LITHUANIA

Legislation

I. International documents legally binding in Lithuania

Directive 2001/20/EC of the European parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use

Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products

Convention of the Council of Europe for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine

II. Legal acts applicable to all types of biomedical research

a) Laws

Law on Ethics of Biomedical Research (2001, last amended in 2016)

Law on Legal Protection of Personal Data (1996, last amended in 2017)

b) Decrees of the Ministry of Health

Decree on the Detailed Requirements for the Content of a Person’s Consent to Participate in Biomedical Research and for the Information about the Biomedical Research as well as a Procedure for Giving and Withdrawing the Consent, No. V-28 (2016)

Decree on the Procedure for Calculating and Paying Compensation for the Expenses Incurred Due to Participation in Biomedical Research and the Time Spent, No. V-15(2016)

Decree on the Rules of Compulsory Civil Liability Insurance for the Principal Investigator and the Sponsor No. 745 (2000, last amended in 2016)

Decree on the List of Interventional Methods of Biomedical Research Causing a Slightly Detrimental and Temporary Impact on the Subject’s Health, No. V-1483 (2014)

Decree of MOH and Ministry of Social Affairs on the Procedure for a Minor’s Participation in Biomedical Research, No. V-235/A1-83(2016)

Decree on the Procedure for Keeping a Record of Biomedical Research, Collecting, Storage and Providing Information on Biomedical Research, No. V-405 (2010)

Decree on the Statute of the Lithuanian Bioethics Committee No. V-895 (2009)

Decree on the Appointment of the Biomedical and Social Sciences or Humanities Specialists for theGroup of Experts on Biomedical Research of the Lithuanian Bioethics Committee No. V-1185 (2014)

Decree on the Composition of the Group of Experts on Biomedical Research of the Lithuanian Bioethics Committee, No. V-1348 (2018)

Decree on the Activities and Reimbursement of the Group of Experts on Biomedical Research of the Lithuanian Bioethics Committee No. V-11 (2015)

Decree on the Territories Assigned to the Jurisdiction of the Regional Biomedical Research Ethics Committees, No. V-1078 (2007)

c) Orders and guidelines of the Lithuanian Bioethics Committee

Order on the Procedure for Submission of the Documents to the Lithuanian Bioethics Committee to Issue Favourable Opinion to Conduct a Clinical Trial on Medicinal Products or Approval to Conduct Biomedical Research by the Sponsor of the Clinical Trial on Medicinal Product or Other Type of Biomedical Research, No. V-24 (2014)

Order on the Sample Form of the Biomedical Research Protocol, Summary of the Protocol of the CV of Investigator, No. V-7 (2016)

Order on the Sample Forms of the Documents Issued by the Lithuanian Bioethics Committee, No. V-10 (2011)

Order on the Procedure of Ethical Supervision of Conduct of Biomedical Research, No. V-19 (2012)

Guidelines for Patient Information Sheet and Informed Consent Form, adopted by the Group of Experts on Biomedical Research of the Lithuanian Bioethics Committee (2016)

III. Legal acts that specifically cover clinical trials on medicinal products

a) Laws

Law on Pharmacy (2006, last amended in 2017)

b) Decrees of the Ministry of Health

Decree on the Procedure for Issuing Favourable Opinion to Conduct Clinical Trial on Medicinal Product, Approval for Clinical Trial on Medicinal Product, Conducting and Controlling Clinical Trials, No. 435 (2006)

Decree on the Rules of Good Clinical Practice, No. 320 (2006)

c) Orders and guidelines of the Lithuanian Bioethics Committee

Order on the Sample Form of the Request to Issue Favourable Opinion to Conduct Clinical Trial on Medicinal Product Form and the Ethical Assessment Form, No. V-6 (2016)

Guidelines to advertise clinical trials, adopted by the Group of Experts on Biomedical Research of the Lithuanian Bioethics Committee on 15 May 2007

IV. Legal acts that cover other biomedical research

a) Decrees of the Ministry of Health

Decree on the Procedure to Issue Approvals to Conduct Biomedical Research, No. V-2 (2008)

b) Orders and guidelines of the Lithuanian Bioethics Committee

Order on the Request to Issue Approval to Conduct Biomedical Research, the Application Form and the Biomedical Research Ethical Assessment Form, No. V-4 (2016)

Order on the Sample Form of the Summary Report of Biomedical Research, No. V-6(2014)

Research Ethics Committees

Historical Overview

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

Ethical review of biomedical research studies 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 studies 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 studies (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 studies 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 the 11 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 a clinical drug trial. The right to issue approvals to conduct other types of biomedical research was left to the LBC or regional REC.

In 2008, amendments of the Law on Ethics of Biomedical Research specified the procedures of the establishment and composition of the regional RECs. In January 2016 the Law set 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.

The most recent amendments of the Law on Ethics of Biomedical Research have been prompted by the need for implementation of the new European requirements for clinical trials on medicinal products, clinical investigations with medical devices and performance studies set out in Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, in Regulation (EU) 2017/745 of the European Parliament of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC, and in Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU.

These amendments of the Law on Ethics of Biomedical Research also included the replacement of the two-tier model of ethical review for multicenter biomedical research with ethical review carried out by one institution. Since 26 May 2022 the LBC is the only ethics committee issuing approvals for multicenter biomedical research and performing ethical review of clinical trials on medicinal products, clinical investigations with medical devices and performance studies. Regional RECs continue to issue approvals to conduct monocenter biomedical research.

Short description of RECs system

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, reviews their reports, organizes seminars and provides guidelines for them.

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.

Main functions of RECs

Main functions of the LBC are:

• to perform ethical review of clinical trials on medicinal products, clinical investigations with medical devices, performance studies and provide conclusions for the SMCA (in case of a clinical trial on medicinal product), and the State Health Accreditation Agency (in case of a clinical investigation with medical devices or a performance study);
• to perform ethical review and to issue approvals for multicenter biomedical research studies.

In order to implement these functions, the LBC has a Group of Experts on Biomedical Research (hereinafter – the Group). The Group consists of 9 members, of whom 5 experts are 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 multicenter biomedical research projects, clinical trials on medicinal products, clinical investigations with medical devices and performance studies submitted to the LBC and making decisions regarding their ethical and legal acceptability.

Main function of regional RECs is to issue approvals for the biomedical research projects that are carried out only in the region (monocenter), which has been assigned to its mandate by a special Decree of the Minister of Health.

Contacts

Lithuanian Bioethics Committee
Studentų str. 45A, Vilnius
Ph. + 370 5 212 4565
e-mail: lbek@bioetika.sam.lt
website: https://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: 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: www.lsmuni.lt/lt/struktura/kiti-padaliniai-ir-organizacijos/kauno-regioninis-biomedicininiu-tyrimu-etikos-komitetas/