Belgium Secondary and Future Use Consent Requirements

Separate main-trial use from future use

Data and samples required to answer the approved protocol belong to the main trial information and consent. Research outside the protocol needs a separate, clear and optional decision under Article 28(2) of Regulation (EU) No 536/2014 and applicable data-protection and national law.

Do not describe all research by the sponsor or its partners as one unlimited purpose. Explain the research fields, sample types, data categories, storage period or criteria, recipients, locations and governance with enough detail for a meaningful choice.

Refusal of optional future use should not prevent participation in the main trial unless the additional use is scientifically integral to the protocol and assessed as such. Use separate tick boxes and signature logic where needed.

Mandatory Belgian biological-sample form

Conditional. Submit the EU biological-sample compliance template under Part II section S whenever the trial collects, stores or proposes future use of human biological material. For the applications covered by Belgium's post-1 January 2025 rule, use of that template is mandatory.

Insert the prescribed Belgian text in section 5.1 and select one of two positions:

• all use described in the protocol is limited to research involving the same disease, treatment or drug
• the protocol includes research beyond that scope, in which case the relevant material falls under Belgian biobank legislation and will be registered in a Belgian biobank

Belgium's clinical-trial exemption is therefore not a blanket exemption for every future project. Breast cancer research does not automatically permit research on all cancers. Minor modifications to the same drug may remain within the same-drug concept, but the dossier should justify the classification.

Data-related future use

Explain whether future data remain coded, may be linked with other datasets, may leave the European Economic Area or may be shared with academic or commercial researchers. Identify governance and access conditions rather than promising absolute anonymity.

Consent to participate in the main trial and the legal basis for data processing are different concepts. Explain the applicable GDPR basis and the limits on withdrawal caused by research integrity, legal retention and safety reporting. Article 28(2) allows the participant to withdraw consent for use outside the protocol, but withdrawal does not invalidate activities already lawfully carried out.

Sample-related future use

Describe collection, remaining material, storage location, duration, types of analysis, genetic testing, sharing, return of results, incidental findings, destruction and withdrawal. Match the ICF, protocol, laboratory manual and mandatory EU form.

If future use exceeds the same disease, treatment or drug, confirm the receiving Belgian biobank and its governance. Do not state that clinical-trial status alone keeps the material outside biobank law.

Anonymisation and lifting traceability

BAREC and the CT-College distinguish coded samples from samples whose traceability is permanently lifted. Anonymisation means the donor can no longer be identified or linked to the material. It also removes important donor rights, including control over destination and receipt of meaningful findings.

Mandatory when proposed. Obtain explicit consent before lifting traceability of samples from a living donor. Explain the legal consequences and maintain a system that records the choice. If the participant refuses anonymisation, procedures must ensure that the samples are not anonymised.

Do not promise later withdrawal or return of individual results after irreversible anonymisation. Explain that loss of traceability makes those actions impossible.

Participant choices and withdrawal

Use choices that reflect the actual research plan. Examples include storage for the same disease, broader health research, genetic research, commercial collaboration, international sharing and irreversible anonymisation. Avoid so many overlapping options that the site cannot operationalise them.

Explain how to withdraw permission, who to contact and what happens next. Where material remains identifiable or coded, stop new optional use and destroy or block remaining samples when required by the consent and law. Research already completed and data already included in analyses may remain usable. Irreversibly anonymised material cannot be retrieved.

Special populations

For minors, the parent or guardian gives the legally required permission and the capable minor receives age-appropriate information and provides assent. Review the choice as the child matures and obtain personal consent at adulthood for continued optional use where required.

For an adult lacking capacity, confirm that the representative has authority and that the proposed future use satisfies the applicable safeguards. Optional broad use should not be assumed merely because the representative consented to the main trial.

Final secondary-use checks

• Use the current mandatory EU biological-sample template and Belgian section 5.1 text.
• Classify every use as within or beyond the same disease, treatment or drug.
• Identify the Belgian biobank when use falls outside the exemption.
• Separate main-trial participation from optional future use.
• Describe coding, sharing, transfers, storage and withdrawal accurately.
• Obtain explicit consent for irreversible anonymisation and operationalise refusals.
• Align parent, representative and adult re-consent pathways with the population.

Use the Belgium patient-facing QC checklist for the final reconciliation. Return to the Belgium CTIS hub for all related guides.