engleski

Ethics and biomedical research in Croatia

This paper gives an overview of the research ethics structures development in Croatia from the beginning to the newest developments related to harmonization with the Clinical Trails Directive (Directive 2001/20/EC). Three phases of research ethics structures development are identified. In the first phase the focus of implementation of research ethics structures were individuals, especially investigators, and the quality of research ethics review. The second phase of the development began in 1990-ies. At this stage a shift from individuals, especially, investigators and the quality of research ethics review towards a more institutional approach can be observed, with emphasis also being placed on the introduction of research ethicsnational strategies (laws and guidelines). The needed twist in the development of research ethics in Croatiawas finally achieved in the year 2003, when under the influence of the Directive 2001/20/EC, final changesto the research ethics structures were introduced.

research ethics; Croatia

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