Romania CTIS Part II Secondary Use Consent Requirements

Start with the main Romania consent requirements

Secondary use is a variation of the Romania patient information and consent requirements.

Mandatory. Participant-facing information used in Romania should be in Romanian.

Decide whether future use is separate

First separate research required by the current protocol from research that may happen later.

If the sample analysis or data use is part of the approved clinical-trial objectives, describe it in the main participant information.

If future research is genuinely optional and not required for trial participation, make that optional status clear in the document and signature logic. Do not make an optional future-use choice look like a condition of joining the main study.

Biological-sample information

For samples collected in the trial, explain what is collected, why it is collected, where it is analysed or stored and how it is linked to the participant.

Romania's published sample template distinguishes direct identification, pseudonymised coding and anonymised samples.

It also asks who has access to samples and code lists, how long samples are stored and whether samples are transferred to another organisation.

Future use

If samples will be stored for a purpose beyond the protocol, define the future-use purpose as clearly as possible.

The Romanian template asks where the samples will be stored, for how long, who can access them and whether the donor will be recontacted to provide new consent for future research.

Do not assume that a broad phrase such as "future medical research" resolves every ethics question.

Data-related secondary use

If optional future use involves coded trial data rather than samples, describe the scope, recipients and expected research use in the participant-facing document.

Keep the wording consistent with the data-protection declaration and the sponsor's actual processing arrangements.

Do not present clinical-trial consent as the sole legal basis for all personal-data processing.

Withdrawal

Explain what happens if the participant later withdraws permission for optional future use.

Distinguish material that can still be linked to the participant from material that has been irreversibly anonymised.

Avoid promising destruction or deletion where it is no longer technically possible or where legal retention obligations apply.

Ethics review of new future use

Romania's sample template warns that secondary future use may require additional ethics review depending on the new purpose.

For a future project that was not described in the approved trial documents, do not assume that the original CTIS approval automatically authorises the new research.

Separate and optional consent logic

Where secondary use is optional, use a separate choice or clearly separated signature or initials section so the participant can accept the main trial without being forced into future research.

If future use is integral to the protocol rather than optional, do not label it optional simply to create a separate checkbox.

Submission package

Include the Romanian participant-facing secondary-use wording or separate form if used, plus the relevant Part II biological-sample information.

Check consistency with the protocol, laboratory plan, transfers, retention, privacy notices and withdrawal wording.

Use the Romania patient-facing QC guide and the Romania Part II checklist. Return to the Romania CTIS hub for related guides.