ABSTRACT

The process of the development of ethical review for biomedical research in Lithuania, comparable with that in Western countries, was strongly facilitated by foreign pharmaceutical companies. This chapter provides an overview of the ethical review of biomedical research in Lithuania. Biomedical research in Lithuania may be performed only subject to an approval obtained from the Lithuanian Bioethics Committee or the Regional Biomedical Research Ethics Committee. Conducting biomedical research without prior approval is unlawful. The Lithuanian Bioethics Committee shall inform the Regional Biomedical Research Ethics Committees about biomedical research to be carried out in their respective regions. The approvals to conduct clinical research on medical instruments or substances shall be issued upon a recommendation of the State Health Care Accreditation Agency. Research ethics committees (RECs) are enabled to approve and reject applications for biomedical research projects except when they involve research on medicinal products.