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ETHICS
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LITHUANIA

How does the ethical review process work in Lithuania and which are the designated ethics committees?

 

The Law on Ethics of Biomedical Research came into force in 2000 and established a two level system of review in Lithuania. There is a national review body, the Lithuanian Bioethics Committee, and Regional Biomedical Research Ethics Committees. These are situated in counties where there is a University.

 

The Regional RECs may only consider research to be carried out solely in their region and are under the authority of the National Committee. In the case of multi-centre clinical research, approval from the National Committee is required. All approvals by the Regional RECs must be notified to the National Committee. Approval by the State Drug Control Agency is necessary for clinical research of medicinal products. In the case of clinical research on medical instruments or substances, approval from the State Health Care Accreditation Agency is required.

 

The Lithuanian Bioethics Committee was established in 1995 and is appointed by the MInistry of Health. In addition to approving biomedical research in certain cases, it provides advise on ethical issues to the Ministry of Health and other government bodies, informs and educates the public and gives support and education to the regional RECs.

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