Historical overview

Since its independence Lithuania has implemented a rather comprehensive system of ethical review of biomedical research. This system is based on a two-tier model of ethical review for multicenter biomedical research and consists of a national body　- the Lithuanian Bioethics Committee (LBC) and regional research ethics committees. This system is enforced by the Law on Ethics of Biomedical Research. Lithuania has been one of the few countries in Eastern and Central Europe where this field was regulated by a specific law.

Ethical review of biomedical research was started by two research ethics committees in the late eighties/early nineties in Lithuania. These were two institutional review boards established at Kaunas Medical University and at the Institute of Oncology in Vilnius, which were issuing approvals to conduct biomedical research projects including clinical drug trials. However, a formalized ethical review was only started after a special Decree on the Ethical Expertise of Biomedical Research of the Minister of Health has was passed in 1997. Following the Decree, the Lithuanian Bioethics Committee became the only institution authorized to issue approvals to conduct biomedical research projects (approvals for clinical drug trials had to be issued upon the recommendations of the State Medicines Control Agency (SMCA)).

A further important step in developing the system of ethical review of biomedical research projects including drug trials was the Law on Ethics of Biomedical Research, which came into force in 2001. The Law introduced a two-tier system of research ethics committees and enforced the basic ethical principles and specific regulations of biomedical research.

Another very important change took place in 2004 and was related to the implementation of the Directive 2001/20/EC of the European Parliament and of the Council on the Conduct of Clinical Trials on Medicinal Products for Human Use, which came into force on the11th of May, 2004. As a result, the Law on Ethics of Biomedical Research and the Law on Pharmacy were amended and harmonized with the Directive. The main change in the system was related to the shift of the roles of the LBC and the SMCA in the process of approval of clinical trials on medicinal products. Following the Directive, the role of the Competent Authority was shifted to the SMCA (since 1997 and before the implementation of the Directive, this role had been delegated to the LBC), while leaving the LBC the role of the body to issue an opinion on clinical drug trial. The right to issue approvals to conduct other types of biomedical research was left to the LBC or to the regional research ethics committees.

Amendments of the Law on Ethics of Biomedical Research which further specified the procedures of the establishment and composition of the regional research ethics committees were made in 2008.

The most recent amendments of the Law on Ethics of Biomedical Research came into force in January, 2016. Among other changes, the amended Law sets the regulations for establishment of biobanks, specifies the requirements for inclusion of minors, persons not able to consent in research, compensation for expenses of research participants.