Latvia Patient Information and Consent Requirements

Latvian language and document identity

Mandatory. Provide the participant-facing documents in Latvian. The wording must be understandable to the expected participant population. If a participant group cannot understand Latvian, plan a suitable additional language version and consent process rather than relying on an unapproved ad hoc translation.

Give every document a descriptive title, version, and date. Include the sponsor protocol number and EU CT number. The Latvia national overview also asks for the study-centre name and address, the data-controller identity, and contact details for ZVA, the assigned ethics committee, and the Data State Inspectorate. Use controlled fields only where the final site or committee detail is not yet known, then complete them before use.

Information the participant needs

The information should allow a reasonable person to decide whether to participate without needing the protocol. Cover the following in plain Latvian:

• the trial title, purpose, research nature, sponsor, and responsible site
• why the person is being invited and the expected number of participants where relevant
• treatment groups, randomisation, placebo, blinding, and the chance of assignment
• visits, procedures, samples, questionnaires, recordings, and total participation period
• foreseeable risks, burdens, side effects, reproductive risks, and risk-control measures
• expected benefit, including a clear statement when personal benefit is not expected
• suitable alternatives to participation and usual-care options
• pregnancy testing, contraception, breastfeeding restrictions, and reporting of pregnancy when relevant
• the purpose, destination, storage period, coding, transfer, and future use of biological samples
• collection and use of personal data, recipients, transfers, retention, safeguards, and participant rights
• compensation of expenses, payments, free trial-related medicines and procedures, insurance, and injury arrangements
• voluntary participation, withdrawal, consequences of withdrawal, and treatment after withdrawal
• new information that could affect willingness to continue
• contacts for trial questions, urgent medical issues, participant rights, privacy, ZVA, and the ethics committee

Latvian rules require the investigational medicinal products, devices needed to administer them, and other medicines, devices, and examinations specified in the protocol to be provided to the participant free of charge. State this where it helps the participant understand costs.

Consent choices and structure

Keep consent statements specific. Separate the mandatory agreement to participate from optional activities such as future research, optional biopsies, recordings, genetic analysis beyond the trial purpose, or re-contact for another study. Refusing an optional choice must not block participation in the main trial unless the protocol makes that activity scientifically necessary and the information explains this accurately.

Do not combine permission for trial participation with broad acceptance of unrelated data or sample use. The Latvia secondary-use consent requirements explain how to structure optional future-use choices.

Signatures and dates when consent is obtained

Mandatory. Before enrollment, obtain written informed consent from the competent adult participant. The participant and the person conducting the consent interview sign and date the consent record. Give the participant adequate time to consider the information and provide a copy of the signed consent documentation.

If the participant can consent but cannot write, an appropriate alternative means may be used in the presence of at least one impartial witness. The witness signs and dates the consent document. The Latvia impartial witness guide explains this narrow pathway.

When the participant cannot provide consent, use the legally valid representative pathway and still give the participant information suited to their understanding. Respect an objection to participation. The Latvia limited-capacity and legal representative guide explains Latvia's decision-maker order and capacity-change process.

Population-specific documents

Prepare a separate document or a clearly tailored version for each population and consent pathway in the protocol.

• Healthy volunteers. Explain the absence of therapeutic purpose, screening, washout, confinement, restrictions, payments, and medical-care arrangements. Use the Latvia healthy volunteer consent guide.
• Minors. Use age-appropriate information. A legal representative gives written consent, and a minor from age 14 also gives written consent. Use the Latvia minor consent and assent guide.
• Emergency enrollment. Prepare a deferred information and consent pathway only if every Article 35 condition is met. Use the Latvia emergency enrollment consent guide.
• Pregnancy follow-up. Separate the pregnant participant pathway from the pregnant-partner pathway because the partner is a separate data subject. Use the Latvia pregnancy follow-up guide.

Changes during the trial

When new information may affect willingness to continue, inform participants promptly, document the information, and obtain voluntary written consent for continued participation. Submit a substantial modification before implementing a material change to the participant information or consent process unless an urgent safety measure applies.

If a minor reaches 18 or an adult regains the capacity to consent, obtain consent directly from that participant for continued involvement as soon as legally and practically possible. A person may refuse or withdraw at any time without adverse effects on later medical care.

Use the Latvia patient-facing document QC checklist before finalising the CTIS set, and return to the Latvia CTIS guide hub for all special-population variations.