Research with embryos and gametes whereby embryos are created fall under the Embryo Act (in Dutch) and therefore must undergo a central review by the CCMO. Scientific research with gametes whereby embryos are not created and whereby the gametes are specifically developed for the purpose of the research, fall under the review regime of the WMO. The CCMO has also been assigned with the review of this type of research, in accordance with the Central Review Decree (Besluit Centrale Beoordeling, BCB, in English)
Protocols for scientific research with gametes which are leftover after an IVF or KI treatment do not have to be reviewed under the scope of the WMO or the Embryo Act.
The Embryo Act compels institutions where embryos are created outside of the body to put together a protocol documenting the concerned handeling of gametes and embryos (section 2).
The assessment of research with the foetus also falls within the remit of the Embryos Act. Non-invasive observational research with the foetus can be reviewed by an accredited MREC. Invasive observational research with the foetus, or research where conditions are deliberately altered (intervention study), has to be reviewed by the CCMO.
Highlights Embryo Act
The Embryo Act prohibits the cloning of human beings, sex selection and the creation of human-animal hybrids. The Act also prohibits alterations to genetic material in the nucleus of gametes or embryos.
Gametes and embryos that are no longer going to be used in a woman's own pregnancy (for example, following IVF treatment) can be used in:
- culturing embryonic stem cells
- scientific research
The consent of those individuals from whom the gametes were taken or for whom the embryo was originally intended is required. Scientific research with humans is subject to the following conditions:
- the knowledge gained as a result of the research must be of importance to the field of medicine;
- there must be no alternative research method;
- the CCMO or an accredtied MREC must give prior approval.
The Embryo Act prohibits the generating of embryos specially for scientific research.
Evaluations Embryo Act
The conclusion of the first evaluation of the Act in 2006 was that the the Embryo Act functions well. However, what did come to light was that the Act insufficiently focuses on the developments in science. The first evaluation report (in Dutch) makes clear that the scientific investigators adhere to the Act and also that the Dutch IVF treatment centres practice in general in accordance with the aims as laid down in the Act.
The second evaluation of the Embryo Act (In Dutch) was carried out in September 2012. The overall conclusion was that the Act is well observed. However, issues were also mentioned in the second evaluation report, such as the obstruction of scientific research as a result of the ban on the creation of embryos (section 24a). This may place the Netherlands at a disadvantage. A similar country study, which forms part of the evaluation report, showed that there are no indications that the differences in the legislation between the Netherlands and other countries lead to investigators taking their research elsewhere. The meeting partners did say that the strict legislation in the Netherlands leads to a disadvantage in research which focuses on, for example, a responsible introduction of new reproduction techniques.