THE NETHERLANDS

Legislation

In the Netherlands we have several laws. Most important law is the Act with rules on medical research involving human subjects (Medical Research Human Subjects Act). In Dutch it is called the WMO. This WMO act is translated into an English version at the website https://wetten.overheid.nl, where all national legislation can be found.

The following acts are also translated into English

• Decree of 23 June 2003 containing rules for compulsory insurance in medical research involving human subjects (Medical Research(Human Subjects) Compulsory Insurance Decree).
• Decree of 3 January 2006, amending the Central Review of Medical Research Involving Human Subjects Decree (enlargement of medical research that requires central review).
• The Embryo Act.

Research Ethics Committees

Short description of RECs system

There are 24 accredited MREC‘s in the Netherlands that review medical/scientific research proposals. The majority are linked to an institution such as an academic medical centre or a hospital. Research covered by the Medical Research Involving Human Subjects Act must be submitted to an accredited MREC for approval before it is carried out. In some cases, the Central Committee on Research Involving Human Subjects (CCMO in Dutch: ‘Centrale Commissie Mensbonden Onderzoek’) acts as the MREC. The MREC reviews protocols in accordance with the rules laid down in the Dutch law; the Medical Research Involving Human Subjects Act (WMO).

Research subject to the WMO cannot be carried out without a positive judgment. Drugs trials, medical devices and genetic research are all covered by the above-mentioned WMO. The MREC’s review all clinical trials on investigational medicinal products as well as non therapeutic observational studies, and the CCMO reviews medical research in the field of gene therapy, iRNA, anti-sense oligonucleotides, (stem) cell therapy, xenotransplantation and non-therapeutic interventional studies with minors and incapacitated subjects. Research with spare embryos and IVF technology (e.g., embryonic stem cell research) is covered by the Embryos Act and are reviewed by the CCMO. Both the accredited MREC’s and the CCMO are independent governmental bodies with a legal status that reach a legally binding decision on research protocols, and thus are not advisory boards. Only accredited research ethics committees (MREC’s or the CCMO) can review biomedical research with human subjects. The criteria for accreditation are laid down in the WMO.

The Central Committee (CCMO) is responsible for the accreditation of MREC’s. If an MREC no longer fulfils the criteria, the CCMO can withdraw the accreditation. Only one decision of one accredited MREC is required for research projects in the Netherlands including multicentre research.

Networking between RECs

The CCMO is the body responsible for implementing the Medical Research Involving Human Subjects Act (WMO). The CCMO has a broad range of legal tasks (accrediting MREC’s, competent authority for clinical research with medicinal products, in specific cases reviewing protocols for medical research involving human subjects, registering all WMO research reviewed in the Netherlands, administrative body for appeals and objections and providing information about the implementation and application of the WMO. More information can be found on www.ccmo.nl.

The Dutch Association of Medical Research Ethics Committees (NVMETC in Dutch: ‘Nederlandse Vereniging voor Medisch Etische Toetsingscommissies’) is a platform for MREC’s in the Netherlands. The goals of the NVMETC are fostering best practices in judgment by MREC’s, fostering the quality and harmonizing the implementing of legal criteria, discussing medical ethical issues, maintain relationship with other relevant bodies like the CCMO and provide information for its members. One of the main goals of the Association is quality improvement of the accredited MREC’s. The NVMETC developed a quality improvement programme for MRECs by peer-to-peer review. Another main task is supplying relevant news and information to its members by a Newsletter (Forum) and organizing seminars for information and discussion on actual topics and practical issues. Furthermore the NVMETC set up a training programme for MREC members and its secretaries. All the Dutch MREC’s are member of the NVMETC (24 accredited and 34 not-accredited local committees). More information can be found on www.nvmetc.nl.