Lithuania CTIS Patient Information and Consent Requirements

What the standard Lithuania consent package needs to do

Mandatory. The participant must receive information before deciding whether to join the trial, and consent must be voluntary, informed, documented and obtained before trial-specific participation unless a lawful special pathway applies.

The document should make clear that this is research. It should not imply that the investigational treatment is proven to help the participant.

The core content normally includes:

• who is sponsoring and conducting the trial
• why the trial is being done
• why the person is being invited
• trial design, including randomisation or placebo where applicable
• what procedures, visits, tests and treatments are involved
• expected duration and follow-up
• foreseeable risks, burdens and inconveniences
• possible benefits without overstating benefit
• available treatment alternatives where relevant
• pregnancy, contraception and reproductive precautions where relevant
• use of biological samples
• confidentiality and personal data processing
• reimbursement, compensation and insurance
• the right to refuse or withdraw
• what happens to already collected data after withdrawal
• whom to contact about the trial, participant rights and research-related injury

The document should be built from the actual protocol and submitted Part II information. Generic consent language is not enough if it does not match what will happen at Lithuanian sites.

Lithuanian language requirements

Mandatory. The Lithuanian Bioethics Committee states that Part II documents covered by its national recommendations must be submitted in Lithuanian. Participant information and consent intended for Lithuania should therefore be prepared in Lithuanian for CTIS Part II.

The translation should preserve the meaning of the approved master content rather than follow the source text word for word. Medical terminology should be understandable to the target participant population.

If the trial plans to consent a person who does not understand Lithuanian, the sponsor should define the language and consent pathway in advance and ensure the participant receives information in a language they understand. The national recruitment and consent procedure should explain how such cases will be handled.

Readability and document design

Mandatory. Lithuanian national recommendations say the information and consent form should be written in an understandable way and avoid specialist terminology where possible.

Use short sections, plain explanations and consistent terminology. Separate what is required for the main trial from optional choices. A participant should be able to tell which procedures are research-specific, what is optional and what happens if they say no.

The Lithuania patient-facing document QC checklist provides a final protocol-to-ICF and readability check.

Consent and signature logic

Under Article 29 of the Clinical Trials Regulation, informed consent is signed and dated by the person conducting the consent interview and by the participant or legally designated representative. If the participant cannot write, an appropriate alternative method can be used in the presence of at least one impartial witness.

Lithuanian ICF guidance provides fields for the participant or consent-giver, the investigator or authorised research person, signatures, date and time. Where another person gives consent, the basis on which that person is entitled to represent the participant should be documented.

At CTIS submission. Submit the blank approved version with its signature blocks. The participant and interviewer do not sign it for the initial application.

When consent is obtained. The applicable parties sign and date the consent record. The participant or representative should receive a copy. The Lithuanian recommendations also expect the copy to be signed by the investigator or authorised research person.

Lithuanian Bioethics Committee FAQ guidance confirms that electronic consent can be possible, but the legal validity of the electronic signature method must be established. A simple electronic signature is not automatically equivalent to a handwritten signature. The FAQ explains the conditions for prior agreement and durable-medium storage, and separate requirements apply to tablet signatures.

Privacy and personal data

The ICF should explain the data processing in practical participant language. Lithuanian national guidance calls for information on confidentiality, the data controller where relevant, data sources and categories, who may access identifiable or coded data, recipients, storage and the participant's rights.

This participant-facing explanation is separate from the sponsor's mandatory Part II GDPR compliance statement.

Avoid using consent to the clinical trial as a catch-all permission for every future data use. The legal basis for clinical-trial data processing and the ethical informed-consent process are related but not identical.

Biological samples

If biological samples are collected, explain why they are collected, what analyses will be performed for the main trial, where they will be sent or stored and how long they will be retained when this information is relevant to the participant.

Conditional. If samples or coded data may be used for future research beyond the main trial, keep that choice separate and optional. The Lithuanian Bioethics Committee recommends either a separate future-use ICF or a distinct opt-in choice. The Lithuania secondary-use consent guide covers this in detail.

Reimbursement, compensation and insurance

Explain any reimbursement of travel or other participation costs and any compensation for time. The Lithuanian Bioethics Committee recommends stating an approximate hourly amount in the ICF when participants are compensated for time spent in the research.

When the protocol requires contraception specifically because of trial participation, current Lithuanian FAQ guidance states that the associated costs should be compensated.

The participant information should also explain the applicable insurance or indemnification arrangements and how a participant can seek compensation for trial-related harm.

Free investigational treatment and trial health checks

Recommended. The Lithuanian Bioethics Committee recommends that participant-facing information state that the investigational medicinal product and trial health checks are provided free of charge where that is the case. This can prevent participants from confusing research procedures with ordinary paid healthcare.

Population-specific consent variations

The standard adult ICF is only the default. Use a separate or adapted document set when the protocol includes a population with different consent logic.

• For children and adolescents, use the Lithuania minor consent and assent guide.
• For adults who cannot reasonably assess their interests, use the Lithuania limited-capacity and legal representative guide.
• For emergency enrollment, use the Lithuania emergency enrollment guide.
• Where the participant cannot write, use the Lithuania impartial witness guide.
• For protocol-required pregnancy follow-up, use the Lithuania pregnancy follow-up guide.
• For healthy volunteers, use the Lithuania healthy volunteer consent guide.