The system of ethical review of biomedical research in Lithuania: structure, peculiarities of functioning, ways of development

S. V. Pakharyna, V. Ye. Dobrova

Abstract


The analysis of information sources about the history and current peculiarities of the regulatory framework and functioning of the ethical review system for biomedical research in Lithuania are presented in this paper. The information used in this article has been obtained during the visit of Pakharyna S.V. to the Republic of Lithuania partially supported by the Fogarty International Center, National Institute of Health (NIH), US Grant No.R25 TW007084. It has been found that nowadays there is a two-level system of biomedical research ethical review in Lithuania. In accordance with the local regulatory requirements any biomedical research should be subjected to ethical review and can be started only after receiving the approval from the regional (for local studies) or central (for trials of medicines, medical devices or other multicenter studies) Ethics Committee. The peculiarities of the Lithuanian ethical review system are the legislative framework that is constantly updating and regulating all major types of biomedical research; studies with the broad ethical support and moderate cost of resources; transparency of the Lithuanian Bioethics work. As a result of our analysis a number of approaches for public discussion and implementation in practice of the Ukrainian system of biomedical research ethical review have been suggested.

Keywords


ethical review; ethics committees; clinical trials of drugs; study subject

References


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DOI: https://doi.org/10.24959/cphj.16.1402

Abbreviated key title: Klìn. farm.

ISSN 2518-1572 (Online), ISSN 1562-725X (Print)