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

First confirm that inclusion is permitted

Article 31 of the Clinical Trials Regulation allows enrollment of an incapacitated person only under strict conditions. A legally designated representative must consent. The person must receive information adapted to the person's capacity, be involved as far as possible and have any explicit wish to refuse or withdraw respected.

The protocol must meet the applicable necessity and benefit conditions. No incentive may be offered beyond compensation for expenses and loss directly related to participation. The trial must relate directly to the person's medical condition and meet the required direct-benefit or population-benefit test with minimal risk and burden where the latter route is used.

French law adds rules based on the person's protective status. A person placed under sauvegarde de justice is excluded from this interventional research route. Do not treat a temporary safeguarding measure as authority for another person to sign.

Identify the French consent route

Adult under curatorship

Under curatelle, the participant gives consent with the assistance of the curator. Prepare an adapted participant document with signature fields that show the participant's consent and the curator's assistance. The curator does not simply replace the participant's decision.

Where the CPP considers that the research presents a serious risk of harm to private life or bodily integrity, the competent judge may need to authorize the person's participation. Confirm that point before enrollment and retain evidence in the site file.

Adult under guardianship or another measure with representation

Where the protective measure grants representation for decisions concerning the person, the authorised representative gives the legal authorization. This may arise under tutelle, a future-protection mandate or family authorization with representation, depending on the order in force.

Read the court order or mandate to confirm the representative's scope. For research that presents a serious risk of harm to private life or bodily integrity, authorization may belong to the family council or judge rather than the usual representative. Do not rely only on a verbal description of the arrangement.

Adult unable to consent without a formal protection measure

Where an adult cannot express consent and is not under a legal protective measure, French law uses a priority route. Seek authorization from the trusted person designated under French healthcare law. If there is no such person, use a family member. If no family member is available, use a person maintaining close and stable ties with the participant.

Document why the participant could not consent, the absence or unavailability of a higher-priority person, the relationship of the person consulted and the information provided. This route is not interchangeable with an impartial witness, who attests an unable-to-write consent by a person who still has capacity.

Required document set

Mandatory. French information adapted to the participant's ability to understand. It should explain the trial, foreseeable burdens, right to refuse and how to communicate distress or withdrawal.

Mandatory. A French consent or authorization document for the correct curatorship, representation or no-formal-measure route. A modular form may be used only if each role and legal basis is unambiguous.

Mandatory. The French recruitment and informed consent procedure must explain how capacity is assessed, how legal status and authority are verified, how the participant is involved, how dissent is monitored and when later consent is sought.

Conditional. Include judge or family-council authorization where the French serious-risk rule applies.

Conditional. Prepare separate French genetic-testing information and consent records where genetic examination is planned. Confirm who can authorize that examination under the person's exact status.

Information, assent and dissent

Capacity is decision-specific and may fluctuate. Provide information in a suitable format, at a suitable time, with communication support where needed. Record what the participant understood and how personal wishes were sought.

French law requires the participant to be consulted where the person's condition permits and requires personal adherence to be sought. An explicit refusal or withdrawal cannot be overridden by the representative. Stop or do not begin the person's participation when the person communicates a clear objection, subject only to immediate safety care outside the trial decision.

Do not reduce dissent to a signature question. Behaviour, communication aids and reports from people who know the participant may be relevant, but the investigator remains responsible for the trial decision and documentation.

Signature logic

The CTIS versions are unsigned and include the correct planned fields. At consent, the participant signs where the participant is legally consenting, including the assisted curatorship route. The curator signs to record assistance. A legally authorised representative signs where representation or the no-formal-measure hierarchy applies. The investigator or person conducting the interview also signs and dates under Article 29.

Identify each person's role beside the signature. Avoid one block labelled participant or representative. Give the participant and representative a copy in the form most useful to them.

Re-consent if capacity or status changes

If the participant regains capacity, provide the current French information and seek the participant's own consent for continued participation without undue delay. French law expressly requires consent for continuation when capacity returns in the no-formal-measure route.

If capacity declines, pause any decision that requires valid consent and verify whether a representative pathway now applies. If the protective measure, representative or court order changes, recheck authority and update the consent record. Explain these triggers in the submitted consent procedure.

Payment and privacy

Apply French restrictions on financial benefits for protected persons. Do not offer a constraint indemnity to a person in a category for which French law prohibits it. Reimbursement of justified expenses remains distinct and should be handled without pressure on the decision.

Provide the full privacy notice to the representative and an adapted version to the participant. Explain access, objection and withdrawal in a way that does not suggest the representative owns the participant's data. Reassess privacy communications when the participant regains capacity.

National template position

France has no mandatory national template covering all limited-capacity routes. The sponsor must create a French set that reflects Article 31 of the Clinical Trials Regulation, Article L1122-2 of the Public Health Code and the exact legal measure.

Use the France patient-facing document QC checklist before release. Return to the France CTIS hub for the complete guide series.