Portugal Minor Consent and Assent Requirements

Portugal age and consent pathway

Participant	Representative decision	Minor's decision	Form
Under 16 and not able to form an opinion	Informed consent required	No assent decision can be obtained, but provide information suited to understanding	Representative PIS and ICF, plus suitable child information when meaningful
Under 16 and able to form an opinion and assess the information	Informed consent required	Assent required, regardless of form	Representative PIS and ICF, plus age-appropriate child information and an assent record
Age 16 or 17	Informed consent required	Assent required	Representative PIS and ICF, plus adolescent information and assent form
Turns 16 during the trial	Existing representative consent remains valid	Written assent required to continue	Approved written age-16 assent form
Turns 18 during the trial	Representative consent no longer substitutes for the adult's decision	Written informed consent required to continue	Approved adult PIS and ICF

The statute does not prescribe a fixed set of younger-child age bands. Build documents around comprehension and the study burden. Avoid using one dense adolescent document for every child.

Required minor document set

Mandatory. Prepare Portuguese information and consent for the legally authorized representative. Explain why research with minors is needed, the expected benefit or group benefit, risks, burdens, alternatives, voluntary participation and the child's right to object.

Mandatory when the minor can understand. Prepare age-appropriate Portuguese information and an assent pathway. For a child under 16, assent may be recorded in a form suited to the child's ability. For ages 16 and 17, prepare a clear adolescent assent document.

Conditional. Prepare an adult re-consent PIS and ICF if any participant may reach 18 during participation. Prepare the written age-16 assent form if a participant may reach 16 during the trial.

Conditional. Add separate optional choices for future sample or data use. Do not ask the representative to bundle optional future research into the main trial decision.

CEIC does not publish a mandatory national pediatric template. The optional adult model may inform structure but does not replace age-appropriate drafting.

Information for the child or adolescent

Explain the study at the level the minor can understand. Cover what will happen, discomfort, time, choices, who to ask, and the right to say no or change their mind. Do not rely on the parent document as the only explanation.

For adolescents, include the information needed for a meaningful decision, including reproductive precautions, privacy, sensitive questionnaires, electronic tools and future use. Explain any limits on keeping information from the representative when safety or law requires disclosure.

Parent or representative consent

Verify who is legally authorized to act for the minor under Portuguese law and the child's circumstances. Do not assume that any accompanying adult has authority. Record the representative's name, relationship or authority, signature and date.

Portuguese Law No 9/2026 refers to the legally authorized representative and does not create a universal two-parent signature rule for every trial. The sponsor and site should confirm the correct representative evidence for the individual case and any CEIC condition.

The representative and the person conducting the consent interview sign and date the consent form when consent is obtained. The minor signs an assent form when the approved pathway calls for a written record.

Refusal and dissent

The minor's will to participate must be respected. A capable child's refusal or later dissent cannot be treated as a minor inconvenience. Stop or do not begin trial procedures when the applicable ethical and legal conditions are no longer met.

Consent and assent may be withdrawn at any time without disadvantage to the minor. Explain what happens to treatment, safety follow-up, data and samples after withdrawal.

Children in institutional or protective placement

Portuguese law generally excludes a minor subject to a placement or institutional measure. Enrollment is possible only when nonparticipation would create a potential prejudice or disadvantage for the child. The treating physician must attest this circumstance. If the treating physician is not the investigator, the investigator acts in coordination with that physician.

Treat this as a narrow exception. Explain and justify it in the protocol and consent procedure before submission. Do not apply it merely because recruitment would otherwise be difficult.

Re-consent as age changes

Mandatory. When a participant turns 16 during the trial, obtain written assent to continue. Existing representative consent remains valid.

Mandatory. When a participant turns 18, provide the approved adult information and obtain the participant's own written informed consent to continue. Plan these documents before the birthday so no trial procedures occur without the correct decision.

If legal capacity changes for another reason, reassess the pathway and use the Portugal limited-capacity guide where applicable.

Final review

Confirm that:

every minor receives information suited to comprehension
the representative's legal authority is verified
ages 16 and 17 have an assent pathway
capable children under 16 are asked for assent
refusal and dissent are respected
age-16 written assent and age-18 adult re-consent are planned
institutional placement is addressed only under the statutory exception
optional future use is separate
Portuguese versions match the protocol and representative materials
signature blocks distinguish representative consent from minor assent

Use the Portugal patient-facing document QC checklist before submission. Return to the Portugal CTIS hub for all Portugal guides.