Medical research involving human subjects, human material or laboratory animals has to be carried out according to national law and regulations. Dedicated ethical committees review research protocols to ensure human and animal safety, and research quality.
In the Netherlands, the Medical Research Involving Human Subjects Act (Wet Medisch wetenschappelijk onderzoek met mensen, WMO) is in force since 1998. All medical scientific research in which humans are subjected to (medical) procedures or are required to follow rules of behavior, falls under this Act. All other research with humans (e.g. research with medical data or interviews) is not subject to the WMO.
Research subject to the WMO
Research subject to the WMO must be approved by an independent committee of experts. There are two types of reviewing committees: the Central Committee on Research Involving Human Subjects (CCMO) and accredited medical research ethics committees (MREC, in Dutch: METC). The majority of research protocols are reviewed by MRECs, which are independent administrative authorities. For Amsterdam UMC, a VUmc-linked MREC and an AMC-linked MREC operate. Besides reviewing research protocols to ensure research participants’ safety, the MRECs aim to enhance the quality of research by facilitating researchers and supporting staff as much as possible.
Research not subject to the WMO
Research that is not subject to the WMO, can be differentiated in different types, e.g. research with questionnaires or interviews and research with existing medical data. This research can be submitted to the executive board (in Dutch: Dagelijks Bestuur, DB) of the MREC to obtain a ‘non WMO’-declaration. To collect human material or tissue (e.g. blood, urine, sputum of biopsies) for future research (a so-called biobank) or to conduct research with material from a biobank, approval from the biobank review committee (TcB at VUmc and BTC at AMC) is needed. This committee focuses on evaluation of the legal and ethical aspects of the research.
Research involving laboratory animals is regulated by the Experiments on Animals Act (WOD). In compliance with the WOD, both Amsterdam UMC locations have an institutional license to perform experiments on animals. Moreover, for each project responsible researchers have to apply for a project license at the Central Authority for Scientific Procedures on Animals (CCD). Project permission is based on ethical assessment by an independent local committee of experts known as the Animal Ethics Committee (DEC).
- Research code (PDF)