Italy secondary-use consent requirements

Separate primary research from secondary use

Identify analyses required to answer the current trial objectives. Those activities belong in the main study explanation and must not be described as optional if participation is scientifically impossible without them.

Treat storage beyond the trial, future genetics, exploratory biomarker work, biobanking and research not defined in the current protocol as separate activities. Provide distinct information and a genuine choice. Refusal of future use should not prevent main-study participation unless the protocol and ethics opinion establish that the activity is essential to the trial.

Do not combine every future purpose into one vague statement such as “any research.” Describe the disease area, scientific field or governance boundary precisely enough for an informed choice. If a future project falls outside that scope, obtain new consent or use another lawful route approved for that project.

Information about the material

Describe what samples are collected, from which procedure, in what amount and at what time. Identify which samples are consumed during the trial and which residual or additional samples will be stored.

State the storage location, responsible biobank or custodian, coding method, planned duration, security and conditions for access. Explain whether material may be transferred to academic, commercial or international collaborators. Describe whether researchers receive coded material and whether re-identification is possible through a controlled key.

If the storage duration is not a fixed number of years, explain the governing event and periodic review. Do not say “anonymous” when a code can still be linked to the participant.

Future research scope and governance

Explain the categories of future research, who reviews proposed projects and whether a research ethics opinion is required. Identify the sponsor, biobank committee or other body that controls access. State whether samples or data may support product development, commercial collaboration or intellectual property.

Explain that the participant will not normally own resulting discoveries or receive royalties unless a specific arrangement says otherwise. Avoid language that waives rights to compensation for research injury or other legal rights.

Describe whether the material may be linked with clinical data, registries or other datasets. The linkage and every international transfer must match the separate privacy information, contracts and Part II data-protection statement.

Genetic analysis and findings

State whether genomic, germline, somatic or other genetic analysis may occur. Explain the possibility that genetic data can be identifying and may reveal information relevant to biological relatives. Describe security and access controls.

Set a policy for individual findings. Explain whether results are analytically and clinically validated, whether participants can choose to receive them and which professional will confirm and communicate them. Do not promise return of exploratory findings that cannot be responsibly interpreted.

If family implications or re-contact are possible, explain the limits. A participant's consent does not automatically authorise collection of a relative's data or sample.

Data-only secondary use

Secondary use of coded trial data may be governed differently from optional sample storage, but it still needs transparent information. Describe planned data sharing, research repositories, access criteria, retention and safeguards. Distinguish public summary results from controlled access to participant-level data.

The clinical-consent form and separate privacy document must explain uses necessary for the current trial, safety, inspection and regulatory archiving. Optional future research should have a distinct choice when consent is the intended basis. Do not promise withdrawal of data already included in completed analyses or irreversibly anonymised datasets.

Withdrawal and destruction

Tell the participant how to withdraw permission for future use and whom to contact. Explain what happens to identifiable or coded samples still held. Where feasible and legally permitted, stop new distribution and destroy or irreversibly anonymise remaining material after withdrawal.

State the limits clearly. Material already used, data already generated, completed analyses and samples already irreversibly anonymised may not be retrievable. Retention may also be required for the main trial, safety or regulatory record. Do not obscure these limits in the signature block.

If no valid future-use permission exists after the trial, follow the approved plan for destruction or genuine anonymisation of residual material. Document the action through the custodian or biobank.

Minors and adults with limited capacity

For a minor, obtain the legally valid parent or guardian decision and involve the child according to age and maturity. Plan to obtain the participant's own adult choice at 18 when identifiable material continues to be stored or used and re-contact is practicable. Use the minor consent and assent guide.

For an adult lacking capacity, verify that the legal representative's authority covers optional future research. Provide adapted information, respect the participant's known wishes and obtain personal consent if capacity returns. Use the limited-capacity and legal-representative guide.

CTIS and document package

Submit the Part II biological-sample compliance information when samples are collected, stored or used. Use the latest model listed by AIFA and the applicable EudraLex requirements. This regulatory form does not replace the participant-facing Italian sample consent.

The participant document should include study identifiers, clear optional choices and applicable participant, representative, investigator and witness signature fields. Align it with the protocol, laboratory manual, data-management plan, material-transfer agreements, biobank contract, privacy notice and retention schedule.

Use the main patient information and consent guide, Italy Part II checklist and patient-facing QC checklist. Return to the Italy CTIS guide hub.