Bulgaria CTIS Part II Secondary Use Consent Requirements

When secondary-use consent is needed

Conditional. Add a separate optional consent choice when the sponsor wants to use identifiable or coded trial data outside the main protocol for future scientific research and relies on the participant's additional consent under Article 28(2) of the Clinical Trials Regulation.

Conditional. Add appropriate optional consent when biological samples will be stored or used for future research beyond the main protocol and the planned use requires participant authorisation under the applicable ethical, legal and data-protection framework.

Do not label protocol-required analysis as optional secondary use merely because the analysis occurs later. The distinction is whether the use is part of the authorised clinical-trial protocol or an additional future research use.

Data-related future use

The optional data-use section should explain, at a level the participant can understand:

• that the future scientific use is outside the main trial protocol
• the broad research purpose or scope that can be supported accurately
• what categories of trial data may be used
• whether data are coded, pseudonymised or anonymised before future use
• who may receive or access the data where this can be stated
• relevant transfer arrangements
• how long data may be retained when a defined period applies
• that the future-use choice is optional
• how the participant can withdraw the additional consent
• limits on withdrawal where data have already been anonymised or used, if applicable to the actual data flow

Do not promise that every copy of data can always be deleted after withdrawal. The wording should reflect the sponsor's actual data architecture and applicable law.

Biological-sample future use

Conditional. If human biological samples are collected, stored or intended for future use, the Bulgaria Part II dossier must include the EudraLex declaration on compliance with applicable rules for collection, storage and future use of human biological samples under Article 7(1)(h) of Regulation (EU) No 536/2014. The BDA accepts this declaration in Bulgarian and/or English.

The participant-facing consent should separately describe the actual sample plan. Where relevant, explain:

• sample type and collection
• main-trial use
• storage location and duration
• future research scope
• possible genetic or biomarker analysis
• transfer to laboratories or research partners
• coding or anonymisation
• whether samples may be shared
• what happens to remaining samples after withdrawal or study end

The regulatory declaration does not replace participant information or consent.

Keep the choice separate from main-study participation

Mandatory when the future use is optional. The participant must be able to refuse the future-use choice without that refusal being treated as refusal of the main clinical trial.

Use a separate signature or tick-box choice, or a clearly separated optional consent section, so the decision can be documented independently. Avoid a single signature that makes optional future research inseparable from the core trial consent.

For minors or adults who cannot legally consent, apply the relevant national representative and participant-involvement rules to the optional future-use decision. The Bulgaria minor consent guide and Bulgaria legal-representative guide explain those pathways.

Bulgarian language requirements

Mandatory for participant-facing consent. The Bulgaria PIS and ICF are submitted in Bulgarian, together with the Bulgaria English version. If the future-use consent is a separate participant-facing document, it should be included in the Bulgaria participant-document set and follow the same language approach.

The Part II biological-sample compliance declaration may be submitted in Bulgarian and/or English according to the BDA national document list.

Withdrawal

Regulation (EU) No 536/2014 states that the additional consent for scientific use of data outside the protocol may be withdrawn at any time. The future research itself must comply with applicable data-protection law.

The participant-facing wording should explain how to withdraw and what the practical effect will be. Distinguish stopping new future use from situations where data or samples have already been irreversibly anonymised, consumed in analysis or lawfully incorporated into research outputs, where that is accurate for the sponsor's process.

Do not use withdrawal language from the main clinical-trial consent without adapting it to the secondary-use activity.

Sharing and transfer

If future data or samples may be shared with external laboratories, academic groups, service providers or other research organisations, describe the scope at a level consistent with the approved plan. Avoid vague wording such as shared with anyone for research.

For international transfers, align the participant-facing explanation with the sponsor's GDPR documentation and transfer mechanism. The Bulgaria Part II dossier also includes the sponsor or representative declaration of GDPR compliance.

No separate Bulgaria national secondary-use form

The current BDA Part II list does not publish a mandatory national secondary-use consent template. It does, however, require the EU biological-sample compliance declaration where applicable and requires Bulgaria participant information and ICF documents in Bulgarian.

The practical task is therefore to build a clear optional participant choice that matches the protocol, sample plan, privacy documentation and Part II declarations. The Bulgaria patient-facing document QC checklist is useful for the final consistency review.

For the complete country guide library, return to the Bulgaria CTIS hub.