation and signature rules.

Mandatory. Participant-facing materials used in Estonia must be in Estonian and include the EU CT number.

The information for the minor should be adapted to age and mental maturity rather than copied from the adult form.

Estonia age and consent logic

Children below 7

The Clinical Trials Regulation requires informed consent from the legally designated representative and age-appropriate involvement of the minor.

Estonia's Medicinal Products Act does not state the same additional co-consent rule for children below 7 that it expressly states for ages 7 to 17. The child's ability to understand and express a view should still be respected under the EU rules.

A young-child information sheet may be appropriate when the child can understand simple information. The legal representative provides the formal consent.

Ages 7 to 17

Mandatory. Estonia specifically requires consent from the 7 to 17-year-old participant as well as the legal representative.

The document set should therefore support both decisions. Depending on the trial and age range, this may be achieved with separate child or adolescent information and consent or assent documents plus a parent or guardian consent form, or with a coordinated form that makes each person's decision and signature clear.

The participant's information must be understandable for the relevant age and maturity.

Approaching adulthood

If a participant reaches legal adulthood during the trial and ongoing participation still requires informed consent, plan re-consent using the adult Estonia PIS/ICF as appropriate.

The protocol and consent plan should define when the updated information is provided and how the new consent is documented.

Parent or legal-representative information

The representative should receive the full information needed to make the legal consent decision, including:

• study purpose and design
• why minors are needed
• treatment and procedures
• risks, burdens and potential benefits
• alternatives
• data and sample handling
• reimbursement
• insurance
• withdrawal
• child or adolescent refusal
• future research choices

The representative's consent does not remove the requirement to involve the minor.

Refusal and dissent

Mandatory. Under the Clinical Trials Regulation, an explicit wish of a minor who is capable of forming an opinion and assessing the information to refuse participation or withdraw must be respected.

For Estonia's 7 to 17 group, the national co-consent rule makes this especially clear in document design. Do not create a form where only the parent makes the decision and the adolescent merely acknowledges receiving information.

Signatures

At the actual consent event, ensure the form supports the legally designated representative's signature, the required minor signature for ages 7 to 17, and the signature of the person conducting the consent interview.

The exact number of representative signatures depends on who is legally authorised to represent the minor in the specific situation. Do not assume a two-parent signature rule without a verified legal basis for the case.

Estonia permits legally valid digital signatures. If remote consent is used, the national remote-consent process must be justified and ethics-approved.

Reimbursement and compensation

Estonia's ethics guidance states that minors and their representatives may not be paid compensation for participating in the trial other than reimbursement of direct costs.

The ICF should therefore explain justified reimbursement without presenting payment as an inducement to the child or family.

Data and biological samples

Explain data and sample use in age-appropriate language for the minor and in full detail for the legal representative.

Optional future research should be separated from the main trial decision. Do not allow refusal of optional future use to invalidate otherwise valid participation in the main trial unless that use is genuinely part of the core protocol.

See the Estonia secondary use guide for optional data and sample use.

QC before submission

Confirm that:

• every age band in the protocol has a matching information document
• ages 7 to 17 have a consent pathway for both minor and legal representative
• child language is developmentally appropriate
• dissent and withdrawal are explained
• signatures match the legal pathway
• reimbursement does not include prohibited participation compensation
• EU CT number appears on all participant materials
• Estonian versions are complete

Use the Estonia patient-facing document QC checklist for the final review.

Return to the Estonia CTIS hub for all Estonia guides.