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Eurecnet - National Information: Lithuania

National Information: Lithuania

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 (regional RECs). 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 is 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 (currently Lithuanian University of Health Sciences)and at the Institute of Oncology in Vilnius (currently National Cancer Institute), 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 was passed in 1997. Following the Decree, the LBC 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 principles of biomedical research ethics.

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 regional REC.

Amendments of the Law on Ethics of Biomedical Research which further specified the procedures of the establishment and composition of the regional RECs 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.

System of Research Ethics Committees

The Law on Ethics of Biomedical Research enforced the provisions for the establishment of the system, which is based on a two-tier model of ethical review for multicenter biomedical research and consists of a national body - Lithuanian Bioethics Committee (LBC) and regional biomedical research ethics committees (regional RECs).

The LBC is established by and accountable to the Ministry of Health. LBC provides advice on the bioethical issues to the Ministry of Health and other governmental bodies as well as informs the general public about bioethical issues. The LBC also coordinates the activities of the regional RECs.

One of the main functions of the LBC is the ethical review of biomedical research including clinical drug trials. In order to implement this function, the LBC has established a Group of Experts on Biomedical Research. The Group shall consist of 9 members, of whom 5 experts shall be professionals of biomedical sciences and 4 – professionals holding a degree in the area of social sciences or humanities. The Group is responsible for the evaluation of biomedical research projects submitted to the LBC and making decisions regarding their ethical and legal acceptability. The LBC issues approvals for those biomedical research projects which are going to be carried out in more than one region. (Regional RECs are entitled to issue approvals for the biomedical research projects that are carried out only in the region, which has been assigned to its mandate by a special Decree of the Minister of Health).

According to the Law of Ethics of Biomedical Research and the Law on Pharmacy, in order to commence a clinical trial on medicinal product, the sponsor (investigator) shall obtain a favorable opinion of the LBC as well as the approval of the SMCA. Following the above mentioned laws, the LBC is responsible for issuing a “single opinion” for all clinical drug trials conducted in the country.

Regional RECs are based at the Universities with the tertiary medical education level. The Kaunas Regional Biomedical Research Ethics Committee was established at Kaunas Medical University (currently Lithuanian University of Health Sciences) in 2001. The Vilnius Regional Biomedical Research Ethics Committee was set at Vilnius University in 2008. According to the Law on Ethics of Biomedical Research, the RECs should be composed of 9 members: 4 degree-holding representatives of the respective university, 4 members nominated by the Ministry of Health and 1 member representing patients’ organization. The membership and statute should be approved by both the Rector of the University and the Minister of Health. The regional RECs are accountable to both the University and the LBC.

Networking between RECs:

In Lithuania a national ethics committee (LBC) is a coordinator of research ethics committees’ network. It is assigned by the law to perform formal coordination and monitor the activities of regional RECs. While monitoring the LBC organizes seminars and provides guidelines for regional RECs, reviews reports of the activities of the regional RECs.

Contact / Addresses

Lithuanian Bioethics Committee
Algirdo str. 31, Vilnius
Ph. + 370 5 212 4565
Fax. +370 5 260 8640
e-mail: lbek@bioetika.sam.lt
website: http://bioetika.sam.lt

Vilnius regional biomedical research ethics committee

Vilnius University
M. K. Čiurlionio str. 21/27, Vilnius
Ph. + 370 5 2 68 69 98
e-mail: rbtek@mf.vu.lt
website: https://www.mf.vu.lt/galimybes/vilniaus-regioninis-biomedicininiu-tyrimu-etikos-komitetas

Kaunas Regional Biomedical Research Ethics Committee

Lithuanian University of Health Sciences
Mickevičiaus str. 9, Kaunas
Ph. + 370 37 32 68 89
e-mail: rbtek@mf.vu.lt
website: http://www.lsmuni.lt/lt/struktura/kiti-padaliniai-ir-organizacijos/kauno-regioninis-biomedicininiu-tyrimu-etikos-komitetas/



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