Slovakia CTIS Healthy Volunteer Consent Requirements

Start from the standard Slovakia consent set

Use the Slovakia patient information and consent guide for the common requirements on language, voluntariness, procedures, privacy, samples, withdrawal, injury and signatures. Do not create a shortened form only because the volunteer is healthy.

The blank Participant Information Sheet and Informed Consent Form are submitted under Subject information and informed consent form. They are signed later by the volunteer and the person conducting the consent discussion before any screening or trial-specific procedure.

When the healthy-volunteer variation applies

Conditional. Prepare this variation whenever eligibility does not depend on the participant having the target disease. It may apply to first-in-human, pharmacokinetic, food-effect, interaction, thorough QT, vaccine and bioequivalence trials.

If a study includes both patients and healthy volunteers, create separate information and consent documents. Risks, expected benefits, alternatives and payment explanations will differ.

Explain the absence of therapeutic benefit

Mandatory. State directly that the volunteer is not being treated for an illness and should not expect a medical benefit. Distinguish research assessments from a general health examination. Explain that screening findings may not be clinically complete and describe how relevant incidental findings will be handled.

Do not describe payment as a benefit. Payment may compensate for time, inconvenience and expenses, but it must not obscure the right to stop.

Describe exposure and practical burdens

Explain dose escalation, placebo, randomization, sentinel dosing, fasting, standardized meals, confinement, sleep or activity restrictions, prohibited medicines, alcohol, nicotine, caffeine, driving limits and post-dose observation where applicable.

State blood volumes and sampling frequency in understandable terms. Describe cannulation, biopsies, imaging, lumbar puncture or other invasive procedures plainly. Explain what happens if dosing is stopped or the cohort does not escalate.

Risk, pregnancy and contraception wording

The risk section should reflect the Investigator's Brochure and the uncertainty typical of early development. For first-in-human exposure, state that some risks may be unknown. Explain emergency arrangements and the availability of medical support at the site.

Set out contraception, pregnancy testing, sperm or egg donation restrictions and breastfeeding restrictions exactly as required by the protocol. Explain the rationale in simple terms. Avoid copying a technical contraception appendix without translation into participant language.

Payments and withdrawal

State the payment amount or calculation method, reimbursement of travel and other expenses, payment schedule and tax implications if relevant. Explain whether payment is prorated if the volunteer withdraws or is withdrawn by the investigator.

The volunteer must be free to withdraw without losing payment already earned. Do not make final payment conditional on completing medically unnecessary procedures. The Ethics Committee will assess whether the amount or structure could exert undue influence.

Privacy and samples

Healthy-volunteer databases may contain sensitive health and eligibility information. Explain screening data retention, repeat-volunteer controls and any sharing used to prevent simultaneous enrollment. State the legal and operational basis without promising deletion where regulatory retention applies.

Separate samples required for the study from optional future research. Use the Slovakia secondary use consent guide if samples or data may be retained beyond the defined trial analyses.

Slovakia-specific submission checks

Confirm that the Slovak text includes the current Ethics Committee contact route and clear travel reimbursement information. Keep the English and Slovak versions aligned where both are submitted. Make sure the recruitment and consent procedure explains how healthy volunteers are identified and screened, including databases or recruitment vendors.

For Phase I or bioequivalence units, the site suitability form should demonstrate facilities, staffing and emergency capability appropriate to the protocol. These points belong in the Part II site package, not only in the participant form. Use the Slovakia Part II document checklist for the full file set.

Return to the Slovakia CTIS hub for all country guides.