Spain CTIS Part II Minor Consent and Assent Requirements

Start with the main Spanish consent requirements

All participant and parent materials assessed by the CEIm should be in Spanish. Use the AEMPS Annex VIIIA structure, adapt the content to the reader and submit blank versions in CTIS. The Spain main patient information and consent guide explains the general study, risk, privacy, sample and signature content.

AEMPS points sponsors to the KIDS Barcelona young-person guidance as a recommended aid. It does not replace trial-specific drafting or the legal consent rules.

Spain age bands and decision-makers

Children younger than 12

Mandatory. Obtain prior informed consent from the parents who are not deprived of parental authority or from the legally designated representative. If the child has sufficient judgment, the child must be heard. Give information in a form adapted to the child's age and maturity and record the child's agreement when the child can understand and express a view.

The child's explicit wish not to participate or to withdraw must be respected when the child can form an opinion and assess the information.

Adolescents aged 12 to 17

Mandatory. Obtain the parent or legal-representative consent and the adolescent's own consent. The adolescent document should explain the same material decision points as the parent document in age-appropriate language. It should not be only a simplified leaflet with no consent record.

The adolescent's refusal or later decision to withdraw must be respected.

Reaching age 18 during the trial

Mandatory. Obtain the participant's express adult informed consent before continued participation once the participant reaches the legal age to consent. Plan the re-consent visit, document version and timing before the birthday so there is no gap.

Documents to prepare

Mandatory. Parent or guardian PIS/ICF. Explain the trial, why the child is eligible, procedures, risks, possible benefit, alternatives, compensation, insurance, privacy, samples and withdrawal. State that the child will receive information adapted to their understanding and will sign the applicable document.

Conditional. Younger-child information and assent record. Prepare this when younger children can understand a simple explanation. Use short sentences and concrete descriptions of visits, pain, choices and whom to ask for help. Avoid legal and data-protection text written for adults. The parent document can carry the full legal detail.

Mandatory from age 12. Adolescent PIS/ICF. Provide enough information for the adolescent's own decision and include the adolescent signature and date. Parent or representative consent remains required.

Conditional. Adult re-consent PIS/ICF. Prepare this for participants expected to turn 18 during treatment or follow-up. It can be a concise adult document if the current approved information is still complete, but it must support a fresh express decision.

Conditional. Optional-use forms. Apply the same age and representation logic to optional substudies, future data use and future sample storage. Do not treat parent permission for the main trial as automatic permission for every optional activity.

Parent signature rules in Spain

The consent of the parents is valid when one parent signs with the other parent's express or tacit agreement, provided that agreement is sufficiently documented. AEMPS recommends recording one of these situations:

• Both parents sign.
• One parent signs and confirms that the other parent does not object.
• The signer confirms that they are the sole legal guardian.

Do not build a two-signature requirement into every form when Spanish law permits the documented one-parent route. Do not accept one signature without documenting the basis when the other parent retains parental authority.

When a non-parent legal representative signs, identify the representative and retain evidence of the authority relied on according to site procedure. The investigator should verify the pathway before enrollment.

Information adapted to age and maturity

Explain why the study is being offered, what medicine or placebo may be given, what tests will happen, what may hurt or feel uncomfortable, how long participation lasts and that saying no is allowed.

Use separate versions only when they genuinely help different developmental groups. A single child document may work across a narrow age range, but the language must still fit each reader. Visuals can help, provided they are accurate and do not minimise risk.

Parent and adolescent documents must remain consistent. The adolescent version may be simpler but cannot omit a decision-changing burden or risk.

Consent, assent and signatures

At CTIS submission, upload blank Spanish versions. When enrollment consent is obtained, the parent or representative and investigator sign and date the parent ICF. From age 12, the adolescent and investigator also sign and date the adolescent ICF. For a younger child who can participate in the decision, use the approved assent or acknowledgment method.

Give the family signed and dated copies of the documents they signed. Record any parent agreement that is not shown by a second signature.

Refusal, dissent and withdrawal

The investigator must respect an explicit refusal or wish to withdraw expressed by a minor who can form and evaluate an opinion. Do not override dissent merely because a parent signed.

Explain to parents and children how withdrawal affects treatment, safety follow-up, data and samples. A signed withdrawal form is not mandatory. Optional-use withdrawal should not automatically end the main trial.

Changes in maturity or legal capacity

Review understanding during a long trial. A child who becomes able to understand more should receive updated age-appropriate information. At age 12, the Spanish requirement for the minor's own consent applies even if the child entered under a younger-child process.

At age 18, parent consent no longer substitutes for the participant's own consent. Obtain adult consent before the participant continues.

Spain-specific preparation check

Confirm that the CEIm evaluating Part II has paediatric expertise among its members or has obtained appropriate paediatric advice. Check that the protocol, parent PIS, child documents and consent procedure use the same age bands and signature logic.

Use the Spain patient-facing document QC checklist before submission and return to the Spain CTIS guide hub for the remaining Part II documents.