- Historical development of biomedical research in Lithuania
- KRBTEK composition and working regulations
- Permit requirements
The system of ethical evaluation of biomedical research in Lithuania was begun in 1990. Lithuania is one of the first countries in Eastern and Central Europe where such a system is regulated by a special law.
One of the most important stages in the development of the biomedical research ethical evaluation system is the introduction of a two-tier biomedical research ethical evaluation model. Two types of institutions were chosen for the implementation of the mentioned model: at the national level – the Lithuanian Bioethics Committee (hereinafter – LBEK), and at the regional level – Regional Biomedical Research Ethics Committees (hereinafter – RBTEK). The biomedical research ethical evaluation system, based on the two-tier biomedical research ethical evaluation model, was implemented in 2000, after the adoption of the Law on Biomedical Research Ethics of the Republic of Lithuania.
In Lithuania, biomedical research began with the establishment of the first research ethics committees at Kaunas Medical University (in 1992) and the Institute of Oncology in Vilnius. These committees carried out ethical oversight of biomedical research protocols and clinical drug research documents. However, ethical supervision of biomedical research was regulated by legal act only in 1994, after the adoption of the Law on the Healthcare System of the Republic of Lithuania. Based on it, LBEK became the only institution obliged to issue permits for biomedical research projects. Since 1997, following the adoption of the Order of the Minister of Health of the Republic of Lithuania “On the Provisional Procedure for Conducting Ethical Examinations of Biomedical Research”, permits to conduct biomedical research with drugs have been issued to LBEK after obtaining the approval of the State Medicines Control Service (hereinafter – VVKT).
After the adoption of the Law on Biomedical Research Ethics of the Republic of Lithuania in 2000 and the implementation of the two-tier model of ethical evaluation of biomedical research based on it, the system of ethical evaluation of biomedical research was further developed. After Lithuania joined the European Union in 2004, Directive 2001/20/EC of the Council of Europe and the Parliament “On harmonisation of laws and other legal acts of member states related to the implementation of good clinical practice in clinical trials of medicinal products for human use” was transposed into the Lithuanian legal system.
In harmonising this directive with Lithuanian legislation, some provisions of the Law on Biomedical Research Ethics of the Republic of Lithuania and the Law on Pharmacy of the Republic of Lithuania have been changed. It can be said that the main changes and additions were related to the functions performed by LBEK and VVKT, and more precisely, to the procedure for issuing consent to conduct a clinical trial of a medicinal product. Pursuant to the aforementioned directive, the function of “competent authority” was transferred to VVKT. The directive also established the requirement to ensure that ethics committees are established in all European Union countries to evaluate clinical medicinal product research projects. Another important requirement of the directive is that regardless of the number of research centres in the country, a single opinion must be formed for each research. In Lithuania, this function is performed by the Lithuanian Bioethics Committee. These and other provisions of the directive have been transposed into the law of the Republic of Lithuania during the preparation of a new version of the Law on Pharmacy.
The right to issue permits for other biomedical research (non-medicinal products) remained the competence of LBEK or RBTEK. The last amendments and additions to the Law on Biomedical Research Ethics of the Republic of Lithuania entered into force in 2008, which more precisely defined the establishment of RBTEK and the procedure for establishing it.
- Gintautas Gumbrevičius (VšĮ Kaunas Clinical Hospital);
- Kęstutis Petrikonis (Lithuanian University of Health Sciences);
- Žydrūnė Luneckaitė (Lithuanian University of Health Sciences);
- Eimantas Peičius (Lithuanian University of Health Sciences);
- Džilda Veličkienė (Lithuanian University of Health Sciences);
- Lina Jankauskaitė (Lithuanian University of Health Sciences);
- Saulius Raugelė (VšĮ Klaipėda Seamen’s Hospital);
- Viktorija Bučinskaitė (Lithuanian University of Health Sciences Kaunas Hospital);
- Aušra Degutytė (Lithuanian Patients’ Organisation).
The regulations of the Kaunas Regional Biomedical Research Ethics Committee can be found here .
You can find the work regulations of the expert group of the Kaunas Regional Biomedical Research Ethics Committee here .
Requirements for obtaining a permit for conducting biomedical research
You can view the requirements for issuing biomedical research permits here . Documents for obtaining a permit for biomedical research are accepted no later than 20 days before the meeting of the Committee. They are submitted on the Electronic government gateway website.
Requirements for obtaining authorisation for biomedical research additions/changes
In order to supplement/change the biomedical research, the following documents are submitted:
- Reasoned request with explanation and application – are mandatory. Other relevant documents that need to be adjusted in order to supplement the study with research tasks, additional questionnaires.
- Documents that change as a result of additions are provided with visible corrections (“track changes”) and their edited versions. Documents are given a new version number and a new date.
- In order to include a new researcher in the study, the application must describe the activities planned for them and submit a curriculum vitae (CV) in the form approved by LBEK.
- In order to extend the time of the investigation, an updated signed application of the investigation centre and an interim summary of the investigation execution report are submitted.
When making changes and additions to the biomedical research protocol, it is necessary to notify the insurance company (if applicable) about the changes being made and submit an insurance conclusion or insurance policy to the Kaunas Regional Biomedical Research Ethics Committee.
For example: when an addition to the research protocol is being made, the research protocol, summary of the protocol and informed consent form with “track changes” are provided in printed format or otherwise marked changes/additions in the original documents approved by the Kaunas Regional Biomedical Research Ethics Committee. If one or more additional researchers are included in the study, who will perform the same tasks envisaged by the study, the CVs of the researchers are provided. In order to extend the biomedical research, a request for an extension of a biomedical research is submitted with a reasoned explanation of why the investigation was not conducted within the stipulated research time, an application and a report of the investigation conducted.
Information on all licensed studies can be found here .