Bioethics Center

Practical recommendations:

• If you plan to carry out a scientific-research for your final thesis or for other purposes (for example, to prepare a conference thesis or a scientific publication), you should get the approval of the LSMU Bioethics Centre before starting your research.
• In order to obtain approval for the investigation, you should submit an application consisting of an (a) application form, (b) an ethical self-examination questionnaire and (c) supporting documents for the information provided in the application.
• You can start filling out the application by logging in to the LSMU information system: lsmusis.lsmu.lt-> Persons-> Requests (), having entered all the information about yourself and upon selecting the type of application ->regarding the research approval of the Bioethics Centre.
• Upon choosing the application regarding the research approval of the Bioethics Centre: 1) answer all the questions of the ethical self-analysis questionnaire provided in the form; 2) add additional supporting documents*(.pdf or other widely used format) in individual files, which are necessary for the ethical evaluation of your planned research.

We recommend that you answer the questions in your request in a specific way – by providing factual information about your planned research, as far as possible, in clear detail and well structured.

ATTENTION – your application must be approved by your final thesis supervisor by logging into the LSMU information system, reviewing your application and, if all is as it should be, they will click to approve your application.

Fill out the application in accordance with the instructions provided on the LSMU information system and the recommendations given in the table below. 

Note: If the application has been rejected and in all other cases, for example, when recommending to researchers to contact other institutions (such as the Regional Ethics Committee for Biomedical Research, the Ethics Commission of Lithuania on the Use of Laboratory Animals under the State Food and Veterinary Service, etc.), the Bioethics Centre will inform the researchers via email.

Additional documents (as annexes) to be submitted by the applicant or applicants (if the study is carried out by more than one researcher) when completing the application for approval by the Bioethics Centre:

• Annex 1. Test instrument(s) to be used in the study, including survey questionnaires, questionnaires, measurement scales, etc. (the annex is attached in response to question 11).
• Annex 2. A copy of the consent of the authors of the authorised research instrument (the annex is attached in response to question 12).
• Annex 3. The form of information and consent of the subject, if applicable by the nature of the investigation (the annex is attached in response to question 21, the signatures of the investigator and the supervisor are necessary).
• Annex 4. Consent of the head of the institution or its unit where the survey is planned to be carried out*. (The annex is attached in response to questions 5 and/or 6). (* – Note: If you are planning a study at the LSMU Hospital Kaunas Clinics, you need an approval/consent of the Head of the profile clinic. If you are planning a study at LSMU KL (Kaunas Hospital), the administration’s approval is not required. In other institutions, approval must be sought according to the internal rules).
• Annex 5. Other documents (such as certificates, qualification certifying documents and other documents) necessary for the ethical evaluation of your research project. (The annexes may be added in response to question 18 and/or other questions, depending on the nature of the study).
• Annex 6. Copy of the permission of the Lithuanian Bioethics Committee or Regional Biomedical Research Ethics Committee if the research carried out by the student is part of biomedical research.

We recommend that you already have the necessary documents at the time of filling in the application/request (see the list of documents below) and attach them when filling in the application. If you do not have all the necessary documents prepared during the filling of the application, you will not be able to submit the application, but you will be able to save all the data entered.

We recommend that the names of the attached documents consist of the name of the investigator, the date of submission of documents and the type of document, for example, Surname_11.05_request, or Surname_11.05_ESA, or Surname_11.05_Institution_consent, etc.

If you have any questions about the approval, please first read the explanations in the FAQ section. If you do not find answers or have any further questions about your research, we recommend you contact the Bioethics Centre by email bec@lsmu.lt or by phone +370 37 327233.

The application documents are evaluated by the Centre’s consultants based on the application’s ethical evaluation questionnaire.

ATTENTION! For the permission for biomedical research, as well as for research, the results of which the researchers plan to publish in scientific journals in the field of biomedicine, it is recommended to contact Kaunas Regional Biomedical Research Ethics Committee.

If you have any doubts about the preparation of documents or want to consult on the ethical aspects of the planned scientific-research work organisation, we invite you to individual consultations.

Consultations will be conducted individually on Fridays at the Bioethics Centre or at other agreed time on the MS Teams platform.

We invite you to register for the consultation in advance by e-mail bec@lsmu.lt (in your e-mail please specify the preliminary consultation time, the topic of the scientific-research study and the key questions). In urgent cases, please call the telephone numbers below or contact directly via MS Teams.

Consultations are conducted by the consultants of the Bioethics Centre – Prof. Eimantas Peičius and Dr. Žydrūnė Luneckaitė.

1. Why do I need to obtain an institutional ethical approval or authorisation for my research?

Any kind of research or any other study involving, in the broadest sense, human beings, their personal or medical data, shall be (1) institutionalised, i.e. there shall be an institution that initiates the research, which is (2) represented by a duly authorised researcher/researchers (granted with the status of researcher by the institution), and (3) the research shall pursue a certain goal (i.e. a goal in the broadest sense, such as to gather information of scientific or societal relevance, to accumulate, summarise, analyse knowledge, methodologies, products, etc.). The research authorisation is also required in light of the stringent ethical research requirements as well as moral and legal responsibilities associated with research that are currently applicable to all researchers (including students).

2. What is the purpose and mission of the LSMU Bioethics Centre?

The purpose of the Bioethics Centre as a functional non-academic unit of LSMU is to:

• develop an advanced culture research and academic activities;
• build ethical competence among the members of academic community;
• help ensure the implementation of the values declared in the LSMU Code of Ethics, national legislation of the Republic of Lithuania and international documents in the study process and in students’ scientific research activities;
• optimise and develop ethical supervision of student research at LSMU;
• clearly separate the functions of the Bioethics Centre and the Regional Biomedical Research Ethics Committees (RBRECs).

The mission of the LSMU Bioethics Centre is based on 3 pillars:

EDUCATION

• Raising awareness on the practical requirements and criteria for research ethics
• Helping prepare for and plan a research and avoid “mistakes” and “errors” that could violate human rights and freedoms

SELF-REGULATION AND EMPOWERMENT

• Developing the ethical monitoring of research and a consistent algorithm for ethical evaluation.
• Conducting an independent (impartial) ethical evaluation of non-biomedical research projects (not covered by the Regional Biomedical Research Ethics Committee (RBRECs) (including issuance of the approval of compliance of the research project with the general ethical requirements for research).

CONSULTATION AND ADVICE

• Providing the students and their supervisors with the methodological support in planning and conducting ethical educational research.

3. Do I need a Bioethics Centre (BEC) approval if I am an LSMU student and I plan to conduct research for the purpose of my final thesis (a Bachelor’s, Master’s thesis or a term paper)?

Pursuant clause 27.7 of the LSMU Regulations of Studies, all LSMU students conducting a research activity for educational purposes shall “follow the general ethical requirements, and attain permission from the Bioethics Centre (BEC) of the University for the conduction of student (educational) research projects” (LSMU Regulations of Studies, No. 123-03, 19/09/2019).

4. Can I obtain an approval from the BEC if my research is biomedical as defined in the legislation?

No. Any research classified as biomedical is subject to the authorisation by the Lithuanian Bioethics Committee (LBEC) or a Regional Biomedical Research Ethics Committee. Nevertheless, according to the interpretation of the LBCE, in certain cases, different requirements may apply to biomedical research carried out by students for educational purposes. For more details, please follow this link.

5. How do I know if my research is biomedical or not?

According to the Law on Ethics of Biomedical Research of the Republic of Lithuania, biomedical research is “verification of hypotheses of biomedical sciences by means of methods of scientific research and development of knowledge” about human health, diseases, diagnosis, treatment, or prevention. All biomedical research without exception is subject to specific requirements set out in the Law on Ethics of Biomedical Research that distinguishes biomedical research from other human research by imposing even stricter ethical requirements in relation to biomedical research, both on the researchers themselves (qualifications, etc.), and on the ethical supervision of the research itself.

6. Do I need to obtain an approval from the LSMU Bioethics Centre if I am involved in the conduct of the research that has already been approved by a regional committee?

If you are involved in the conduct of a research that has already been issued with an authorisation, you should apply to the Bioethics Centre and submit the application that should reflect your role and activities. The Bioethics Centre issues an approval specifically for the research part that you are conducting.

7. Does the Bioethics Centre always respond to a submitted application?

The Bioethics Centre may
– either (a) grant you the approval, if your documents and study design meet all the requirements;
– or (b) instruct you to supplement, correct, or amend certain documents, if they do not meet certain ethical criteria, or if the documents do not meet the applicable requirements;
– or (c) recommend that you apply to a Regional Committee.
In cases (A) or (B), the approval of the Bioethics Centre (BEC) entitles the student or students to conduct research as part of their study programme using data of the patients at LSMU Hospital Kaunas Clinics (Kauno klinikos) provided that these are used only for the preparation of a thesis or for research the results of which will be published in eLABa, student conference theses, or in science popularisation sources.

8. In which cases can the Bioethics Centre recommend applying to a Regional Committee?

It is always recommended to apply to the regional committee (RBREC) whenever signs of a biomedical research have been detected. See questions 4 and 5 for more information.
Moreover, if you are an LSMU student or resident planning to conduct a research that, in view of its nature, may potentially be classified as a biomedical research, or if it is a biomedical research, or if you intend to publish the paper in peer-reviewed scientific journals, either on your own or with your supervisor or other co-authors, or to publish the results of the biomedical research, you should contact Kaunas or Vilnius Regional Biomedical Research Ethics Committee.
Application for the authorisation shall be submitted to the Regional Committee by the principal investigator, while you may be included in the list of other persons involved in the conduct of research that will be attached to the authorisation. For more information about Kaunas Regional Biomedical Research Ethics Committee see here.

9. What documents do I need to prepare and submit to the Bioethics Centre for approval?

You need to prepare an Application in order to apply to the Bioethics Centre.
For this purpose, you shall submit (a) a request application for approval, (b) a duly completed Ethical Self-Assessment (ESA) form, including a research abstract and other documents depending on the nature of the intended research.
If your research will include a survey or testing of respondents, you shall attach (c) copies of the research instrument or instruments. If the research will be conducted by directly involving human subjects and collecting their personal or other relevant information, or if you will be involving vulnerable groups, you shall prepare (d) subject information sheets and consent forms.
If the research will be conducted in a certain establishment (i.e. not in a public space), you shall obtain the consent of (e) the head or authorised representative of the respective establishment.
Prior to commencing a study at the LSMU Hospital Kaunas Clinics, consents of the heads of all the clinical departments where the study will be conducted shall be obtained and submitted to the Bioethics Centre.
You may need other documents depending on the nature of the research. They shall be submitted as additional evidence e.g., of the investigator’s qualifications (to perform certain procedures or measurements) or the CE certification of the device used.

All documents except for the Request Application and the ESA are free-form, so you should prepare them in consultation with your supervisor or other competent persons.

10. Do I need an approval by the Bioethics Centre if I conduct a systematic literature review?

Yes, the approval is required. Complete the Request Application and the ESA and submit them to the Administrator at the Bioethics Centre.

11. Is it necessary to prepare an informed consent form for a study involving an anonymous questionnaire survey of research subjects?

An informed consent form is not necessary if the questionnaire is fully anonymous (i.e. the respondents are asked to express their opinions, views, beliefs, etc.), does not collect any objective medical or personal data, and if the anonymity of the research subjects (i.e. the respondents) is guaranteed (i.e. no personally identifiable information is requested) during the survey. However, a separate introduction/information sheet or a short informative preamble to the questionnaire shall be prepared and shall contain the following information:
Investigator’s name, surname, institution, title and/or aim of the research/study; general information about the research methods, research instrument (e.g., anonymous questionnaire); declaration of the guarantees of confidentiality of the research subjects and collected data, and investigator and/or research supervisor’s contact details (email address and/or phone number) for the research subjects to be able to contact them in case of any questions or concerns. The text of the preamble or introduction is free-form, and no templates are available.

12. Is it necessary to obtain the consent of the head of each institution/department/etc. to carry out the study?

Yes. You need to obtain the consent of the head of each institution or other person in charge (representing the institution). If you are planning to conduct the study at the LSMU Hospital Kaunas Clinics, you need to first obtain the consent of the Head of the respective clinical department of LSMU Hospital Kaunas Clinics before applying to the BEC.

13. Do I always need the consent of the head of the institution/department/etc.? Do I need the consent of the head of the institution if I plan to interview the institution staff by e-mail or to use the publicly available data of the institution in the research, e.g. annual reports, etc.?

Yes. You must always obtain the consent of the head of the institution if you plan to conduct any kind of research (survey, interview, or document analysis) at that institution. It is also necessary to obtain the consent of the head of the institution if you plan to collect data directly or indirectly about the employees, patients, or clients of the institution or if you intend to contact them for the purpose of the research using their business phone number or e-mail address. In other unforeseen cases, it is also recommended that you contact the administration of the institution to check with them for the consent of the head of the institution.

14. Is it necessary to obtain the written consent of both parents/guardians if I intend to include minors in the research?

For a detailed explanation by the Lithuanian Bioethics Committee on the inclusion of children in research, see here.

If you have any further questions, please contact bec@lsmu.lt.

The provisions of the Guidelines for the Assessment of Compliance with Research Ethics adopted by the Ombudsman for Academic Ethics and Procedures of the Republic of Lithuania (approved by Order No.V-60 of 10 December 2020, amended by Order No.V-24 of 10 May 2021) (see Guidelines for the assessment of compliance with research ethics). In accordance with these Guidelines, the key reasons for compliance with research ethics are:

“7.1. The aim is to ensure the rights, dignity, and well-being of those involved in research.
7.2. High academic ethical values and principles and the proper handling of (personal) data are secured.
7.3. Risks associated with research subjects, investigators, and third parties are reduced.
7.4. Common high quality and scientifically sound criteria for the conduct of research are agreed.
7.5. Increasing the benefit of research for the society and public confidence in the academic community that conducts it.”

LSMU has initiated the introduction of the procedure for assessing compliance with research ethics, which is implemented by three independent Research Ethics Committees representing the respective fields of science, but operating under a unified system and working procedures:

• Committee in Medicine and Health, Natural and Technology Sciences (evaluates all applications in these science fields, except for research projects falling under the scope of biomedical research).
• Committee in Veterinary, Animal and Other Agricultural Sciences (evaluates all applications in these science fields, except for research projects falling under the scope of the Lithuanian Ethics Committee for the Use of Experimental Animals under the State Food and Veterinary Service).
• Committee in Social Sciences and Humanities (evaluates all applications in these fields).

Information on the composition of the Committees can be found here.

The main objective of the Research Ethics Compliance Committees is to ensure that the planned research complies with research ethics principles, i.e. the rights of the human subjects and/or the welfare and protection of animals involved in the research are secured.

The Research Ethics Compliance Committees perform the following key functions:

• assess the compliance of the planned research with the principles of research ethics;
• decide on the compliance of the planned research with the principles of research ethics on the basis of the application submitted to the Centre;
• provide the applicant with reasoned remarks on the deficiencies identified in the application with regard to the compliance with the principles of research ethics;
• submit research assessment conclusions on the compliance of the planned research with the principles of research ethics to the Centre.

The LSMU Research Ethics Compliance Committees are integrated into the activities of the Bioethics Centre and are guided by the following documents approved by the Board of the LSMU Bioethics Centre:

• LSMU Bioethics Centre Regulations (see Bioethics Centre Regulations);
• The Description of the Procedure for the Organisation of Committees (see the Description of the Procedure for the Organisation of Activities of the Research Ethics Committees);
• Description of the Procedure for Ethical Evaluation of Prospective Research and Students’ Educational Research at the LSMU Bioethics Centre (see Procedure for Ethical Evaluation of Research Compliance with Research Ethics at the LSMU Bioethics Centre).

The LSMU Research Ethics Compliance Committees evaluate the compliance of research projects planned by LSMU researchers, investigators, and other members of the academic community with research ethics, and make decisions in closed sessions on the compliance or non-compliance of the planned research with research ethics.

The Bioethics Centre organises the reception of applications for evaluation of research projects, the administrative screening of applications, and the issuing of certificates of compliance (or non-compliance) with research ethics (based on decisions taken by the Committees) to applicants, as well as methodological support to the Committees.

Investigators shall submit a completed application form in Lithuanian and the supporting documents specified in the application, depending on the nature of the research. For the application form for the evaluation of the research compliance with research ethics, please see here.

Additional documents shall be attached as annexes to the application (if applicable to the nature of the research):

• Annex 1. Copy(-ies) of all research instrument(-s) expected to be used in the research, including any survey questionnaires, data collection forms, scales, etc.
• Annex 2. Copy of the authors’ consent for the authorised research instrument.
• Annex 3. Subject information sheet and informed consent form.
• Annex 4. Consent by the head of the institution or its division where the research will be conducted*. (* – N.B. If you are planning to conduct the research at the LSMU Hospital Kaunas Clinics (Kauno klinikos), you need to obtain the approval/consent by the head(s) of the respective clinical department(s). For other institutions, see their respective rules of internal procedure.
• Other documents (e.g. qualifications, licences, certificates, etc.) that are necessary for the implementation of the research.

Applications for compliance with research ethics shall be submitted to the Bioethics Centre at least 20 working days before each committee meeting. Applications are accepted from Monday to Thursday, 9:00 am to 12:00 (noon), room 117 of the main building of the Veterinary Academy (Tilžės g. 18) or by email: bec.registracija@lsmu.lt.

For all questions regarding the submission of applications, please contact the administrator at the Bioethics Centre by phone: +370 37 327 233.

Schedule of committee meetings

Please note that applications for compliance with research ethics shall be submitted to the Bioethics Centre at least 20 working days before each committee meeting.

Meetings of the Committee in Veterinary, Animal Sciences and other Agricultural Sciences:

• 26 September 2024 (documents are accepted until 5 September);
• 23 October 2024 (documents are accepted until 3 October);
• 28 November 2024 (documents are accepted until 31 October);
• 19 December 2024 (documents are accepted until 22 November).

Meetings of the Committee in Medicine and Health, Natural and Technology Sciences:

• 25 September 2024 (documents are accepted until 4 September);
• 25 October 2024 (documents are accepted until 27 September);
• 20 November 2024 (documents are accepted until 23 October).

Meetings of the Committee in Social Sciences and Humanities:

• 18 September 2024 (documents are accepted until 28 September);
• 16 October 2024 (documents are accepted until 21 September);
• 20 November 2024 (documents are accepted until 23 October);
• 18 December 2024 (documents are accepted until 21 November);
• 15 January 2025 (documents are accepted until 19 December).

Information is coming soon.