Theme 1: The Dutch Review System

It involves accredited Medical Research Ethics Committees (MRECs; in Dutch: Medisch-Ethische ToetsingsCommissie or METC) and the Central Committee on Research Involving Human Subjects (in Dutch: Centrale Commissie Mensgebonden Onderzoek, hereafter referred to simply as the CCMO). The CCMO provides accreditation and oversight of these MRECs, and serves as the reviewing committee for specific types of clinical research involving vulnerable patient groups, as well as a number medical research categories.

The Dutch review system is decentralized, as most of the research files are reviewed by one of the 20 or so accredited MRECs in the Netherlands. It is also a controlled system, as the CCMO provides accreditation and oversight of these MRECs. Finally, the system uses an integrated peer-review process in which all scientific, medical, and ethical aspects of the research file—including the product data as described in the Investigator's Brochure (IB) and the Investigational Medicinal Product Dossier (IMPD)—are assessed by experts serving on the reviewing committee (i.e., an accredited MREC, or the CCMO in special cases).

Clinical research is regulated by the Dutch Medical Research Involving Human Subjects Act (in Dutch: Wet Medisch-wetenschappelijk Onderzoek met mensen or WMO), while research involving surplus human embryos is regulated by the Dutch Embryo Act. The WMO was introduced in 1999 after lengthy discussions in the Dutch parliament regarding non-therapeutic clinical research with minors and incapacitated subjects.

During the discussions, some politicians advocated a complete ban on this type of research involving these vulnerable patient groups. In response, the Dutch medical research community intervened and explained politicians the importance of conducting non-therapeutic research in these vulnerable patient groups. To learn more about this topic, read the article on the next page and then test your knowledge by taking the subsequent quiz.