[Ethical regulation of biomedical research in Hungary].

Hungary joined the Ovideo Treaty (a bioethical health agreement signed by EU countries in 1997), as declared by Law Nr. VI in 2002. In July 1 2002 two departmental orders were enacted: departmental order Nr. [23/2002 (V. 9.)] about the biomedical research in humans and departmental order Nr. [24/2002 (V. 9.)] about the human use and clinical trials of investigational products and the adaptation of Good Clinical Practice (GCP). Both were based on the Health Law. The departmental order on the Medical Research Council [(16/2001 (IV. 28.)] together with these two orders contains the national rules of biomedical research performed in Hungary and also the Hungarian adaptation of various, bioethical principles and directives published by EU or other internationally accepted organisations. According to these regulations from 2002 biomedical research in Hungary could be in agreement with the Oviedo Treaty. Ethical approval and supervision can be obtained from research ethical committees of three types: central, regional and local superimposed upon one another. There are three, central, ethical committees within the frames of the Medical Research Council with national responsibility: Scientific and Research Ethical Committee, Clinical Pharmacological Ethical Committee, Human Reproduction Committee. In some cases regional research ethical committees are entitled to hand out ethical approval and ethical supervision. In those research sites, where the regional research ethical committee is not existent a local committee should be organized for the local ethical control of the research investigations and experiments. This way the ethical requirements and clinical practice by the GCP can be performed in clinical research in Hungary with a special respect to the vulnerable persons possibly involved. The paper gives an overview on recent developments and major ethical principles of the Hungarian biomedical research.