Latvia Secondary Use Consent Requirements

When separate or additional consent is needed

Use a separate section or document when data or samples may be used for scientific purposes outside the trial protocol. Article 28(2) of the Clinical Trials Regulation permits a sponsor to ask at the same time as trial consent for this additional scientific use, subject to data-protection law. The participant may withdraw that consent at any time.

Common triggers include:

• storage for unspecified or broadly described future research
• research in a different disease area or with different objectives
• genetic or genomic analysis outside the main protocol
• transfer to a biobank, repository, academic collaborator, or commercial researcher for future projects
• linkage with external records or datasets not required for the main trial
• future re-contact or invitation to another study

Do not label protocol-required endpoint analysis, safety reporting, monitoring, audit, or legally required record retention as optional secondary use.

Data-related information

Explain the future research purpose or permitted field, data categories, controller or responsible entity, coding, access governance, recipients, storage period or review rule, international transfers, safeguards, and whether results may be published or shared in a way that does not directly identify the participant.

Avoid saying that coded data are anonymous. If a key exists or re-identification remains possible, describe the data as coded or pseudonymised. Explain whether the participant may be re-contacted, whether individual findings may be returned, and how requests or complaints can be made.

Biological-sample information

For retained samples, describe:

• sample type, amount, and whether it is newly collected or left over from trial procedures
• responsible entity and storage location
• planned analyses, including genetic work
• storage period or governance for continued storage
• transfer to other organisations or countries
• access, coding, destruction, anonymisation, and commercial involvement
• return of clinically relevant or incidental findings, if any

Latvia recommends the EudraLex Biological Samples Compliance Template for Part II. Use it when samples are collected, stored, transferred, or kept for future use. Align it with the participant's optional choices.

Optional choice and main-trial participation

Use an unticked choice or another active decision method. State clearly that refusing future use does not prevent participation in the main trial and does not affect medical care. If several distinct activities are optional, use separate choices where a combined answer would be misleading.

For minors, obtain the legal representative's permission and involve the child according to age and maturity. From age 14, Latvia requires the minor's own written consent to trial participation alongside the representative's consent. Plan a new decision at adulthood for continued identifiable storage or future use where applicable. Use the Latvia minor consent and assent guide.

For adults unable to consent, confirm that the representative has authority for the proposed optional future use. Revisit the choice if the participant regains capacity.

Withdrawal

Explain how the participant withdraws future-use consent and what happens next. Distinguish among:

• stopping new future use
• destroying remaining identifiable or coded samples where feasible
• retaining data or results already generated
• continuing use after irreversible anonymisation
• retaining records required for legal, safety, or research-integrity purposes

Do not promise deletion or sample destruction that the sponsor cannot perform. Provide a contact route and explain the practical limit once material has been anonymised or distributed under an approved project.

Check sharing and transfers against the General Data Protection Regulation and Latvian law. Consent to optional research participation does not remove the controller's duty to identify a lawful processing basis, provide transparent information, minimise data, protect transfers, and respect applicable rights.

Review the final set with the Latvia patient-facing document QC checklist and return to the Latvia CTIS guide hub for other consent pathways.