Czechia CTIS Part II Healthy Volunteer Consent Requirements

When to use a healthy-volunteer variation

Use a healthy-volunteer PIS/ICF when the protocol recruits participants because they meet a defined healthy-volunteer population rather than because they have the disease under study. Common examples include First-in-Human, Phase I, bioequivalence and pharmacokinetic studies.

Do not simply replace “patient” with “healthy volunteer.” The risk-benefit explanation, purpose of participation, restrictions, procedures and compensation must reflect the actual protocol.

Required documents

Mandatory. Submit the Czech healthy-volunteer PIS/ICF under the Part II patient-document pathway described in KLH-CTIS-01. It is a blank form at CTIS submission and is signed only when consent is obtained.

Conditional. Submit other Czech participant materials that apply, such as dosing cards, diaries, questionnaires and instructions for use. Electronic questionnaires require screenshots under the current SÚKL rule.

Mandatory. Include the healthy-volunteer recruitment and informed-consent process in SÚKL Template No. 1 and submit all recruitment materials.

The Czechia Part II document checklist covers the rest of the site, investigator, insurance, data and financial documentation.

Main differences from the standard PIS/ICF

Purpose and expected benefit

State clearly that the participant is a healthy volunteer and that the study is research. Do not imply a therapeutic benefit where none is expected. Explain why healthy volunteers are needed and what the investigational product or procedure is intended to evaluate.

Procedures and restrictions

Describe confinement, fasting, food restrictions, exercise restrictions, alcohol or nicotine restrictions, contraception requirements, repeated blood sampling, pharmacokinetic sampling and other study-specific burdens that materially affect the volunteer.

Where the protocol uses dose escalation, explain the design at a level the volunteer can understand without implying that earlier cohorts establish safety for later cohorts.

Risks

Present known and foreseeable risks, including uncertainty around an investigational product when that uncertainty is material. For First-in-Human studies, the participant information should not soften the fact that human experience may be limited.

Explain blood-draw volumes, cannulation, biopsies, imaging or other procedures separately from medicinal-product risks when that improves comprehension.

Compensation and reimbursement

SÚKL's KLH-22 recommends remuneration to trial participants only in Phase I, bioequivalence and pharmacokinetic studies. This is a recommendation, not a blanket entitlement to payment.

Where remuneration is used, explain the amount, schedule and any conditions in the PIS/ICF and keep it consistent with the Part II financial-arrangements documentation. Expense reimbursement should be distinguished from remuneration.

SÚKL recommends standardising participant compensation payments as a lump sum. If payment cards are used, the national conditions include no participant fees, Czech-language support and an alternative method of reimbursement.

Czech consent and signature rules

The core Czech consent rules do not change for a healthy volunteer. The participant receives understandable information, has time to consider participation and signs and dates the consent record with the person conducting the consent interview under the applicable CTR process.

SÚKL requires the Czech PIS/ICF to contain the EU CT Number, full trial title, ethics committee email, source-record access language, the results-availability statement and confirmation that a dated and signed copy is provided to the participant.

Electronic PIS/ICF is permitted, but any electronic signature must meet SÚKL's specified signature criteria.

Pregnancy and contraception

Healthy-volunteer protocols often impose strict pregnancy-prevention requirements. The PIS/ICF should reproduce the actual protocol requirements in clear language and explain potential fetal or breastfeeding risks where relevant.

If a pregnancy occurs and follow-up data will be collected from the participant or a partner, use the Czechia pregnancy follow-up guide to separate trial participation from pregnancy-data consent.

No separate Czech healthy-volunteer template

The current SÚKL Part II template set does not contain a separate PIS/ICF template for healthy volunteers. The national expectation is therefore an appropriately adapted Czech participant document that meets the general PIS/ICF requirements and protocol-specific healthy-volunteer needs.

Use the Czechia patient-facing document QC checklist to confirm the final document is consistent with the protocol and national Part II package.