Slovakia CTIS Limited-Capacity Participant and Legal Representative Consent Requirements

Start from the standard Slovakia consent set

Use the Slovakia patient information and consent guide for the ordinary requirements on Slovak language, trial information, risks, alternatives, privacy, samples, insurance, contacts and signatures. Adapt the reader and legal decision-maker without removing information the representative needs.

Capacity is decision-specific and may change. Do not use diagnosis, age, hospitalization or disability alone as proof that a person cannot consent. The protocol and consent procedure should explain who assesses capacity, when it is reassessed and how the result is documented.

When representative consent may be used

Conditional. This pathway applies when the adult lacks legal capacity to provide informed consent for the trial and enrollment meets Article 31 of the Clinical Trials Regulation. The trial must relate directly to the participant's medical condition or be of a nature that can be carried out only in that population, with the required benefit and risk safeguards.

Identify the legally designated representative under Slovak law. Verify authority before enrollment and retain the evidence in the site file. A caregiver or family member who helps the participant is not automatically the legal representative.

Required documents

Prepare:

• a Slovak Participant Information Sheet and consent form for the legal representative
• a simplified Slovak information or assent document for the participant when the participant can understand part of the trial
• a consent procedure explaining capacity assessment, representative verification, participant involvement, objection and re-consent
• an approved adult consent form for later use if the participant regains capacity

The blank forms are submitted in Part II. At enrollment, the legal representative and the person conducting the discussion sign and personally date the representative form. The participant signs or otherwise records assent when appropriate, but assent does not replace the representative's legal consent.

Participant involvement and objection

Give information in a form matched to the participant's ability. Check whether the participant can form an opinion, express willingness and understand the right to refuse or stop.

Respect an explicit wish not to participate or to withdraw when the participant can form an opinion. The representative's permission cannot override meaningful objection. Explain any immediate safety procedures needed after refusal.

Slovak health-care law also requires the views of a person unable to consent to be recorded when a representative gives health-care consent. Align the trial source documentation with this principle.

Limits on benefit, risk and payments

The application must justify inclusion of adults unable to consent. Explain why the research cannot provide comparable evidence in people who can consent and how pain, discomfort, fear and other foreseeable risks are minimized.

Do not promise the representative a financial or material advantage beyond lawful compensation or expense reimbursement. State participant and caregiver travel reimbursement separately. If a caregiver completes trial assessments, the caregiver's agreement to assist is not legal consent for the participant.

Re-consent after a change in capacity

If the participant regains capacity, provide the approved adult information and obtain the participant's own consent promptly for continued intervention, follow-up and optional activities. The representative's earlier consent does not replace the participant's later decision.

If capacity fluctuates, define how urgent safety decisions, routine visits and optional research will be handled. Document each assessment and avoid repeated consent discussions that create distress without changing the legal position.

Data, samples and caregiver information

Separate processing of participant data from data supplied about a caregiver or representative. Give each data subject the information relevant to them. Do not ask a representative to authorize optional future use more broadly than the participant's known wishes.

For optional sample or data use, provide a separate choice and explain who may withdraw that choice if capacity changes. Use the Slovakia secondary use guide for that addition.

Submission checks

Confirm that the protocol, Part II procedure and forms use the same capacity criteria and legal-representative definition. Check Slovak language, authority evidence, participant information, objection rules, re-consent, signature blocks, reimbursement, privacy and samples.

Use the Slovakia patient-facing QC checklist and Part II document checklist before upload. Return to the Slovakia CTIS hub for the complete series.