Poland Secondary Use Consent Requirements

First separate protocol use from secondary use

Before drafting an optional consent, identify which activities are already part of the approved clinical-trial protocol.

Data collected and analysed for the trial's objectives, safety evaluation, regulatory obligations and other protocol-defined purposes should be described accurately in the main participant information. Do not label all clinical-trial data processing as optional future research.

A distinct Article 28(2) choice is relevant when the sponsor seeks the participant's permission for use outside the protocol exclusively for scientific purposes.

For biological samples, make a similar distinction between protocol-required testing and optional storage or research beyond the main study. The participant should be able to tell what is required for the trial and what is an additional research choice.

Keep the optional choice separate from main participation

Mandatory where optional secondary use is requested. The wording should make clear that agreeing to the additional scientific use is separate from agreeing to the main clinical trial.

A participant should not be led to believe that refusal of optional future use will make them ineligible for the trial unless the activity is actually required by the protocol. If it is required, describe it as part of the main study rather than placing it behind an apparently optional checkbox.

Use separate signature or initial boxes only when they make the choice clearer. Avoid a single all-or-nothing signature covering main participation, indefinite sample storage, unrelated future research and optional genetic analysis if those are genuinely separate decisions.

Data-related secondary use

For optional use of data outside the protocol, explain the scientific scope in terms a participant can understand. The description should address:

• the types of future scientific research contemplated
• whether the data will be coded, pseudonymised or anonymised
• who may receive or access the data
• whether commercial organisations may conduct research
• whether data may be transferred outside Poland or the European Economic Area
• how long data may be retained for the optional research
• whether participants can be recontacted
• how withdrawal of the optional permission works

Avoid descriptions so broad that the participant cannot understand the nature of the additional choice.

Biological-sample secondary use

Conditional. If samples may be stored or used beyond the protocol-required analyses, explain the optional sample pathway separately.

Cover the sample types, storage location or type of repository, planned duration, permitted research scope, possible genetic or genomic analysis, sharing with other researchers, international transfer where relevant, recontact and what happens to remaining samples if the participant withdraws the optional permission.

The European Commission provides a Part II template for compliance with applicable rules for biological samples. Use that template for the regulatory compliance statement where applicable, but do not treat it as a substitute for clear Polish participant information.

If the future-use project becomes materially different from what the participant was told, reassess whether the original permission and data-protection information still cover it.

Polish language requirements

Mandatory. Optional participant-facing information and consent submitted in Poland should be available in Polish under the current European Commission language requirements for Part II patient-facing documents.

Use the same defined terms in the main ICF and optional consent. If the main form says "coded data" and the future-use form says "anonymous data," make sure those terms describe the actual data state and are not being used interchangeably.

Translation should preserve the fact that the secondary-use choice is optional. Small wording changes such as translating "may" as a mandatory instruction can change the consent logic.

Withdrawal from optional secondary use

Article 28(2) states that consent for use of data outside the protocol exclusively for scientific purposes may be withdrawn at any time.

Explain how the participant can withdraw and what the practical effect will be. Distinguish stopping new optional use from information or analyses that have already been lawfully generated and cannot realistically be reversed.

For stored biological samples, state whether remaining identifiable or coded samples can be destroyed or made unavailable for future optional research after withdrawal and identify any limits that genuinely apply.

Do not write that optional consent is "irrevocable" if the Article 28(2) pathway is being used.

Informed consent and GDPR are separate questions

Clinical-trial informed consent and the legal basis for personal-data processing under the General Data Protection Regulation are not the same thing. European Commission guidance on the CTR and GDPR expressly treats these frameworks separately.

The participant-facing package should therefore be internally consistent about both:

• the participant's optional scientific-research choice under the clinical-trial framework
• the sponsor's data-protection information and lawful processing basis under the GDPR

Do not state automatically that withdrawal of optional research consent erases every piece of trial data. Regulatory record retention, safety obligations and other lawful processing may continue under a separate basis. Explain the actual consequences of withdrawal rather than using generic GDPR language.

Poland applies the GDPR together with the Polish Data Protection Act. Data-controller details, purposes, recipients, transfers, retention and rights should match the sponsor's approved data flow.

Sharing and international transfer

If optional research permits sharing with other institutions, describe the categories of recipients and the safeguards or governance that matter to the participant's decision.

If coded data or samples may leave Poland or the European Economic Area, avoid a vague statement that information may be sent "worldwide." Explain the transfer in line with the sponsor's data-protection notice and actual research network.

Do not promise that no recipient can ever re-identify data if the information remains pseudonymised and a code key still exists. Use technically accurate terminology.

Minors and participants lacking capacity

Conditional. Optional secondary-use choices must follow the consent authority that applies to the participant at the time. A parent, legal representative or participant should not be given a checkbox that they are not legally entitled to decide.

For minors, involve the child or adolescent according to age and maturity and use the Poland-specific consent structure described in the Poland minor consent and assent guide.

For adults lacking capacity, adapt the information and representative pathway using the Poland limited-capacity and legal representative consent guide.

Where optional use continues after a minor reaches adulthood or an adult regains capacity, plan how the person's own decision will be addressed. Do not assume that a representative's earlier optional choice can always be treated as permanent.

Documents to prepare

Depending on the protocol, the Poland Part II package may include:

• an optional secondary-use section within the Polish main PIS and ICF
• a separate Polish future-use information and consent form
• a separate optional genetic or genomic research choice where the scope differs materially
• the European Commission biological-sample compliance template where applicable
• data-protection information consistent with the sponsor's GDPR statement
• age- or capacity-specific versions where the population requires them

Choose the simplest architecture that keeps mandatory trial participation and optional research decisions unmistakably separate.

Signatures and CTIS timing

Submit the blank controlled Polish optional forms with the Part II application when they are intended for use in Poland. Participants do not sign the dossier copies.

At the site, obtain the optional decision at the point described in the approved procedure and before optional collection or use that depends on that decision. Date and document each separate choice clearly enough that the site can later prove what the participant agreed to.

If optional consent is withdrawn, document the date and apply the approved withdrawal process to future secondary use.

Use the Poland patient-facing document QC checklist to check optionality, privacy and sample wording. Return to the Poland CTIS Part II guide hub for the complete Poland guide library.