Croatia healthy volunteer consent requirements

When to use this variation

Conditional. Use a healthy-volunteer version whenever people without the condition under study are recruited. This is common in Phase I, bioavailability, food-effect, interaction, pharmacokinetic, pharmacodynamic, and some vaccine trials.

Do not reuse a patient document that refers to treatment of the participant's disease, expected therapeutic benefit, or disease-specific alternatives. A participant may be medically screened and still be a healthy volunteer for the trial's purpose.

Required documents

Submit a blank, versioned, and dated Croatian informed consent for healthy volunteers under Subject information and informed consent form. Keep the participant information and the signature section in one unified document. It is not signed at CTIS submission.

Submit Croatian recruitment advertisements, prescreening scripts, visit cards, restrictions, diaries, and participant instructions that will be used. Describe recruitment, prescreening, databases, repeat-participation checks, and consent in the Recruitment arrangements procedure.

Prepare separate consent where the protocol includes optional genetics, optional sample storage, pregnancy follow-up, a caregiver or third party, home delivery, or another use outside the main healthy-volunteer participation.

Explain non-therapeutic participation clearly

State that the volunteer is not being treated for an illness and should not expect medical benefit from participation. Explain the scientific purpose without suggesting that screening or participation is a substitute for ordinary health assessment.

Describe first-in-human status where applicable, prior human exposure, dose escalation, sentinel dosing, stopping rules, and important uncertainty in plain language. Place serious and reasonably foreseeable risks where they are easy to find.

Explain placebo as a substance without the active trial medicine. Do not describe it as a false medicine. If the study is blinded, explain what the participant, investigator, and emergency team will and will not know.

Procedures, restrictions, and practical burdens

List screening tests, admission, confinement, fasting, meals, posture requirements, dosing, blood volumes, urine collection, biopsies, imaging, heart monitoring, cognitive tests, questionnaires, follow-up, and washout periods. State which findings may make the volunteer ineligible and how clinically relevant incidental findings will be handled.

Explain restrictions on alcohol, nicotine, caffeine, food, exercise, driving, medicines, supplements, blood donation, other trials, and pregnancy. Give exact periods rather than vague wording. Describe overnight stays, free time limits, communication rules, and when a participant may leave the unit.

Where an electronic diary or device is required, explain data collection and return. Central Ethics Committee guidance recommends that the sponsor provide a study device for participant questionnaires and diaries and that it be returned at the end of participation.

Reproductive precautions

When effects on reproductive cells, embryo, fetus, or unborn child are unknown or potentially harmful, Croatian national specifics expect both partners to use reliable contraception. Define every acceptable method and the required period before, during, and after exposure.

If pregnancy follow-up is planned for a female volunteer or a male volunteer's partner, state that the pregnant person will be asked to consider a separate consent. Do not collect partner data through the volunteer alone. The Croatia pregnancy follow-up guide explains the separate documents.

Payments and reimbursement

Explain the payment or reimbursement amount, calculation, schedule, conditions, and effect of early withdrawal. Distinguish compensation for time and inconvenience from reimbursement of actual expenses. Do not describe payment as a medical benefit or penalty for withdrawal.

Central Ethics Committee guidance asks the dossier to define the maximum net amount in euros for travel and other participant expenses. The ethics assessment will consider whether financial arrangements could exert improper influence. Align the participant wording with the Part II financial-arrangements document.

State that the sponsor bears all protocol-related costs, including treatment, tests, visits, and treatment of trial-related injury. Explain insurance and whom the participant should contact if injured.

Consent and signature process

The consent conversation must occur before any trial-specific screening or procedure. Under Croatian law, it is conducted by a physician or dentist who is the principal investigator or a delegated investigator. The volunteer and interviewer sign and date the paper document, and the volunteer receives a signed copy.

Routine electronic consent is not permitted under current Croatian guidance. An impartial witness is used only if a capable volunteer cannot write. Language difficulty, lack of understanding, or impaired decision-making requires a different solution and cannot be cured by a witness signature.

Withdrawal must remain possible at any time without adverse consequences. Explain how payment is calculated after withdrawal and what happens to data and samples already collected.

Croatia-specific final checks

• The document is in professionally translated and proofread Croatian.
• It is one unified Informirani pristanak, not a separate information sheet and signature-only form.
• Global and Croatian planned enrollment are stated.
• Every optional decision has DA and NE choices.
• Trial restrictions and payment terms match the protocol and financial document.
• Croatian contacts, Central Ethics Committee rights wording, AZOP route, and insurance wording are present.
• Health information is obtained from the volunteer rather than by contacting outside healthcare professionals.
• Separate consent is used for optional future research and pregnancy follow-up.

Return to the Croatia CTIS hub for the other participant-document variations.