Belgium Healthy Volunteer Consent Requirements

When to use the healthy-volunteer form

Use the template for an adult healthy-volunteer trial involving an investigational medicinal product. This commonly includes early-phase pharmacology, safety, tolerability, pharmacokinetic or pharmacodynamic studies, but the protocol's population definition controls.

Do not use the adult-patient template simply because the investigational product may eventually treat a disease. The consent document must describe the current participant population and the absence of expected therapeutic benefit.

For an investigational vaccine in healthy adults, the separate vaccine template remains the relevant reference. The CT-College states that it is under revision and strongly recommends its use to avoid ethics questions. The general healthy-volunteer template does not silently replace that specialised route.

Required documents

Mandatory. Submit the blank healthy-volunteer ICF in each official regional language needed at the sites. Include the EU recruitment and informed-consent procedure template and describe screening, databases or panels, pre-recruitment, repeat-volunteer controls and the consent interview.

Conditional. Submit recruitment advertisements, website text, call scripts and other material used to attract volunteers. Clearly disclose compensation and avoid language that presents payment as a reason to ignore risk.

Conditional. Add separate forms for pregnancy follow-up, optional genetic or sample research, impaired capacity arising during the trial or other special pathways. Healthy status does not remove these consent requirements.

Differences from an adult-patient ICF

The healthy-volunteer form should make clear that:

• the participant does not have a condition expected to benefit from the investigational product
• no therapeutic benefit is expected
• first-in-human or limited human experience creates uncertainty where applicable
• confinement, fasting, restrictions, repeat dosing, challenge procedures and washouts may create burdens
• screening can reveal incidental findings and the document explains how they are handled
• prohibited medicines, alcohol, nicotine, recreational drugs, strenuous activity and diet restrictions are described precisely
• reproductive precautions and exposure windows match the protocol and product data
• compensation is linked to time and burden, not successful completion or tolerance of risk
• withdrawal and early termination payment rules are transparent

Describe sentinel dosing, dose escalation or stopping rules only to the level needed for an informed decision. Do not imply that safety monitoring eliminates risk.

Recruitment and pre-recruitment

Belgium requires recruitment material in at least the official language or languages of the region where it is used. Submit the final presentation under Part II when applicable.

If an early-phase unit uses pre-recruitment before trial authorisation, follow the CT-College recommendation and describe the approach in the mandatory recruitment and informed-consent procedure. Pre-recruitment must not become trial-specific consent or trial conduct before authorisation. Make the distinction clear in the scripts and database wording.

BAREC's general list of patient-facing documents that need no ethics review does not exempt recruitment advertising. If an item influences a volunteer's decision, submit it.

Compensation and insurance

The ICF must distinguish reimbursement of expenses from compensation for time, inconvenience or burden. State payment amounts, schedule, deductions after withdrawal and any non-cash benefits. Match the Part II finance documents and site agreement.

Belgium requires no-fault trial insurance. Explain how a participant obtains information or makes a claim without asking the participant to waive legal rights. The insurance certificate is submitted separately under Part II.

Language, consent and signatures

Use the official participant language of each trial region. Preserve the approved standard text in the Dutch, French and English template versions and translate the study-specific content carefully. German must be prepared where the German-speaking participant population is recruited.

The blank form is not signed at CTIS submission. Consent is obtained before any trial-specific screening or procedure unless a clearly authorised pre-screening process applies. The participant and person conducting the interview sign and date the approved form. For electronic consent, the investigator signs last and the participant retains a locked copy.

Healthy volunteers must have enough time to decide and a genuine right to refuse or withdraw. Compensation should not be structured so that withdrawal causes a disproportionate financial loss.

Final checks

• Use the latest CT-College healthy-volunteer template and current sponsor statement.
• Include a sponsor statement if the mandatory template is not used or fixed wording changes.
• Use the vaccine-specific template for vaccine trials and note its recommended status.
• Match screening, restrictions, confinement, blood volumes, reproductive precautions and payments to the protocol.
• Confirm that recruitment claims are neutral and that all regional languages are present.
• Explain repeat-volunteer and safety-database checks where the procedure uses them.

Use the Belgium patient-facing QC checklist for the final cross-document review and return to the Belgium CTIS hub for the connected guides.