France CTIS Part II Healthy Volunteer Consent Requirements

Required document set

Mandatory. A French healthy-volunteer information sheet and consent form, either as a dedicated document or a clearly separated cohort version. File it in Part II section L with the initial application.

Mandatory. The French recruitment and informed consent procedure must describe volunteer identification, screening, decision time, compensation, any exclusion period and the consent process. File it in section K.

Mandatory. The EU compensation form must state expense reimbursement and any constraint indemnity, including when no payment is planned. The signed Additional France application document must state any exclusion period.

Conditional. Submit recruitment advertisements, screeners, digital pages, diaries and other participant materials before use.

Conditional. Prepare a separate French genetic-testing information and consent form when a genetic examination is included.

Main differences from the standard participant document

State clearly that the volunteer is not selected because treatment of a disease is expected. Do not suggest direct medical benefit unless the protocol provides a realistic individual benefit that can be described without exaggeration. Explain the scientific purpose and why healthy participants are needed.

Describe first-in-human or early-phase uncertainty where applicable. Explain dose escalation, sentinel dosing, placebo, inpatient stays, fasting, activity limits, intensive blood sampling and other burdens in participant language. State stopping rules or safety monitoring only to the level needed for an informed decision.

List restrictions that protect the volunteer or trial integrity, such as other study participation, blood donation, medicines, alcohol, nicotine, food, exercise, contraception and pregnancy prevention. Give the applicable period before, during and after dosing.

Explain screening results and incidental findings, including what is returned, what may not be clinically validated and when medical referral may be recommended. Do not imply that screening replaces ordinary healthcare.

Compensation and absence of undue influence

French law permits reimbursement of expenses and an indemnity for the constraints of research. It does not permit another financial advantage. Explain the amount, calculation, payment schedule and the effect of early withdrawal. Payment should reflect time and burden, not be framed as payment for risk.

The total constraint indemnity paid to one person for research participation cannot exceed EUR 6,000 during twelve consecutive months under the Order of 15 February 2023. Reconcile the participant wording with the EU compensation form and the sponsor's payment process.

Exclusion period and national register

State any period during which the volunteer may not participate in another research project. Enter that period in the Additional France application document and keep it consistent with the protocol and participant information.

Where French rules require entry in the national register for people participating in research, the privacy information should explain the registration, data used and applicable rights. Confirm the exact process for the study with the sponsor's France privacy and site teams. Do not use a generic database statement that conflicts with the current MR-001 notice.

Consent and signatures

The unsigned version filed in CTIS includes signature and date fields for the volunteer and the investigator or other person conducting the consent interview. At consent, both sign and date after the volunteer has received the French information, had adequate decision time and had questions answered. Give the volunteer a copy.

Keep optional genetic work, future sample use and other optional substudies distinct from main participation. A volunteer may refuse an optional element without losing access to the main trial unless that element is genuinely required by the protocol and presented as such.

Minors and protected adults

Do not adapt this adult healthy-volunteer form into a minor pathway. The limited French one-parent authorization exception does not apply to a minor who is a healthy volunteer, and the Clinical Trials Regulation imposes strict necessity and condition-related requirements for research in minors. Any proposed inclusion of a protected adult also requires the separate legal-capacity analysis and cannot rely on the standard volunteer signature block.

Use the France minor guide or France limited-capacity guide before finalising such a protocol. Return to the France CTIS hub for the full guide set.

National template position

France has no mandatory national template for the healthy-volunteer information and consent form. Use the standard EU and French information requirements, the EU recruitment-procedure and compensation templates, the Additional France application document and the MR-001 information rules.