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) came into 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 the scope of 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 accredited independent committee of experts. The accreditation is granted by the Competent Authority. Both Amsterdam UMC location VUmc and location AMC have an accredited medical research ethics committee (MREC; METc VUmc and METC AMC). Their job is to protect the rights of participants in medical research. Research protocols are only approved if the MREC establishes that the risks and burden for participants are in balance with the potential benefit for medical science or health care. Some types of research are not within the authority of MRECs and have to be approved by the Central Committee on Research Involving Human Subjects (CCMO). An example is research involving non-therapeutic interventions in children or incompetent persons.
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 METc VUmc or METC AMC 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 focusses 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)