[Ethical assessment of biomedical experiments in The Netherlands].

The ethical evaluation of biomedical experiments is loyally accepted in the Netherlands. It was introduced everywhere during the last 15 years. Among the targets we find not only the protection of the experimental objects--animals and humans--but also the protection of researchers who may find moral support in the approval of their projects by a Committee of Ethical Evaluation. Concerning experiments in animals, the legal framework is provided by the Law on Animal Experiments. This law was drawn up in accordance with the directive of the E.U. To be allowed to practice experiments in animals, an institute must possess a licence; the researchers are moreover obliged to be appropriately trained with regard to experiments in animals. To that end an adequately functioning organization has been set up. The intensive supervision is widely decentralized and effected for the greater part by experts working within the institutes. The "intra muros" Committees supervising the experiments in animals play an important part in the ethical evaluation. More than 50 of those Committees are active at this time. Setting the ethical standards is done in close collaboration between the Authorities and the researchers. Researchers and animal protection associations have established a "Platform for the Replacement of Experiments in Animals", in which they support development of alternative methods for research. The legislation concerning medical experiments in humans is not yet completely enforced, but in practice the ethical evaluation has been effected for many years in every hospital of the Netherlands. At present about 150 "Committees for medico-ethical evaluation" are at work. Their task may be very heavy, especially in the academic hospitals, where, mostly, over 150 projects are advised on every year. Adequate training facilities are provided for the members of the committees. The passing of the bill on experiments in humans is stagnating owing to political reasons. Besides the approval of the present practice, the bill-draft contains some elements that are difficult to accept by researchers; among other things, the researchers refuse a possible political influence on the ethical advice. Moreover, there exists a menace to see the insurers changing their rules: the legislation on privacy might also hamper the development of a research seeming too closely patient-linked. Sufficient attention is not given to the financial aspects of the evaluation-process. The real cost of the evaluation should be incorporated into the budget of research projects.