Austria Pregnancy Follow-Up Consent Requirements

Pregnancy of a trial participant

The current AustrianEthics Guidance ICF Version 4 states that the participant information should explicitly explain what happens if a trial participant becomes pregnant. It should state that study medication is stopped, that the participant may withdraw from further trial participation without giving a reason, which protocol-defined measures continue, whether blinding will be broken where relevant, what additional pregnancy data will be collected and how those data will be obtained.

Where protocol-defined measures continue during pregnancy, the guidance points to Article 33 of the CTR and states that only minimal additional burdens and associated risks are permissible for the pregnant participant in the described follow-up context.

The document should distinguish continuation of pregnancy safety follow-up from continuation of investigational treatment.

When the main ICF can cover follow-up

Permitted within the main ICF. AustrianEthics states that consent in the main ICF can cover follow-up of the pregnant participant herself until the birth, provided the scope is properly described.

The main ICF should make clear what data will be collected, how long the follow-up lasts, how contact will occur and which privacy rules apply. Do not use a generic sentence such as “pregnancy will be followed” without defining the actual process.

When a separate pregnancy follow-up consent is required

Mandatory. Submit and use a separate information and consent document when additional data about the participant or unborn child will be collected beyond what is defined in the protocol or pregnancy monitoring form.

Mandatory. Use a separate document when health data about the child will be collected after birth. AustrianEthics explicitly states that the mother's main ICF cannot cover post-birth health-data collection about the child.

Mandatory. Use separate consent when the study plans to contact treating physicians to collect health data about the pregnant participant or child. AustrianEthics states that collection of data through third parties such as treating physicians needs separate consent from the pregnant participant.

The separate document should describe the data, duration and method of collection and the privacy aspects in detail. The participant must be able to refuse the additional data collection.

Follow-up duration after birth

AustrianEthics Guidance Version 4 states that follow-up of the born child beyond six months should be justified, for example in the cover letter or protocol. Do not use a long post-birth period without explaining the scientific reason.

The consent document should state the planned duration rather than leaving follow-up open-ended.

Pregnant partner of a trial participant

The current Austrian national Guidance ICF Version 4 reviewed for this guide gives detailed requirements for pregnancy of a female trial participant. It does not publish a separate universal Austrian rule or national template for pregnancy follow-up of a trial participant's pregnant partner.

Do not present a partner follow-up form as universally mandatory in Austria solely because the protocol contains contraception or pregnancy reporting. If the protocol plans to collect identifiable health information from a pregnant partner, treat the document need as protocol and data-collection dependent and subject the proposed partner information and consent to the same Austrian language and privacy review before use.

This distinction prevents a protocol-driven partner form from being misrepresented as a national requirement.

Privacy and medical-record access

The Austrian pregnancy guidance requires detailed information on the type of data collected, duration and method of collection and privacy aspects. If treating physicians will be contacted for health information, obtain the separate consent described above before that collection.

Use the Austrian mandatory data-protection wording in the participant-facing consent set and add pregnancy-specific information without contradicting that wording. If child data after birth are collected, identify clearly whose data are being collected and the legal consent process for that follow-up.

Signatures and language

Pregnancy follow-up documents intended for participants in Austria are German. Certified translations are required for planned participants who do not sufficiently understand German.

When the separate document is an informed-consent form, apply the Austrian informed-consent signature rule and the CTR dating and interview-signature requirements. The participant should receive a copy of the signed consent record.