France CTIS Part II Secondary-Use Consent Requirements

Separate protocol use from secondary use

First map every data and sample activity to the approved trial protocol. Analyses needed to answer the protocol's objectives and meet safety or legal duties belong in the main trial information. Do not describe required trial activity as optional future research.

Article 28(2) of the Clinical Trials Regulation allows the sponsor to ask for consent to use trial data for scientific purposes outside the protocol. That consent is optional and may be withdrawn at any time. It does not remove GDPR, CNIL or French sample-law requirements.

Use a separate section or document that makes the optional nature visible. A separate document is preferable where the future purpose, retention, recipients, sample governance or withdrawal route needs substantial explanation. Refusal must not prevent main trial participation unless the activity is in fact a required protocol component and has been presented that way.

Data-related use cases

Secondary data use may include research beyond the protocol question, linkage to another dataset, development of a research resource, method development or sharing with additional researchers. Define the scientific field or purpose, data categories, degree of coding, access rules, recipients, retention and expected transfers.

Do not use phrases such as any future research without enough context for an informed choice. If the future projects cannot yet be named, state the meaningful boundaries, governance, review and prohibited uses.

Determine the GDPR legal basis independently from trial consent. Explain the controller's legal basis and participant rights accurately. Optional consent under the Clinical Trials Regulation does not automatically become the GDPR legal basis for every future processing operation.

Biological-sample use cases

Identify each sample type, remaining quantity, storage location, custodian, coded status, retention, access, sharing, destination and end-of-storage action. Explain whether samples may be used up, destroyed, returned or retained after withdrawal under a lawful completed-use rule.

Submit the EU biological-sample compliance template in French and keep it consistent with the consent options. Comply with Articles L1243-3 and L1243-4 of the French Public Health Code for collection and changed u se.

The France national Part II guidance states that a new consent is obtained before using samples for a changed purpose. Treat a material new purpose as a new-consent trigger rather than relying on a broad old statement. Complete any required collection declaration or authorization process before the new use begins.

Genetic examinations

French Civil Code Article 16-10 requires express written prior consent after the person has been informed of the nature and purpose of a genetic examination. The national Part II guidance expects a separate genetic testing information and consent document.

Do not rely only on the main trial signature or a general future-sample checkbox for genetic analysis. Where future genetics is proposed, explain the nature and purpose at the level currently known, results-return policy, familial implications, storage, sharing and withdrawal. Re-consent may be needed when a later genetic purpose falls outside the original explanation.

Required document set

Optional. A separate French secondary-data-use information and consent form where the sponsor asks for scientific use outside the protocol under Article 28(2).

Conditional. A French future-sample information and consent form where storage or use is not required by the main protocol or where the secondary purpose needs a distinct choice.

Conditional. A separate French genetic-testing information and express written consent form whenever a genetic examination is planned.

Mandatory. The French EU biological-sample compliance template in Part II section R.

Mandatory. Participant privacy information that accurately describes the main and secondary processing, recipients, transfers, retention and rights under the applicable MR-001 or CNIL authorization route.

Conditional. Updated information and new consent before a changed sample purpose or materially different secondary use begins.

Consent design and signatures

Give each optional activity a clear yes and no choice. Separate data reuse, remaining-sample storage, future sample research, genetic analysis, commercial collaborator access and result recontact when they create meaningfully different decisions.

State which choices may be changed and how. Avoid a single broad signature that makes unrelated permissions inseparable. The participant and the person conducting the consent interview sign and date a consent document that records a decision under Article 29. A separate optional-choice page should identify the main information version and be copied to the participant.

For minors and adults under protection, confirm who can authorize the optional use and how the participant is involved. Re-consent the participant at adulthood or restored capacity where required. Do not assume that authorization for main trial participation covers optional future research.

Withdrawal and objection

Explain how the participant can withdraw optional consent or object to future processing. State which new uses, transfers or analyses will stop. Distinguish remaining identifiable samples from samples already used, data already generated and datasets that have been irreversibly anonymised.

Do not promise that every prior research result will be erased. Explain the lawful status of completed analyses and records needed for integrity or legal duties. If withdrawal options differ for data, samples and genetic results, describe each route separately.

Sharing and international transfers

Name or describe recipient categories and the purposes for which they receive data or samples. Explain access controls and coding. Where a repository or research network is known, identify it in participant language.

For data transfers, list the destination countries, recipients or recipient categories, purpose and adequacy status expected by the France national guidance. If future destinations are not yet known, the later project may require updated information or consent before transfer. Do not use a blanket worldwide-transfer clause as a substitute for the France assessment.

For sample transfers, identify physical destinations and governance where known. Confirm that sample movement and data transfer use consistent identifiers and that the receiving organisation cannot exceed the permitted purpose.

National template position

France has no mandatory national secondary-use consent template. The sponsor creates French documents consistent with Article 28(2) of the Clinical Trials Regulation, the Public Health Code, Civil Code Article 16-10, GDPR, MR-001 and the national Part II guidance.

Check the optional-use set with the France patient-facing document QC checklist. Return to the France CTIS hub for the complete guide collection.