Lithuania CTIS Minor Consent and Assent Requirements

Lithuania age bands for information and assent

Lithuanian national Part II recommendations distinguish two practical age groups.

Children under 12

Mandatory. The recruitment and consent procedure should explain how the child will be informed orally in a way appropriate to age and maturity.

The national recommendation asks the sponsor to state whether written information will also be provided. It also expects the information process and the child's opinion to be documented in the trial records.

A separate written child information sheet can still be useful for younger children when developmentally appropriate, but the national guidance does not make one universal written format mandatory for every child under 12.

Children aged 12 and above

Mandatory. The child should receive information orally and in writing.

Conditional. If the child is capable of understanding the information, the child should sign an assent form. The assent document should use language suitable for the child's age and maturity rather than reproduce the adult ICF.

Parent and legal-representative consent

Lithuanian Bioethics Committee FAQ guidance states that consent from both parents is normally required for a child's participation in biomedical research.

There are defined exceptions.

Consent from both parents may not be obtainable when one parent is deceased, incapacitated, declared dead or missing by a court, or has restricted parental rights.

One parent may act on behalf of the other when a notarised power of attorney authorises this representation for health-related decisions.

A court may also grant one parent the exclusive right to make the relevant health or representation decisions.

The site should document why only one parent is signing whenever the usual two-parent pathway is not followed. Do not treat physical absence or inconvenience alone as enough to remove the second-parent requirement.

What documents to prepare

The exact set depends on the protocol population.

For younger children

Prepare:

• parent or legal-representative information and consent form
• age-appropriate oral information plan
• written child information when appropriate to the population
• trial-record method for documenting information and the child's view
• recruitment and consent procedure describing the pathway

For adolescents aged 12 and above

Prepare:

• parent or legal-representative information and consent form
• written adolescent information and assent form
• oral information process
• signature blocks for the adolescent where capable of understanding
• recruitment and consent procedure describing assent and parent consent

All submitted Part II documents should follow Lithuania's Lithuanian-language requirement.

Consent and assent are different

Parental consent is the legal authorisation for the minor's participation. Assent records the child's affirmative agreement when the child is capable of understanding.

Do not phrase assent as if the child has the same legal role as an adult participant. At the same time, do not treat the child's opinion as symbolic.

The Clinical Trials Regulation requires minors to be involved in the consent process according to age and mental maturity. Lithuanian guidance adds concrete age-based expectations for the information process.

Refusal and dissent

A child capable of understanding the information has the right to express a wish not to participate or to withdraw.

Lithuanian Bioethics Committee guidance states that the child's wish should be respected even when the parents consent, except where non-participation or withdrawal would be contrary to the child's interests. In that exceptional situation, the representatives decide while taking the investigator's opinion into account.

The participant documents and site process should therefore explain how dissent is recognised, documented and escalated.

Re-consent when the child becomes an adult

Mandatory. If a participant reaches the age of legal competence during the clinical trial, the Clinical Trials Regulation requires the participant's own express informed consent before continued participation.

Lithuania's national Part II consent-procedure recommendations also ask sponsors to describe this transition.

Plan the adult re-consent document before it becomes operationally urgent. The adult version should be the current approved ICF, not the historic version used when the participant first entered as a minor.

Signature logic

At CTIS submission, the parent consent and assent forms are submitted blank.

When consent is obtained:

• the required parent or legally entitled representative signs the parent consent
• the second parent signs where the normal two-parent pathway applies
• the child aged 12 or above signs assent when capable of understanding
• the person conducting the consent interview signs and dates the relevant consent record
• the basis for any exception to the normal representative pathway is documented

If a participant or representative cannot write, use the Lithuania impartial witness consent guide.

Final minor-document QC

Before submission, confirm:

• the protocol age range matches the prepared documents
• under-12 and 12-plus information pathways are addressed
• both-parent consent is the default unless a documented exception applies
• the assent form uses developmentally appropriate language
• refusal and withdrawal are addressed
• the adulthood re-consent plan is described
• every version is in Lithuanian
• signature blocks match the actual legal pathway

Use the Lithuania patient-facing QC checklist for the full final review.