Hungary CTIS Healthy Volunteer Consent Requirements

When to use a healthy-volunteer variation

Conditional. Use a healthy-volunteer information and consent form when the protocol enrolls people who do not have the condition being studied, commonly in Phase I pharmacology, pharmacokinetic or other non-therapeutic studies.

If a study includes both patients and healthy volunteers, do not assume one participant document works equally well for both. The expected benefit, alternative treatment, risk context and compensation discussion differ.

What must differ from a patient ICF

State clearly that the person is volunteering for research and is not being treated for a disease through trial participation.

Describe procedures and foreseeable discomfort in concrete terms. For an early-phase study, this may include confinement, fasting, repeated blood sampling, dosing, monitoring, restrictions, contraception and follow-up.

Explain that direct medical benefit may not be expected. Do not imply therapeutic benefit to make the study more attractive.

Explain the investigational product, available human exposure information and important unknowns in language suitable for a lay volunteer.

Describe withdrawal rights and any safety follow-up that could remain relevant after dosing.

Compensation and reimbursement

The ETT Bioethics Code states that healthy or ill people participating in Phase I trials may receive uniformly defined financial compensation for inconvenience, loss of time and loss of income. Similar compensation may be given in non-therapeutic pharmacokinetic or pharmacodynamic research.

The amount should not create undue influence. The ethics review considers whether compensation is disproportionate to the burden.

Separate compensation for participation from reimbursement of documented expenses. State each clearly in the participant documents and ensure the financial Part II documents use the same amounts and logic.

Hungary also asks for a list and commercial value of small retention items given to participants during the study.

Hungarian language and consent

Mandatory. The final healthy-volunteer information and consent form for use in Hungary should be in Hungarian and meet the same ETT-KFEB language-quality expectations as other participant documents.

Mandatory during consent. The volunteer signs and dates after receiving information. The investigator or person providing the information also signs.

Conditional. If the volunteer cannot read or write, use the Hungary-specific two-witness oral-consent pathway described in the impartial witness guide.

Privacy

The ETT-KFEB GDPR recommendation expressly includes healthy volunteers. Privacy information should normally be integrated into the participant document. If provided as a separate appendix, the appendix should contain a volunteer signature field and the main consent should refer to it.

Describe data categories, coding or anonymisation, access, recipients, storage, transfers, safeguards, rights and NAIH contact details.

Samples and genetics

If blood or other biological samples are collected, explain the purpose, amount, storage, transfers and future use.

Genetic research requires separate genetic information and consent under Hungarian rules. Do not bundle an optional genetic substudy into the mandatory healthy-volunteer signature.

Insurance and emergency information

Provide the Hungarian insurer contact details and the trial-injury information required in the main ICF.

For applicable trials, provide the final Hungarian patient emergency card and explain that it should be carried during the trial. Check the ETT-KFEB card guidance for the Phase IV and bioequivalence exceptions.

Back to the Hungary CTIS hub

The complete Hungary guide directory is at https://trialagents.com/ctis/hungary/en.