Netherlands CTIS Pregnancy Follow-Up Consent Requirements

Pregnant trial participant

If a trial directly enrolls pregnant or breastfeeding participants, the protocol, risk assessment and main Dutch information and consent document must address pregnancy-specific participation from the start. In the Netherlands, CCMO is the designated reviewing committee for medicinal-product trials involving pregnant or breastfeeding participants.

The Clinical Trials Regulation permits such research only under its protective conditions. The expected direct benefit must outweigh risks and burden, or the non-beneficial research must be necessary for the population, potentially benefit pregnant or breastfeeding people or children, and involve minimal risk and burden.

If a participant becomes pregnant unexpectedly during another trial, follow the protocol's stopping, treatment, safety-reporting and follow-up rules. Review the scope of the original consent before collecting pregnancy, outcome or infant information.

Conditional. Use a separate Dutch pregnancy follow-up information and consent form if the original authorised IVO did not clearly cover the planned follow-up, extra medical-record access, infant information or follow-up duration.

Pregnant partner of a trial participant

The trial participant cannot consent to the processing of the pregnant partner's health information. Informing the sponsor that a pregnancy occurred is different from collecting a detailed pregnancy history, obstetric records, outcome or infant data from the partner.

Mandatory before direct follow-up. Give the pregnant partner a Dutch information and consent document that explains why their data is requested, what participation involves, whether medical professionals will be contacted, the follow-up period and their right to decline.

Refusal must not affect the trial participant's care or trial participation. Do not route the partner's signature through the participant or ask the participant to disclose health information that should come from the partner or treating professional.

Information to include

Purpose and scope

Explain that the follow-up collects safety information after exposure to an investigational product or trial intervention. State whether exposure was maternal or paternal and avoid implying causation.

Define the data needed, which can include:

• timing and duration of exposure
• estimated conception and delivery dates
• relevant maternal medical and medication history
• pregnancy tests and prenatal findings
• pregnancy complications
• pregnancy outcome and delivery information
• fetal or newborn outcomes
• infant health and developmental follow-up where justified
• breastfeeding exposure where relevant

Collect only data needed by the protocol, safety plan or pharmacovigilance process. Do not create an open-ended permission for all maternal or infant records.

Procedures and contacts

State who will contact the pregnant person, how often, by what method and for how long. Explain questionnaires, calls and any request to contact an obstetrician, midwife, general practitioner, paediatrician or other healthcare professional.

If medical-record access is required, ask for explicit permission and identify the type of record and professional. Give the pregnant person a contact for questions, withdrawal and privacy concerns.

Risks and burden

Most pregnancy follow-up is observational, but it can still create privacy, emotional and time burden. Explain any blood tests, extra scans, sample collection or infant assessments separately. Do not call a procedure routine if it occurs only for research.

Duration and end of follow-up

Give a defined end point, such as pregnancy outcome, a set period after delivery or a stated infant age. Explain what happens if the person withdraws, the pregnancy ends early or contact is lost.

Privacy and data processing

Treat the pregnant person, fetus and infant information carefully. Explain coding, recipients, access, storage, international transfers and retention. Identify the controller or joint controllers and data-protection contacts.

For a newborn or infant, explain who provides permission for collection and access under the approved pathway. Do not assume that consent from one adult covers every holder of parental authority for research procedures involving the child.

If biological samples or optional future use are proposed, use separate choices. The Netherlands secondary-use consent guide explains the Dutch optional-consent structure.

Insurance and compensation

Do not imply that pregnancy follow-up creates the same insurance coverage as trial participation. Use the authorised insurance terms. Dutch public information explains that harm to an unborn child is generally covered in research focused on pregnant people or the fetus, but may not be covered in an unrelated trial when pregnancy occurs.

Explain any reimbursement for follow-up time or travel and align it with the P1 arrangements form. Payment should not make optional pregnancy follow-up appear required.

Consent and signatures

Submit blank Dutch pregnancy follow-up documents in Part II when they form part of the planned consent process. Use L1 for the information and consent form and L2 only for a separate non-ICF item integral to consent.

At conduct, the pregnant trial participant signs if new or additional consent is required. A pregnant partner signs their own form. The researcher or authorised interviewer signs and dates the process. Give the person a signed copy and document any healthcare-professional authorisation.

For a participant under 16 or an adult lacking capacity, apply the relevant Dutch age or representative pathway in addition to the pregnancy-specific content.

Withdrawal and later use

Explain that the person can stop future follow-up. State whether data already collected remain in the safety record and how unused samples are handled. Do not promise deletion when retention is required to protect trial integrity or safety reporting.

Separate consent for optional future research from consent for the defined pregnancy safety follow-up. Withdrawal from secondary use should not be confused with stopping collection for the active safety question.

Final checks

• The pregnant participant and pregnant partner pathways are separate.
• The original trial consent scope has been reviewed before adding a new form.
• The pregnant partner gives their own consent before direct follow-up.
• Maternal, outcome and infant data are limited to the stated purpose.
• Medical-record access and professional contact are explicit.
• Follow-up duration and contact frequency are defined.
• Privacy wording covers all people whose data is collected.
• Optional samples and future use have separate choices.
• Insurance language matches the authorised Dutch coverage.
• The assigned reviewing committee is correct for a trial enrolling pregnant or breastfeeding participants.

Return to the Netherlands English CTIS hub for the complete guide series.