France CTIS Part II Minor Consent and Assent Requirements

Who is a minor in France

A person under 18 is a minor under French civil law. The Clinical Trials Regulation does not set fixed child and adolescent document bands. French law requires information adapted to the minor's capacity for understanding and requires the minor to be consulted to the extent possible.

For document design, sponsors commonly create a parent or guardian information and authorization form plus age-adapted child and adolescent information or assent materials. The age ranges must be justified by readability and maturity, not presented as statutory French bands. A single age-adapted document may be adequate for a narrow cohort. A broad pediatric range usually needs more than one version.

Conditions for including minors

Before preparing forms, confirm that the protocol satisfies Article 32 of the Clinical Trials Regulation. The minor's legally designated representative must authorize participation. The minor must receive age and maturity-adapted information from trained or experienced staff and must be involved in the consent process.

The trial must concern the condition from which the minor suffers or be of such a nature that it can be carried out only on minors. The expected direct benefit or population benefit, scientific validity and minimal risk and burden conditions must also be met. No financial incentive may be offered beyond compensation for expenses and loss directly related to participation, subject to stricter French restrictions.

Required document set

Mandatory. A French parent or parental-authority information and authorization document. It should contain the full trial information and the signature blocks required by the applicable parental route.

Mandatory. French information adapted to each minor who can understand any part of the decision. This may be a child information sheet, an adolescent information and assent form, or another developmentally appropriate format.

Mandatory. The French recruitment and informed consent procedure must explain how parental authority is verified, who provides information to each age group, how personal adherence is sought, how refusal is recorded, and when re-consent occurs.

Conditional. A separate French genetic-testing information and consent document is required where genetic examination is planned. Its authorization and explanation must be appropriate to the minor pathway.

Conditional. Separate optional-use forms are needed where future data or sample use is not covered by the main pediatric consent set. The France secondary-use guide explains that structure.

Parent and guardian authorization

The normal French route requires authorization from the holders of parental authority. Where two people hold parental authority, plan for both to authorize and sign. Verify the legal status rather than assuming that an accompanying adult is entitled to consent.

French law permits authorization by one holder of parental authority only when all statutory conditions are met. The trial must involve only minimal foreseeable risk and burden, the minor cannot be a healthy volunteer, and the other holder must be unable to provide authorization within a time compatible with the trial. Treat this as a documented exception, not a convenience route.

If parental authority is exercised through another legally recognised arrangement, obtain evidence of the signer's authority under the site's controlled process. Do not ask the CPP to infer authority from a family relationship alone.

Information, assent and personal adherence

Give the minor honest information about the purpose, procedures, foreseeable discomforts, choices and right to stop. Use language and formats suited to the child's or adolescent's understanding. A short child sheet supplements the full parent document and does not remove the duty to answer the minor's questions.

French law describes seeking the minor's personal adherence rather than imposing one national assent-form model. A signature can be a useful record when the minor can meaningfully sign, but the process and the minor's response matter more than a ceremonial signature. Do not imply that the minor's signature replaces parental authorization.

The investigator must consider the minor's explicit wish to refuse participation or withdraw at any time. French law states that a minor's refusal cannot be overridden. Record a refusal and do not continue merely because a parent has authorized participation.

Signature logic

The versions uploaded in CTIS are unsigned but include the planned fields. At enrollment, the required holder or holders of parental authority and the person conducting the consent interview sign and date the authorization record. Give the family a copy.

Where the protocol uses a child or adolescent assent signature, label it as the minor's personal agreement or adherence, not as the sole legal authorization. Include a field for the staff member who provided the age-adapted explanation where this is not already clear from the main consent record.

Document any use of the one-parent exception and why the other holder could not provide authorization in time. Avoid adding an automatic missing-parent checkbox without a reason and verification process.

Re-consent at 18 and changes in understanding

When a participant reaches 18 during the trial, provide the current adult French information and seek the participant's own consent for continued participation. Plan the timing in the recruitment and informed consent procedure so re-consent is not missed at the next visit.

As a child matures before 18, provide updated information and seek age-appropriate personal adherence when it becomes meaningful. This is good consent practice even though legal majority has not yet been reached. A major protocol change may also require re-information and renewed parent authorization or assent through the approved modification.

Payment and privacy

French law does not permit a constraint indemnity for minors. Reimbursement of justified expenses should be described without making participation financially attractive to the family. Align the wording with the EU compensation form.

Explain the child's data rights in a way the child can understand and give the parent the full MR-001 or other applicable privacy notice. Address who receives information while the person is a minor and how privacy contacts and rights change at adulthood.

National template position

France has no mandatory national template for child, adolescent or parent information and authorization documents. The sponsor must create French versions that meet Article 32 of the Clinical Trials Regulation, Article L1122-2 of the Public Health Code and the national Part II guidance.

Before submission, apply the population checks in the France patient-facing document QC guide. Return to the France CTIS hub for the full guide series.