Austria Healthy Volunteer Consent Requirements

When to use the healthy-volunteer variation

Use a healthy-volunteer version when the protocol enrolls people because they meet non-disease eligibility criteria rather than because they have the condition being treated or studied. This is common in early-phase pharmacology, pharmacokinetic, food-effect and first-in-human work, but the document should follow the actual protocol rather than the phase label alone.

The healthy-volunteer ICF is still uploaded in CTIS Part II Section L. Recruitment material used before inclusion is handled in Section K and is also subject to the German-language requirement.

Documents to prepare

Mandatory. Prepare the German healthy-volunteer Patient Information Sheet and Informed Consent Form. Use the Austrian national ICF structure or make sure the sponsor format covers every topic in that national template. Reproduce the Austrian sample insurance and data-protection passages verbatim.

Conditional. Add separate documents for any additional pathway that applies, such as an impartial witness, pregnancy follow-up, optional genetic investigation, future sample use or secondary use of data. Healthy-volunteer status does not remove those separate consent requirements.

Conditional. When a planned volunteer does not sufficiently understand German, provide certified participant-facing translations into a language the volunteer understands.

Explain benefit and burden accurately

Healthy volunteers should not be given wording that implies a therapeutic benefit when the protocol does not offer one. Explain the purpose of participation, investigational exposure, study procedures, confinement or visit burden, sampling, restrictions and foreseeable risks in plain language.

The Clinical Trials Regulation requires the participant to understand the nature, objectives, benefits, implications, risks and inconveniences of the trial and the available alternatives. For a healthy volunteer, that usually means being clear that participation is for research and that the benefit may be societal or scientific rather than personal.

Compensation and reimbursement

Mandatory where payments or reimbursements are offered. Describe the compensation and reimbursement arrangements consistently across the ICF and CTIS Part II financial-arrangements information. The Clinical Trials Regulation prohibits undue influence in the consent process and distinguishes legitimate compensation for expenses and loss of earnings from an inducement.

AustrianEthics Guidance Version 4 adds practical national rules. If Austrian sites use different reimbursement methods, the master participant information should list the options available across participating Austrian sites. If a site offers more than one method, the consent form should provide a choice.

Conditional. If reimbursement is handled through an external service provider, the current Austrian guidance requires the participant to be informed about the provider and the data-processing arrangement. Where the service is optional, the participant must be able to refuse it and use another permitted reimbursement route without losing trial participation. The guidance also sets conditions on fees, usability, Austrian-law terms and data minimisation.

Insurance

Mandatory. Healthy volunteers are trial participants for Austrian insurance purposes. The sponsor must have the no-fault personal injury insurance required by section 40 of the Austrian Medicines Act. The participant information must use the mandatory national insurance wording and include the Austrian insurance contact point.

The Part II insurance package is separate from the ICF. It includes the policy, terms and conditions and insurance confirmation required by AustrianEthics. The Austria Part II document checklist explains the CTIS Section O package.

Privacy and optional research

Use the Austrian sample data-protection wording verbatim. If the protocol includes optional genetic testing, future storage of biological samples or reuse of data outside the trial purpose, separate the optional decision from main trial participation.

The Austria secondary and future use consent guide explains the national rules for sample storage, sample anonymisation and secondary use of pseudonymised data for new technologies.

Consent and signatures

Consent is obtained before participation. The participant and the person conducting the consent interview sign and date the consent document. Austrian national guidance accepts wet ink or qualified electronic signature for informed consent.

If a volunteer can consent but cannot write, do not substitute a staff signature. Use the Austria impartial witness consent procedure.