Review by CCMO
In the case of certain types of research the legislator chose to combine expertise in one single committee. This concerns the review of research with specific ethical, legal or social aspects and research in fields with limited expertise.
The review of these types of research has been appointed to the Central Committee on Research Involving Human Subjects (CCMO) in the Central Review of Medical Research Involving Human Subjects Decree. The reviewing task of the CCMO is limited to a number of specific fields of research:
- non-therapeutic interventional research with subjects under the age of 16 years and incapacitated subjects;
- research with unauthorised prophylactic vaccines;
- research on the development of cell therapy;
- research on gene therapy, other products that specifically influence the functioning of the genetic material, naked DNA/ (m)RNA or a medicinal product with GMO;
- research with a product containing living (micro-)organisms or viruses directly aimed at combating disease-causing factors;
- research in the field of xenotransplantation with live animal parts. A moratorium (in Dutch) applies to this type of research;
- research with human gametes whereby cells taken from human subjects for use in the research are obtained through procedures (for example extracting sperm through a surgical procedure);
- research with human gametes whereby embryos are produced as part of ivf treatment;
- research with embryos left over of an ivf treatment (leftover embryos);
- invasive observational research on fetuses;
- research in which the condition of the fetus is intentionally altered;
- research with a medicinal product, clinical investigations with medical devices and/or medical devices for in-vitro diagnostics involving pregnant and/or breastfeeding women.