Spain CTIS Part II Limited-Capacity Participant and Legal Representative Consent Requirements

Start with the standard Spanish PIS/ICF

This is a variation of the main Spanish document, not a replacement for its trial content. The participant and representative need clear information about the study, risks, burdens, alternatives, privacy, samples, compensation, insurance and withdrawal. The Spain main patient information and consent guide covers those baseline sections.

Submit all participant-facing versions in Spanish and follow the AEMPS Annex VIIIA format and readability guidance.

When the representative pathway applies

Use this pathway only when the adult cannot understand, retain, use or communicate the information needed for the specific trial decision despite suitable support. Capacity is decision-specific and may change over time.

The protocol should justify enrolling adults unable to consent and meet Article 31 of the Clinical Trials Regulation. The trial must be essential for this population and either offer a direct benefit that outweighs risk and burden or meet the Regulation's limited population-benefit and minimal-risk conditions.

Check whether the person gave or refused consent before losing capacity and whether they left relevant prior instructions. Spanish rules require those prior instructions to be respected. The approved trial documents should describe how this check will be made.

Documents to prepare

Mandatory. Accessible participant information. Give the adult information in a form suited to their communication and comprehension needs. This may use simplified text, supported communication, audio, large print or another accessible format. The objective is to help the person decide, not simply to notify them after a representative decides.

Conditional. Participant assent or agreement record. When the participant cannot provide legally valid consent but can understand parts of the study, record their agreement in an appropriate way. Avoid an adult document that appears childish.

Conditional. Representative PIS/ICF. Prepare this when another person must provide consent. It should identify the basis on which the person is acting, explain that the participant's wishes and interests govern the decision and include the correct signature block.

Conditional. Re-consent document. Prepare an adult participant version for foreseeable recovery of capacity, such as after an acute episode, sedation or critical illness.

No separate Spanish national LAR template is published. AEMPS Annex VIIIA includes a signature pathway for a legal representative, family member or related person. The site must confirm which person is legally able to act in the individual circumstances.

Information and support for the participant

Spanish law requires information for a person with a disability to be accessible and understandable and requires appropriate support to favour the person's own consent. Document what support was used and why it was sufficient or insufficient.

Include the participant in the discussion to the greatest extent possible. Explain the trial in manageable parts, allow time, use the person's communication method and involve a trusted supporter where appropriate.

The participant's explicit objection must be respected. The EU Regulation also requires the investigator to consider the wish of a person able to form an opinion and assess the information to refuse participation or withdraw.

Who provides consent

Royal Decree 1090/2015 refers to the participant's legal representative or, as appropriate, a person connected by family or factual relationship. Do not assume that any relative may sign. The site should verify the current legal authority and retain the supporting evidence required by its procedure.

The representative decides on behalf of the participant, based on the participant's rights, wishes, prior instructions and interests. The representative must receive the information that would be needed for an informed trial decision.

Consent and signature logic

At CTIS submission, upload blank Spanish participant and representative forms. When consent is obtained, the authorised representative, family member or related person and the investigator sign and date the approved representative ICF. AEMPS Annex VIIIA provides this signature structure.

Where the participant can express agreement, use the approved participant signature, mark or other record in addition to representative consent. Give the participant and representative copies in the appropriate format.

Objection, dissent and withdrawal

Do not enroll or continue a participant who expresses an applicable refusal. Explain how non-verbal resistance, distress or changed behaviour will be assessed and documented, particularly when the study adds repeated or invasive procedures.

The participant or authorised decision-maker may withdraw consent. Explain the effect on study procedures, safety follow-up, data and samples. A signed withdrawal form cannot be required as the only valid route.

Re-consent when capacity changes

Mandatory. If the participant regains capacity, obtain their informed consent before continued participation. Provide the current approved information, answer questions and obtain the participant and investigator signatures.

Do not rely indefinitely on representative consent when recovery is possible. Build capacity review into relevant visits and define who assesses it. If capacity fluctuates, follow the CEIm-approved procedure and document each material change.

Spain-specific review points

The CEIm should have relevant disease expertise or seek appropriate clinical, ethical and psychosocial advice for the affected group. Check that the protocol justification, capacity assessment, PIS versions and signature pathways agree.

If enrollment may occur in an emergency before any representative can consent, the separate emergency conditions apply. Use the Spain emergency enrollment consent guide rather than treating urgency as ordinary representative consent.

Use the Spain patient-facing document QC checklist for final review and return to the Spain CTIS guide hub for the country package.