Slovenia CTIS Limited-Capacity and Legal Representative Consent Requirements

When the pathway applies

Conditional. Use the legal-representative pathway only when the adult is unable to understand, retain, weigh, or communicate the information needed for the trial decision and national law recognises the representative's authority.

Capacity is decision-specific and can change. The protocol and consent procedure should identify who assesses capacity, when reassessment occurs, how fluctuating capacity is managed, and how the legal representative is verified.

Do not use this pathway solely because a person cannot read, cannot write, has a physical disability, or needs an interpreter. A person who understands and can decide should consent personally, with accessible communication or the impartial-witness procedure where needed.

Article 31 conditions

The application should demonstrate that:

• informed consent will be obtained from the legally designated representative
• the participant receives information according to the participant's capacity to understand
• an explicit wish to refuse or withdraw is respected
• no prohibited incentive or financial inducement is offered beyond compensation for expenses and loss of earnings directly related to participation where permitted
• the research is necessary in the population unable to consent and cannot validly be performed only with people able to consent
• the trial relates directly to the participant's condition or satisfies the narrow group-benefit conditions
• expected benefit, risk, and burden satisfy Article 31

Describe these points in the protocol and the recruitment and informed consent procedure. The representative document should not merely repeat the adult standard form without explaining the representative's role.

Slovenia legal representative framework

The Patients' Rights Act states that when a patient cannot consent because of mental-health difficulties or another cause affecting decision-making ability, a medical intervention requires authorisation from the legal representative. If no representative exists, the healthcare provider informs the competent authority so that a representative can be appointed.

KME RS guidance directs applicants to obtain consent from the participant's close person or legal representative when the invited person cannot consent, with specific reference to Article 37 of the Patients' Rights Act. For a CTIS medicinal-product trial, verify the person who qualifies as the legally designated representative for the actual situation. Do not let an informal family relationship replace documented legal authority when the CTR requires a legally designated representative.

Required documents

Prepare:

• A Slovenian legal-representative Patient Information Sheet and Informed Consent Form.
• A Slovenian participant information or assent document suited to the participant's understanding.
• A capacity-assessment and representative-verification procedure for the site file and consent process.
• A direct re-consent form for participants who regain capacity.
• An impartial-witness section if the representative or capable participant can consent but cannot write.
• Separate optional-consent documents for secondary use when appropriate.

Upload blank, versioned participant-facing forms in CTIS Part II. Capacity assessments and completed representative evidence are conduct records, not pre-signed application documents.

Information for the participant

Give information through a person trained or experienced in working with the relevant population. Use language, pictures, supported communication, repetition, or other aids appropriate to the participant.

Explain what will happen, discomfort, risks, possible benefit, alternatives, the voluntary nature of participation, and the right to object. Even when the participant cannot provide legal consent, seek cooperation and assent to the extent meaningful.

An explicit refusal or resistance from a participant capable of forming an opinion must be respected. Do not treat silence, passivity, or inability to sign as agreement.

Information for the legal representative

Explain that the representative must decide according to the participant's presumed wishes and interests, not the representative's convenience or preference. Cover the trial purpose, necessity of research in this population, procedures, risks, burdens, expected benefit, alternatives, privacy, samples, insurance, withdrawal, and the participant's right to object.

State how capacity will be reviewed and that the participant will consent personally if capacity returns. Explain what happens if the representative changes or loses authority.

Consent and signature logic

At CTIS submission, the representative, participant, witness, and interviewer do not sign the blank forms.

When consent is obtained, the legally designated representative and the person conducting the interview sign and date the approved representative consent form. Record the participant's assent, cooperation, refusal, or dissent according to the approved procedure. Give signed and dated copies to the representative and, where useful, the participant.

If the representative can decide but cannot write, use the Slovenia impartial witness pathway. An interpreter helps comprehension but does not become the legal representative merely by translating.

Regained or fluctuating capacity

Reassess capacity at protocol-defined and clinically relevant points. If the participant regains capacity, provide the current Slovenian information and obtain the participant's express informed consent before continued trial participation. Explain how previously collected data and samples are handled if the person does not consent to continue.

For fluctuating capacity, document each assessment and avoid repeated consent procedures that add burden without improving protection. The approved plan should define when direct consent, representative consent, or renewed discussion is needed.

Optional research and samples

A representative should not be asked to authorise vague, unlimited future use without a clear legal and ethical basis. Separate optional research from main-trial requirements, explain withdrawal limits, and plan to seek the participant's own choice if capacity returns. Use the Slovenia secondary-use guide.

No dedicated national limited-capacity template

No current Slovenia-specific CTIS form for limited-capacity participants or legal representatives was identified on the official JAZMP or KME RS pages. Use the CTR conditions, Patients' Rights Act, and current KME RS guidance, then tailor the forms to the protocol and population.

Return to the Slovenia CTIS hub for the complete guide set.