Finland Secondary and Future-Use Consent Requirements

This is an addition to the main consent set

Use the Finland Patient Information and Consent Requirements guide for the clinical-trial consent. Do not duplicate that document in the future-use sheet. Explain the future research, controller, samples, data and rights as a separate activity.

Article 28(2) of Regulation (EU) No 536/2014 permits a sponsor to request consent for scientific use of data outside the protocol. Tukija's dedicated template applies when the request concerns future use of biological samples and related data, including leftover samples or additional samples taken in the trial.

Required submission documents

Mandatory when future sample use is requested. Submit:

• the EU Compliance with Member State Applicable Rules for the Collection, Storage and Future Use of Human Biological Samples form, with the future-use section completed
• a separate Finnish and/or Swedish future-use Participant Information Sheet
• a matching separate Informed Consent Form
• a description of how the optional choice is offered and recorded

The biological-sample compliance form is mandatory even when no samples are collected. In that case, mark No and complete the remaining fields as not applicable according to Tukija's instruction.

For data-only reuse outside the protocol, document the separate Article 28(2) choice and the applicable GDPR basis. Tukija's sample template can inform the structure, but do not present it as a national form for a use case that involves no samples or sample-related data.

What the separate information sheet should cover

Voluntary and independent choice

State near the start that future-use consent is voluntary and refusal does not affect clinical-trial participation, treatment or healthcare. Do not combine the choice with the main trial signature or use a preselected checkbox.

Future sponsor, controller and governance

Identify the organisation responsible for future studies and the data controller. Explain how future projects are selected and ethically or scientifically reviewed. If the future sponsor is not yet known, describe the governance model and its limits accurately.

Samples, data and purposes

Describe each sample type, whether it is leftover or additional, when it is collected, the related data, foreseeable research fields and possible genetic analyses. If future purposes are not yet specific, say so and justify the scope rather than implying unrestricted use.

Explain whether only samples no longer needed for the clinical trial will be used. If extra samples are taken, describe the procedure and burden.

Storage, retention and transfers

Name the biobank, laboratory or storage location when known. State a defined retention period or explain the applicable retention logic. Describe destruction or anonymisation at the end of storage.

Explain sharing with other researchers, institutions or commercial organisations and transfers outside the EU or EEA. Identify known countries and safeguards. State whether recipients receive coded samples and data and who keeps the code key.

Benefits, risks and return of findings

State that the donor normally receives no direct benefit. Explain privacy, genetic and informational risks and any physical burden from extra sampling. State whether individual or incidental findings may be returned, how they will be validated and whether the participant can choose not to receive them.

Data protection and contacts

Provide the controller, purpose, legal basis, recipients, retention, rights, complaint route and data-protection officer. Give a practical contact for questions and withdrawal. Future use must be described from its own data-protection perspective, not by referring broadly to the clinical-trial notice.

Consent, withdrawal and signatures

The participant and the person receiving future-use consent sign and date the separate approved form. The original is archived by the identified party and a copy is given to the participant. The blank submission copy remains unsigned.

Participants may withdraw future-use consent without reason or detriment. After withdrawal, samples and data should not be used in new research. Tukija's template explains that studies already begun may be completed and temporary retention may continue where needed to ensure reliability. State these limits clearly.

Withdrawal from future use is not the same as withdrawal from the clinical trial. Provide separate contact routes and records so the site does not stop the wrong activity.

For minors or adults with reduced capacity, apply the appropriate representative and re-consent rules to the optional future-use decision. Do not assume that consent to the main trial automatically supplies authority for future research.

Run the package through the Finland patient-facing document QC checklist. The Finland CTIS hub links the main consent and population-specific guides.