The review system on research with human participants in the Netherlands is characterised as a decentralised controlled and
integrated peer review system. It consists of an independent governmental body, the Central Committee on Research Involving
Human Subjects (or Central Committee), which regulates the review of research proposals by accredited Medical Research Ethics
Committees (MRECs). The legal basis was founded in 1999 with the Medical Research Involving Human Subjects Act. The review
system is a decentralised arrangement since most research proposal are reviewed by the 30 accredited MRECs in the country.
It is a controlled system in which the Central Committee is responsible for the accreditation and oversight of the MRECs and
can make legally binding directives for these committees. The assessment of research proposals is an integrated peer review
process in which all documents of the research file are reviewed by experts in one committee only. A small number of research
proposals are assessed by the Central Committee and not by accredited MRECs. These proposals are on specific research categories
such as gene therapy, cell therapy and embryo research. The review of research with surplus human embryos is regulated separately
in the Embryos Act. The Central Committee provides support to the accredited MRECs and to researchers and sponsors. It is
currently developing an internet portal to reduce the bureaucracy and make the review process more efficient and transparent.
The Central Committee stimulates confidence on medical research in society by providing a public trial registry with core
data on reviewed research proposals.
Keywords Medical research - Clinical trial - Accreditation - Ethics - Review - Trial registry - the Netherlands
This paper does reflect his personal observation and opinion