Hungary CTIS Patient Information and Informed Consent Requirements

What the main Hungarian consent document should do

Mandatory. The document must identify the trial with the EU clinical trial number, protocol number and trial title. It must name the Hungarian healthcare provider where the trial is conducted and identify the principal investigator or other person providing the information by name and role.

Mandatory. The consent record should include the participant's name, place of birth and date of birth. Where a minor or a participant with restricted capacity requires another person to exercise the relevant consent right, include the identity details of that authorised person. ETT-KFEB expressly states that the participant's study code number should not appear in the ICF.

Mandatory. Explain that the activity is research. State the purpose, expected duration, planned number of participants, procedures, intervention frequency and what participation will involve.

Mandatory. Explain available accepted treatment alternatives, including whether joining the trial means interrupting an existing treatment and what that could mean for the participant.

Mandatory. Explain reasonably foreseeable risks, burdens and discomforts, including the possibility of unforeseen adverse events. State expected benefits, or state plainly if no direct benefit is expected.

Conditional. If placebo may be assigned, explain the probability of receiving placebo and what that means for treatment.

Mandatory. Explain the investigational medicinal product in language a participant can understand. The national Q&A expects the product and, where useful, a short explanation of its mechanism.

Mandatory. State that participation is voluntary and that consent can be withdrawn without having to give a reason and without disadvantage. Explain what happens after withdrawal, including any study-specific follow-up that is lawful and consented.

Hungarian language and readability

Participant-facing documents for use in Hungary should be in final Hungarian form. ETT-KFEB specifically warns against literal translation, inconsistent forms of address and incorrect references to foreign laws.

A translation should therefore be clinically accurate and locally natural. Replace references to US or other foreign legislation with the Hungarian and EU rules that actually apply. Keep terminology consistent across the main ICF, recruitment materials, emergency card, pregnancy documents, genetic consent and any substudy information.

The Hungary patient-facing QC checklist provides a final language and consistency review.

Consent, signatures and dates

Mandatory during consent. The participant or other person giving consent signs and dates the document after receiving the information. The principal investigator or the person providing the information also signs. The date of consent must be recorded.

At CTIS submission, upload the final blank version. It is not pre-signed by a participant or investigator for the purpose of submission.

ETT-KFEB expects one signature set for each consent document. Do not duplicate signature pages merely because the document contains several information sections.

Conditional. If the person cannot read or write and the information and consent are therefore given orally, Hungary requires two witnesses to sign. ETT-KFEB also asks the witnesses to provide an address or contact detail. This is a national requirement that is more specific than a generic one-witness global form. The Hungary impartial witness guide explains the pathway.

Patient emergency card

Mandatory when applicable. The final Hungarian patient emergency card is part of the Part II participant-document package and should be attached to the main ICF. The ICF should tell the participant that the card will be issued, explain the personal data shown on it and instruct the participant to keep it with them during the trial for safety.

The card normally contains the participant name and date of birth, protocol identification, investigational product, relevant mechanism, indication, contraindications, dangerous interactions, site address, investigator or designated doctor and a 24-hour telephone number.

If the card contains both the participant's identity and study code, the ICF should explain why that combination is necessary for patient safety and obtain agreement to the arrangement.

ETT-KFEB's specific emergency-card guidance says the card is not needed for Phase IV or bioequivalence trials.

Trial-related injury, insurance and compensation

Mandatory. Explain what treatment, compensation and other remedies are available if trial-related injury occurs. Provide the name and Hungarian contact details of the person or organisation the participant should contact.

Mandatory. Name the insurer and provide a Hungarian contact, the contact person's name and telephone number. This is a concrete Hungary-specific content item and should not be replaced with a generic statement that the sponsor has insurance.

Conditional. If participants receive cost reimbursement, list the exact eligible cost types. ETT-KFEB says only documented expenses may be reimbursed and rejects vague wording that the sponsor "may" reimburse unspecified costs.

Conditional. If a third-party service manages reimbursement, explain the essential arrangement, any relevant fees and which data the site or participant gives to the service. Obtain consent where required for the data transfer or participant-service relationship.

Privacy and data protection

ETT-KFEB expects privacy information to be integrated into the participant information and consent document where possible. If a separate appendix is used, it should have its own participant or healthy-volunteer signature field and the main ICF should still refer to the privacy information.

The privacy text should state clearly whether the sponsor and other parties receive personal, coded or anonymous data. It should list the categories of data actually collected and use the same terminology consistently.

Explain who may access identifiable source information and that such access occurs at the site under the conditions described by ETT-KFEB. Explain coding or anonymisation, recipients, storage duration and location, purposes of use, and international data transfers, especially transfers to third countries and their safeguards.

Give the participant the contact details for the Hungarian National Authority for Data Protection and Freedom of Information, NAIH, as part of the rights information.

ETT-KFEB states in its national guidance that consent is the legal basis it expects to be described for processing in clinical medicinal-product trials. The wording should be checked against the sponsor's current GDPR legal analysis because the sponsor remains responsible for lawful processing.

Biological samples and genetic information

Mandatory when samples are collected. Explain what samples are taken, why, how long they are kept, where they are stored, who receives them, what analyses are performed, whether samples are coded or anonymised, and what happens at withdrawal.

Conditional. Genetic testing or genetic research requires separate genetic information and genetic consent document or documents. The Hungarian Genetics Act requires detailed written informed consent before genetic sampling. The consent can specify whether the sample or data may be used only for the primary purpose, for broader purposes allowed by law, or specifically for research, and how it may be stored.

Do not hide an optional genetic substudy inside a mandatory main-trial signature. Use a clearly separate decision where the genetic activity is optional.

For future use of data or samples, follow the Hungary secondary-use consent guide.

Pregnancy and contraception

The main ICF should explain protocol-specific pregnancy risks, contraception requirements, pregnancy testing, restrictions and what happens if pregnancy occurs.

A pregnancy follow-up form is not automatically required for every trial. It becomes relevant when the protocol or safety plan calls for collection of pregnancy, maternal, outcome or infant information.

A pregnant partner of a participant is a separate data subject. ETT-KFEB's GDPR recommendation expressly recognises separate information documents for pregnant partners and requires each such document to address the privacy information relevant to that person. The Hungary pregnancy follow-up guide explains the distinction.

Minors and limited-capacity participants

Do not reuse the adult ICF without adapting the information and signature logic.

For minors, provide information in a form appropriate to age and maturity and obtain the legally required representative consent and participant involvement. The Hungary minor consent and assent guide explains the national and CTR rules.

For adults whose capacity to exercise healthcare rights is restricted, prepare the participant and representative information needed for that situation and plan re-consent if capacity changes. See the Hungary limited-capacity and legal-representative guide.

Emergency enrollment

Emergency enrollment is not a general waiver of consent. It is a narrow pathway subject to the CTR and Hungarian Health Act conditions. If the protocol proposes it, the participant documents must explain the initial emergency pathway and later information and consent process. See the Hungary emergency enrollment guide.

Back to the Hungary CTIS hub

All Hungary English guides are listed at https://trialagents.com/ctis/hungary/en.