Portugal Secondary Use Consent Requirements

When separate or additional consent is needed

Conditional. Add a separate optional consent or clearly separated optional module when data or samples may be used beyond the main trial purpose. Examples include:

• future research not defined as a trial objective
• storage in a repository or biobank
• future genetic or genomic analysis
• sharing with additional researchers or institutions
• reuse for a new disease area or product-development purpose
• retention beyond the main trial schedule
• collection of extra samples solely for future research

Do not label safety reporting, regulatory retention or analysis required by the approved trial as optional secondary use. Explain those main-trial uses in the main privacy and sample sections.

Required document set

Mandatory when applicable. Submit the EudraLex template on compliance with Member State rules for the collection, storage and future use of human biological samples. The MedEthicsEU Portugal overview identifies this template as mandatory. Complete the Portuguese national details.

Conditional. Submit a separate Portuguese future-use PIS and ICF or a clearly separated optional section in the main form. Provide independent yes and no choices for materially different activities, especially genetic testing, extra samples, commercial collaboration or recontact.

Mandatory. Keep the sponsor's GDPR compliance statement and participant privacy wording consistent with the proposed secondary data use.

Portugal has no separate mandatory national future-use ICF template. The CEIC adult consent model is optional. The EudraLex biological-sample compliance template remains the key Part II submission document.

Secondary use of personal data

Portuguese Law No 58/2019 states that consent for scientific-research data processing may cover several research areas or be limited to specific domains or projects, provided recognized ethical standards are respected. This allows a defined broad-consent approach for data, but not vague permission for any use by anyone.

Explain the research areas, data types, responsible organizations, possible recipients, safeguards, transfers, retention, recontact and whether results may be returned. Use coding or anonymization where the purpose can be achieved that way.

Consent is not the only possible data-protection legal basis for every clinical-trial activity. Keep the ethical consent to participate distinct from the controller's GDPR legal basis and transparency duties.

Secondary use of biological samples

Portuguese Law No 12/2005 requires separate informed consent for biological material used for research and expects the purpose and storage duration to be stated. A sample collected for one purpose cannot normally be used for another without new authorization, unless it has been irreversibly anonymized under the legal conditions.

For a biological-sample bank, written consent should identify:

• the bank's purposes and responsible body
• the kinds of research planned
• potential risks and benefits
• storage conditions and duration
• privacy and confidentiality measures
• whether individual or general results may be communicated

Identifiable samples should be used only when the research cannot be done with anonymous material. Describe coding, access controls and where the code key is held. Genetic research needs the additional protections in Portuguese health and genetic-information law.

Optional consent logic

State clearly that:

• the future-use decision is optional
• saying no does not affect main-trial participation or care
• the person can choose among distinct optional activities where offered
• future projects remain subject to scientific and ethics governance
• permission does not remove data-protection and confidentiality duties

Avoid one broad checkbox that combines future data use, genetic testing, sample storage, international transfer, commercial research and recontact. Split choices when a reasonable person might agree to one and refuse another.

For minors or adults represented by another person, explain what happens when the participant reaches adulthood or gains capacity. Plan re-consent when continued identifiable future use requires the participant's own decision.

Withdrawal

Explain how to withdraw optional future-use consent and whom to contact. For identifiable biological material, Portuguese law provides for withdrawal and destruction within its scope. State any practical point after which destruction is impossible, such as irreversible anonymization, exhaustion of the sample or inclusion in completed research.

Distinguish samples from data. Data already used in completed analyses, safety records or legally required clinical-trial records may need to remain. Do not promise that every copy will be deleted.

Sharing and transfer

Identify planned sharing with academic, public or commercial researchers and transfers outside Portugal or the European Economic Area. Describe coding and contractual or legal safeguards. Do not imply that coding is the same as anonymization.

Portuguese law requires a transfer of a large number of samples or a collection to another national or foreign entity to respect the bank's consented purpose and receive approval from the responsible ethics committees. Reflect this governance in the consent and sample-compliance form when relevant.

Return of results and incidental findings

Explain whether individual results, genetic findings or incidental findings may be returned, by whom and under what clinical validation and counseling process. Avoid promising useful personal results from exploratory research.

If no individual results will be returned, say so. Explain how general research results may be communicated without identifying participants.

Final review

Confirm that:

• main-trial use and optional future use are separated
• Portuguese information explains defined research areas and recipients
• biological-sample purpose and storage duration are stated
• biobank consent contains the national information elements
• genetic research and incidental findings are addressed where relevant
• each optional choice has a yes and no response
• refusal does not affect trial participation
• withdrawal wording distinguishes samples, data and completed research
• sharing and international transfers are described accurately
• the EudraLex biological-sample template matches the PIS and ICF

Use the Portugal patient-facing document QC checklist before submission. Return to the Portugal CTIS hub for the complete guide series.