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Issuing approval to conduct biomedical research

Legal regulations on biomedical research (Information is available in Lithuanian)

Where to apply for approval to conduct biomedical research?

Following the Law on Ethics of Biomedical Research, and the Decree of the Ministry of Health on the Procedure to Issue Approvals to Conduct Biomedical Research, the approvals to conduct biomedical research, except for clinical drug trials, are issued by the Lithuanian Bioethics Committee (thereinafter - LBC) or by the relevant Regional Biomedical Research Ethics Committee (thereinafter – Regional Committee)

There are two Regional Committees in Lithuania. They are based at the Lithuanian University of Health Sciences in Kaunas and at the Medical Faculty of Vilnius University. The territories assigned to the jurisdiction of the Regional Committees are determined by the Decree of the Ministry of Health on the Territories Assigned to the Jurisdiction of the Regional Biomedical Research Ethics Committees.

The Regional Committees issue approval to conduct biomedical research only where biomedical research is planned to be conducted at the research centres located solely within the territory attributed to the activities of a respective Regional Committee:

In this case the approval is granted by the Regional Committee, all the required documents should be submitted to the appropriate Regional Committee, which undertakes ethical review before granting the approval.

The LBC issues approval to conduct biomedical research where biomedical research is planned to be conducted within the territory attributed to activities of more than one Regional Committee. Should biomedical research be carried out in more than one region, whereby the opinion(s) of Regional Committee(s) are required, additional set(s) of documents shall be submitted (originals or copies) to the Lithuanian Bioethics Committee in order to distribute them to the Regional Committees.

Documents can be submitted directly to the Lithuanian Bioethics Committee or remotely (by post, via courier or electronically via E-Government Gateway (https://www.epaslaugos.lt/portal/)).

What documents should be submitted?

The list of documents to be submitted to the relevant research ethics committee in order to obtain the approval to conduct biomedical research is approved by the Decree of the Ministry of Health . Below you will find the list of documents:

  1. Request to Grant an Approval to Conduct Biomedical Research (form in Lithuanian) 
  2. Application Form for the Biomedical Research in Lithuania (form in Lithuanian) (each research center completes individually)
  3. Protocol of Biomedical Research (template in Lithuanian) NEW from 30 October, 2024
  4. Protocol Summary (template in Lithuanian) 
  5. Subject Information Form and Informed Consent Form (requirements in Lithuanian) 
  6. Form for Ethical Assessment of Biomedical Research (form in Lithuanian) 
  7. Curriculum vitae of the investigators (template in Lithuanian) 
  8. A copy of the civil responsibility insurance policy of the principal investigator and the sponsor of the biomedical research or letter of guarantee of insurance company OR in case of studies which involve interventional research methods having only a slightly detrimental and temporary impact on the subject’s health - a copy of a contract on insurance of civil liability for damage caused to patients of a health care institution which itself or whose employee is the sponsor of such research or whose employee is an investigator in such research, which provides for compensation for the damage that may result from such research (if applicable)
  9. Scientific report of biomedical research (if any)

Receipt and examination of applications and issue of approvals

Decision about granting approval to conduct biomedical research is made by the Group of Experts of Biomedical Research at the meeting. Meetings are organized once a month. Information about upcoming meetings can be found on the LBC’s web page. More information is also available by contacting LBC by phone: +370 5 212 45 65.

The application shall be reviewed in a meeting if all the documents were duly completed and received no later than 20 working days before the date of the next scheduled meeting.

Following the Law on Biomedical Research, the application and documents must be examined and an approval must be issued or a reasoned refusal to grant it must be given within 45 calendar days from the registration of the documents. The approval is issued only after the payment of all the State fees.

State fee for issuing Lithuanian Bioethics Committee's approval

There is a fixed state fee for the examination of an application and issuing Lithuanian Bioethics Committee's approval to conduct biomedical research.

Expiry date of the approval

Approval to conduct biomedical research is valid until the end of the research project indicated in the Application Form for the Biomedical Research in Lithuania (section 4).

Making amendments in the course of the research

After the commencement of the biomedical research, the sponsor or the principal investigator may make amendments to the protocol after having received permission from the institution which granted the approval (LBC or Regional Committee).

The end of a research

Within 30 days of the end of a biomedical research the sponsor or the principal investigator shall notify the relevant Ethics Committee that the research has ended. Thereby a summary of research report is required to be submitted in 90 days after the end of the research.

Last updated: 27-11-2024