Spain CTIS Part II Secondary and Future Use Consent Requirements

Start with the main study consent

The main Spanish PIS/ICF should describe the data and sample uses required for the trial and related drug development activities. The Spain main patient information and consent guide explains the standard document and data-protection appendix.

Do not label legally required trial processing as optional. Separate choices apply when the purpose goes beyond the approved study scope.

Separate data from biological samples

Data and human biological samples have related but distinct rules. A data-only future research choice does not automatically authorise storage of tissue or blood. A sample-storage choice does not by itself authorise every future data use.

Map each purpose, material, repository, recipient and withdrawal route before drafting. The protocol, PIS/ICF, laboratory manual, data plan and AEMPS Annex XIII should reach the same conclusion.

Future use of trial data

Conditional separate consent. AEMPS requires separate consent for future data uses that are not limited to the defined drug development programme or that concern unrelated diseases or research areas. The choice may be a clear yes or no box in the general ICF or a separate form.

Explain the general type of research, governance review, coding, data categories, expected users, sharing, transfers, retention, recontact and whether results may be returned. AEMPS states that an ethics committee should have issued a favourable opinion before the future processing. If not, the responsible research entity needs the prior report described in Annex VIIIA from a data-protection officer or expert in European data-protection law.

Refusal must not affect the main trial when the future use is genuinely optional. Avoid wording such as “I consent to any future research.” Give a scope that the participant can understand.

Trial-purpose biological samples

Mandatory when samples are collected. Explain the sample types, number and volume, collection procedures, risks, purposes, coding, analysis locations, storage during the trial and responsible entity. AEMPS Annex VIIIB says this information should preferably sit in the general PIS/ICF.

If a sample or biopsy is optional even within the trial, provide a separate choice. If the protocol requires it for the main trial, do not present it as optional.

Future use of remaining samples

Conditional. Optional. State that remaining samples will be destroyed after the trial unless the participant agrees to future storage and use. AEMPS describes three practical routes:

• A biobank registered in Spain, which may release samples for authorised projects after its scientific and ethics review.
• A collection registered in Spain, used within the stated research line and not transferred outside the consented conditions without an applicable new decision.
• A repository abroad, described using the applicable legal model, location, access, transfer and research-purpose information.

Identify the biobank, collection or responsible repository and its location where available. Describe whether third parties or researchers outside Spain or the European Economic Area may receive samples and under what safeguards.

Documents to prepare

Mandatory when samples are involved. Biological-sample text in the PIS/ICF. Use AEMPS Annex VIIIB for collection, risks, coding, storage, future use, withdrawal and findings.

Conditional. Separate sample PIS/ICF. AEMPS recommends a specific document when samples are obtained for a substudy or future studies. A separate document is also useful when only a subset of participants is invited.

Conditional. Future data-use choice. Use a separate form or an independent yes or no choice in the main ICF.

Mandatory Part II information when samples apply. Complete AEMPS Annex XIII in Spanish or English, or provide the same information in the dossier with a clear reference. The form covers new and archived samples, quantities, purpose, analysis, storage, coding, access, transfer, future use, recontact, ethics review and unsolicited findings. AEMPS identifies Annex XIII as the accepted Spanish Part II form.

Participant-facing documents must be in Spanish and are blank at CTIS submission. They are signed only when consent is obtained.

Separate and optional consent logic

Use an independent choice for each materially different optional purpose. At minimum, distinguish main-trial participation from future data use and future sample storage. Add separate choices for optional biopsies, genetic research or recontact when the decision would change independently.

Avoid bundled consent that makes a participant accept all future research to join the trial. The consent form should show that “no” to future use leaves the main trial decision unchanged.

Sharing and transfers

Explain who may receive coded data or samples, the purpose and whether recipients are inside or outside the European Economic Area. State that recipients should not receive the code key and should agree not to re-identify participants.

For sample transfers, put a material-transfer agreement or equivalent arrangement in place. AEMPS Annex XIII asks how samples will be managed after analysis, including return, destruction, storage or anonymisation.

Do not promise that a sample held in a biobank can never be shared if the biobank model allows authorised release. Describe the actual governance route.

Withdrawal of optional consent

Explain how the participant can withdraw future-use consent and whom to contact. For samples, AEMPS guidance allows the participant to request destruction or anonymisation. Data already generated from analyses may continue to be used and retained where legal obligations apply.

Withdrawal cannot retrieve samples or data that were already irreversibly anonymised or validly used before withdrawal. Explain this limitation clearly without discouraging withdrawal.

Keep withdrawal from optional future use separate from withdrawal from the main trial. A participant may stop future use while remaining in treatment or follow-up.

Findings and recontact

Explain whether participants may choose to receive validated findings relevant to their health or genetic findings. AEMPS Annex VIIIA includes yes or no choices for this purpose. Define who validates and communicates a finding and how the participant will be recontacted.

Do not promise return of exploratory or unvalidated results. Address the rare case in which information may be needed to avoid serious harm according to the approved Spanish pathway.

Minors and adults unable to consent

Apply the main-trial decision-maker rules to optional future use. For minors, parent or representative permission does not remove the child's right to age-appropriate information and applicable agreement. Review consent when the child reaches the relevant age threshold and adulthood.

For an adult unable to consent, verify that the representative may authorise the optional future use. Optional research with no prospect of benefit needs particular ethical justification. Respect objection and re-consent if capacity changes.

Final Spain review

Confirm the exact destination of remaining samples, not only the sponsor's general intention. Match the Spanish consent choices to AEMPS Annex XIII and the contracts or governance arrangements. Check that the form names the person or entity participants can contact about withdrawal and sample use.

Use the Spain patient-facing document QC checklist before submission and return to the Spain CTIS guide hub for the complete national package.