Slovenia CTIS Patient Information and Consent Requirements

Slovenian language and document structure

Mandatory. Every document intended for participants must be in Slovenian. The national rule applies to the PIS, ICF, recruitment content, diaries, cards, questionnaires, instructions, age-specific information, legal-representative documents, and optional-consent materials. Administrative Part II documents may generally be in Slovenian or English.

Use natural Slovenian terminology and short sentences. Define technical terms. Keep the information sheet and consent choices visually easy to follow. Avoid treating a literal translation as adequate without clinical and linguistic review.

The PIS and ICF may be one integrated document or two coordinated documents. In either structure, the title, protocol identifier, EU trial number, population, version, date, and site contact details must match. Optional activities should not be hidden inside one general agreement.

Content required in the Patient Information Sheet

Trial identity and purpose

State the full and plain-language trial title, sponsor, protocol number, EU trial number, reason for the research, investigational treatment, comparison where applicable, and why the person is being invited. Make clear that the activity is research and identify any aspects that differ from ordinary care.

Procedures, visits, and duration

Explain screening, randomisation, blinding, treatment, placebo or comparator, visits, hospital stays, samples, imaging, questionnaires, devices, follow-up, and participant responsibilities. Give realistic time commitments and the expected duration of the person's participation. Identify procedures performed only for research.

Risks, burdens, and safety measures

Describe reasonably foreseeable adverse effects, procedural risks, reproductive and genetic risks, inconvenience, pain, travel, time, and uncertainty. Explain important safety checks, emergency contacts, treatment discontinuation rules, and circumstances in which the investigator or sponsor may stop participation.

Where teratogenic or reproductive risk exists, provide specific written information on pregnancy and fetal risk, contraception requirements, and the period during which pregnancy must be avoided. KME RS guidance expects a signed acknowledgment of that information from women of childbearing potential and the same warning for healthy female partners of male participants when the risk applies. Use the Slovenia pregnancy follow-up guide for the separate follow-up pathway.

Expected benefits and alternatives

Do not imply personal benefit when none is expected. Explain possible direct benefit, benefit to future patients, and uncertainty. Describe reasonable alternatives to participation, including standard care where applicable. State what happens to ordinary healthcare if the person declines or withdraws.

Voluntary participation and withdrawal

State that participation is voluntary. The person may refuse or withdraw without giving a reason and without loss of appropriate healthcare or damage to the relationship with the treating physician. Explain which trial activities stop, what safety follow-up may still be requested, what happens to collected samples, and why some data may need to be retained for legal and scientific integrity.

Privacy, confidentiality, and data use

Explain who controls and processes personal data, what data are collected, why, who receives them, who may inspect source records, coding or pseudonymisation, international transfers, safeguards, retention periods, and participant rights. State clearly when complete deletion cannot be promised.

Do not describe informed consent to participate as automatically providing the legal basis for all data processing. Slovenia's Information Commissioner and the European Data Protection Board treat trial consent and GDPR legal basis as separate questions. Optional future research must be separated from the main trial and described in the Slovenia secondary-use guide.

Biological samples

Explain which samples are required, why they are taken, the tests planned, coding, storage, transfers, access, destruction or retention, genetic analysis, incidental findings where relevant, and withdrawal limits. If optional future use is planned, give it a separate choice. The participant must be able to refuse future use without losing access to the main trial when that use is not necessary for trial participation.

Compensation, expenses, treatment, and insurance

Describe travel reimbursement, meals, accommodation, compensation or payment, the schedule, and what happens after early withdrawal. The amount must not create improper pressure to participate.

Explain care and compensation for trial-related injury and provide a practical contact route. Slovenian law requires insurance or another guarantee for sponsor and investigator liability before the trial starts. Do not make broader promises than the policy supports.

Results, new information, and contacts

Explain whether and how overall results will be available, how important new information will be communicated, and whether individual findings will be returned. Provide the name, role, address, and telephone number of the investigator or qualified contact who can answer questions and provide urgent medical advice.

The official KME RS page also identifies JAZMP, KME RS, patient-rights representatives, the Human Rights Ombudsman, and the Information Commissioner as national contact points. Include the trial and participant-rights contacts that KME RS expects for the specific document, using current contact details rather than copying an old address from a saved template.

Informed Consent Form content

The signature page should confirm that the participant:

• received and understood the written and oral information
• had the opportunity to ask questions and received satisfactory answers
• had enough time to decide
• understands participation is voluntary
• understands the right to withdraw without giving a reason and without harm to ordinary care
• agrees to the defined trial procedures
• understands the injury and insurance information
• receives a signed and dated copy

Use separate statements and signature boxes for genuinely optional activities, such as future research samples, optional genetic work, optional contact for other studies, or pregnancy-partner follow-up. A refusal of an optional item must not be presented as refusal of the main trial.

KME RS publishes a one-page model titled Form of Voluntary and Informed Consent After Information. It records written and oral information, withdrawal rights, voluntary participation, anonymised scientific use, participant and investigator signatures, dates, and two copies. It is a useful national reference but is not a complete substitute for a trial-specific CTR PIS and ICF.

Consent interview, signatures, and copies

At CTIS submission. Upload blank forms. Future participants, legal representatives, witnesses, and interviewers do not sign the submission version.

When consent is obtained. A suitably qualified member of the trial team conducts the interview. The participant and the person conducting the interview personally sign and date the consent record. KME RS guidance says the participant signs in the investigator's presence and that the form is prepared in two copies, one for the participant and one for the research archive.

Allow sufficient time for consideration. Confirm understanding rather than relying only on a signature. Give the participant the written information and a signed and dated copy of the consent record.

If the person can consent but cannot write, use the Slovenia impartial witness pathway. If the person lacks legal capacity, use the limited-capacity pathway. An interpreter may support comprehension but does not automatically replace an impartial witness or a legally designated representative.

Changes and re-consent during the trial

Provide new information that could affect willingness to continue. Update the Slovenian PIS and ICF when a substantial change affects participant information, risk, procedures, privacy, compensation, or optional use. Obtain approval through the appropriate CTIS route before using the revised material unless an urgent safety measure applies.

Re-consent is needed when the approved change affects the basis on which participation was agreed or when legal status changes. Examples include a minor reaching adulthood, an adult regaining capacity, a new optional research use, or material new safety information.

Population-specific document set

• Healthy volunteers need an adapted explanation of non-therapeutic participation, payment, burden, and reproductive risk. Use the healthy volunteer guide.
• Minors need parent or legal-representative consent and age-appropriate information and assent. Use the minor consent and assent guide.
• Adults unable to consent need a legal-representative document and participant information suited to their understanding. Use the limited-capacity guide.
• Emergency enrollment is allowed only when Article 35 conditions and the approved protocol are met. Use the emergency enrollment guide.
• A participant or representative unable to write may need an impartial witness. Use the impartial witness guide.
• Pregnancy follow-up and partner data need distinct information and consent logic. Use the pregnancy follow-up guide.
• Optional future use of data and samples needs a separate, non-coercive choice. Use the secondary-use guide.

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