Research with gametes and/or (leftover) embryos
Research with embryos, and gametes creating embryos, are subject to the Dutch Embryo Act [Embryowet]. Article 3(2) of the Embryo Act stipulates that this type of research is assessed by CCMO.
Scientific research with gametes where no embryos are created by which no and where gametes are specifically developed for the purpose of the research, falls within the scope of the Dutch Medical Research Involving Human Subjects Act [Wet medisch-wetenschappelijk onderzoek met mensen, WMO]. Article 1, part d of the Central Review Decree [Besluit Centrale Beoordeling, BCB] stipulates that this type of research is assessed by CCMO.
Research with gametes left over after an IVF or artificial insemination treatment does not fall within the scope of the WMO or the Embryo Act.
The Embryo Act compels institutions creating embryos outside the body to compose a protocol documenting the procedures with gametes and embryos (Embryo Act article 2).
Highlights Embryo Act
The Embryo Act prohibits the cloning of human beings, gender 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 not used in a woman's own pregnancy (for example, following IVF treatment) can be used for:
- donation,
- culturing embryonic stem cells,
- scientific research.
Consent is required of those individuals from whom the gametes were taken or for whom the embryo was originally intended. Conditions for scientific research:
- the knowledge gained as a result of the research must be important to the field of medicine;
- there must be no alternative research method;
- CCMO or an accredited MREC must give prior approval.
The Embryo Act prohibits generating embryos specially for scientific research.