Latvia Minor Consent and Assent Requirements

Latvia age bands and documents

Children aged 0 to 13

Mandatory. Obtain written consent from the child's legal representative. Submit a Latvian legal-representative Participant Information Sheet and Informed Consent Form as a blank final document in CTIS Part II.

Conditional. Provide a separate, age-appropriate Latvian child information or assent document when the child can understand the trial. Latvia recommends obtaining the younger child's own agreement depending on maturity. The Clinical Trials Regulation requires the minor to receive information adapted to age and mental maturity from investigators or team members trained or experienced in working with children.

The child's wish must be considered. Do not use a young child's signature as a substitute for legal-representative consent.

Minors aged 14 to 17

Mandatory. Obtain the minor's own written consent and the legal representative's written consent. Prepare either coordinated documents for each signer or a combined set that gives each person suitable information and separate signature lines. Both permissions are required for enrollment in Latvia.

Information for the adolescent should be direct and understandable, not a copy of the parent document with minor wording changes. Explain confidentiality boundaries, pregnancy and contraception where relevant, data and sample use, withdrawal, and whom the adolescent can contact.

Parent and legal-representative process

Identify who qualifies as the legal representative under Latvian law and document the authority at the site. The national clinical-trial rule uses the singular legal representative and does not state that two parental signatures are always required. Do not create a universal two-parent rule without a trial-specific legal basis. Plan how the site handles shared custody, guardianship, disagreement, or unavailable documentation before recruitment begins.

The legal representative must receive the trial purpose, methods, duration, anticipated benefits and risks, participation conditions, withdrawal rights, data and sample information, compensation, insurance, and contacts. The child's welfare, expected direct benefit or the permitted group-benefit pathway, risk, burden, and scientific necessity must satisfy Article 32 of the Clinical Trials Regulation.

Assent, refusal, and dissent

The minor must be involved in the decision according to age and maturity. A capable adolescent's refusal means enrollment should not proceed. For younger children, verbal or behavioural objection must be taken seriously. Article 32 requires the investigator to respect the explicit wish of a minor who can form an opinion and assess the information to refuse participation or withdraw.

Do not confuse Latvian rules for necessary medical treatment with voluntary clinical-trial participation. A legal representative's ability to authorise treatment in the child's best interests does not remove the Clinical Trials Regulation protections for refusal and dissent in research.

Signatures and copies

At consent, the legal representative and the person conducting the interview sign and date the applicable form. From age 14, the minor also signs and dates their own consent. If a separate assent form is used for a younger child, the child may sign when appropriate, but the document should not imply legal consent.

Give the legal representative and the minor suitable copies. Record the discussion and any verbal assent or dissent according to the approved process. Blank documents submitted in CTIS are not signed.

Re-consent as age or capacity changes

Reassess the pathway when a child reaches 14 during the trial. Obtain the minor's written consent for continued participation alongside the legal representative's consent.

When the participant reaches 18, obtain adult informed consent for continued participation as soon as possible. Use the current adult information and consent version and explain ongoing follow-up, data use, samples, and optional choices. Do not assume the earlier representative permission continues as adult consent.

If new safety information could affect willingness to continue, provide an age-appropriate update and obtain the required renewed written consent. Review the completed set with the Latvia patient-facing document QC checklist, and return to the Latvia CTIS guide hub for related variations.