Italy limited-capacity and legal-representative consent requirements

Assess capacity for this decision

Capacity is not all-or-nothing. Assess whether the person can express a choice, understand the relevant information, appreciate how it applies to their situation and use the information to reach a decision. Consider the complexity and risk of the particular trial.

Use support before concluding that the person lacks capacity. Provide simpler explanations, accessible formats, communication aids, extra time and a trusted support person when appropriate. Treat reversible causes such as delirium, pain, medication effects or an acute communication barrier where possible.

Document who assessed capacity, when, what information was used, the support offered and the conclusion. Repeat the assessment if capacity may fluctuate or improve.

Identify the legally authorised representative

Italian arrangements can include a court-appointed guardian, known as a tutore, a curator for a person subject to inabilitation, or an amministratore di sostegno, a support administrator. The authority depends on the court order and the legal measure. Do not infer authority from a family relationship alone.

Review the appointment document and confirm that it covers healthcare or research decisions of this kind. Record the representative's identity, relationship, legal basis and scope. Keep appropriate evidence in the trial records without copying unnecessary personal or court information into CTIS templates.

The CCNCE guidance explains that a healthcare proxy named in an advance directive, or fiduciario, is not automatically the legal representative for clinical-trial consent. Obtain legal and ethics advice when authority is uncertain. Do not enrol until the valid route is resolved, unless the separate emergency provisions of Article 35 apply.

Information for the representative

Give the representative the same decision-critical information required for adult consent. Explain the trial purpose, investigational nature, procedures, risks, burdens, potential benefit, alternatives, privacy, samples, reimbursement, injury arrangements and withdrawal.

The decision should reflect the participant's presumed will, values and interests rather than the representative's convenience. The Clinical Trials Regulation restricts research involving an incapacitated person to defined conditions, including appropriate relation to the person's condition and justified benefit or scientific value with minimal risk and burden.

Use the relevant CCNCE model and legal-representation appendix. The representative and the doctor or investigator conducting the discussion sign and date the approved form. Give the representative a copy.

Information and agreement from the participant

Provide information adapted to the participant's ability even when the representative gives the legally operative consent. Explain what will happen, what may be uncomfortable, who will see the information and that the person can communicate a wish to stop.

Seek the participant's affirmative agreement where meaningful. The CCNCE guidance recommends a double-consent approach where possible, combining representative authorisation with the participant's own supported agreement. Do not use an incapable person's signature as if it were independent legal consent.

Respect an objection. The Clinical Trials Regulation requires the investigator to respect an incapacitated participant's explicit wish to refuse or withdraw when the person can form an opinion and assess the information. Resistance during a procedure may also signal dissent and requires immediate clinical assessment.

Distinguish a representative from a witness

A legal representative makes the decision when the participant lacks capacity. An impartial witness does not. A witness observes or supports the consent record when a capable participant cannot write. These roles are not interchangeable.

Do not ask a relative or witness to sign “for” a participant who lacks decision-making capacity. Use the legally authorised representative route. See the impartial-witness consent guide for the separate unable-to-write situation.

Fluctuating capacity and re-consent

Plan reassessment for conditions in which capacity may return, such as acute neurological illness, sedation or temporary psychiatric crisis. If the participant regains capacity, provide the current approved adult information and obtain the person's own informed consent for continued participation without undue delay.

Explain the earlier enrolment and what data or samples have already been collected. Allow the participant to decide about future participation and optional activities. If the person declines, stop new non-essential collection, follow approved safety procedures and explain the lawful treatment of data already obtained.

If capacity is later lost after valid personal consent, follow the protocol and national law for continued participation. Do not assume that the original consent covers every new optional activity or material change.

Privacy and optional samples

Provide the separate Italian privacy information and data-processing consent through the legally valid route. Explain data access, retention, transfers and withdrawal to both the representative and participant at an appropriate level.

Keep optional genetics, future sample storage and secondary research separate from main-study participation. The representative's authority to approve optional future use should be checked, and the participant's known wishes or objections must be respected. Use the secondary-use consent guide.

Package and site checks

The CTIS package should include the adapted participant information, representative consent form, consent-procedure description and any population-specific recruitment materials. The protocol should describe capacity assessment, representative verification, objections, reassessment and re-consent.

Train sites to distinguish inability to communicate, inability to write and inability to decide. Make the assessment tools and escalation contacts available before recruitment begins.

Use the main patient information and consent guide and patient-facing QC checklist. For a sudden emergency where prior consent is impossible, use the separate emergency-enrolment guide. Return to the Italy CTIS guide hub.