The Bioethics Centre of the Lithuanian University of Health Sciences (LSMU) is a non-academic functional unit of the University that provides the ethical evaluation of student research, advice and education in bioethics.  The LSMU Bioethics Centre has been operating since 2003.

PURPOSE

Our primary purpose is to provide ethical supervision of the works performed by the LSMU students (attending integrated, first-, and second-cycle study programmes) and other undergraduate students and to assess the compliance of their research with the general principles of research ethics.

Pursuant to the Declaration of Helsinki (1964–2008) and the European Convention on Human Rights and Biomedicine (1997), all scientific projects in the field of biomedical sciences (including student research) shall not violate human dignity and human rights, conflict with research subjects’ interests, ensure the free consent of the informed person (subject), as well as guarantee the privacy of research subjects, confidentiality and anonymity of their personal data, and shall provide as much social and scientific benefit as possible and as little possible harm or potential risk to research individuals in the broadest sense.

MISSION

Our mission is to develop students’ ethical competence in research activities and to improve the ethical climate of the entire academic community, thereby ensuring coherent mutual relations and organisational culture comparable to the world’s leading universities.

VISION

Our long-term vision is for the LSMU graduates as future health professionals, scientists or researchers or representatives of health care authorities to meet high moral standards and to be able to conduct legal, high-quality and ethical research in the fields of biomedicine and other health sciences.

How do I obtain the institutional approval of the Bioethics Centre for scientific research?

Practical recommendations

  • If you are planning scientific research intended for a final thesis or other purposes (e.g., a conference thesis or scientific publication), you should obtain the institutional approval granted by the Bioethics Centre at the Lithuanian University of Health Sciences.
  • In order to obtain the institutional approval for scientific research, you should submit the Application consisting of the (a) Application form, (b) Ethical Self-Assessment Form, and (c) documents supporting the information provided in the Application.
  • Complete the Application by logging into the LSMU Information System: lsmusis.lsmuni.lt -> Persons -> Applications (), enter complete personal information, and select the type of Application -> For Research Approval by Bioethics Centre.
  • Having selected the Application For Research Approval by Bioethics Centre:
  • first, (a) answer the questions provided in the Ethical Self-Assessment Form, and
  • then (b) attach the additional required documents as individual files (*.pdf or other popular format), as they are necessary for the ethical evaluation of your prospective research.

Your answers to the questions in the Application should be as direct as possible: you should include facts about the planned research supported by the arguments as concisely, comprehensively, and clearly as possible.

Complete the Application following the instructions provided in the LSMU Information System and recommendations in Table 1.

Table 1. Application status description and recommendations

Application status Status description and recommendations
In preparation While you are completing the application, it has the “In preparation” status until you submit it. This is the draft application. You will be able to see the previously entered data when you open the application for completion during your next session (DO NOT forget to click “Save” after you have entered the data).
Submitted Your application has been submitted to the Bioethics Centre. Please make sure that all the information you have entered is correct and that all required documents have been attached to the application before you submit the application. To submit the application click “Submit” (the application status will change to “Submitted”). You can view your application any time in electronic format by downloading it to your PC or printing it.
Returned for correction The Bioethics Centre has a duty to consider your Application within 30 calendar days from the date of submission. If you have received a notification that your Application status is “Returned for Corrections”, open your Application to see the remarks, questions or recommendations on the improvement of the Application or completion of the documentation issued by the consultants at the Bioethics Centre. Your Application will be reconsidered only after resubmission of the (amended) Application.
Ready for endorsement by the Commission The Application is ready for the consideration/decision by the Bioethics Centre.
Endorsed by the Commission You Application has been considered; conclusion pending.
Approved If you have received a notification that your Application status is “Approved”, this means that the “Approval” has been issued for your research. You may download the Approval to your PC or print it.
Rejected* Your Application has been rejected. To see the explanation, open your Application in the LSMU Information System. You will also receive a notification by email.

*- N.B. If your Application has been rejected and in all other cases, e.g. if the investigator is advised to apply to other institutions (such as the regional Biomedical Research Ethics Committee, Commission for the Use of Experimental Animals under the State Food and Veterinary Service of Lithuania, etc.), the investigator will be notified by the Bioethics Centre by an email.

Supporting documents for the Application for Research Approval by the Bioethics Centre

The following additional documents shall be submitted (as Annexes) by the applicant or applicants (where two or more investigators will be conducting the research) when completing the Application for Research Approval by the Bioethics Centre:

  • 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. (to be attached when answering question 11)
  • Annex 2. Copy of the consent by the author(s) of the authorised research instrument (to be attached when answering question 12)
  • Annex 3. Information sheet and informed consent form for the research subjects, if applicable to the research (to be attached when answering question 21); the investigator and work supervisor’s signatures are required
  • Annex 4. Consent (permission) to conduct the survey from the head of the institution or its division where the survey will be conducted* (to be attached when answering question 5/ 6)

(* – N.B. If you are planning to conduct the research at the LSMU Hospital Kaunas Clinics, you need to obtain the endorsement/consent from the head(s) of the respective clinical department(s). If you are planning to conduct the research at the LSMU Kaunas Hospital, you do not need any approval by the administration of the institution. For other institutions, see their respective rules of procedure).

  • Annex 5. Other documents (e.g., certificates, documented evidence of qualification (credentials), and other documents) as may be necessary for the ethical evaluation of your research project (to be attached when answering question 18 and/or other questions depending on the nature of the research)
  • Annex 6. Copy of the approval by the Regional Biomedical Research Ethics Committee, if the research conducted by the student is part of a biomedical research.

For your own convenience, we recommend that you have the necessary documents (see the list of documents below) ready and attach them when completing the application. If you do not have all the necessary documents ready at the time of completion, you will not be able to submit the application, but you will be able to save all the data already entered.

The titles of the attached documents should consist of the investigator’s surname, date of submission and type of document, e.g. Surname_11.05_application, 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 FAQs section. If you haven’t found the answer to your question or have further questions about your research, we recommend that you contact the Bioethics Centre at bec@lsmu.lt or by phone 37 327233 or 37 327232.

The application documents are evaluated by the consultants of the Centre on the basis of the Application Ethical Evaluation Sheet.

ATTENTION! For authorisation of a biomedical research or of a research the results of which are planned to be published in biomedical scientific journals, it is recommended to apply to Kaunas Regional Biomedical Research Ethics Committee.

Consultants of the Bioethics Centre:

Assoc. Prof. Dr. Žydrūnė Luneckaitė – zydrune.luneckaite@lsmu.lt
Dr. Aušra Urbonienė – ausra.urboniene@lsmu.lt
Prof. Dr. Eimantas Peičius – eimantas.peicius@lsmu.lt

If you have any concerns regarding the preparation of your documents or need advice on the ethical aspects of the set-up of your planned research work, we are ready to arrange a one-to-one consultation.

One-to-one consultations are provided on Fridays at the Bioethics Centre or any other agreed time online (via MS Teams) on the Bioethics Centre Channel.

We encourage you to register for the consultation in advance at bec@lsmuni.lt  (in your email, please indicate the tentative time of the consultation, topic of your research paper, and key questions you would like to address).
In urgent cases, please call the numbers below or contact us directly via our MS Teams chat: eimapeic0704@kmu.lt.

Consultations are provided by the Bioethics Centre consultants 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 considering 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 function and mission of the LSMU Bioethics Centre?

The Bioethics Centre as a functional non-academic unit of LSMU performs the following functions:

  • 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 research and avoid “mistakes” 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 RBRECs) (including issuance of the approval of compliance of the research project with the general ethical requirements for research)

CONSULTATIONS AND GUIDANCE

– 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 to 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 explanation please see the explanation here.

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 the specific requirements set out in the Law on Ethics of Biomedical Research. The Law 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 BEC 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, the study protocol should reflect your role and activities. If you have been included in the study protocol as “other person involved in the research”, you do not need any additional authorisations as they cannot duplicate each other.  However, students are often involved in the conduct of a study without adding them to the protocol, i.e. without including the student de jure in the study. In these cases, you should either seek to be included into the protocol by the researchers who have involved you in the study, or you can apply to the BEC for approval specifically for the part of the study performed by you.

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 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 a applying to a Regional Committee?

It is always recommended to apply to the RBREC whenever signs of 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 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 BEC.
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 a BEC approval 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 to obtain 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@lsmuni.lt.

Bioethics Center
Tilžės g. 18, Kaunas, Lithuania
Prof. dr. Eimantas Peičius
Head of the Bioethics Center
+370 37 327 232 eimantas.peicius@lsmu.lt
Main Building of the LSMU Veterinary Academy, room 117
All contacts