Ireland CTIS Pregnancy Follow-Up Consent Requirements

Separate the two pathways

Prepare distinct documents for:

1. A trial participant who becomes pregnant.
2. The pregnant partner of a trial participant.

The participant's main consent may cover safety reporting obligations, but optional pregnancy follow-up collection should be explained clearly and consented to in the approved way. Published NREC decisions commonly request a dedicated pregnancy follow-up participant information leaflet and consent form.

For a pregnant partner, provide information directly and obtain her separate consent before collecting identifiable health information, contacting clinicians or accessing medical records, unless a specific legal basis permits the immediate safety report.

The pregnant participant or pregnant partner signs and dates her own follow-up consent form, and the person conducting consent signs and dates it. A trial participant must not sign for a pregnant partner. Ireland has no dedicated mandatory national pregnancy follow-up template, so use trial-specific documents aligned with the main consent set and published NREC expectations.

Explain what will be collected

Tailor the list to the protocol. It may include:

• timing of exposure to the investigational product
• pregnancy course and relevant medical history
• medicines, tests and complications
• estimated and actual delivery dates
• pregnancy outcome
• delivery information
• newborn health information and follow-up period

State which information comes from the person, the trial participant, the obstetric or primary-care team, medical records and any infant clinician. Do not collect an unrestricted medical history because it may be useful.

Medical-record and clinician access

Name the records and professionals the sponsor or site may contact. Explain what will be requested, why, how often and for how long. Obtain specific permission for record access and clinician contact where required.

Make clear that refusing optional follow-up does not affect ordinary care or the partner's relationship with the participant's trial site.

Parent, fetus and infant information

Explain that pregnancy information can include data about the pregnant person, fetus and child. Define the follow-up endpoint and avoid open-ended collection.

If the protocol proposes infant samples, genetic testing or follow-up beyond routine safety outcome collection, prepare a specific legal, ethical and consent analysis. Do not treat consent to pregnancy outcome reporting as blanket permission for future child research.

Data-protection information

Identify the controller, purposes, data categories, recipients, transfers, retention and rights. Explain the sponsor's safety-reporting and legal-retention duties. Distinguish consent to optional follow-up from other lawful processing required for pharmacovigilance.

If the pregnant partner withdraws, state which future contacts will stop and which information already reported must be retained. Keep this wording consistent with the Irish NREC data statement and DPIA.

Sensitive communication

Describe how the site will contact the pregnant person without disclosing trial participation inappropriately. Give a choice of safe contact method. Explain how pregnancy loss, termination, congenital anomaly, neonatal illness and death information will be requested sensitively.

Staff should not pressure the participant to obtain partner consent. The partner can contact the site directly and decide independently.

Submission checks

• Participant and partner pathways use separate documents.
• The pregnant partner consents for herself.
• Data fields and follow-up duration match the protocol.
• Medical-record and clinician access are explicit.
• Maternal, fetal and infant data are distinguished.
• Optional collection is separated from required safety reporting.
• Withdrawal and legal retention are accurate.
• Contact methods protect confidentiality.
• Documents contain no language that pressures pregnancy decisions.

Return to the Ireland CTIS Part II guide hub for the complete national series.