Belgium Limited-Capacity Participant and Legal Representative Consent Requirements

When the variation applies

Use this pathway only when an adult cannot give informed consent for the trial decision. A diagnosis, disability, temporary confusion or use of supported communication does not automatically remove capacity. Assess whether the person can understand, retain and weigh the relevant information and communicate a choice with appropriate support.

The protocol should explain why adults lacking capacity need to be included and how capacity will be assessed and reviewed. Regulation (EU) No 536/2014 also limits such trials to defined conditions, including consent from the legally designated representative, information adapted to the participant's capacity, respect for prior wishes and the prospect of direct benefit or the strictly limited group-benefit route allowed by Article 31.

Belgian representative hierarchy

The Law of 7 May 2017 refers to Articles 12 and 14 of the Belgian Patients' Rights Act. For an adult unable to exercise patient rights, use the following order:

1. A representative designated by the adult in a specific written, dated and jointly signed mandate.
2. A court-appointed administrator authorised to exercise the relevant patient rights.
3. A cohabiting spouse, legal cohabitant or de facto cohabiting partner.
4. In order, an adult child, a parent, or an adult sibling.
5. If nobody in the hierarchy acts, or if representatives conflict, the healthcare professional safeguards the patient's interests, where appropriate through multidisciplinary consultation.

Confirm the person's authority before consent and document the basis. A trusted person who merely assists the participant is not automatically the legally designated representative.

Required documents

Mandatory. Provide the representative with a full information and consent form in the required official regional language. It should explain the representative's role, the trial, reasons for including adults lacking capacity, risks, burdens, expected benefit, alternatives, withdrawal and the participant's rights.

Mandatory. Provide the participant with information adapted to the person's comprehension. This may be a simplified information sheet, supported communication or the main ICF explained in an accessible way. Document how the participant was involved and how assent or objection was assessed.

Conditional. Add documents for a temporary-capacity pathway, advance refusal, impartial witness, emergency enrolment, pregnancy follow-up or optional future use when those situations can occur. Describe each route in the mandatory EU recruitment and informed-consent procedure template.

Submit blank forms in Part II. The representative and the person conducting the consent interview sign and date the approved form when consent is obtained. If the participant can provide a meaningful assent signature, include it without presenting assent as the legal authorisation.

Participant wishes, objection and dissent

The representative must act in the participant's interests and in line with the person's expressed values, care preferences and life goals. The participant should be involved as far as possible in proportion to understanding.

Do not enrol a person who gave a relevant prior refusal while capable. During the trial, respect an explicit wish by the participant to refuse participation or withdraw where the person can form and express an opinion. Resistance, distress or a clear objection should trigger review rather than being treated as non-compliance.

The representative may withdraw permission. Explain what trial activities stop, what safety care continues and how data already generated may still be used lawfully.

Re-consent when capacity changes

Capacity may improve after treatment, recovery from an acute episode or a change in condition. Build reassessment points into the protocol. Once the participant can consent personally, provide the approved adult information and obtain the participant's own consent for continued participation without undue delay.

If a participant who originally consented loses capacity, check any prior instructions, the approved protocol and the representative hierarchy before further trial decisions. Do not assume that the original signature answers every new optional choice or substantial change.

Main differences from the standard adult ICF

• Explain why this population is scientifically necessary.
• Identify the legal basis and authority of the representative.
• Provide accessible information directly to the participant.
• Separate representative consent from participant assent.
• Describe objection and withdrawal safeguards.
• Include capacity reassessment and personal re-consent.
• Avoid language that allows the representative to waive participant rights.

Use the Belgium patient-facing QC checklist to test the documents against the protocol. The Belgium emergency-enrolment guide covers the separate situation where neither the participant nor a representative can consent before an urgent intervention. Return to the Belgium CTIS hub for all guides.