Abstract

Biomedical research is important for development of science, diagnostics and production of new, effective methods of treatment, with lowest possible risk. Biomedical research in human subjects opens number of legal and ethical issues, more often the issue of informed consent. Substitute provision of informed consent for unconscious persons or those who due to other reasons are not capable of giving consent is connected to number of controversies arising from abuse of rights. Recent international documents emphasize right to autonomy of persons with disabilities and require state parties to abolish guardianship regimes, which represents big challenges, especially in psychiatry. The purpose of this research was to determin how often psychiatric research in psychiatry is perform and to implement a comparative analysis of legislation in countries which conduct such research at most. The situation in Croatia has also been analyzed and review of effects of ban of substitute decision making given. The results showed that most of psychiatric biomedical research in Europe has been conducted for Altheimer’s disease and dementias, where informed consent is especially important. The comparative analysis showed that substitute informed consent is allowed in extraordinary situations, only for therapeutic purposes. Furthermore, the results direct the legislator in further possibilities of reforms in Croatian law.

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