Greece Limited-Capacity Participant and Legal Representative Consent Requirements

When the pathway applies

Greek implementing law defines the relevant participants by reference to court-ordered full deprivation, partial deprivation or assistance because of a mental or intellectual disorder, prodigality, drug dependence or alcoholism. Confirm the scope of the court order. A diagnosis, temporary confusion, family preference or hospitalization alone does not establish this legal status.

The legally designated representative is the court-appointed judicial supporter who exercises the relevant care function. Keep evidence of appointment and authority in the site file and provide it to the National Ethics Committee if requested.

This ordinary limited-capacity route is different from the special emergency representative definition used only for Article 35 emergency enrollment. The Greece emergency enrollment guide explains that separate route.

Documents to prepare

Mandatory. Prepare a Greek participant information and agreement form adapted to the person's ability to understand. It should explain the trial, procedures, expected benefits, risks, alternatives, rights and withdrawal in direct language.

Mandatory. Prepare a Greek legally designated representative information and consent form. It must explain that the decision should reflect the participant's presumed wishes, not the representative's own preference.

The forms may be integrated when that produces a clear process, but separate versions are often easier to read and sign. At CTIS submission the forms are blank. Include future signature and full-date fields for the participant where able, the court-appointed judicial supporter, and the investigator or authorized study-team member.

Participant agreement and objection

The participant receives clear information in language and a format that the person can understand. Obtain the participant's own written agreement when and to the extent the person is able to understand the trial, its expected benefits and risks.

A capable expression of refusal or a wish to withdraw is binding. The representative cannot override it. Explain any medical risks of stopping and document the conversation without pressuring the participant.

The representative's consent must express the participant's presumed will and can be withdrawn at any time without negative consequences for the participant.

Consent process and signatures

Conduct the interview with the participant and representative in person under the Greek paper-consent guidance. The qualified investigator or authorized team member allows questions and enough time for a decision. All applicable signers enter a full date. Give a signed copy to the participant and representative in an accessible form.

Do not use witness signatures as a substitute for a legally designated representative. A witness supports the consent process when the person cannot use the ordinary reading or writing pathway. The Greece impartial witness guide explains when one or two witnesses are needed.

Capacity changes and re-consent

Assess decision-making ability throughout participation when the condition can change. If the participant becomes able to provide informed consent, continued participation should move to the ordinary adult consent pathway. Obtain the participant's own consent promptly using the approved Greek adult form and document what information and prior activities were discussed.

If capacity decreases after ordinary consent was obtained, follow the approved protocol and obtain the legally designated representative's consent where continued participation relies on the limited-capacity pathway. Continue to inform the participant and respect objection.

The Greek implementing decision does not state a separate re-consent deadline for every change in capacity. Define the operational timing in the protocol and consent procedure and address uncertainty with the National Ethics Committee before enrollment.

Trial eligibility safeguards

The CTR permits inclusion of incapacitated participants only when its Article 31 conditions are met. The trial must relate directly to the participant's condition, be scientifically necessary in the protected population, and meet the applicable benefit, risk and burden limits. No incentives may be offered beyond compensation for expenses and loss of earnings directly related to participation.

Greek law separately excludes people serving compulsory military service, people serving custodial sentences, people barred by court decision and people living in institutions from clinical trials. Check these exclusions before creating a representative pathway.

Use the Greece patient-facing QC checklist and return to the Greece CTIS guide hub for related documents.