Research involving fetuses, pregnant and/or breastfeeding women

Research involving fetuses

Article 20, paragraph 1 of the Dutch Embryo Act [Embryowet] stipulates that scientific research involving fetuses is permitted if the study may contribute to the diagnosis, prevention or treatment of serious disorders in the fetus concerned and if the research cannot be postponed until after birth.

If the study does not contribute to the diagnosis, prevention or treatment of serious disorders in the fetus concerned, it is only permitted if:

• It may contribute to the diagnosis, prevention or treatment of serious disorders in other fetuses;
• The participant burden and participation risks to the fetus concerned and the pregnant woman are minimal, and
• It cannot be postponed until after birth.

This is stipulated in Article 20, paragraph 2 of the Embryo Act.

In accordance with article 3, sub 3a of the Embryo Act, non-invasive observational research involving the fetus is assessed by an accredited MREC, unless it concerns research with a medicinal product or clinical investigations with medical devices or medical devices for in-vitro diagnostics. CCMO is the designated review committee for these types of research based on the Central Review Decree [Besluit Centrale Beoordeling]. CCMO is the designated review committee for all other research involving fetuses.

Research involving pregnant and/or breastfeeding women

The EU regulations on clinical trials (CTR), medical devices (MDR) and medical devices for in-vitro diagnostics (IVDR) contain specific rules for research involving pregnant and breastfeeding women. These rules include the research participation risks and research participant burden for the woman, the embryo, the fetus and the newborn child.

Research with a medicinal product and clinical investigations with medical devices and medical devices for in-vitro diagnostics involving pregnant and/or breastfeeding women are permitted if the study can reasonably provide a direct benefit to the pregnant or breastfeeding woman, or her embryo, fetus or child after birth greater than the study risks and study burden.

If the study does not yield a direct benefit, research with a medicinal product and clinical investigations with medical devices for in-vitro diagnosis involving pregnant and/or breastfeeding women are only permitted if:

• research of a similar nature cannot be carried out with women who are not pregnant or breastfeeding;
• the study contributes to the achievement of results which may benefit pregnant or breastfeeding women or, from a reproductive point of view, other women or other embryos, fetuses or children; and
• the participant burden and participation risks to the pregnant or breastfeeding woman, embryo, fetus or child involved after birth are minimal.

These exceptions do not apply to clinical investigations with medical devices falling within the scope of the MDR.

CCMO is the designated review committee for research with a medicinal product and clinical investigations with medical devices and/or medical devices for in-vitro diagnostics involving pregnant and/or breastfeeding women. This is laid down in article 1, parts h, i and j of the Central Review Decree [Besluit Centrale Beoordeling].

On the basis of the Embryo Act, CCMO assesses scientific research in which the fetus is subjected to invasive procedures or in which the condition of the fetus is intentionally changed. For research involving pregnant women, however, it is not always clear in advance whether the intervention the women undergo as part of the study will or may have an effect on the unborn or newborn child. Centralising the assessment of research falling under the Embryo Act as well as research falling under the MDR, CTR or IVDR ensures the correct application of the legal framework for both the authorisation and the corresponding assessment framework.