Poland CTIS Part II Healthy Volunteer Consent Requirements

When a healthy-volunteer variation is needed

Use a healthy-volunteer PIS and ICF where the protocol enrolls adults without the disease or condition being studied. This is common in first-in-human, pharmacokinetic, food-effect, drug-interaction and bioavailability studies, although the exact trial design varies.

The document should identify the population plainly. Do not reuse a patient ICF that refers to treatment benefit, standard-of-care alternatives or disease follow-up that do not apply to healthy volunteers.

Polish language and submission timing

Mandatory. Submit the Polish participant-facing version in Part II. The current European Commission CTR Q&A Annex II marks Poland as requiring national-language translated patient-facing documents.

The CTIS submission copy is blank. The volunteer and person conducting the consent interview sign and date the approved ICF when consent is obtained, before trial-specific procedures unless another lawful CTR pathway applies.

Explain the absence of therapeutic benefit

Where the protocol does not offer a prospect of direct health benefit, say so clearly. Explain that the study is designed to obtain information about the investigational product, such as safety, tolerability, pharmacokinetics or pharmacodynamics.

Avoid wording such as "treatment", "therapy" or "your study medicine may help you" unless that meaning is scientifically and clinically accurate for the trial.

Healthy-volunteer risks and restrictions

The information should give special attention to burdens that can be more prominent in healthy-volunteer trials. Include only those that apply to the protocol, such as:

• first-in-human or limited prior human experience
• unknown or incompletely characterised adverse effects
• fasting, diet or fluid restrictions
• caffeine, alcohol, nicotine or medication restrictions
• confinement or overnight stays
• repeated blood sampling and total blood volume
• cannulation, telemetry or frequent vital-sign monitoring
• reproductive precautions and contraception
• washout periods and restrictions on participating in other trials
• follow-up after dosing

The risk description must match the current investigator brochure, protocol and safety information. Do not use a generic Phase I risk paragraph as a substitute for the actual product profile.

Payments, reimbursement and undue influence

Conditional. If volunteers are paid, the Part II financial-arrangements information and participant documents should describe the payment or reimbursement approach consistently. Separate reimbursement of expenses from any compensation for time, inconvenience or study participation.

The Clinical Trials Regulation contains specific restrictions on incentives for protected populations. Healthy competent adults are not subject to those same categorical restrictions, but payment is still part of the ethical assessment. It should not be presented as a guaranteed gain regardless of participation conditions, and the ICF should explain what happens to payment if the volunteer withdraws or is withdrawn.

Do not rely on old NKB guidance on participant remuneration. In 2026 NKB formally revoked its earlier remuneration guidance when it introduced the current good-practice framework. Use current law, current ethics assessment practice and the submitted financial-arrangements information.

Compensation for trial-related harm in Poland

Mandatory. The healthy-volunteer PIS must include the same Poland-specific compensation information as other participant documents. The Patient Rights Ombudsman states that informed-consent information must explain the Clinical Trials Compensation Fund and the mandatory civil liability insurance of the sponsor and investigator.

This is separate from payment for participation. Do not combine a volunteer's study payment with the explanation of compensation for injury.

Screening and medical information

Explain the screening procedures and why health information is collected from a person who is otherwise considered healthy. If the trial includes laboratory tests, ECGs, drug or alcohol testing, pregnancy testing, infectious-disease testing or other sensitive screening, state this before consent.

If screening could reveal a clinically relevant finding, explain the planned communication and referral process as supported by the protocol and site procedure. Do not promise access to every research result unless the trial actually provides it.

Reproductive precautions

Conditional. Where reproductive restrictions apply, state the required contraception period, pregnancy testing, sperm or egg donation restrictions, and what the volunteer should do if pregnancy occurs.

If the trial includes pregnancy follow-up after exposure, align the healthy-volunteer ICF with the Poland pregnancy follow-up guide, including a separate process for a pregnant partner where identifiable partner health information is collected.

Consent and withdrawal

The volunteer must have adequate time to consider participation and may refuse or withdraw without having to justify the decision. Explain any medically necessary follow-up after withdrawal and any safety restrictions that still need to be followed after dosing.

If payment is prorated, the withdrawal section should make the calculation understandable and should not imply that a volunteer forfeits legitimate expense reimbursement merely for exercising the right to withdraw.

Healthy-volunteer document set

For a typical Poland healthy-volunteer trial, prepare:

• Polish PIS and ICF for healthy adult volunteers
• Polish recruitment materials where used
• recruitment and informed consent procedure reflecting how healthy volunteers are identified and approached
• financial-arrangements information describing payment and reimbursement
• Poland compensation and insurance information
• any reproductive or pregnancy follow-up document required by the protocol
• optional future-use consent where the sponsor requests scientific use beyond the protocol

Use the Poland patient-facing QC checklist before upload. Return to the Poland CTIS Part II guide hub for the complete Poland library.